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2.
BMC Pulm Med ; 20(1): 125, 2020 May 07.
Artigo em Inglês | MEDLINE | ID: mdl-32380988

RESUMO

BACKGROUND: High-concentration oxygen therapy causes increased arterial partial pressure of carbon dioxide (PaCO2) in patients with COPD, asthma, pneumonia, obesity and acute lung injury. The objective of these studies was to investigate whether this physiological response to oxygen therapy occurs in stable patients with neuromuscular disease or kyphoscoliosis, and bronchiectasis. METHODS: Three randomised cross-over trials recruited stable patients with neuromuscular disease or kyphoscoliosis (n = 20), bronchiectasis (n = 24), and COPD (n = 24). Participants were randomised to receive 50% oxygen and 21% oxygen (air), each for 30 min, in randomly assigned order. The primary outcome was transcutaneous partial pressure of carbon dioxide (PtCO2) at 30 min. The primary analysis was a mixed linear model. RESULTS: Sixty six of the 68 participants had baseline PtCO2 values < 45 mmHg. The intervention baseline adjusted PtCO2 difference (95% CI) between oxygen and room air after 30 min was 0.2 mmHg (- 0.4 to 0.9), P = 0.40; 0.5 mmHg (- 0.2 to 1.2), P = 0.18; and 1.3 mmHg (0.7 to 1.8), P < 0.001, in the neuromuscular/kyphoscoliosis, bronchiectasis and COPD participants respectively. CONCLUSIONS: The small increase in PtCO2 in the stable COPD patients with high-concentration oxygen therapy contrasts with the marked increases in PaCO2 seen in the setting of acute exacerbations of COPD. This suggests that the model of studying the effects of high-concentration oxygen therapy in patients with stable respiratory disease is not generalisable to the use of oxygen therapy in the acute clinical setting. Appropriate studies of high-concentration compared to titrated oxygen in acute clinical settings are needed to determine if there is a risk of oxygen-induced hypercapnia in patients with neuromuscular disease, kyphoscoliosis or bronchiectasis. TRIAL REGISTRATION: Australian New Zealand Clinical Trials Registry ACTRN12615000970549 Registered 16/9/15, ACTRN12615000971538 Registered 16/9/15 and ACTRN12615001056583 Registered 7/10/15.


Assuntos
Bronquiectasia/terapia , Hipercapnia/fisiopatologia , Doenças Neuromusculares/terapia , Oxigenoterapia/métodos , Doença Pulmonar Obstrutiva Crônica/terapia , Adulto , Idoso , Austrália , Monitorização Transcutânea dos Gases Sanguíneos , Bronquiectasia/complicações , Dióxido de Carbono/sangue , Estudos Cross-Over , Método Duplo-Cego , Feminino , Humanos , Hipercapnia/etiologia , Modelos Lineares , Masculino , Pessoa de Meia-Idade , Doenças Neuromusculares/complicações , Pressão Parcial , Doença Pulmonar Obstrutiva Crônica/complicações , Taxa Respiratória
3.
BMC Pulm Med ; 20(1): 7, 2020 Jan 09.
Artigo em Inglês | MEDLINE | ID: mdl-31918697

RESUMO

BACKGROUND: Pulse oximetry is widely used in the clinical setting. The purpose of this validation study was to investigate the level of agreement between oxygen saturations measured by pulse oximeter (SpO2) and arterial blood gas (SaO2) in a range of oximeters in clinical use in Australia and New Zealand. METHODS: Paired SpO2 and SaO2 measurements were collected from 400 patients in one Australian and two New Zealand hospitals. The ages of the patients ranged from 18 to 95 years. Bias and limits of agreement were estimated. Sensitivity and specificity for detecting hypoxaemia, defined as SaO2 < 90%, were also estimated. RESULTS: The majority of participants were recruited from the Outpatient, Ward or High Dependency Unit setting. Bias, oximeter-measured minus arterial blood gas-measured oxygen saturation, was - 1.2%, with limits of agreement - 4.4 to 2.0%. SpO2 was at least 4% lower than SaO2 for 10 (2.5%) of the participants and SpO2 was at least 4% higher than the SaO2 in 3 (0.8%) of the participants. None of the participants with a SpO2 ≥ 92% were hypoxaemic, defined as SaO2 < 90%. There were no clinically significant differences in oximetry accuracy in relation to clinical characteristics or oximeter brand. CONCLUSIONS: In the majority of the participants, pulse oximetry was an accurate method to assess SaO2 and had good performance in detecting hypoxaemia. However, in a small proportion of participants, differences between SaO2 and SpO2 could have clinical relevance in terms of patient monitoring and management. A SpO2 ≥ 92% indicates that hypoxaemia, defined as a SaO2 < 90%, is not present. TRIAL REGISTRATION: Australian and New Zealand Clinical Trials Registry (ACTRN12614001257651). Date of registration: 2/12/2014.


