Combivent vs. Salbutamol in Patients With Metacholine Induced Bronchospasm

Study Overview
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Brief Summary
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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.

Official Title
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Combivent vs. Salbutamol in Patients With Metacholine Induced Bronchospasm

Conditions
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Asthma

Intervention / Treatment
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* Drug: Salbutamol sulfate/Ipratropium bromide
* Drug: Salbutamol


Participation Criteria
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Eligibility Criteria
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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

Ages Eligible for Study
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Minimum Age: 7 Years
Maximum Age: 12 Years

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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No

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Treatment
Allocation: Randomized
Intervention Model: Crossover Assignment
Masking: Double


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: Arm 1 - CombiventTM followed by Salbutamol<br> | Drug: Salbutamol sulfate/Ipratropium bromide<br>* Salbutamol sulfate 120 mcg + Ipratropium bromide 20 mcg per puff<br>* Other names: CombiventTM;Drug: Salbutamol<br>* Salbutamol 100 mcg per puff<br>* Other names: Ventolin®;|
| Active Comparator: Arm 2 - Salbutamol followed by CombiventTM<br> | Drug: Salbutamol sulfate/Ipratropium bromide<br>* Salbutamol sulfate 120 mcg + Ipratropium bromide 20 mcg per puff<br>* Other names: CombiventTM;Drug: Salbutamol<br>* Salbutamol 100 mcg per puff<br>* Other names: Ventolin®;|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Increase in PD20 (provocative dose that reduce forced expiratory volume at one second (FEV1) by 20%) |  | Baseline and 30 minutes after treatment | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Change from baseline in systolic and diastolic blood pressure |  | Baseline, 30 and 60 min after treatment | 
| Change from baseline in heart rate |  | Baseline, 30 and 60 min after treatment | 
| Change from baseline in respiratory rate |  | Baseline, 30 and 60 min after treatment | 
| Occurrence of adverse events |  | up to 8 days | 
| SaO2 (oxygen saturation) during metacholine challenge |  | continuously after adminstration of study drug |