AsthmaPhase 3NCT02182700
Efficacy and Safety of Combivent® Aerosol and Spacer, in Adult Patients With Moderate to Severe Asthma Crisis
A Phase 3 study testing salbutamol sulfate + ipratropium bromide in people with Asthma, run by Boehringer Ingelheim.
Trial summary
Study to evaluate the bronchodilator efficacy and safety of a fixed combination of salbutamol sulfate (120 mcg) + ipratropium bromide (20mcg) (Combivent® MDI) in aerosol plus spacer in adult patients with moderate-to-severe asthma crisis who arrived at the emergency room. Read more about this study
- Who is it for?
- Ages 18 to 40 years
- Conditions the study is for
- Asthma
- What is being tested?
- salbutamol sulfate + ipratropium bromide
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 47 participants
- Where
- No sites listed yet
- Study dates
- Jul 1998to Dec 1999
- Phase
- Phase 3
- 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 18 to 40 years
- All sexes
- No healthy volunteers
- Adult
Who may be able to join
- Male or female patients with a diagnosis of asthma according to the American Thoracic Society (ATS) presenting at the emergency room with an acute moderate and/or severe asthma attack
- Patients aged between18 to 40 years
- Patients able to perform spirometry (PEFR and FEV1)
- PEFR < 60% and > 25 % of predicted normal value or a FEV1 <= 60% of predicted normal value
- Patients able to sign witnessed informed consent
Who cannot join
- Patients with very severe or life threatening obstruction, manifested by:
- Cyanosis of tongue and lips
- Confusion, drowsiness, coma or exhaustion
- Silent chest on auscultation or weak respiratory effort
- PEFR < 25% the predicted normal value
- Bradycardia (of less 60 beats/min)
Show all 20Show fewer
- Patients with a smoking history of more than 10 pack/years
- Patients with chronic obstructive pulmonary disease (COPD)
- Patients on treatment for or suspected as having glaucoma
- Patients with uncontrolled hypertension
- Patients with known allergy or contra-indications to either salbutamol, ipratropium or hydrocortisone or their excipients
- Female patients known or suspected to be pregnant or nursing
- Patients known or 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 included pulmonary fibrosis, bronchiectasis, cystic fibrosis, pulmonary tuberculosis, pulmonary complications of AIDS, lung cancer
- Patients requiring drugs for the treatment of the acute asthma attack other than the study drug, hydrocortisone or oxygen
- Patients who have previously recruited into this study
- Patients who have been on other investigational drugs within three months prior to study entry
- Patients with acute myocardial infarction, pulmonary edema or other life threatening disease, which in the judgment of the ER (Emergency room) physician precluded entry into the study
- Patients with obvious or previous diagnosed serious hepatic or renal impairment or bladder neck obstruction
About this study
Official title: Open Study on the Efficacy and Safety of Combivent® Aerosol (120 mcg Salbutamol Sulfate Plus 20 mcg Ipratropium Bromide) + Spacer, 12 to 24 Puffs, in Adult Patients With Moderate to Severe Asthma Crisis
Study to evaluate the bronchodilator efficacy and safety of a fixed combination of salbutamol sulfate (120 mcg) + ipratropium bromide (20mcg) (Combivent® MDI) in aerosol plus spacer in adult patients with moderate-to-severe asthma crisis who arrived at the emergency room.
- Conditions
- Asthma
- Being tested
- salbutamol sulfate + ipratropium bromide
- 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 Combivent® aerosol
120 mcg (salbutamol sulfate) + 20 mcg (ipratropium bromide), inhalation (metered aerosol plus spacer)
| Study group | Role | What they receive |
|---|---|---|
| Combivent® aerosol | Experimental | Not described Receives: Drug: salbutamol sulfate + ipratropium bromide |
What is being measured
The primary outcome is the main question the study is designed to answer.