Assuntos
Hipóxia/diagnóstico , Oximetria , Adolescente , Adulto , Idoso , Idoso de 80 Anos ou mais , Austrália , Gasometria , Feminino , Hospitais , Humanos , Hipóxia/sangue , Modelos Logísticos , Masculino , Pessoa de Meia-Idade , Monitorização Fisiológica/métodos , Nova Zelândia , Oxigênio/sangue , Estudos Prospectivos , Sensibilidade e Especificidade , Adulto Jovem
4.
BMC Pulm Med ; 18(1): 157, 2018 Oct 03.
Artigo em Inglês | MEDLINE | ID: mdl-30285695

RESUMO

BACKGROUND: In exacerbations of chronic obstructive pulmonary disease, administration of high concentrations of oxygen may cause hypercapnia and increase mortality compared with oxygen titrated, if required, to achieve an oxygen saturation of 88-92%. Optimally titrated oxygen regimens require two components: titrated supplemental oxygen to achieve the target oxygen saturation and, if required, bronchodilators delivered by air-driven nebulisation. The effect of repeated air vs oxygen-driven bronchodilator nebulisation in acute exacerbations of chronic obstructive pulmonary disease is unknown. We aimed to compare the effects of air versus oxygen-driven bronchodilator nebulisation on arterial carbon dioxide tension in exacerbations of chronic obstructive pulmonary disease. METHODS: A parallel group double-blind randomised controlled trial in 90 hospital in-patients with an acute exacerbation of COPD. Participants were randomised to receive two 2.5 mg salbutamol nebulisers, both driven by air or oxygen at 8 L/min, each delivered over 15 min with a 5 min interval in-between. The primary outcome measure was the transcutaneous partial pressure of carbon dioxide at the end of the second nebulisation (35 min). The primary analysis used a mixed linear model with fixed effects of the baseline PtCO2, time, the randomised intervention, and a time by intervention interaction term; to estimate the difference between randomised treatments at 35 min. Analysis was by intention-to-treat. RESULTS: Oxygen-driven nebulisation was terminated in one participant after 27 min when the PtCO2 rose by > 10 mmHg, a predefined safety criterion. The mean (standard deviation) change in PtCO2 at 35 min was 3.4 (1.9) mmHg and 0.1 (1.4) mmHg in the oxygen and air groups respectively, difference (95% confidence interval) 3.3 mmHg (2.7 to 3.9), p < 0.001. The proportion of patients with a PtCO2 change ≥4 mmHg during the intervention was 18/45 (40%) and 0/44 (0%) for oxygen and air groups respectively. CONCLUSIONS: Oxygen-driven nebulisation leads to an increase in PtCO2 in exacerbations of COPD. We propose that air-driven bronchodilator nebulisation is preferable to oxygen-driven nebulisation in exacerbations of COPD. TRIAL REGISTRATION: Australian New Zealand Clinical Trials Registry number ACTRN12615000389505 . Registration confirmed on 28/4/15.


Assuntos
Albuterol/administração & dosagem , Broncodilatadores/administração & dosagem , Dióxido de Carbono/sangue , Oxigênio/administração & dosagem , Doença Pulmonar Obstrutiva Crônica/terapia , Idoso , Idoso de 80 Anos ou mais , Monitorização Transcutânea dos Gases Sanguíneos , Análise por Conglomerados , Progressão da Doença , Método Duplo-Cego , Feminino , Humanos , Modelos Lineares , Masculino , Pessoa de Meia-Idade , Nebulizadores e Vaporizadores , Nova Zelândia , Pressão Parcial
5.
Respirology ; 23(4): 378-384, 2018 04.
Artigo em Inglês | MEDLINE | ID: mdl-28940962

