Chronic Obstructive Pulmonary DiseasePhase 2NCT00403286
A Dose-Finding Study Evaluating Safety and Efficacy in Patients With Chronic Obstructive Pulmonary Disease
A Phase 2 study testing Fluticasone Propionate/Formoterol Fumarate, Fluticasone Propionate and Formoterol Fumarate in people with Chronic Obstructive Pulmonary Disease, run by Dey at 49 sites in United States.
Trial summary
The purpose of the study is to determine the appropriate dose of fluticasone propionate/formoterol fumarate that is closest to Advair Diskus (fluticasone propionate/salmeterol xinafoate using pulmonary function, safety, and levels of study drug in blood plasma in patients with chronic obstructive pulmonary disease. 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?
- Fluticasone Propionate/Formoterol Fumarate, Fluticasone Propionate and Formoterol Fumarate
- Could I receive a placebo?
- Yes, some participants may receive a placebo
- How many people
- 457 participants
- Where
- 49 sitesUnited States
- Study dates
- Nov 2006to May 2007
- 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 40 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- Diagnosis of COPD
- Female of child-bearing potential to use adequate birth control
- Smoker or ex-smoker with history of at least 10 years of smoking at least one pack of cigarettes per day
- Meet lung function requirements
Who cannot join
- Diagnosis of asthma
- Other significant disease than COPD
- Pregnant or lactating female
- Female planning to become pregnant
Trial locations and contacts
49 sites in 1 country.
49 sites in 1 country
United States49 sites
Research Site
Abingdon, Virginia, 24210
Research Site
Albuquerque, New Mexico, 87108
Research Site
Atlanta, Georgia, 30309
Research Site
Austin, Texas, 78750
Research Site
Birmingham, Alabama, 35209
Research Site
Buena Park, California, 90620
Research Site
Camillus, New York, 13031
Research Site
Charlotte, North Carolina, 28207
Research Site
Cherry Hill, New Jersey, 08003
Research Site
Cincinnati, Ohio, 45227
Research Site
Cincinnati, Ohio, 45231
Research Site
Cincinnati, Ohio, 45242
Research Site
Clearwater, Florida, 33765
Research Site
Coeur d'Alene, Idaho, 83814
Research Site
Costa Mesa, California, 92626
Research Site
Dallas, Texas, 75231
Research Site
DeLand, Florida, 32720
Research Site
East Providence, Rhode Island, 02914
Research Site
Encinitas, California, 92024
Research Site
Greenville, North Carolina, 29615
Research Site
Henderson, Nevada, 89014
Research Site
Hines, Illinois, 60141
Research Site
Jasper, Alabama, 35501
Research Site
Lenexa, Kansas, 66219
Research Site
Liverpool, New York, 13088
Research Site
Los Angeles, California, 90095
Research Site
Madisonville, Kentucky, 42431
Research Site
Medford, Oregon, 97504
Research Site
Milwaukee, Wisconsin, 53217
Research Site
Minneapolis, Minnesota, 55402
Research Site
Morrisville, North Carolina, 27560
Research Site
Oklahoma City, Oklahoma, 73104
Research Site
Phoenix, Arizona, 85006
Research Site
Portland, Oregon, 97213
Research Site
Raleigh, North Carolina, 27607
Research Site
Richmond, Virginia, 23225
Research Site
Saint Charles, Missouri, 63301
Research Site
San Antonio, Texas, 78229
Research Site
San Diego, California, 92120
Research Site
South Burlington, Vermont, 05403
Research Site
Spartanburg, South Carolina, 29303
Research Site
St Louis, Missouri, 63122
Research Site
Tacoma, Washington, 98405
Research Site
Tamarac, Florida, 33321
Research Site
Tampa, Florida, 33603
Research Site
Topeka, Kansas, 66606
Research Site
Wheat Ridge, Colorado, 80033
Research Site
Wheaton, Maryland, 20902
Research Site
Woodstock, Georgia, 30189
About this study
Official title: A Multi-Center, Randomized, Double-Blind, Parallel-Group, Dose-Finding Trial to Evaluate the Safety and Efficacy of Fluticasone Propionate Combined With Formoterol Fumarate in Patients With Chronic Obstructive Pulmonary Disease
The purpose of the study is to determine the appropriate dose of fluticasone propionate/formoterol fumarate that is closest to Advair Diskus (fluticasone propionate/salmeterol xinafoate using pulmonary function, safety, and levels of study drug in blood plasma in patients with chronic obstructive pulmonary disease.