Number of patients discharged with a peak flow expiratory flow rate (PEFR) >= 70% predicted normal value at the end of the first and the second treatment
Measured: 60 and 120 min after starting treatment
Secondary outcomes (4)
Number of patients whose PEFR >= 60% within the first or the second hour
Measured: 60 and 120 min after start of treatment
Hospitalisation period at the Intensive Care Unit (ICU)
Measured: up to 3rd hour after treatment
Hospitalisation time at the general ward
Measured: up to 3rd hour after treatment
Number of relapses and/or new episodes
Measured: 7 days after finishing treatment
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 startJul 1998
- Primary completionDec 1999
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 3
- Primary purpose
- Treatment
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Enrolment
- 47 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
- NCT02182700
- Sponsor's protocol ID
- 1012.32
- 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
- Open Study on the Efficacy and Safety of Combivent® Aerosol (120 mcg Salbutamol Sulfate Plus 20 mcg Ipratropium Bromide) + Spacer, 12 to 24 Puffs, in Adult Patients With Moderate to Severe Asthma Crisis
- ClinicalTrials.gov ID
- NCT02182700
- Acronym / sponsor ID
- 1012.32
- Conditions
- Asthma
- Phase
- Phase 3
- Study type
- Interventional
- Recruitment status
- Terminated
- Enrolment
- 47 participants (actual)
- Lead sponsor
- Boehringer IngelheimIndustry (pharma, biotech, devices)
- Study start
- Jul 1998
- Primary completion
- Dec 1999 (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.
Study to evaluate the bronchodilator efficacy and safety of a fixed combination of salbutamol sulfate (120 mcg) + ipratropium bromide (20mcg) (Combivent® MDI) in aerosol plus spacer in adult patients with moderate-to-severe asthma crisis who arrived at the emergency room.
Study design
- Primary purpose
- Treatment
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| Combivent® aerosol | Experimental | Drug: salbutamol sulfate + ipratropium bromide |
Who may qualify
- Ages
- 18 to 40 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult
Key inclusion criteria (5 listed)
- Male or female patients with a diagnosis of asthma according to the American Thoracic Society (ATS) presenting at the emergency room with an acute moderate and/or severe asthma attack
- Patients aged between18 to 40 years
- Patients able to perform spirometry (PEFR and FEV1)
- PEFR < 60% and > 25 % of predicted normal value or a FEV1 <= 60% of predicted normal value
- Patients able to sign witnessed informed consent
Key exclusion criteria (20 listed)
- Patients with very severe or life threatening obstruction, manifested by:
- Patients with a smoking history of more than 10 pack/years
- Patients with chronic obstructive pulmonary disease (COPD)
- Patients on treatment for or suspected as having glaucoma
- Patients with uncontrolled hypertension
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: Combivent® aerosol120 mcg (salbutamol sulfate) + 20 mcg (ipratropium bromide), inhalation (metered aerosol plus spacer) | Drug | Combivent® aerosol |
Primary outcome
Number of patients discharged with a peak flow expiratory flow rate (PEFR) >= 70% predicted normal value at the end of the first and the second treatment
Time frame: 60 and 120 min after starting treatment
4 secondary outcomes
Number of patients whose PEFR >= 60% within the first or the second hour
Time frame: 60 and 120 min after start of treatment
Hospitalisation period at the Intensive Care Unit (ICU)
Time frame: up to 3rd hour after treatment
Hospitalisation time at the general ward
Time frame: up to 3rd hour after treatment
Number of relapses and/or new episodes
Time frame: 7 days after finishing treatment
Results and safety
The study was stopped early. Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 8 Jul 2014.
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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 3 study testing salbutamol sulfate + ipratropium bromide 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 5 inclusion and 20 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: stopped early, 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 3 studies compare the treatment with the current standard treatment or a placebo in a large group, to confirm how well it works and watch for side effects.
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 was stopped early. Results are not available in the source record.
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?
Number of patients discharged with a peak flow expiratory flow rate (PEFR) >= 70% predicted normal value at the end of the first and the second treatment (time frame: 60 and 120 min after starting 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.