RESUMO

BACKGROUND AND OBJECTIVE: Hypercapnia is associated with worse clinical outcomes in exacerbations of COPD. The present study aimed to determine the effects of nasal high flow (NHF) therapy on transcutaneous partial pressure of carbon dioxide (PtCO2 ) in stable COPD patients. METHODS: In a single-blind randomized controlled cross-over trial, 48 participants with COPD were allocated in random order to all of four 20 min interventions: NHF at 15 L/min, 30 L/min and 45 L/min or breathing room air with each intervention followed by a washout period of 15 min. The primary outcome measure was PtCO2 at 20 min, adjusted for baseline PtCO2 . Secondary outcomes included respiratory rate at 20 min, adjusted for baseline. RESULTS: The mean (95% CI) change in PtCO2 at 20 min was -0.6 mm Hg (-1.1 to 0.0), P = 0.06; -1.3 mm Hg (-1.9 to 0.8), P < 0.001; and -2.4 mm Hg (-2.9 to -1.8), P < 0.001; for NHF at 15 L/min, 30 L/min and 45 L/min compared with room air, respectively. The mean (95% CI) change in respiratory rate at 20 min was -1.5 (-2.7 to -0.3), P = 0.02; -4.1 (-5.3 to -2.9), P < 0.001; and -4.3 (-5.5 to -3.1), P < 0.001; breaths per minute compared with room air, respectively. CONCLUSION: NHF results in a small flow-dependent reduction in PtCO2 and respiratory rate in patients with stable COPD.


Assuntos
Hipercapnia/fisiopatologia , Oxigenoterapia/métodos , Doença Pulmonar Obstrutiva Crônica/fisiopatologia , Doença Pulmonar Obstrutiva Crônica/terapia , Idoso , Idoso de 80 Anos ou mais , Monitorização Transcutânea dos Gases Sanguíneos , Dióxido de Carbono/sangue , Estudos Cross-Over , Feminino , Humanos , Hipercapnia/etiologia , Masculino , Pessoa de Meia-Idade , Nariz , Pressão Parcial , Doença Pulmonar Obstrutiva Crônica/complicações , Taxa Respiratória , Método Simples-Cego
6.
Med J Aust ; 207(10): 430-434, 2017 Nov 20.
Artigo em Inglês | MEDLINE | ID: mdl-29129174

RESUMO

OBJECTIVE: To compare the effects on transcutaneous carbon dioxide tension (Ptco2) of high concentration and titrated oxygen therapy in medical inpatients with morbid obesity who were not selected for a pre-existing diagnosis of obesity hypoventilation syndrome. DESIGN: A randomised, crossover trial undertaken between February and September 2015. SETTING: Internal medicine service, Wellington Regional Hospital, New Zealand. PARTICIPANTS: 22 adult inpatients, aged 16 years or more, with a body mass index exceeding 40 kg/m2. INTERVENTIONS: Participants received in random order two 60-minute interventions, with a minimum 30-minute washout period between treatments: titrated oxygen therapy (oxygen delivered, if required, via nasal prongs to achieve peripheral oxygen saturation [Spo2] of 88-92%), and high concentration oxygen therapy (delivered via Hudson mask at 8 L/min, without regard to Spo2). Ptco2 and Spo2 were recorded at 10-minute intervals. MAIN OUTCOME MEASURE: Ptco2 at 60 minutes, adjusted for baseline. RESULTS: Baseline Ptco2 was 45 mmHg or lower for 16 participants with full data (73%). The mean difference in Ptco2 between high concentration and titrated oxygen therapy at 60 minutes was 3.2 mmHg (95% CI, 1.3-5.2 mmHg; P = 0.002). CONCLUSION: High concentration oxygen therapy increases Ptco2 in morbidly obese patients. Our findings support guidelines that advocate oxygen therapy, if required in patients with morbid obesity, be titrated to achieve a target Spo2 of 88-92%. CLINICAL TRIAL REGISTRATION: Australian New Zealand Clinical Trials Registry, ACTRN12610000522011.


Assuntos
Hipóxia/terapia , Obesidade Mórbida/complicações , Oxigenoterapia/métodos , Adulto , Idoso , Monitorização Transcutânea dos Gases Sanguíneos , Estudos Cross-Over , Feminino , Hospitalização , Humanos , Hipercapnia/etiologia , Hipóxia/complicações , Masculino , Pessoa de Meia-Idade , Oxigenoterapia/efeitos adversos
7.
BMJ Open Respir Res ; 4(1): e000217, 2017.
Artigo em Inglês | MEDLINE | ID: mdl-29071080

