AsthmaPhase 2NCT00096616
Combivent® CFC Metered Dose Inhaler (MDI) in Moderate to Severe Asthma
A Phase 2 study testing Combivent® CFC MDI and Albuterol HFA MDI in people with Asthma, run by Boehringer Ingelheim at 27 sites in United States.
Trial summary
The purpose of this study is to demonstrate the superior bronchodilator efficacy of inhaled Combivent® CFC MDI vs. Albuterol HFA MDI in moderate to severe asthma patients. Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Asthma
- What is being tested?
- Combivent® CFC MDI and Albuterol HFA MDI
- How many people
- 113 participants
- Where
- 27 sitesUnited States
- Study dates
- Nov 2004to Mar 2006
- Phase
- Phase 2
- 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 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- Patient greater than or equal to 18 years of age,
- non-smokers,
- diagnosed with asthma, with an FEV1 less than or equal to 70 percent of predicted normal,
- stable use of Beta agonist
- daily use of inhaled steroids for one year
Who cannot join
- Patients with other significant diseases other than asthma, requiring oxygen,
- intubated within 5 years,
- asthma exacerbation within 6 weeks of trial,
- use of unstable doses (greater than 10 mg/day of prednisone or equivalent) of steroids,
- participating in another interventional trial
Trial locations and contacts
27 sites in 1 country.
27 sites in 1 country
United States27 sites
Boehringer Ingelheim Investigational Site
Auburn, Maine
Johns Hopkins Asthma & Allergy
Baltimore, Maryland
Boehringer Ingelheim Investigational Site
Berlin, New Jersey
620 South 20th Street, NHB 104
Birmingham, Alabama
Cooper Green Hospital
Birmingham, Alabama
Brigham & Women's Hospital
Boston, Massachusetts
Boehringer Ingelheim Investigational Site
Charleston, South Carolina
Boehringer Ingelheim Investigational Site
Cherry Hill, New Jersey
Boehringer Ingelheim Investigational Site
Coeur d'Arlene, Idaho
Division of Pulmonary & Critical Care Medicine
Durham, North Carolina
Penn State University, Hershey Medical Center
Hershey, Pennsylvania
Ben Taul General Hospital
Houston, Texas
Southern California Clinical Trials
Lakewood, California
University of Wisconsin Hospital
Madison, Wisconsin
North Shore University Hospital
Manhasset, New York
University of Miami School of Medicine
Miami, Florida
NYU School of Medicine
New York, New York
Norwalk Hospital
Norwalk, Connecticut
Boehringer Ingelheim Investigational Site
Olathe, Kansas
Boehringer Ingelheim Investigational Site
Palmdale, California
Boehringer Ingelheim Investigational Site
Panama City, Florida
Boehringer Ingelheim Investigational Site
River Forest, Illinois
LSU MC-Sheveport
Shreveport, Louisiana
Spartanburg Medical Research
Spartanburg, South Carolina
University of Texas Health Center at Tyler
Tyler, Texas
Boehringer Ingelheim Investigational Site
Wheat Ridge, Colorado
Wake Forest University, Center for Human Genomics
Winston-Salem, North Carolina
About this study
Official title: A Single Dose, Randomized, Double-blind Crossover Comparison of Combivent CFC MDI and Albuterol HFA MDI in Patients With Moderate to Severe Persistent Asthma and Persistent Symptoms Despite Treatment With Inhaled Corticosteroids
The purpose of this study is to demonstrate the superior bronchodilator efficacy of inhaled Combivent® CFC MDI vs. Albuterol HFA MDI in moderate to severe asthma patients.
- Conditions
- Asthma
- Being tested
- Combivent® CFC MDI, Albuterol HFA MDI
- Medical subject headings
- Asthma
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Combivent® CFC MDIDrug
Albuterol HFA MDIDrug
What is being measured
The primary outcome is the main question the study is designed to answer.
FEV1 area under the curve (AUC) 0 to 6 hours Peak FEV1
Secondary outcomes (1)
FEV1 at each timepoint Peak FVC FVC at each timepoint FVC AUC 0-6 Adverse events Vital signs
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted15 Nov 2004 (estimated)
- Study startNov 2004
- Primary completionMar 2006
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (1)Papers the sponsor has linked to this study.
