A Study of Daily Dosing With Levalbuterol, Racemic Albuterol, and Placebo in Pediatric Subjects With Asthma

• Status: Completed
• Trial end date: 2002-07-01
• Target enrollment: 0
• Participant gender: All

Summary

Multicenter, randomized, double-blind, placebo- and active-controlled, Phase II, parallel-group study of up to four weeks in duration. The study consisted of a screening visit followed by a one-week single blind placebo period. At next visit, each subject was randomized to one of four treatment groups: 90 mcg levalbuterol, 180 mcg levalbuterol, 180 mcg racemic albuterol, or placebo. All study medication was administered as 2 actuations 4 times a day for 21 days.

• Phase: Phase 2
• Accepts Healthy Volunteers?: No

Details

• Lead Sponsor: Sunovion
• Treatments: Albuterol

Criteria

Inclusion Criteria:

• Subject's parent/legal guardian provided written informed consent prior to participation in the study.

• Subject and the subject's parent/legal guardian were willing and able to comply with the study procedures and visit schedules.

• Subject (male or female) was between the ages of 4 to 11 years (inclusive) at the time of consent.

• Female subject 8 years of age or older had a negative serum pregnancy test at screening.

• Subject had a documented diagnosis of asthma for a minimum of 6 months prior to screening, as defined by the AARC.

• Subject demonstrated a baseline FEV1 within greater than or equal to 45% and less than or equal to 80% of predicted for their height, age, gender, and race

• Following abstention from medications used to treat asthma subject demonstrated greater than or equal to 12% reversibility of airflow obstruction within 15-30 minutes following inhalation of 180 mcg (2 actuations of 90 mcg) racemic albuterol MDI.

• Subject had stable baseline asthma (in the opinion of the Investigator) and had been using a beta-adrenergic agonist and/or anti-asthma anti-inflammatory medication, and/or over-the-counter asthma medication for at least 6 months prior to screening.

• Subject was in good health (with the exception of asthma) and not suffering from any chronic condition that might affect their respiratory function.

• Subject had a chest x-ray that was not diagnostic of pneumonia, atelectasis, pulmonary fibrotic disease, pneumothorax, chronic obstructive pulmonary disease, etc. The most recent chest x-ray taken within 12 months prior to randomization was allowed to be used.

• Subject's parent/legal guardian was able to complete diary cards and medical event calendars reliably on a daily basis, understand dosing instructions and questionnaire completion, and demonstrate how to use the MiniWright PEF meter to complete morning and evening peak expiratory flow measurements.

Exclusion Criteria:

• Subject was expected to require parenteral corticosteroids, adrenergic bronchodilators, non-prescription asthma medications, or ipratropium bromide as per list below:

Corticosteroids - Parenteral = 30 days wash out period. Adrenergic bronchodilators - Inhaled, short-acting = greater than or equal to 7 hours wash out period, Nebulized, short acting = greater than or equal to 10 hours wash out period, Inhaled, long acting = greater than or equal to 24 hours wash out period, Oral QID or TID preparation =greater than or equal to 24 hours wash out period, Oral BID preparations = greater than or equal to 36 hours wash out period, Nonprescription asthma medications = greater than or equal to 48 hours wash out period, Ipratropium bromide = greater than or equal to 48 hours wash out period (Study medication and rescue medication were allowed to be used as needed but were required to be with-held prior to Study visits according to the schedule noted above)

• Female subject was pregnant or lactating.

• Subject participated in an investigational drug study within 30 days prior to screening, or was currently participating in another clinical trial.

• Subject had a schedule that prevented him or her from taking the first daily dose of study medication and/or starting study visits before 9 AM.

• Subject had travel commitments during the study that would have interfered with trial measurements and/or compliance.

• Subject had a history of hospitalization for asthma within 60 days prior to screening, or was scheduled for in-patient hospitalization, including elective surgery during the course of the trial.

• Subject had a known sensitivity to levalbuterol or racemic albuterol, including Ventolin or any of the excipients contained in any of these formulations.

• Subject was using any prescription drug with which albuterol sulfate administration was contraindicated

• Subject was currently diagnosed with life-threatening asthma, defined as a history of asthma episodes requiring intubation, associated with hypercapnia, respiratory arrest, or hypoxic seizures within 12 months prior to screening..

• Subject had clinically significant abnormalities that may have interfered with the metabolism or excretion of the study drug (e.g., abnormalities of the renal, hepatic, metabolic, or endocrine function).

• Subject had a history of cancer.

• Subject had hyperthyroidism, diabetes, hypertension, cardiac diseases, or seizure disorders that were not well controlled by medication or that may have interfered with the successful completion of this protocol.

• Subject had a history of substance abuse or drug abuse within 12 months prior to screening.

• Subject had a documented history of bronchopulmonary aspergillosis or any form of allergic alveolitis.

• Subject suffered from a clinically significant upper or lower respiratory tract infection in the 2 weeks prior to screening. (Note: Any subject who developed a clinically significant respiratory tract infection during the study was required to be discontinued.)

• Subject had clinically significant abnormal laboratory values (hematology, blood chemistry, or urinalysis).

• Subject had a clinically significant abnormal 12-lead ECG that would have put the subject at risk for experiencing adverse cardiac events.

• Subject had a history of cigarette smoking or use of other tobacco products.

• Subject was a staff member or a relative of a staff member at the time of the study.