- Conditions
- Chronic Obstructive Pulmonary Disease
- Being tested
- Fluticasone Propionate/Formoterol Fumarate, Fluticasone Propionate, Formoterol Fumarate, Fluticasone Propionate/Salmeterol Xinafoate, Placebo
- Keywords
- Chronic, Obstructive, Pulmonary, Disease, COPD, Safety, Efficacy, Pharmacokinetic, Dose-finding
- Medical subject headings
- Pulmonary Disease, Chronic Obstructive, Bronchiolitis Obliterans Syndrome, Disease
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Fluticasone Propionate/Formoterol FumarateDrug
Inhalation suspension for nebulization 1000/20 mcg bid for 2 weeks
Fluticasone Propionate/Formoterol FumarateDrug
Inhalation Suspension for nebulization 1000/10 mcg bid for 2 weeks
Fluticasone Propionate/Formoterol FumarateDrug
Inhalation Suspension for nebulization 500/20 mcg bid for 2 weeks
Fluticasone Propionate/Formoterol FumarateDrug
Inhalation Suspension for nebulization 500/10 mcg bid for 2 weeks
Fluticasone PropionateDrug
Inhalation Suspension for nebulization 1000 mcg bid for 2 weeks
Formoterol FumarateDrug
Inhalation Solution for nebulization 20 mcg bid for 2 weeks
Fluticasone Propionate/Salmeterol XinafoateDrug
Inhalation Powder delivered by Diskus device 250/50 mcg bid for 2 weeks
PlaceboDrug
Inhalation Solution for nebulization 2 mL bid for 2 weeks
| Study group | Role | What they receive |
|---|---|---|
| C 10/1 | Experimental | Not described Receives: Drug: Fluticasone Propionate/Formoterol Fumarate |
| C 5/2 | Experimental | Not described Receives: Drug: Fluticasone Propionate/Formoterol Fumarate |
| C 5/1 | Experimental | Not described Receives: Drug: Fluticasone Propionate/Formoterol Fumarate |
| FP 1000 | Experimental | Not described Receives: Drug: Fluticasone Propionate |
| FF 20 | Experimental | Not described Receives: Drug: Formoterol Fumarate |
| AD 250/50 | Active comparator | Not described Receives: Drug: Fluticasone Propionate/Salmeterol Xinafoate |
| Plc | Placebo comparator | Not described Receives: Drug: Placebo |
| C 10/2 | Experimental | Not described Receives: Drug: Fluticasone Propionate/Formoterol Fumarate |
What is being measured
The primary outcome is the main question the study is designed to answer.
2-hour post-dose FEV1
Measured: 2 weeks
AUC(0-12) and Cmax in plasma
Measured: 2 weeks
pre-dose FEV1
Measured: 2 weeks
Amount and percent total dose excreted in urine
Measured: 2 weeks
Secondary outcomes (3)
FEV1 AUC(0-2)
Measured: 2 weeks
COPD exacerbations
Treatment Emergent Adverse Events
Measured: 2 weeks
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted23 Nov 2006 (estimated)
- Study startNov 2006
- Primary completionMay 2007
- Study completionMay 2007
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- 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 2
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Double blind
- Enrolment
- 457 participants (actual)
Sponsor and investigators
- Lead sponsor
- Dey
- Sponsor type
- Industry (pharma, biotech, devices)
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT00403286
- Sponsor's protocol ID
- 191-076
- Status last verified
- Jun 2009
- First submitted
- 21 Nov 2006
- Last updated
- 30 Jun 2009
- Results posted
- No
Study at a glance
From the registry record, last updated by the sponsor on 30 Jun 2009. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- A Multi-Center, Randomized, Double-Blind, Parallel-Group, Dose-Finding Trial to Evaluate the Safety and Efficacy of Fluticasone Propionate Combined With Formoterol Fumarate in Patients With Chronic Obstructive Pulmonary Disease
- ClinicalTrials.gov ID
- NCT00403286
- Acronym / sponsor ID
- 191-076
- Conditions
- Chronic Obstructive Pulmonary Disease
- Keywords
- Chronic, Obstructive, Pulmonary, Disease, COPD, Safety, Efficacy, Pharmacokinetic
- Phase
- Phase 2
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 457 participants (actual)
- Lead sponsor
