Combivent vs. Salbutamol in Patients With Metacholine Induced Bronchospasm

Launched by BOEHRINGER INGELHEIM · Jul 7, 2014

Keywords

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Gender

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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