RESUMO

INTRODUCTION: In adult asthma, combination inhaled corticosteroid (ICS)/fast-onset long-acting beta agonist (LABA) used solely as reliever therapy may represent an effective and safe alternative to ICS maintenance and short-acting beta agonist (SABA) reliever therapy. OBJECTIVE: To compare the efficacy and safety of ICS/fast-onset LABA reliever therapy with ICS maintenance and SABA reliever therapy in adults with asthma. METHODS AND ANALYSIS: A 52-week, open-label, parallel group, multicentre, phase III randomised controlled trial with 1:1 randomisation to either budesonide/formoterol Turbuhaler 200/6 µg, one actuation as required for symptom relief, or budesonide Turbuhaler 200 µg, one actuation twice daily and terbutaline Turbuhaler 250 µg, two actuations as required for symptom relief. 890 adults aged 18-75 years with asthma for whom maintenance ICS and SABA reliever therapy is indicated by current guidelines will be recruited in New Zealand. The primary outcome variable is the rate of severe exacerbations per patient per year. This study will investigate a novel treatment regimen that might lead to a paradigm shift in asthma management for adults for whom guidelines currently recommend maintenance ICS and SABA reliever therapy. ETHICS AND DISSEMINATION: Ethical approval has been granted (15/NTB/178). Study findings will be published according to Iinternational Committee of Medical Journal Editors' recommendations. TRIAL REGISTRATION NUMBER: ACTRN12616000377437; Pre-results.

8.
Respirology ; 22(6): 1149-1155, 2017 08.
Artigo em Inglês | MEDLINE | ID: mdl-28470831

RESUMO

BACKGROUND AND OBJECTIVE: Increased arterial carbon dioxide tension (PaCO2 ) is an important complication of acute exacerbations of COPD. The effects of nasal high-flow cannulae (NHF) on PaCO2 in patients with COPD exacerbations, and whether this therapy should be used in this clinical situation, are less certain. We aimed to investigate the effect of NHF on PaCO2 in patients admitted to hospital with a COPD exacerbation. METHODS: We performed a single-centre randomized controlled cross-over trial in 24 hospital inpatients with acute exacerbations of COPD receiving oxygen via standard nasal prongs (SNPs). Patients received both supplemental oxygen via NHF (35 L/min) and SNP for 30 min each, with oxygen titrated to maintain the patient's baseline oxygen saturation, measured by pulse oximetry (SpO2 ). Interventions were administered in random order with a minimum 15-min washout between interventions. The primary outcome was difference in transcutaneous carbon dioxide tension (PtCO2 ) at 30 min adjusted for time zero. RESULTS: The difference in PtCO2 adjusted for time zero was lower after 30 min for NHF compared with SNP (-1.4 mm Hg (95% CI: -2.2 to -0.6), P = 0.001). There was no difference in SpO2 at 30 min (-0.02% (95% CI: -0.8 to 0.7), P = 0.96). The reduction in respiratory rate for NHF at 30 min was not statistically significant (-2.0 breaths/min (95% CI: -4.5 to 0.4), P = 0.099). CONCLUSION: Short-term use of NHF results in a small reduction in PtCO2 compared with SNP in patients with acute exacerbations of COPD, but whether this is clinically significant is uncertain.


Assuntos
Cânula , Oxigenoterapia/instrumentação , Doença Pulmonar Obstrutiva Crônica/fisiopatologia , Doença Pulmonar Obstrutiva Crônica/terapia , Idoso , Idoso de 80 Anos ou mais , Monitorização Transcutânea dos Gases Sanguíneos , Estudos Cross-Over , Feminino , Hospitalização , Humanos , Masculino , Pessoa de Meia-Idade , Oximetria , Doença Pulmonar Obstrutiva Crônica/complicações , Taxa Respiratória
9.
NPJ Prim Care Respir Med ; 27(1): 33, 2017 May 11.
Artigo em Inglês | MEDLINE | ID: mdl-28496190

RESUMO

Asthma mortality surveys report delays in seeking medical review and overuse of beta-agonist therapy as factors contributing to a fatal outcome. However, the strength of these associations is limited because many asthma deaths are unwitnessed. We undertook a secondary analysis of data from a 24-week randomised controlled trial of 303 patients with high-risk asthma, randomised to combination budesonide/formoterol inhaler according to a single maintenance and reliever therapy regimen or fixed dose budesonide/formoterol with salbutamol as reliever (Standard) regimen. Medication use was measured by electronic monitors. The thresholds for high, marked and extreme beta-agonist use days were defined in the single maintenance and reliever therapy arm as: >8, >12 and >16 actuations of budesonide/formoterol in excess of four maintenance doses, respectively; and in the Standard arm as: >16, >24 and >32 actuations of salbutamol, respectively. Whether a medical review was obtained within 48 h of an overuse episode was determined by review of data collected during the study by participant report. The mean (standard deviation) proportion of days in which high, marked and extreme beta-agonist overuse occurred without medical review within 48 h was 0·94(0·20), 0·94(0·15) and 0·94(0·17), and 0·92(0·19), 0·90(0·26) and 0·94(0·15) for single maintenance and reliever therapy and Standard regimens, respectively. In at least 90% of days, in which beta-agonist overuse occurred, patients did not obtain medical review within 48 h of beta-agonist overuse, regardless of the magnitude of overuse or the inhaled corticosteroid/long-acting beta-agonist regimen. RELIEVER INHALER OVERUSE AND DELAY IN MEDICAL REVIEW IN ASTHMA: In asthma, overuse of beta-agonist reliever medication and delay in seeking medical review in an exacerbation are linked to asthma deaths. Janine Pilcher at the Medical Research Institute of New Zealand, and co-workers, conducted a review of data from a study of 303 adult patients with severe asthma, followed over 24 weeks. The patients were allocated to either a budesonide/formoterol, or a salbutamol inhaler to take for symptom relief, in addition to their maintenance treatment. Inhalers were fitted with electronic monitors, to accurately document every use. In both groups, on 90% of days when an exacerbation requiring excess use of an inhaler occurred, patients did not follow-up with medical professionals within 48 h as advised. Further, in both groups, 'extreme' reliever inhaler use was recorded at least once in around one in four patients.


