COVID-19 is an emerging, rapidly evolving situation.
Get the latest public health information from CDC:

Get the latest research information from NIH: Menu

Combivent vs. Salbutamol in Patients With Metacholine Induced Bronchospasm

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details. Identifier: NCT02182713
Recruitment Status : Completed
First Posted : July 8, 2014
Last Update Posted : July 8, 2014
Information provided by (Responsible Party):
Boehringer Ingelheim

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.

Condition or disease Intervention/treatment Phase
Asthma Drug: Salbutamol sulfate/Ipratropium bromide Drug: Salbutamol Phase 4

Layout table for study information
Study Type : Interventional  (Clinical Trial)
Actual Enrollment : 30 participants
Allocation: Randomized
Intervention Model: Crossover Assignment
Masking: Double (Participant, Investigator)
Primary Purpose: Treatment
Official Title: Combivent vs. Salbutamol in Patients With Metacholine Induced Bronchospasm
Study Start Date : May 1998
Actual Primary Completion Date : September 1998

Arm Intervention/treatment
Experimental: Arm 1 - CombiventTM followed by Salbutamol Drug: Salbutamol sulfate/Ipratropium bromide
Salbutamol sulfate 120 mcg + Ipratropium bromide 20 mcg per puff
Other Name: CombiventTM

Drug: Salbutamol
Salbutamol 100 mcg per puff
Other Name: Ventolin®

Active Comparator: Arm 2 - Salbutamol followed by CombiventTM Drug: Salbutamol sulfate/Ipratropium bromide
Salbutamol sulfate 120 mcg + Ipratropium bromide 20 mcg per puff
Other Name: CombiventTM

Drug: Salbutamol
Salbutamol 100 mcg per puff
Other Name: Ventolin®

Primary Outcome Measures :
  1. Increase in PD20 (provocative dose that reduce forced expiratory volume at one second (FEV1) by 20%) [ Time Frame: Baseline and 30 minutes after treatment ]

Secondary Outcome Measures :
  1. Change from baseline in systolic and diastolic blood pressure [ Time Frame: Baseline, 30 and 60 min after treatment ]
  2. Change from baseline in heart rate [ Time Frame: Baseline, 30 and 60 min after treatment ]
  3. Change from baseline in respiratory rate [ Time Frame: Baseline, 30 and 60 min after treatment ]
  4. Occurrence of adverse events [ Time Frame: up to 8 days ]
  5. SaO2 (oxygen saturation) during metacholine challenge [ Time Frame: continuously after adminstration of study drug ]

Information from the National Library of Medicine

Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the contacts provided below. For general information, Learn About Clinical Studies.

Layout table for eligibility information
Ages Eligible for Study:   7 Years to 12 Years   (Child)
Sexes Eligible for Study:   All
Accepts 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

Layout table for additonal information
Responsible Party: Boehringer Ingelheim Identifier: NCT02182713    
Other Study ID Numbers: 1012.36
First Posted: July 8, 2014    Key Record Dates
Last Update Posted: July 8, 2014
Last Verified: July 2014
Additional relevant MeSH terms:
Layout table for MeSH terms
Bronchial Spasm
Bronchial Diseases
Respiratory Tract Diseases
Bronchodilator Agents
Autonomic Agents
Peripheral Nervous System Agents
Physiological Effects of Drugs
Anti-Asthmatic Agents
Respiratory System Agents
Tocolytic Agents
Reproductive Control Agents
Adrenergic beta-2 Receptor Agonists
Adrenergic beta-Agonists
Adrenergic Agonists
Adrenergic Agents
Neurotransmitter Agents
Molecular Mechanisms of Pharmacological Action
Cholinergic Antagonists
Cholinergic Agents