Automatic piercing spinhaler (Halermatic): a comparative study.

Fifty patients, 27 females and 23 males with a mean age of 30 years and a history of chronic asthma, were studied during treatment with cromolyn sodium administered via the standard spinhaler and a new automatic piercing spinhaler, Halermatic. The study period consisted of a baseline period of 3 weeks (spinhaler use) and an 8-week period of Halermatic use. In the final analysis of results, it was noted that fewer inhalations (P less than .001) were needed to empty the cromolyn Spincaps with the Halermatic and a higher number of patients (61%) preferred the Halermatic over the Spinhaler.

Use of ipratropium aerosol in the long-term management of asthma.

In order to assess the efficacy and safety of ipratropium in the long-term management of chronic asthma, 20 stable and ambulatory asthmatics were followed for 1 year. Clinical and spirometric examinations were performed on all 20 patients at the start of the study and on six other occasions. FEV1, FVC, MMFR, heart rate, and blood pressure were recorded immediately before and 30, 60, 120, and 180 min after the administration of 40 micrograms of ipratropium. During these visits, patients were asked to rate their breathing during the preceding period, describe (any) side effects, and assess the impact of ipratropium in their inhalation. During their visits, significant improvements in FEV1 and FVC (p less than 0.05) were noted for a majority of the patients. As the study progressed, more and more patients were observed to experience significant improvements in their FEV1, FVC, and MMFR. All ECG measurements and biochemical tests were normal. Side effects of minimal severity were reported on two occasions during the 100 patient-visits. Our study indicates that an ipratropium-based regimen is efficacious, safe, and well received by chronic asthmatics.

A double-blind comparative study of pelletized cromolyn versus cromolyn blend in the treatment of asthma.

In a randomized, double-blind, group comparative study, 100 asthmatic patients known to be responsive to cromolyn sodium were treated either with pelletized cromolyn (cromolyn sodium, 20 mg) or with cromolyn blend, Intal (cromolyn sodium, 20 mg + lactose, 20 mg). There was no statistically significant difference between the two treatment groups for asthma severity, breathlessness on exertion, cough, the number of inhalations needed to obtain the dose from the capsule, and morning peak flow. No local or systemic side effects were encountered during the 6-month duration of the study. It is concluded that pelletized cromolyn offers most of the advantages of cromolyn therapy without the need for the patients to inhale lactose at the same time. Also, pelletized cromolyn has a distinct therapeutic advantage for use in lactose-in-tolerant patients.

Treatment of seasonal conjunctivitis: comparison of 2% and 4% sodium cromoglycate ophthalmic solutions.

In a double-blind, noncrossover, group study a 2% ophthalmic solution of sodium cromoglycate (Opticrom) was compared with a 4% solution in the treatment of ragweed-pollen-induced conjunctivitis. The 22 female and 18 male patients, ranging in age from 10 to 61 years, had a history of troublesome eye symptoms during the ragweed season for at least 2 years and had previously obtained minimal relief with the 2% solution. They were randomly assigned to two treatment groups in matched pairs and instructed to use one drop of the medication in each eye four times a day for 4 weeks. Treatment efficacy was evaluated from the patients' daily diaries, periodic clinical assessments and subjective reports by the patients at the end of the trial. Analysis of the symptom severity scores and evaluations by both the patients and the clinician indicated that the 4% solution was more effective than the 2% solution in controlling the symptoms. No local or systemic side effects were encountered.

Treatment of ragweed allergic conjunctivitis with 2% cromolyn solution in unit doses.

Previous studies have shown the effectiveness of topical cromolyn solution in the treatment of allergic conjunctivitis. However, the preservative, phenylethanol, produces an immediate burning or stinging sensation when the drops are first instilled in the eye. A double-blind, crossover, placebo controlled study using 2% cromolyn solution was conducted, without the preservative and supplied in unit doses. Twenty six patients took part in the trial. They had ragweed pollen-induced conjunctivitis. The results of the trial indicate that the active drug was effective in controlling the signs and symptoms of allergic conjunctivitis in 22 of the 26 patients, i.e., 84.6% (p less than 0.001). Two patients preferred the placebo. There were no complaints of stinging or burning sensation after the instillation of the drops in the eyes. There were no cases of infection of the eye. Without the preservative, the cromolyn solution does not damage the soft contact lens.

Oral cromolyn therapy in patients with food allergy: a preliminary report.

In a preliminary double-blind, placebo controlled, crossover study, 10 out of 16 patients (62.5%) had remissions in acute symptoms of food allergy with oral cromolyn therapy. The effective dosage for each patient had to be sought individually. No serious side effects were encountered.

Efficacy double-blind, crossover study of sodium cromoglycate in patients with seasonal allergic rhinitis.

In a double-blind, crossover, placebo-controlled study, consisting of 100 clinical trials, the active drug (sodium cromoglycate) was effective in 83.2%, while in 11.6% the placebo was judged more effective (p less than 0.0001). Four patients suffered minor side effects. No deleterious effect on the nasal mucosa was noticed and no one complained that the drug produced sedation.