- 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 2
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Crossover
- Masking
- Double blind
- Enrolment
- 113 participants (actual)
Sponsor and investigators
- Lead sponsor
- Boehringer Ingelheim
- Sponsor type
- Industry (pharma, biotech, devices)
- Investigators
- Boehringer Ingelheim Study Coordinator, Study chair, Boehringer Ingelheim
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT00096616
- Sponsor's protocol ID
- 1012.50
- Status last verified
- Oct 2013
- First submitted
- 12 Nov 2004
- Last updated
- 1 Nov 2013
- Results posted
- No
Publications
Gelb AF, Karpel J, Wise RA, Cassino C, Johnson P, Conoscenti CS. Bronchodilator efficacy of the fixed combination of ipratropium and albuterol compared to albuterol alone in moderate-to-severe persistent asthma. Pulm Pharmacol Ther. 2008 Aug;21(4):630-6. doi: 10.1016/j.pupt.2008.02.005. Epub 2008 Mar 5.
PubMed 18403223
Study at a glance
From the registry record, last updated by the sponsor on 1 Nov 2013. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- A Single Dose, Randomized, Double-blind Crossover Comparison of Combivent CFC MDI and Albuterol HFA MDI in Patients With Moderate to Severe Persistent Asthma and Persistent Symptoms Despite Treatment With Inhaled Corticosteroids
- ClinicalTrials.gov ID
- NCT00096616
- Acronym / sponsor ID
- 1012.50
- Conditions
- Asthma
- Phase
- Phase 2
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 113 participants (actual)
- Lead sponsor
- Boehringer IngelheimIndustry (pharma, biotech, devices)
- Study start
- Nov 2004
- Primary completion
- Mar 2006 (actual)
- First posted
- 15 Nov 2004 (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 is to demonstrate the superior bronchodilator efficacy of inhaled Combivent® CFC MDI vs. Albuterol HFA MDI in moderate to severe asthma patients.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Crossover
- Masking
- Double blind
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (5 listed)
- Patient greater than or equal to 18 years of age,
- non-smokers,
- diagnosed with asthma, with an FEV1 less than or equal to 70 percent of predicted normal,
- stable use of Beta agonist
- daily use of inhaled steroids for one year
Key exclusion criteria (5 listed)
- Patients with other significant diseases other than asthma, requiring oxygen,
- intubated within 5 years,
- asthma exacerbation within 6 weeks of trial,
- use of unstable doses (greater than 10 mg/day of prednisone or equivalent) of steroids,
- participating in another interventional trial
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 |
|---|---|---|
| Combivent® CFC MDI | Drug | – |
| Albuterol HFA MDI | Drug | – |
Primary outcome
FEV1 area under the curve (AUC) 0 to 6 hours Peak FEV1
1 secondary outcome
FEV1 at each timepoint Peak FVC FVC at each timepoint FVC AUC 0-6 Adverse events Vital signs
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 1 Nov 2013.
- Derived from this study: PubMed 18403223Gelb AF, Karpel J, Wise RA, Cassino C, Johnson P, Conoscenti CS. Bronchodilator efficacy of the fixed combination of ipratropium and albuterol compared to albuterol alone in moderate-to-severe persistent asthma. Pulm Pharmacol Ther. 2008 Aug;21(4):630-6. doi: 10.1016/j.pupt.2008.02.005. Epub 2008 Mar 5.
- 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.
Boehringer Ingelheim Study Coordinator study chair
Boehringer Ingelheim
27 sites in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 2 study testing Combivent® CFC MDI and Albuterol HFA MDI in people with Asthma, run by Boehringer Ingelheim at 27 sites in United States.
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 5 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 1 Nov 2013. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 27 sites in United States. Whether a site is taking part right now should be confirmed with that site. See every site.
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 2 studies give the treatment to a larger group to see whether it has the intended effect and to keep checking safety.
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?
FEV1 area under the curve (AUC) 0 to 6 hours Peak FEV1. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT00096616, which also lists 1 linked publication.
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 1 Nov 2013.