Back to resultsCombivent 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
About this trial
This is an interventional treatment trial for Asthma
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
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
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
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Combivent vs. Salbutamol in Patients With Metacholine Induced Bronchospasm
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