Chronic Obstructive Pulmonary DiseasePhase 2NCT00774761
A Study Evaluating Systemic Exposure and Pharmacodynamics 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 12 sites in United States.
Trial summary
The purpose of this study is to evaluate the systemic exposure and pharmacodynamics of two doses of nebulized fluticasone/formoterol combination as compared to the monocomponents. 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?
- No, everyone receives an active treatment
- How many people
- 97 participants
- Where
- 12 sitesUnited States
- Study dates
- Nov 2008to May 2009
- 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
- Able to understand the requirements of the study and provide consent
- Medical diagnosis of COPD
- A current or prior history of at least 10-pack years of cigarette smoking
- Female of child-bearing potential to use adequate birth control
Who cannot join
- Diagnosis of asthma
- Other significant disease than COPD
- Has donated a unit of blood within 30 days of study, or intends to donate
- QTc greater than 0.460 seconds
- Subjects who had radiation or chemotherapy in the previous 12 months
- Subjects who had lung resection
- History of illegal drug abuse or alcohol abuse within the past 5 years
Trial locations and contacts
12 sites in 1 country.
12 sites in 1 country
United States12 sites
Investigative Site
Charlotte, North Carolina, 28207
Investigative Site
Greenville, South Carolina, 29615
Investigative Site
Madisonville, Kentucky, 42431
Investigative Site
Medford, Oregon, 97504
Investigative Site
Panama City, Florida, 32405
Investigative Site
San Antonio, Texas, 78205
Investigative Site
San Diego, California, 92120
Investigative Site
Spartanburg, South Carolina, 29303
Investigative Site
Spokane, Washington, 99207
Investigative Site
Sunset, Louisiana, 70584
Investigative Site
Tacoma, Washington, 98405
Investigative Site
Union, South Carolina, 29379
About this study
Official title: A Randomized, Multiple-Dose,Double-Blind,Crossover Trial to Assess the Systemic Exposure of Fluticasone Propionate (FP)/Formoterol Fumarate (FF) Fixed-Dose Combination in Subjects With Chronic Obstructive Pulmonary Disease (COPD)
The purpose of this study is to evaluate the systemic exposure and pharmacodynamics of two doses of nebulized fluticasone/formoterol combination as compared to the monocomponents.
- Conditions
- Chronic Obstructive Pulmonary Disease
- Being tested
- fluticasone propionate/formoterol fumarate, fluticasone propionate, formoterol fumarate
- Keywords
- Chronic, Obstructive, Pulmonary, Disease, COPD, Pharmacodynamic, Pharmacokinetic
- 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
fluticasone propionateDrug
inhalation suspension
formoterol fumarateDrug
inhalation solution
| Study group | Role | What they receive |
|---|---|---|
| 1 | Experimental | Not described Receives: Drug: fluticasone propionate/formoterol fumarate |
| 2 | Experimental | Not described Receives: Drug: fluticasone propionate/formoterol fumarate |
| 3 | Active comparator | Not described Receives: Drug: fluticasone propionate |
| 4 | Active comparator | Not described Receives: Drug: fluticasone propionate |
| 5 | Active comparator | Not described Receives: Drug: formoterol fumarate |
What is being measured
The primary outcome is the main question the study is designed to answer.
Plasma AUC(0-t) after 1 week of dosing
Measured: PK sampling over 24 hrs
Secondary outcomes (1)
FEV1
Measured: pre-dose and 2 hrs post-dose
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted17 Oct 2008 (estimated)
- Study startNov 2008
- Primary completionApr 2009
- Study completionMay 2009
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
- Crossover
- Masking
- Double blind
- Who is masked
- Participant, Investigator
- Enrolment
- 97 participants (actual)
Sponsor and investigators
- Lead sponsor
- Dey
- Sponsor type
- Industry (pharma, biotech, devices)
- Responsible party
- Sponsor
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT00774761
- Sponsor's protocol ID
- 191-087
- Status last verified
- May 2013
- First submitted
- 16 Oct 2008
- Last updated
- 20 May 2013
- Results posted
- No
- Data monitoring committee
- No
Study at a glance
From the registry record, last updated by the sponsor on 20 May 2013. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- A Randomized, Multiple-Dose,Double-Blind,Crossover Trial to Assess the Systemic Exposure of Fluticasone Propionate (FP)/Formoterol Fumarate (FF) Fixed-Dose Combination in Subjects With Chronic Obstructive Pulmonary Disease (COPD)
- ClinicalTrials.gov ID
- NCT00774761
- Acronym / sponsor ID
- 191-087
- Conditions
- Chronic Obstructive Pulmonary Disease
- Keywords
- Chronic, Obstructive, Pulmonary, Disease, COPD, Pharmacodynamic, Pharmacokinetic
- Phase
- Phase 2
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 97 participants (actual)
- Lead sponsor
- DeyIndustry (pharma, biotech, devices)
- Study start
- Nov 2008
- Primary completion
- Apr 2009 (actual)
- Study completion
- May 2009 (actual)
- First posted
- 17 Oct 2008 (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 evaluate the systemic exposure and pharmacodynamics of two doses of nebulized fluticasone/formoterol combination as compared to the monocomponents.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Crossover
- Masking
- Double blind (participant, investigator)
- Number of arms
- 5
| Arm | Type | Receives |
|---|---|---|
| 1 | Experimental | Drug: fluticasone propionate/formoterol fumarate |
| 2 | Experimental | Drug: fluticasone propionate/formoterol fumarate |
| 3 | Active comparator | Drug: fluticasone propionate |
| 4 | Active comparator | Drug: fluticasone propionate |
| 5 | Active comparator | Drug: 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)
- Able to understand the requirements of the study and provide consent
- Medical diagnosis of COPD
- A current or prior history of at least 10-pack years of cigarette smoking
- Female of child-bearing potential to use adequate birth control
Key exclusion criteria (7 listed)
- Diagnosis of asthma
- Other significant disease than COPD
- Has donated a unit of blood within 30 days of study, or intends to donate
- QTc greater than 0.460 seconds
- Subjects who had radiation or chemotherapy in the previous 12 months
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 | Drug | 1, 2 |
| fluticasone propionateinhalation suspension | Drug | 3, 4 |
| formoterol fumarateinhalation solution | Drug | 5 |
Primary outcome
Plasma AUC(0-t) after 1 week of dosing
Time frame: PK sampling over 24 hrs
1 secondary outcome
FEV1
Time frame: pre-dose and 2 hrs post-dose
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 20 May 2013.
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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.
12 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 12 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 7 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 20 May 2013. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 12 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?
Plasma AUC(0-t) after 1 week of dosing (time frame: PK sampling over 24 hrs). 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 20 May 2013.