Clinical trial NCT02182713: Combivent vs. Salbutamol in Patients With Metacholine Induced Bronchospasm
Official title: Combivent vs. Salbutamol in Patients With Metacholine Induced Bronchospasm
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: PHASE4
Conditions: Asthma
Lead sponsor: Boehringer Ingelheim
Sponsor class: INDUSTRY
First posted: 2014-07-08
Enrollment: 30
Sex: ALL
Minimum age (years): 7
Maximum age (years): 12
Standard ages: CHILD
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: CROSSOVER
Primary purpose: TREATMENT

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.


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

Primary outcomes:
measure: Increase in PD20 (provocative dose that reduce forced expiratory volume at one second (FEV1) by 20%)
timeFrame: Baseline and 30 minutes after treatment
Secondary outcomes:
measure: Change from baseline in systolic and diastolic blood pressure
timeFrame: Baseline, 30 and 60 min after treatment
measure: Change from baseline in heart rate
timeFrame: Baseline, 30 and 60 min after treatment
measure: Change from baseline in respiratory rate
timeFrame: Baseline, 30 and 60 min after treatment
measure: Occurrence of adverse events
timeFrame: up to 8 days
measure: SaO2 (oxygen saturation) during metacholine challenge
timeFrame: continuously after adminstration of study drug
Other outcomes:
Locations:
Study officials:
References: