AsthmaPhase 4NCT02182713
Combivent vs. Salbutamol in Patients With Metacholine Induced Bronchospasm
A Phase 4 study testing Salbutamol sulfate/Ipratropium bromide and Salbutamol in people with Asthma, run by Boehringer Ingelheim.
Trial 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… Read more about this study
- Who is it for?
- Ages 7 to 12 years
- Conditions the study is for
- Asthma
- What is being tested?
- Salbutamol sulfate/Ipratropium bromide and Salbutamol
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 30 participants
- Where
- No sites listed yet
- Study dates
- May 1998to Sep 1998
- Phase
- Phase 4
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 7 to 12 years
- All sexes
- No healthy volunteers
- Child
Who may be able to join
- 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
Who cannot join
- 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
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- 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
About this study
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
- Being tested
- Salbutamol sulfate/Ipratropium bromide, Salbutamol
- Medical subject headings
- Asthma
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Salbutamol sulfate/Ipratropium bromideDrug
Also called CombiventTM
Salbutamol sulfate 120 mcg + Ipratropium bromide 20 mcg per puff
SalbutamolDrug
Also called Ventolin®
Salbutamol 100 mcg per puff
| Study group | Role | What they receive |
|---|---|---|
| Arm 1 - CombiventTM followed by Salbutamol | Experimental | Not described Receives: Drug: Salbutamol sulfate/Ipratropium bromide; Drug: Salbutamol |
| Arm 2 - Salbutamol followed by CombiventTM | Active comparator | Not described Receives: Drug: Salbutamol sulfate/Ipratropium bromide; Drug: Salbutamol |
What is being measured
The primary outcome is the main question the study is designed to answer.
Increase in PD20 (provocative dose that reduce forced expiratory volume at one second (FEV1) by 20%)
Measured: Baseline and 30 minutes after treatment
Secondary outcomes (5)
Change from baseline in systolic and diastolic blood pressure
Measured: Baseline, 30 and 60 min after treatment
Change from baseline in heart rate
Measured: Baseline, 30 and 60 min after treatment
Change from baseline in respiratory rate
Measured: Baseline, 30 and 60 min after treatment
Occurrence of adverse events
Measured: up to 8 days
SaO2 (oxygen saturation) during metacholine challenge
Measured: continuously after adminstration of study drug
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted8 Jul 2014 (estimated)
- Study startMay 1998
- Primary completionSep 1998
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for AsthmaStudies of the same condition, open and under way.
- More trials run by Boehringer IngelheimThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase 4
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Crossover
- Masking
- Double blind
- Who is masked
- Participant, Investigator
- Enrolment
- 30 participants (actual)
Sponsor and investigators
- Lead sponsor
- Boehringer Ingelheim
- Sponsor type
- Industry (pharma, biotech, devices)
- Responsible party
- Sponsor
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT02182713
- Sponsor's protocol ID
- 1012.36
- Status last verified
- Jul 2014
- First submitted
- 3 Jul 2014
- Last updated
- 8 Jul 2014
- Results posted
- No
Study at a glance
From the registry record, last updated by the sponsor on 8 Jul 2014. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Combivent vs. Salbutamol in Patients With Metacholine Induced Bronchospasm
- ClinicalTrials.gov ID
- NCT02182713
- Acronym / sponsor ID
- 1012.36
- Conditions
- Asthma
- Phase
- Phase 4
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 30 participants (actual)
- Lead sponsor
- Boehringer IngelheimIndustry (pharma, biotech, devices)
- Study start
- May 1998
- Primary completion
- Sep 1998 (actual)
- First posted
- 8 Jul 2014 (estimated)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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 design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Crossover
- Masking
- Double blind (participant, investigator)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| 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 |
Who may qualify
- Ages
- 7 to 12 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Child
Key inclusion criteria (6 listed)
- 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
Key exclusion criteria (26 listed)
- 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
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Salbutamol sulfate/Ipratropium bromideAlso: CombiventTMSalbutamol sulfate 120 mcg + Ipratropium bromide 20 mcg per puff | Drug | Arm 1 - CombiventTM followed by Salbutamol, Arm 2 - Salbutamol followed by CombiventTM |
| SalbutamolAlso: Ventolin®Salbutamol 100 mcg per puff | Drug | Arm 1 - CombiventTM followed by Salbutamol, Arm 2 - Salbutamol followed by CombiventTM |
Primary outcome
Increase in PD20 (provocative dose that reduce forced expiratory volume at one second (FEV1) by 20%)
Time frame: Baseline and 30 minutes after treatment
5 secondary outcomes
Change from baseline in systolic and diastolic blood pressure
Time frame: Baseline, 30 and 60 min after treatment
Change from baseline in heart rate
Time frame: Baseline, 30 and 60 min after treatment
Change from baseline in respiratory rate
Time frame: Baseline, 30 and 60 min after treatment
Occurrence of adverse events
Time frame: up to 8 days
SaO2 (oxygen saturation) during metacholine challenge
Time frame: continuously after adminstration of study drug
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 8 Jul 2014.
- Related InfoLink provided by the sponsor.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
The record lists no contact. Use the official record to reach the sponsor.
Questions about this trial
What is this clinical trial studying?
A Phase 4 study testing Salbutamol sulfate/Ipratropium bromide and Salbutamol in people with Asthma, run by Boehringer Ingelheim.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 6 inclusion and 26 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 8 Jul 2014. Status can change between updates, so confirm with the study contact before making plans.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
What does this phase mean?
Phase 4 studies take place after a treatment is approved, to learn more about its long-term benefits and risks in everyday use.
Not every study follows the same path, and some studies (observational studies, device studies) have no phase.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Increase in PD20 (provocative dose that reduce forced expiratory volume at one second (FEV1) by 20%) (time frame: Baseline and 30 minutes after treatment). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 8 Jul 2014.