Combivent vs. Salbutamol in Patients With Metacholine Induced Bronchospasm

• Status: Completed
• Trial end date: 1969-12-31
• Target enrollment: 0
• Participant gender: All

Summary

The purpose of this study was to evaluate whether 2 puffs of fixed combination of aerosolized 120 mcg salbutamol sulphate (equivalent to 100 mcg of the base) + 20 mcg ipratropium bromide confers significant additional protection against metacholine induced bronchoconstriction in asthmatic atopic patients when compared to 2 puffs of aerosolized 100 mcg salbutamol alone.

• Phase: Phase 4
• Accepts Healthy Volunteers?: No

Details

• Lead Sponsor: Boehringer Ingelheim
• Treatments: Albuterol; Bromides; Ipratropium

Criteria

Inclusion Criteria:

• Male or female patients with a diagnosis of asthma according to the American Thoracic Society Criteria

• Patients aged 7 to 12 years inclusive

• Patients able to perform spirometry

• Patients with FEV1 (forced expiratory volume in the first second) ≥ 80% of predicted normal value after saline

• Patients with PD20 (provocative dose that reduces FEV1 by 20 %) metacholine lower than 8 mg/ml

• Patients or responsible relatives willing and able to sign an informed consent form

Exclusion Criteria:

• Patients on treatment for or suspected as having glaucoma

• Patients with known allergy of contra-indications to either salbutamol, ipratropium or their excipients

• Patients suspected on clinical grounds to have pneumonia, pneumothorax or pneumomediastinum

• Patients with a history of chest surgery

• Patients with other respiratory conditions if diagnosed. These include pulmonary fibrosis, bronchiectasis, cystic fibrosis, sarcoidosis, pulmonary tuberculosis, pulmonary complications of AIDS

• Patients requiring drugs for the treatment of the acute asthma attack other than the study drugs or oxygen

• Patients who have been previously recruited into this study

• Patients with myocardiopathy, pulmonary edema or other life threatening diseases, which in the judgement of the pediatrician precludes their entry into the study

• Patients with obvious or previously diagnosed serious hepatic or renal disease

• Patients who have been under the following drugs within the specified periods of time prior to determination of Baseline FEV1 or metacholine challenge

• INHALED:

• Short acting β2 agonists: 6 hours

• Long acting β2 agonists: 12 hours

• Ipratropium bromide: 8 hours

• DSCG (disodium cromoglicate): 7 days

• Nedocromil: 7 days

• ORAL:

• Short acting β2 agonists: 18 hours

• Anticholinergics: 7 days

• Short acting theophylline: 24 hours

• Long acting theophylline: 72 hours

• Antihistamines: 7 days

• Astemizole: 3 months

• Ketotifen: 3 months

• INHALED or ORAL: Other investigational drugs: 3 months

• INHALED or ORAL: Corticosteroids: 30 days