Combivent vs. Salbutamol in Patients With Metacholine Induced Bronchospasm

Combivent vs. Salbutamol in Patients With Metacholine Induced Bronchospasm

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.

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