Asthma
Conditions
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.
Interventions
DRUGSalbutamol sulfate/Ipratropium bromide
Salbutamol sulfate 120 mcg + Ipratropium bromide 20 mcg per puff
DRUGSalbutamol
Salbutamol 100 mcg per puff
Sponsors
Boehringer Ingelheim
Study design
Allocation
RANDOMIZED
Intervention model
CROSSOVER
Primary purpose
TREATMENT
Masking
DOUBLE (Subject, Investigator)
Eligibility
Sex/Gender
ALL
Age
7 Years to 12 Years
Healthy volunteers
No
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
Design outcomes
Primary
| Measure | 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
| Measure | 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 |
Outcome results
None listed