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1.
Pediatrics ; 135(2): e348-56, 2015 Feb.
Article in English | MEDLINE | ID: mdl-25624374

ABSTRACT

BACKGROUND: Inadequate designs and conflicting results from previous studies prompted the US Food and Drug Administration to publish guidelines for the design of clinical trials evaluating the effects of orally inhaled and intranasal corticosteroids on the growth of children. This study conformed to these guidelines to evaluate the effect of triamcinolone acetonide aqueous nasal spray (TAA-AQ) on the growth of children with perennial allergic rhinitis (PAR). METHODS: This randomized, double-blind, placebo-controlled, parallel-group, multicenter study evaluated the effect of once-daily TAA-AQ (110 µg) on the growth velocity (GV) of children aged 3-9 years with PAR by using stadiometry at baseline (4-6 months), during treatment (12 months), and at follow-up (2 months). Hypothalamus-pituitary-adrenal (HPA) axis function was assessed by measuring urinary cortisol levels. Details of adverse events were recorded. RESULTS: Of 1078 subjects screened, 299 were randomized, and 216 completed the study (placebo, 107; TAA-AQ, 109). In the primary analysis (modified intent-to-treat: placebo, 133; TAA-AQ, 134), least-squares mean GV during treatment was lower in the TAA-AQ group (5.65 cm/year) versus placebo (6.09 cm/year). The difference (-0.45 cm/year; 95% confidence interval: -0.78 to -0.11; P = .01), although clinically nonsignificant, was evident within 2 months of treatment and stabilized thereafter. At follow-up, the GV approached baseline (6.70 cm/year) in the TAA-AQ group (6.59 cm/year) and decreased slightly in the placebo group (5.89 cm/year vs 6.06 cm/year at baseline). No HPA axis suppression was observed. CONCLUSIONS: By using rigorous Food and Drug Administration-recommended design elements, this study detected a small, statistically significant effect of TAA-AQ on the GV of children with PAR.


Subject(s)
Body Height/drug effects , Rhinitis, Allergic, Perennial/drug therapy , Triamcinolone Acetonide/administration & dosage , Triamcinolone Acetonide/adverse effects , Administration, Intranasal , Administration, Oral , Child , Child, Preschool , Double-Blind Method , Female , Humans , Hydrocortisone/urine , Hypothalamo-Hypophyseal System/drug effects , Least-Squares Analysis , Male , Pituitary-Adrenal System/drug effects
2.
Mt Sinai J Med ; 78(5): 759-72, 2011.
Article in English | MEDLINE | ID: mdl-21913204

ABSTRACT

Allergy to natural rubber latex is an important clinical condition that occurred after the institution of universal precautions to protect healthcare workers. A rapid increase and production of both examination and surgical gloves resulted in an epidemic of allergy to latex protein. Healthcare workers in both the medical and dental environments, as well as specific groups of individuals including those with spina bifida, myelodysplasia, and food allergies (banana, kiwi, avocado, and others), were at increased risk of sensitization. Clinical symptoms in the latex allergic individual ranged from type I hypersensitivity reaction including rhinoconjunctivitis, asthma, and systemic reaction to type IV hypersensitivity reaction, which occur from the chemicals added during the manufacturing process. Diagnosis of latex allergy is based on a clinical history that correlates the development of symptoms in relationship to exposure. In the United States there are no skin tests approved by the Food and Drug Administration. Therefore a combination of clinical judgment and serologic testing such as ImmunoCAP and Immulite is helpful. The primary treatment of latex allergy is avoidance of exposure to the latex protein.


Subject(s)
Latex Hypersensitivity , Latex/chemistry , Allergens/analysis , Humans , Latex Hypersensitivity/diagnosis , Latex Hypersensitivity/epidemiology , Latex Hypersensitivity/prevention & control , Latex Hypersensitivity/therapy , Risk Factors
3.
Expert Opin Biol Ther ; 9(3): 377-82, 2009 Mar.
Article in English | MEDLINE | ID: mdl-19216626

ABSTRACT

An overview of short-term specific immunotherapy (ST-SIT) highlighting Pollinex Quattro (PQ) Tree is presented. The product development of this novel allergy vaccine using modifying agent glutaraldehyde, adjuvant monophosphoryl lipid and L-tyrosine have heralded a superior ST-SIT. Since 1999 when PQ was founded in Germany, various research trials assessing both the standardization and clinical studies have been done. A review of these studies demonstrates the efficacy and safety of PQ Tree in both pediatric and adult trials. The uniqueness of this product allows a shorter course of four pre-seasonal injections to provide control of allergy symptomatology in seasonal rhinitis patients. The PQ Tree product studies show a similar efficacy and safety profile to the grass formulation trial.


