Combivent vs. Salbutamol in Patients With Metacholine Induced Bronchospasm

July 7, 2014 updated by: Boehringer Ingelheim
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

Status

Indicates the current recruitment status or the expanded access status.
Completed

Conditions

Conditions

The disease, disorder, syndrome, illness, or injury that is being studied. On ClinicalTrials.gov, conditions may also include other health-related issues, such as lifespan, quality of life, and health risks.

Intervention / Treatment

Intervention / Treatment

A process or action that is the focus of a clinical study. Interventions include drugs, medical devices, procedures, vaccines, and other products that are either investigational or already available. Interventions can also include noninvasive approaches, such as education or modifying diet and exercise.

Study Type

Study Type

Describes the nature of a clinical study. Study types include interventional studies (also called clinical trials), observational studies (including patient registries), and expanded access.
Interventional

Enrollment (Actual)

Enrollment

The number of participants in a clinical study. The "anticipated" enrollment is the target number of participants that the researchers need for the study.
30

Phase

Phase

The stage of a clinical trial studying a drug or biological product, based on definitions developed by the U.S. Food and Drug Administration (FDA). The phase is based on the study's objective, the number of participants, and other characteristics. There are five phases: Early Phase 1 (formerly listed as Phase 0), Phase 1, Phase 2, Phase 3, and Phase 4. Not Applicable is used to describe trials without FDA-defined phases, including trials of devices or behavioral interventions.
  • Phase 4

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Eligibility Criteria

The key requirements that people who want to participate in a clinical study must meet or the characteristics they must have. Eligibility criteria consist of both inclusion criteria (which are required for a person to participate in the study) and exclusion criteria (which prevent a person from participating). Types of eligibility criteria include whether a study accepts healthy volunteers, has age or age group requirements, or is limited by sex.

Ages Eligible for Study

3 years to 8 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

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

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

Arms and Interventions

Participant Group / Arm

Participant Group / Arm

A group or subgroup of participants in a clinical trial that receives a specific intervention/treatment, or no intervention, according to the trial's protocol.
Intervention / Treatment

Intervention / Treatment

A process or action that is the focus of a clinical study. Interventions include drugs, medical devices, procedures, vaccines, and other products that are either investigational or already available. Interventions can also include noninvasive approaches, such as education or modifying diet and exercise.
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

Primary Outcome Measures

In a clinical study's protocol, the planned outcome measure that is the most important for evaluating the effect of an intervention/treatment. Most clinical studies have one primary outcome measure, but some have more than one.
Outcome Measure
Time Frame
Increase in PD20 (provocative dose that reduce forced expiratory volume at one second (FEV1) by 20%)
Time Frame: Baseline and 30 minutes after treatment
Baseline and 30 minutes after treatment

Secondary Outcome Measures

Secondary Outcome Measures

In a clinical study's protocol, a planned outcome measure that is not as important as the primary outcome measure for evaluating the effect of an intervention but is still of interest. Most clinical studies have more than one secondary outcome measure.
Outcome Measure
Time Frame
Change from baseline in systolic and diastolic blood pressure
Time Frame: Baseline, 30 and 60 min after treatment
Baseline, 30 and 60 min after treatment
Change from baseline in heart rate
Time Frame: Baseline, 30 and 60 min after treatment
Baseline, 30 and 60 min after treatment
Change from baseline in respiratory rate
Time Frame: Baseline, 30 and 60 min after treatment
Baseline, 30 and 60 min after treatment
Occurrence of adverse events
Time Frame: up to 8 days
up to 8 days
SaO2 (oxygen saturation) during metacholine challenge
Time Frame: continuously after adminstration of study drug
continuously after adminstration of study drug

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Sponsor

The organization or person who initiates the study and who has authority and control over the study.
Boehringer Ingelheim

Publications and helpful links

The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.

Helpful Links

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start

Study Start

The actual date on which the first participant was enrolled in a clinical study. The "anticipated" study start date is the date that the researchers think will be the study start date.
May 1, 1998

Primary Completion (Actual)

Primary Completion

The date on which the last participant in a clinical study was examined or received an intervention to collect final data for the primary outcome measure. Whether the clinical study ended according to the protocol or was terminated does not affect this date. For clinical studies with more than one primary outcome measure with different completion dates, this term refers to the date on which data collection is completed for all the primary outcome measures. The "anticipated" primary completion date is the date that the researchers think will be the primary completion date for the study.
September 1, 1998

Study Registration Dates

First Submitted

First Submitted

The date on which the study sponsor or investigator first submitted a study record to ClinicalTrials.gov. There is typically a delay of a few days between the first submitted date and the record's availability on ClinicalTrials.gov (the first posted date).
July 3, 2014

First Submitted That Met QC Criteria

First Submitted That Met QC Criteria

The date on which the study sponsor or investigator first submits a study record that is consistent with National Library of Medicine (NLM) quality control (QC) review criteria. The sponsor or investigator may need to revise and submit a study record one or more times before NLM's QC review criteria are met. It is the responsibility of the sponsor or investigator to ensure that the study record is consistent with the NLM QC review criteria.
July 7, 2014

First Posted (Estimate)

First Posted

The date on which the study record was first available on ClinicalTrials.gov after National Library of Medicine (NLM) quality control (QC) review has concluded. There is typically a delay of a few days between the date the study sponsor or investigator submitted the study record and the first posted date.
July 8, 2014

Study Record Updates

Last Update Posted (Estimate)

Last Update Posted

The most recent date on which changes to a study record were made available on ClinicalTrials.gov. There may be a delay between when the changes were submitted to ClinicalTrials.gov by the study's sponsor or investigator (the last update submitted date) and the last update posted date.
July 8, 2014

Last Update Submitted That Met QC Criteria

Last Update Submitted That Met QC Criteria

The most recent date on which the study sponsor or investigator submitted changes to a study record that are consistent with National Library of Medicine (NLM) quality control (QC) review criteria. It is the responsibility of the sponsor or investigator to ensure that the study record is consistent with the NLM QC review criteria.
July 7, 2014

Last Verified

Last Verified

The most recent date on which the study sponsor or investigator confirmed the information about a clinical study on ClinicalTrials.gov as accurate and current. If a study with a recruitment status of recruiting; not yet recruiting; or active, not recruiting has not been confirmed within the past 2 years, the study's recruitment status is shown as unknown.
July 1, 2014

More Information

Terms related to this study

Additional Relevant MeSH Terms

Other Study ID Numbers

Other Study ID Numbers

Identifiers or ID numbers other than the NCT number that are assigned to a clinical study by the study's sponsor, funders, or others. These numbers may include unique identifiers from other trial registries and National Institutes of Health grant numbers.
  • 1012.36

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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