Combivent vs. Salbutamol in Patients With Metacholine Induced Bronchospasm

NCT02182713 | Completed Phase 4

• 1 other identifier: 1012.36
• Study Type: interventional
• Target: 30
• Locations: 0 countries
• Sites: N/A

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.

Conditions

Asthma

Outcome Measures

Primary Outcomes (1)

• Increase in PD20 (provocative dose that reduce forced expiratory volume at one second (FEV1) by 20%)

  Baseline and 30 minutes after treatment

Secondary Outcomes (5)

• 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

Study Arms (2)

Arm 1 - CombiventTM followed by Salbutamol

EXPERIMENTAL

Drug: Salbutamol sulfate/Ipratropium bromide; Drug: Salbutamol

Arm 2 - Salbutamol followed by CombiventTM

ACTIVE COMPARATOR

Drug: Salbutamol sulfate/Ipratropium bromide; Drug: Salbutamol

Interventions

Salbutamol sulfate/Ipratropium bromide DRUG

Salbutamol sulfate 120 mcg + Ipratropium bromide 20 mcg per puff

Also known as: CombiventTM

Arm 1 - CombiventTM followed by Salbutamol; Arm 2 - Salbutamol followed by CombiventTM

Salbutamol DRUG

Salbutamol 100 mcg per puff

Also known as: Ventolin®

Arm 1 - CombiventTM followed by Salbutamol; Arm 2 - Salbutamol followed by CombiventTM

Eligibility Criteria

• Age: 7 Years - 12 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Child (0-17)

You may qualify if:

• 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

You may not qualify if:

• 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

Sponsors & Collaborators

• Boehringer Ingelheim: lead

MeSH Terms

Conditions

Asthma

Interventions

Albuterol; Ipratropium

Condition Hierarchy (Ancestors)

Bronchial Diseases; Respiratory Tract Diseases; Lung Diseases, Obstructive; Lung Diseases; Respiratory Hypersensitivity; Hypersensitivity, Immediate; Hypersensitivity; Immune System Diseases

Intervention Hierarchy (Ancestors)

Ethanolamines; Amino Alcohols; Alcohols; Organic Chemicals; Amines; Phenethylamines; Ethylamines; Atropine Derivatives; Tropanes; Azabicyclo Compounds; Aza Compounds; Belladonna Alkaloids; Solanaceous Alkaloids; Alkaloids; Heterocyclic Compounds; Bridged Bicyclo Compounds, Heterocyclic; Heterocyclic Compounds, Bridged-Ring

Study Design

• Study Type: interventional
• Phase: phase 4
• Allocation: RANDOMIZED
• Masking: DOUBLE
• Who Masked: PARTICIPANT, INVESTIGATOR
• Purpose: TREATMENT
• Intervention Model: CROSSOVER
• Sponsor Type: INDUSTRY
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: July 3, 2014
• First Posted: July 8, 2014
• Study Start: May 1, 1998
• Primary Completion: September 1, 1998
• Last Updated: July 8, 2014

Record last verified: 2014-07