Combivent vs. Salbutamol in Patients With Metacholine Induced Bronchospasm

NCT ID: NCT02182713

Last Updated: 2014-07-08

Basic Information

• Recruitment Status: COMPLETED
• Clinical Phase: PHASE4
• Total Enrollment: 30 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 1998-05-31

Brief 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.

Conditions

Asthma

Study Design

• Allocation Method: RANDOMIZED
• Intervention Model: CROSSOVER
• Primary Study Purpose: TREATMENT
• Blinding Strategy: DOUBLE

Study Groups

Arm 1 - CombiventTM followed by Salbutamol

Group Type: EXPERIMENTAL

Salbutamol sulfate/Ipratropium bromide

Intervention Type: DRUG

Salbutamol sulfate 120 mcg + Ipratropium bromide 20 mcg per puff

Salbutamol

Intervention Type: DRUG

Salbutamol 100 mcg per puff

Arm 2 - Salbutamol followed by CombiventTM

Group Type: ACTIVE_COMPARATOR

Salbutamol sulfate/Ipratropium bromide

Intervention Type: DRUG

Salbutamol sulfate 120 mcg + Ipratropium bromide 20 mcg per puff

Salbutamol

Intervention Type: DRUG

Salbutamol 100 mcg per puff

Interventions

Salbutamol sulfate/Ipratropium bromide

Salbutamol sulfate 120 mcg + Ipratropium bromide 20 mcg per puff

Intervention Type: DRUG

Salbutamol

Salbutamol 100 mcg per puff

Intervention Type: DRUG

Other Intervention Names

CombiventTM; Ventolin®

Eligibility 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

• Minimum Eligible Age: 7 Years
• Maximum Eligible Age: 12 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: No

Sponsors

Boehringer Ingelheim

INDUSTRY

Sponsor Role: lead

Responsible Party

Responsibility Role: SPONSOR

Other Identifiers

1012.36

Identifier Type: -

Identifier Source: org_study_id