Chronic Obstructive Pulmonary DiseasePhase 3NCT00462540
A Crossover Study in the Treatment of Patients With COPD
A Phase 3 study testing Formoterol Fumurate inhalation solution 20 mcg and Ipratropium bromide 18 mcg and albuterol sulfate 103 mcg in people with Chronic Obstructive Pulmonary Disease, run by Dey at 15 sites in United States.
Trial summary
The purpose of this study is to compare the efficacy of Formoterol Fumarate Inhalation Solution (FFIS) 20 mcg BID to Combivent® Inhalation Aerosol [2 inhalations from metered dose inhaler (MDI)of 18 mcg ipratropium bromide and 103 mcg albuterol sulfate QID], and to Compare the preference/compliance of BID nebulization… Read more about this study
- Who is it for?
- Ages 40 years and older
- Conditions the study is for
- Chronic Obstructive Pulmonary Disease
- What is being tested?
- Formoterol Fumurate inhalation solution 20 mcg and Ipratropium bromide 18 mcg and albuterol sulfate 103 mcg
- How many people
- 100 participants
- Where
- 15 sitesUnited States
- Study dates
- May 2007to Oct 2007
- 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 40 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- Diagnosis of COPD
- Smoker or exsmoker with at least 10 years smoking at least one pack of cigarettes per day
- Meet lung function requirements
Who cannot join
- Diagnosis of Asthma
- Significant disease other than COPD
- Female pregnant or lactating or planning to become pregnant
Trial locations and contacts
15 sites in 1 country.
15 sites in 1 country
United States15 sites
Research Site
Charlotte, North Carolina, 28207
Research Site
Coeur d'Alene, Idaho, 83814
Research Site
Denver, Colorado, 80206
Research Site
Gaffney, South Carolina, 29340
Research Site
Johnson City, Tennessee, 37601
Research Site
Morgantown, West Virginia, 26505
Research Site
Panama City, Florida, 32405
Research Site
Pensacola, Florida, 32504
Research Site
Portland, Oregon, 97213
Research Site
San Antonio, Texas, 78205
Research Site
San Diego, California, 92120
Research Site
Spartanburg, South Carolina, 29303
Research Site
Spokane, Washington, 99204
Research Site
Sunset, Louisiana, 70584
Research Site
Wheat Ridge, Colorado, 80033
About this study
The purpose of this study is to compare the efficacy of Formoterol Fumarate Inhalation Solution (FFIS) 20 mcg BID to Combivent® Inhalation Aerosol [2 inhalations from metered dose inhaler (MDI)of 18 mcg ipratropium bromide and 103 mcg albuterol sulfate QID], and to Compare the preference/compliance of BID nebulization to QID use of MDI
- Conditions
- Chronic Obstructive Pulmonary Disease
- Being tested
- Formoterol Fumurate inhalation solution 20 mcg, Ipratropium bromide 18 mcg and albuterol sulfate 103 mcg
- Keywords
- COPD, Formoterol, Ipratropium, Crossover
- Medical subject headings
- Pulmonary Disease, Chronic Obstructive
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Formoterol Fumurate inhalation solution 20 mcgDrug
Ipratropium bromide 18 mcg and albuterol sulfate 103 mcgDrug
What is being measured
The primary outcome is the main question the study is designed to answer.
Lung function after 2 weeks of treatment
Secondary outcomes (2)
Lung function at each time point, patient questionnaires, medication compliance,
adverse events, clinical labs, vital signs, ECGs, physical exams
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted19 Apr 2007 (estimated)
- Study startMay 2007
- Primary completionSep 2007
- Study completionOct 2007
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 Chronic Obstructive Pulmonary DiseaseStudies of the same condition, open and under way.
- 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
- Randomised
- Intervention model
- Crossover
- Masking
- None (open label)
- Enrolment
- 100 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Dey
- Sponsor type
- Industry (pharma, biotech, devices)
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT00462540
- Sponsor's protocol ID
- 201-081
- Status last verified
- Mar 2009
- First submitted
- 17 Apr 2007
- Last updated
- 4 Mar 2009
- Results posted
- No
Publications
Sutherland ER, Brazinsky S, Feldman G, McGinty J, Tomlinson L, Denis-Mize K. Nebulized formoterol effect on bronchodilation and satisfaction in COPD patients compared to QID ipratropium/albuterol MDI. Curr Med Res Opin. 2009 Mar;25(3):653-61. doi: 10.1185/03007990802708152.
PubMed 19232039
Study at a glance
From the registry record, last updated by the sponsor on 4 Mar 2009. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- A Crossover Study in the Treatment of Patients With COPD
- ClinicalTrials.gov ID
- NCT00462540
- Acronym / sponsor ID
- 201-081
- Conditions
- Chronic Obstructive Pulmonary Disease
- Keywords
- COPD, Formoterol, Ipratropium, Crossover
- Phase
- Phase 3
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 100 participants (estimated)
- Lead sponsor
- DeyIndustry (pharma, biotech, devices)
- Study start
- May 2007
- Primary completion
- Sep 2007 (actual)
- Study completion
- Oct 2007 (actual)
- First posted
- 19 Apr 2007 (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 compare the efficacy of Formoterol Fumarate Inhalation Solution (FFIS) 20 mcg BID to Combivent® Inhalation Aerosol [2 inhalations from metered dose inhaler (MDI)of 18 mcg ipratropium bromide and 103 mcg albuterol sulfate QID], and to Compare the preference/compliance of BID nebulization to QID use of MDI
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Crossover
- Masking
- None (open label)
Who may qualify
- Ages
- 40 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (3 listed)
- Diagnosis of COPD
- Smoker or exsmoker with at least 10 years smoking at least one pack of cigarettes per day
- Meet lung function requirements
Key exclusion criteria (3 listed)
- Diagnosis of Asthma
- Significant disease other than COPD
- Female pregnant or lactating or planning to become pregnant
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 |
|---|---|---|
| Formoterol Fumurate inhalation solution 20 mcg | Drug | – |
| Ipratropium bromide 18 mcg and albuterol sulfate 103 mcg | Drug | – |
Primary outcome
Lung function after 2 weeks of treatment
2 secondary outcomes
Lung function at each time point, patient questionnaires, medication compliance,
adverse events, clinical labs, vital signs, ECGs, physical exams
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 4 Mar 2009.
- Results publication: PubMed 19232039Sutherland ER, Brazinsky S, Feldman G, McGinty J, Tomlinson L, Denis-Mize K. Nebulized formoterol effect on bronchodilation and satisfaction in COPD patients compared to QID ipratropium/albuterol MDI. Curr Med Res Opin. 2009 Mar;25(3):653-61. doi: 10.1185/03007990802708152.
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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.
15 sites in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 3 study testing Formoterol Fumurate inhalation solution 20 mcg and Ipratropium bromide 18 mcg and albuterol sulfate 103 mcg in people with Chronic Obstructive Pulmonary Disease, run by Dey at 15 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 3 inclusion and 3 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 4 Mar 2009. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 15 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 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 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?
Lung function after 2 weeks of treatment. 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 NCT00462540, 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 4 Mar 2009.