Combivent vs. Salbutamol in Patients With Metacholine Induced Bronchospasm

Boehringer Ingelheim

Status and phase

Completed

Phase 4

Conditions

Asthma

Treatments

Drug: Salbutamol

Drug: Salbutamol sulfate/Ipratropium bromide

Study type

Interventional

Funder types

Industry

Identifiers

NCT02182713

1012.36

Details and patient eligibility

About

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.

Enrollment

30 patients

Sex

All

Ages

7 to 12 years old

Volunteers

No Healthy Volunteers

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