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.

Study Overview

• Status: Completed
• Conditions: Asthma
• Intervention / Treatment: Drug: Salbutamol sulfate/Ipratropium bromide; Drug: Salbutamol

• Study Type: Interventional
• Enrollment (Actual): 30
• Phase: Phase 4

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 5 years to 10 years (Child)
• Accepts Healthy Volunteers: No
• Genders Eligible for Study: All

Description

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

Study Plan

How is the study designed?

Design Details

• Primary Purpose: Treatment
• Allocation: Randomized
• Interventional Model: Crossover Assignment
• Masking: Double

Number of Arms

2

Arms and Interventions

Participant Group / 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 Names: CombiventTM; Drug: Salbutamol; Salbutamol 100 mcg per puff; Other Names: 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 Names: CombiventTM; Drug: Salbutamol; Salbutamol 100 mcg per puff; Other Names: Ventolin®

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Time Frame
Increase in PD20 (provocative dose that reduce forced expiratory volume at one second (FEV1) by 20%)	Baseline and 30 minutes after treatment

Secondary Outcome Measures

Outcome Measure	Time Frame
Change from baseline in systolic and diastolic blood pressure	Baseline, 30 and 60 min after treatment
Change from baseline in heart rate	Baseline, 30 and 60 min after treatment
Change from baseline in respiratory rate	Baseline, 30 and 60 min after treatment
Occurrence of adverse events	up to 8 days
SaO2 (oxygen saturation) during metacholine challenge	continuously after adminstration of study drug

Collaborators and Investigators

• Sponsor: Boehringer Ingelheim

Publications and helpful links

Helpful Links

• Related Info

Study record dates

Study Major Dates

• Study Start: May 1, 1998
• Primary Completion (Actual): September 1, 1998

Study Registration Dates

• First Submitted: July 3, 2014
• First Submitted That Met QC Criteria: July 7, 2014
• First Posted (Estimate): July 8, 2014

Study Record Updates

• Last Update Posted (Estimate): July 8, 2014
• Last Update Submitted That Met QC Criteria: July 7, 2014
• Last Verified: July 1, 2014

More Information

Terms related to this study

• Additional Relevant MeSH Terms: Respiratory Tract Diseases; Bronchial Diseases; Bronchial Spasm; Physiological Effects of Drugs; Adrenergic Agents; Neurotransmitter Agents; Molecular Mechanisms of Pharmacological Action; Autonomic Agents; Peripheral Nervous System Agents; Cholinergic Antagonists; Cholinergic Agents; Adrenergic Agonists; Anticonvulsants; Bronchodilator Agents; Anti-Asthmatic Agents; Respiratory System Agents; Reproductive Control Agents; Adrenergic beta-2 Receptor Agonists; Adrenergic beta-Agonists; Tocolytic Agents; Albuterol; Bromides; Ipratropium
• Other Study ID Numbers: 1012.36