Assuntos
Albuterol/administração & dosagem , Antiasmáticos/administração & dosagem , Asma/tratamento farmacológico , Combinação Budesonida e Fumarato de Formoterol/administração & dosagem , Uso Excessivo de Medicamentos Prescritos , Administração por Inalação , Adulto , Asma/diagnóstico , Quimioterapia Combinada , Feminino , Humanos , Masculino , Nebulizadores e Vaporizadores , Resultado do Tratamento
10.
BMJ Open ; 7(3): e013850, 2017 03 20.
Artigo em Inglês | MEDLINE | ID: mdl-28320793

RESUMO

OBJECTIVE: There is preclinical evidence that consumption of berryfruit extract may reduce chronic airways inflammation and modify airway remodelling in allergen-induced models of lung inflammation. We investigated the effect of berryfruit extract on the fractional expired nitric oxide (FeNO), a biomarker of eosinophilic airways inflammation, in adults with steroid-naïve asthma. DESIGN: Randomised placebo-controlled cross-over double-blind trial. SETTING: Single-centre community-based trial. PARTICIPANTS: 28 steroid-naïve mild asthmatics with Feno >40 ppb, of whom 25 completed both study interventions. INTERVENTIONS: Participants were randomised to receive, according to the cross-over design, 100 mg berryfruit polyphenolic extract (BFPE) or placebo for 4 weeks, with a 4-week washout period between the interventions. PRIMARY OUTCOME MEASURE: The primary outcome variable was FeNO at 4 weeks, analysed by a mixed linear model, with a random effect for participant and baseline FeNo as a covariate. RESULTS: The mean (SD) natural logarithm transformed (ln) FeNO after 4 weeks of treatment for the BFPE and placebo groups was 4.28 (0.47) and 4.22 (0.47), respectively. The paired change from baseline mean (SD) BFPE minus placebo ln FeNO was -0.03 (0.39), N=25. The mixed linear model estimate, with baseline covariate adjustment, difference in ln FeNO, was -0.002 (95% CI -0.15 to 0.14), p=0.98. This is equivalent to a ratio of geometric mean FeNO of 1.0 (95% CI 0.86 to 1.15). CONCLUSIONS: In steroid-naïve participants with mild asthma and elevated FeNO, there was no effect of BFPE on FeNO, a biomarker of eosinophilic airways inflammation. Caution is required in the extrapolation of apparent benefit in murine models of lung eosinophilia to clinical efficacy in patients with asthma. TRIAL REGISTRATION NUMBER: ANZCTR: 12613000451707; Results.


Assuntos
Antiasmáticos/uso terapêutico , Asma/tratamento farmacológico , Frutas , Fitoterapia/métodos , Extratos Vegetais/farmacologia , Adolescente , Adulto , Idoso , Estudos Cross-Over , Método Duplo-Cego , Feminino , Volume Expiratório Forçado , Humanos , Masculino , Pessoa de Meia-Idade , Resultado do Tratamento , Adulto Jovem
11.
Respirology ; 22(1): 200-202, 2017 01.
Artigo em Inglês | MEDLINE | ID: mdl-27587269

RESUMO

This scientific letter considers the rationale for the target oxygen saturation measured by pulse oximetry (SpO2 ) range of 92-96% for oxygen therapy in adult patients without COPD or other conditions associated with chronic respiratory failure, recommended by the Thoracic Society of Australia and New Zealand, in contrast to the 94-98% target range recommended by the British Thoracic Society. We conclude from the available evidence that the SpO2 target of 92-96% may be preferable to 94-98%.