Subject(s)
Hypersensitivity/drug therapy , Vaccines/therapeutic use , Clinical Trials as Topic , Humans , Hypersensitivity/immunology , Trees/chemistry , Trees/immunology
4.
Ann Pharmacother ; 41(10): 1728-33, 2007 Oct.
Article in English | MEDLINE | ID: mdl-17698895

ABSTRACT

OBJECTIVE: To determine whether nebulized budesonide inhalation suspension (BIS) is effective in treating adults with asthma that has been uncontrolled by inhaled therapies. CASE SUMMARIES: Three adults with severe persistent asthma were switched to BIS after poor outcomes with other controller medications, including inhaled corticosteroids (ICSs). BIS dosages were initiated with 1 mg twice daily. Based on physician discretion as symptoms improved, dosages were decreased to 0.5 mg twice daily (2 pts.) or once daily (1 pt.). Patients were instructed to self-manage their asthma, increasing their dosages during periods of asthma worsening. Peak expiratory flow (PEF) was assessed before and after the initiation of BIS. The number of healthcare visits and oral corticosteroid courses recorded in patient medical records during the 3 years before and 5 years after initiation of BIS therapy were compared. In all 3 cases, BIS improved asthma control. BIS consistently increased PEF and reduced the number of urgent care visits and oral corticosteroid courses. All patients reported satisfaction with BIS therapy. DISCUSSION: Despite proven effectiveness of ICSs for persistent asthma, some patients fail to respond optimally to treatment administered via an inhaler. These 3 case reports suggest that BIS is effective in treating adults with severe persistent asthma who fail to respond optimally to treatment with other ICS preparations. Failure to use inhalers properly, previous poor adherence in 1 case, or patient preference for the nebulizer might explain why nebulized BIS was more effective than other inhaler therapies. CONCLUSIONS: Switching adults with uncontrolled asthma to BIS therapy may be a valuable treatment option for those who are unable to achieve optimal asthma control, despite asthma education and training on inhaler technique.


Subject(s)
Asthma/drug therapy , Asthma/psychology , Budesonide/administration & dosage , Administration, Inhalation , Adult , Anti-Asthmatic Agents/administration & dosage , Asthma/physiopathology , Female , Humans , Middle Aged , Patient Education as Topic/methods , Patient Satisfaction , Treatment Outcome
5.
Ann Allergy Asthma Immunol ; 98(2): 172-4, 2007 Feb.
Article in English | MEDLINE | ID: mdl-17304886

ABSTRACT

Aspirin desensitization is indicated for patients who have aspirin-exacerbated respiratory disease and whose asthma and/or rhinosinusitis is suboptimally controlled with inhaled corticosteroids and leukotriene-modifying drugs. In this practice paper, the general requirements for aspirin desensitization are presented, the locations where desensitizations can be safely performed are outlined, prechallenge patient preparation is discussed, an oral aspirin challenge protocol is presented, treatment of adverse reactions is reviewed, and maintenance of aspirin desensitization is discussed.


Subject(s)
Anti-Inflammatory Agents, Non-Steroidal/therapeutic use , Aspirin/therapeutic use , Desensitization, Immunologic , Drug Hypersensitivity/drug therapy , Anti-Inflammatory Agents, Non-Steroidal/adverse effects , Anti-Inflammatory Agents, Non-Steroidal/immunology , Aspirin/adverse effects , Aspirin/immunology , Asthma/chemically induced , Asthma/drug therapy , Asthma/prevention & control , Drug Hypersensitivity/prevention & control , Humans , Rhinitis/chemically induced , Rhinitis/drug therapy , Rhinitis/prevention & control , Sinusitis/chemically induced , Sinusitis/drug therapy , Sinusitis/prevention & control
6.
Otolaryngol Head Neck Surg ; 129(1): 16-23, 2003 Jul.
Article in English | MEDLINE | ID: mdl-12869911

ABSTRACT

OBJECTIVE: We compared 220 microg daily intranasal aqueous triamcinolone acetonide (TAA AQ) with 200 microg daily fluticasone propionate (FP) for relief of seasonal allergic rhinitis symptoms. Study design and setting Randomized, parallel-group, investigator-blind study included patients with symptomatic seasonal allergic rhinitis. After a baseline period, TAA AQ or FP was taken for about 21 days. Nasal symptom (discharge, stuffiness, itching, sneezing) severity was recorded twice daily; total nasal symptom score was calculated. Health-related quality of life was assessed by Rhinoconjunctivitis Quality of Life Questionnaire. RESULTS: Reductions in individual symptoms and total nasal symptom score were statistically significant versus baseline and were equivalent between treatments: -3.15 +/- 0.19 with TAA AQ (n = 148) and approximately 3.17 +/- 0.18 with FP (n = 147) (95% confidence interval for the difference, -0.7391 to 0.3693). Clinically and statistically significant improvements in Rhinoconjunctivitis Quality of Life Questionnaire scores were comparable. CONCLUSION: TAA AQ and FP were equally efficacious in relieving seasonal allergic rhinitis symptoms and improving health-related quality of life. SIGNIFICANCE: Differences in molecular potency of intranasal steroids do not confer differences in efficacy.


Subject(s)
Androstadienes/administration & dosage , Anti-Inflammatory Agents/administration & dosage , Rhinitis, Allergic, Seasonal/drug therapy , Triamcinolone Acetonide/administration & dosage , Administration, Intranasal , Adult , Aged , Female , Fluticasone , Humans , Male , Middle Aged , Quality of Life , Single-Blind Method , Treatment Outcome
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