- DeyIndustry (pharma, biotech, devices)
- Study start
- Nov 2006
- Primary completion
- May 2007 (actual)
- Study completion
- May 2007 (actual)
- First posted
- 23 Nov 2006 (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 the study is to determine the appropriate dose of fluticasone propionate/formoterol fumarate that is closest to Advair Diskus (fluticasone propionate/salmeterol xinafoate using pulmonary function, safety, and levels of study drug in blood plasma in patients with chronic obstructive pulmonary disease.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Double blind
- Number of arms
- 8
| Arm | Type | Receives |
|---|---|---|
| C 10/1 | Experimental | Drug: Fluticasone Propionate/Formoterol Fumarate |
| C 5/2 | Experimental | Drug: Fluticasone Propionate/Formoterol Fumarate |
| C 5/1 | Experimental | Drug: Fluticasone Propionate/Formoterol Fumarate |
| FP 1000 | Experimental | Drug: Fluticasone Propionate |
| FF 20 | Experimental | Drug: Formoterol Fumarate |
| AD 250/50 | Active comparator | Drug: Fluticasone Propionate/Salmeterol Xinafoate |
| Plc | Placebo comparator | Drug: Placebo |
| C 10/2 | Experimental | Drug: Fluticasone Propionate/Formoterol Fumarate |
Who may qualify
- Ages
- 40 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (4 listed)
- Diagnosis of COPD
- Female of child-bearing potential to use adequate birth control
- Smoker or ex-smoker with history of at least 10 years of smoking at least one pack of cigarettes per day
- Meet lung function requirements
Key exclusion criteria (4 listed)
- Diagnosis of asthma
- Other significant disease than COPD
- Pregnant or lactating female
- Female 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 |
|---|---|---|
| Fluticasone Propionate/Formoterol FumarateInhalation suspension for nebulization 1000/20 mcg bid for 2 weeks | Drug | C 10/2 |
| Fluticasone Propionate/Formoterol FumarateInhalation Suspension for nebulization 1000/10 mcg bid for 2 weeks | Drug | C 10/1 |
| Fluticasone Propionate/Formoterol FumarateInhalation Suspension for nebulization 500/20 mcg bid for 2 weeks | Drug | C 5/2 |
| Fluticasone Propionate/Formoterol FumarateInhalation Suspension for nebulization 500/10 mcg bid for 2 weeks | Drug | C 5/1 |
| Fluticasone PropionateInhalation Suspension for nebulization 1000 mcg bid for 2 weeks | Drug | FP 1000 |
| Formoterol FumarateInhalation Solution for nebulization 20 mcg bid for 2 weeks | Drug | FF 20 |
| Fluticasone Propionate/Salmeterol XinafoateInhalation Powder delivered by Diskus device 250/50 mcg bid for 2 weeks | Drug | AD 250/50 |
| PlaceboInhalation Solution for nebulization 2 mL bid for 2 weeks | Drug | Plc |
Primary outcome
2-hour post-dose FEV1
Time frame: 2 weeks
AUC(0-12) and Cmax in plasma
Time frame: 2 weeks
pre-dose FEV1
Time frame: 2 weeks
Amount and percent total dose excreted in urine
Time frame: 2 weeks
3 secondary outcomes
FEV1 AUC(0-2)
Time frame: 2 weeks
COPD exacerbations
Treatment Emergent Adverse Events
Time frame: 2 weeks
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 30 Jun 2009.
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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.
49 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 Fluticasone Propionate/Formoterol Fumarate, Fluticasone Propionate and Formoterol Fumarate in people with Chronic Obstructive Pulmonary Disease, run by Dey at 49 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 4 inclusion and 4 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 30 Jun 2009. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 49 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. Some participants in this study may receive a placebo. 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?
2-hour post-dose FEV1 (time frame: 2 weeks). The study lists 4 primary outcomes in all. 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 30 Jun 2009.