Assuntos
Hiperóxia , Hipóxia , Oxigenoterapia , Oxigênio , Doença Pulmonar Obstrutiva Crônica , Insuficiência Respiratória , Idoso , Austrália , Doença Crônica , Precisão da Medição Dimensional , Feminino , Humanos , Hiperóxia/etiologia , Hiperóxia/prevenção & controle , Hipóxia/diagnóstico , Hipóxia/etiologia , Hipóxia/terapia , Masculino , Nova Zelândia , Oximetria/métodos , Oxigênio/administração & dosagem , Oxigênio/efeitos adversos , Oxigênio/sangue , Oxigenoterapia/efeitos adversos , Oxigenoterapia/métodos , Oxigenoterapia/normas , Planejamento de Assistência ao Paciente/normas , Guias de Prática Clínica como Assunto , Doença Pulmonar Obstrutiva Crônica/sangue , Doença Pulmonar Obstrutiva Crônica/complicações , Doença Pulmonar Obstrutiva Crônica/fisiopatologia , Doença Pulmonar Obstrutiva Crônica/terapia , Insuficiência Respiratória/sangue , Insuficiência Respiratória/complicações , Insuficiência Respiratória/fisiopatologia , Insuficiência Respiratória/terapia
12.
N Z Med J ; 129(1445): 83-102, 2016 Nov 18.
Artigo em Inglês | MEDLINE | ID: mdl-27857242

RESUMO

The purpose of the Asthma and Respiratory Foundation NZ Adult Asthma Guidelines is to provide simple, practical and evidence-based recommendations for the diagnosis, assessment and management of asthma in adults (aged 16 and over) in a quick reference format. The intended users are health professionals responsible for delivering asthma care in the community and hospital Emergency Department settings, and those responsible for the training of such health professionals.


Assuntos
Asma/terapia , Serviços de Saúde Comunitária/organização & administração , Prevenção Primária/organização & administração , Adolescente , Adulto , Antiasmáticos/uso terapêutico , Asma/diagnóstico , Asma/prevenção & controle , Feminino , Hospitais Comunitários/organização & administração , Humanos , Masculino , Nova Zelândia , Guias de Prática Clínica como Assunto , Encaminhamento e Consulta , Adulto Jovem
13.
Respir Med ; 119: 115-121, 2016 10.
Artigo em Inglês | MEDLINE | ID: mdl-27692131

RESUMO

BACKGROUND: Fluticasone furoate (FF)/vilanterol (VI) is a once-daily maintenance treatment for asthma and chronic obstructive pulmonary disease. The duration of bronchodilation beyond 24 h has not been determined previously. METHODS: Adults aged 18-65 (n = 32), with asthma and reversibility to salbutamol (≥15% and ≥200 mL increase in forced expiratory volume in 1 s [FEV1]) participated in a double-blind, placebo-controlled, crossover study. Patients were admitted to a clinical trials unit for 72 h, and inhaled, in random order, placebo or FF/VI 100/25 mcg via ELLIPTA dry powder inhaler on two occasions 7-14 days apart. FEV1 was measured at baseline, 15 and 30 min, 1, 2, 4, 12, 24, 36, 48, 60, and 72 h. The differences in change in FEV1 from baseline between treatments and corresponding two-sided 95% confidence intervals (CI) were calculated at each time point. FINDINGS: FF/VI produced a rapid onset of bronchodilation (adjusted mean difference in change from baseline in FEV1 versus placebo at 15 min, 252 mL [95% CI 182-322]). Maximum bronchodilation was observed at 12 h (adjusted mean difference in the change from baseline in FEV1, 383 mL [95% CI 285-481]). Bronchodilation was maintained throughout the 72-h assessment period (adjusted mean difference in the change in FEV1 from baseline at 72 h, 108 mL (95% CI 15-200]). FF/VI was well tolerated and no serious side effects were reported. INTERPRETATION: A single dose of FF/VI 100/25 mcg showed evidence of a 72-h bronchodilator duration of action in adults with asthma.


