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Combivent vs. Salbutamol in Patients With Metacholine Induced Bronchospasm

Primary Purpose

Asthma

Status
Completed
Phase
Phase 4
Locations
Study Type
Interventional
Intervention
Salbutamol sulfate/Ipratropium bromide
Salbutamol
Sponsored by
Boehringer Ingelheim
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional treatment trial for Asthma

Eligibility Criteria

7 Years - 12 Years (Child)All SexesDoes not accept healthy volunteers

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

Sites / Locations

    Arms of the Study

    Arm 1

    Arm 2

    Arm Type

    Experimental

    Active Comparator

    Arm Label

    Arm 1 - CombiventTM followed by Salbutamol

    Arm 2 - Salbutamol followed by CombiventTM

    Arm Description

    Outcomes

    Primary Outcome Measures

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

    Secondary Outcome Measures

    Change from baseline in systolic and diastolic blood pressure
    Change from baseline in heart rate
    Change from baseline in respiratory rate
    Occurrence of adverse events
    SaO2 (oxygen saturation) during metacholine challenge

    Full Information

    First Posted
    July 3, 2014
    Last Updated
    July 7, 2014
    Sponsor
    Boehringer Ingelheim
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    1. Study Identification

    Unique Protocol Identification Number
    NCT02182713
    Brief Title
    Combivent vs. Salbutamol in Patients With Metacholine Induced Bronchospasm
    Official Title
    Combivent vs. Salbutamol in Patients With Metacholine Induced Bronchospasm
    Study Type
    Interventional

    2. Study Status

    Record Verification Date
    July 2014
    Overall Recruitment Status
    Completed
    Study Start Date
    May 1998 (undefined)
    Primary Completion Date
    September 1998 (Actual)
    Study Completion Date
    undefined (undefined)

    3. Sponsor/Collaborators

    Responsible Party, by Official Title
    Sponsor
    Name of the Sponsor
    Boehringer Ingelheim

    4. Oversight

    5. Study Description

    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.

    6. Conditions and Keywords

    Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
    Asthma

    7. Study Design

    Primary Purpose
    Treatment
    Study Phase
    Phase 4
    Interventional Study Model
    Crossover Assignment
    Masking
    ParticipantInvestigator
    Allocation
    Randomized
    Enrollment
    30 (Actual)

    8. Arms, Groups, and Interventions

    Arm Title
    Arm 1 - CombiventTM followed by Salbutamol
    Arm Type
    Experimental
    Arm Title
    Arm 2 - Salbutamol followed by CombiventTM
    Arm Type
    Active Comparator
    Intervention Type
    Drug
    Intervention Name(s)
    Salbutamol sulfate/Ipratropium bromide
    Other Intervention Name(s)
    CombiventTM
    Intervention Description
    Salbutamol sulfate 120 mcg + Ipratropium bromide 20 mcg per puff
    Intervention Type
    Drug
    Intervention Name(s)
    Salbutamol
    Other Intervention Name(s)
    Ventolin®
    Intervention Description
    Salbutamol 100 mcg per puff
    Primary Outcome Measure Information:
    Title
    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 Measure Information:
    Title
    Change from baseline in systolic and diastolic blood pressure
    Time Frame
    Baseline, 30 and 60 min after treatment
    Title
    Change from baseline in heart rate
    Time Frame
    Baseline, 30 and 60 min after treatment
    Title
    Change from baseline in respiratory rate
    Time Frame
    Baseline, 30 and 60 min after treatment
    Title
    Occurrence of adverse events
    Time Frame
    up to 8 days
    Title
    SaO2 (oxygen saturation) during metacholine challenge
    Time Frame
    continuously after adminstration of study drug

    10. Eligibility

    Sex
    All
    Minimum Age & Unit of Time
    7 Years
    Maximum Age & Unit of Time
    12 Years
    Accepts Healthy Volunteers
    No
    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

    12. IPD Sharing Statement

    Links:
    URL
    http://trials.boehringer-ingelheim.com/content/dam/internet/opu/clinicaltrial/com_EN/results/1012/1012.36_U00-0040.pdf
    Description
    Related Info

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    Combivent vs. Salbutamol in Patients With Metacholine Induced Bronchospasm

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