Assuntos
Albuterol/administração & dosagem , Androstadienos/administração & dosagem , Asma/tratamento farmacológico , Álcoois Benzílicos/administração & dosagem , Clorobenzenos/administração & dosagem , Doença Pulmonar Obstrutiva Crônica/tratamento farmacológico , Administração por Inalação , Adolescente , Corticosteroides/uso terapêutico , Agonistas de Receptores Adrenérgicos beta 2/uso terapêutico , Adulto , Idoso , Albuterol/farmacologia , Androstadienos/farmacologia , Asma/fisiopatologia , Álcoois Benzílicos/farmacologia , Broncodilatadores/uso terapêutico , Clorobenzenos/farmacologia , Estudos Cross-Over , Método Duplo-Cego , Combinação de Medicamentos , Feminino , Volume Expiratório Forçado/efeitos dos fármacos , Humanos , Masculino , Pessoa de Meia-Idade , Nova Zelândia/epidemiologia , Placebos , Doença Pulmonar Obstrutiva Crônica/fisiopatologia , Adulto Jovem
15.
Pulm Med ; 2016: 7951272, 2016.
Artigo em Inglês | MEDLINE | ID: mdl-27127650

RESUMO

OBJECTIVES: Delivery of warmed, humidified air via nasal high flow therapy could potentially reduce replication of temperature-sensitive viruses in the upper respiratory tract. This study investigates whether nasal high flow therapy is well tolerated by healthy adults at 37°C and 41°C. METHODS: In this randomised, double-blind, controlled crossover pilot trial, nasal high flow therapy was used to deliver humidified air at 35 L/min, at either 37°C or 41°C, for three one-hour sessions of use over one day. The alternative was delivered at least 14 days later. Ten healthy, nonsmoking adults were asked, via questionnaire after each day's use, whether they would use nasal high flow therapy while being unwell with a cold or flu if it was demonstrated to improve symptoms. RESULTS: All participants completed both interventions. Eighty percent responded "yes" to future use of nasal high flow therapy, for both 37°C and 41°C. There was no significant change from baseline in saccharin times following either intervention or in the following morning. CONCLUSIONS: Delivering humidified air via nasal high flow therapy at both 37°C and 41°C is well tolerated by healthy adults. This supports investigation into the potential use of nasal high flow therapy as treatment in viral upper respiratory tract infections. Trial Registration. This trial is registered with ACTRN12614000183684 (tolerability study of nasal delivery of humidified & warmed air).


Assuntos
Ar , Temperatura Alta/efeitos adversos , Administração Intranasal , Adulto , Estudos Cross-Over , Método Duplo-Cego , Feminino , Voluntários Saudáveis , Humanos , Umidade , Masculino , Projetos Piloto , Estudos Prospectivos , Inquéritos e Questionários
16.
BMJ Open Respir Res ; 3(1): e000128, 2016.
Artigo em Inglês | MEDLINE | ID: mdl-27026805

RESUMO

BACKGROUND: The SmartTouch Ventolin monitor (Adherium, Auckland, New Zealand) is an electronic monitor for use with a Ventolin metered dose inhaler, which records the date and time of inhaler actuations. This technology has the potential to allow in-depth analysis of patterns of inhaler use in clinical trial settings. The aim of this study was to determine the accuracy of the SmartTouch Ventolin monitor in recording Ventolin actuations. METHODS: 20 SmartTouch Ventolin monitors were attached to Ventolin metered dose inhalers. Bench testing was performed over a 10-week period, to reflect the potential time frame between visits in a clinical trial. Inhaler actuations were recorded in a paper diary, which was compared with data uploaded from the monitors. RESULTS: 2560 actuations were performed during the 10-week study period. Monitor sensitivity for diary-recorded actuations was 99.9% with a lower 97.5% confidence bound of 99.7%. The positive predictive value for diary-recorded actuations was 100% with a 97.5% lower confidence bound of 99.9%. CONCLUSIONS: The SmartTouch Ventolin monitor is highly accurate in recording and retaining electronic data. It can be recommended for use in clinical trial settings in which training and quality control systems are incorporated into study protocols to ensure accurate data acquisition.

17.
Respirology ; 21(5): 858-66, 2016 07.
Artigo em Inglês | MEDLINE | ID: mdl-26897389

RESUMO

BACKGROUND AND OBJECTIVE: The optimal management of people with asthma with a significant smoking history is uncertain. The aim of this study was to determine whether the efficacy/safety profile of single combination inhaled corticosteroid (ICS)/long acting beta-agonist (LABA) inhaler maintenance and reliever therapy is influenced by smoking status. METHODS: We undertook secondary analyses from an open-label 24-week randomized study of 303 high risk adult asthma patients randomized to budesonide/formoterol 200/6-µg-metred dose inhaler for maintenance (two actuations twice daily) and either budesonide/formoterol 200/6-µg-metred dose inhaler one actuation ('single ICS/LABA maintenance and reliever therapy (SMART)' regimen) or salbutamol 100 µg 1-2 actuations for symptom relief ('Standard' regimen). Smoking status was classified in to three groups, as 'current', 'ex' or 'never', and a smoking/treatment interaction term tested for each outcome variable. The primary outcome variable was number of participants with at least one severe exacerbation. RESULTS: There were 59 current, 97 ex and 147 never smokers included in the analyses. The smoking status/treatment interaction term was not statistically significant for any of the outcome measures. With adjustment for smoking status, the number of participants with severe exacerbations was lower with the SMART regimen (OR 0.45, 95% CI: 0.26-0.77, P = 0.004; P value for interaction between smoking status and treatment 0.29). CONCLUSION: We conclude that the favourable safety/efficacy profile of the SMART regimen applies to patients with high risk asthma, irrespective of smoking status.


Assuntos
Agonistas de Receptores Adrenérgicos beta 2/administração & dosagem , Albuterol/administração & dosagem , Asma/tratamento farmacológico , Broncodilatadores/administração & dosagem , Budesonida/administração & dosagem , Fumarato de Formoterol/administração & dosagem , Fumar/fisiopatologia , Administração por Inalação , Adolescente , Adulto , Idoso , Asma/fisiopatologia , Combinação de Medicamentos , Feminino , Glucocorticoides/administração & dosagem , Humanos , Masculino , Pessoa de Meia-Idade , Risco , Resultado do Tratamento , Adulto Jovem
18.
Aust Prescr ; 38(3): 98-100, 2015 Jun.
Artigo em Inglês | MEDLINE | ID: mdl-26648631

RESUMO

A major change is needed in the entrenched culture of routinely administering high-concentration oxygen to acutely ill patients regardless of need. Oxygen is a drug that should be prescribed for specific indications. There should be a documented target range for oxygen saturation, and regular monitoring of the patient's response. There are risks from unrelieved hypoxaemia due to insufficient oxygen therapy, and from provoked hyperoxaemia due to excessive oxygen therapy. Oxygen therapy should therefore be titrated so that the saturation is within a range that avoids these risks. If oxygen requirements are increasing, the clinician should review the patient and consider transfer to a higher level of care. If oxygen requirements are decreasing, consider reducing or discontinuing oxygen therapy.

19.
BMJ Open Respir Res ; 2(1): e000097, 2015.
Artigo em Inglês | MEDLINE | ID: mdl-26629345

RESUMO

BACKGROUND: Electronic monitoring of inhaled asthma therapy is suggested as the 'gold standard' for measuring patterns of medication use in clinical trials. The SmartTurbo (Adherium (NZ) Ltd, Auckland, New Zealand) is an electronic monitor for use with a turbuhaler device (AstraZeneca, UK). The aim of this study was to determine the accuracy of the SmartTurbo in recording Symbicort actuations over a 12-week period of use. METHODS: Twenty SmartTurbo monitors were attached to the base of 20 Symbicort turbuhalers. Bench testing in a research facility was undertaken on days 0, 5, 6, 7, 8, 9, 14, 21, 28, 56 and 84. Patterns of 'low-use' (2 sets of 2 actuations on the same day) and 'high-use' (2 sets of 8 actuations on the same day) were performed. The date and time of actuations were recorded in a paper diary and compared with data uploaded from the SmartTurbo monitors. RESULTS: 2800 actuations were performed. Monitor sensitivity was 99.9% with a lower 97.5% confidence bound of 99.6%. The positive predictive value was 99.9% with a 97.5% lower confidence bound of 99.7%. Accuracy was not affected by whether the pattern of inhaler use was low or high, or whether there was a delay in uploading the actuation data. CONCLUSIONS: The SmartTurbo monitor is highly accurate in recording and retaining electronic data in this 12-week bench study. It can be recommended for use in clinical trial settings, in which quality control systems are incorporated into study protocols to ensure accurate data acquisition.

20.
Respirology ; 20(8): 1182-91, 2015 Nov.
Artigo em Inglês | MEDLINE | ID: mdl-26486092

RESUMO

The purpose of the Thoracic Society of Australia and New Zealand guidelines is to provide simple, practical evidence-based recommendations for the acute use of oxygen in adults in clinical practice. The intended users are all health professionals responsible for the administration and/or monitoring of oxygen therapy in the management of acute medical patients in the community and hospital settings (excluding perioperative and intensive care patients), those responsible for the training of such health professionals, and both public and private health care organizations that deliver oxygen therapy.


Assuntos
Oxigenoterapia/normas , Oxigênio/administração & dosagem , Sociedades Médicas , Adulto , Austrália , Humanos , Nova Zelândia , Oxigênio/sangue
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