Chronic Obstructive Pulmonary Disease (COPD)Phase 2NCT01113593
A Study Characterizing Pharmacodynamic Profiles in Subjects With Chronic Obstructive Pulmonary Disease
A Phase 2 study testing Formoterol Fumarate and Foradil Aerolizer in people with Chronic Obstructive Pulmonary Disease (COPD), run by Dey at 4 sites in United States.
Trial summary
The purpose of this study is to characterize the pharmacodynamic profile of Formoterol Fumarate and Foradil Aerolizer Read more about this study
- Who is it for?
- Ages 40 years and older
- Conditions the study is for
- Chronic Obstructive Pulmonary Disease (COPD)
- What is being tested?
- Formoterol Fumarate and Foradil Aerolizer
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 45 participants
- Where
- 4 sitesUnited States
- Study dates
- May 2010to May 2010
- 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 informed consent
- A Clinical diagnosis of COPD
- A current or prior history of at least 10-pack years of cigarette smoking
- women of child-bearing potential (WOCBP) must have a negative pregnancy test at the Screening Visit and agree to avoid becoming pregnant for the duration of study
Who cannot join
- A Clinical Diagnosis of Asthma
- Other significant disease than COPD
- Subjects who radiation or chemotherapy within the previous 12 months
- Subjects who had any lung resection
- QTcB greater than 0.460 seconds
- History of illegal drug abuse or alcohol abuse within the past 5 years
Trial locations and contacts
4 sites in 1 country.
United States4 sites
Study site
Clearwater, Florida
Study site
DeLand, Florida
Study site
Greenville, South Carolina
Study site
Spartanburg, South Carolina
About this study
Official title: A Randomized, Multiple-Dose, Crossover Study Characterizing the Pharmacodynamic Profiles of Formoterol Fumarate Inhalation Solution and Formoterol Dry Powder Inhaler in Subjects With Stable Chronic Obstructive Pulmonary Disease
The purpose of this study is to characterize the pharmacodynamic profile of Formoterol Fumarate and Foradil Aerolizer
- Being tested
- Formoterol Fumarate, Foradil Aerolizer
- Keywords
- COPD
- 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 FumarateDrug
Inhalation solution
Formoterol FumarateDrug
Inhalation solution
Formoterol FumarateDrug
Inhalation solution
Foradil AerolizerDrug
Dry powder inhaler
Foradil AerolizerDrug
Dry powder inhaler
| Study group | Role | What they receive |
|---|---|---|
| 1 | Experimental | Not described Receives: Drug: Formoterol Fumarate |
| 2 | Experimental | Not described Receives: Drug: Formoterol Fumarate |
| 3 | Experimental | Not described Receives: Drug: Formoterol Fumarate |
| 4 | Experimental | Not described Receives: Drug: Foradil Aerolizer |
| 5 | Experimental | Not described Receives: Drug: Foradil Aerolizer |
What is being measured
The primary outcome is the main question the study is designed to answer.
Forced expiratory volume at one second (FEV1) measured (in liters) by serial spirometry to compare dosing effect and characterize pharmacodynamic profile of Formoterol Fumarate and Foradil
Measured: 12 hours on Day 1 and Day 7 of dosing during each treatment period
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted30 Apr 2010 (estimated)
- Study startMay 2010
- Primary completionMay 2010
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Chronic Obstructive Pulmonary Disease (COPD)Studies 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
- Quadruple blind
- Who is masked
- Participant, Care provider, Investigator, Outcomes assessor
- Enrolment
- 45 participants (actual)
Sponsor and investigators
- Lead sponsor
- Dey
- Sponsor type
- Industry (pharma, biotech, devices)
- Responsible party
- Sponsor
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT01113593
- Sponsor's protocol ID
- 191-089
- Status last verified
- May 2013
- First submitted
- 27 Apr 2010
- Last updated
- 27 May 2013
- Results posted
- No
- Data monitoring committee
- No
Study at a glance
From the registry record, last updated by the sponsor on 27 May 2013. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- A Randomized, Multiple-Dose, Crossover Study Characterizing the Pharmacodynamic Profiles of Formoterol Fumarate Inhalation Solution and Formoterol Dry Powder Inhaler in Subjects With Stable Chronic Obstructive Pulmonary Disease
- ClinicalTrials.gov ID
- NCT01113593
- Acronym / sponsor ID
- 191-089
- Keywords
- COPD
- Phase
- Phase 2
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 45 participants (actual)
- Lead sponsor
- DeyIndustry (pharma, biotech, devices)
- Study start
- May 2010
- Primary completion
- May 2010 (actual)
- First posted
- 30 Apr 2010 (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 characterize the pharmacodynamic profile of Formoterol Fumarate and Foradil Aerolizer
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Crossover
- Masking
- Quadruple blind (participant, care provider, investigator, outcomes assessor)
- Number of arms
- 5
| Arm | Type | Receives |
|---|---|---|
| 1 | Experimental | Drug: Formoterol Fumarate |
| 2 | Experimental | Drug: Formoterol Fumarate |
| 3 | Experimental | Drug: Formoterol Fumarate |
| 4 | Experimental | Drug: Foradil Aerolizer |
| 5 | Experimental | Drug: Foradil Aerolizer |
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 informed consent
- A Clinical diagnosis of COPD
- A current or prior history of at least 10-pack years of cigarette smoking
- women of child-bearing potential (WOCBP) must have a negative pregnancy test at the Screening Visit and agree to avoid becoming pregnant for the duration of study
Key exclusion criteria (6 listed)
- A Clinical Diagnosis of Asthma
- Other significant disease than COPD
- Subjects who radiation or chemotherapy within the previous 12 months
- Subjects who had any lung resection
- QTcB greater than 0.460 seconds
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 FumarateInhalation solution | Drug | 1 |
| Formoterol FumarateInhalation solution | Drug | 2 |
| Formoterol FumarateInhalation solution | Drug | 3 |
| Foradil AerolizerDry powder inhaler | Drug | 4 |
| Foradil AerolizerDry powder inhaler | Drug | 5 |
Primary outcome
Forced expiratory volume at one second (FEV1) measured (in liters) by serial spirometry to compare dosing effect and characterize pharmacodynamic profile of Formoterol Fumarate and Foradil
Time frame: 12 hours on Day 1 and Day 7 of dosing during each treatment period
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 27 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.
4 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 Formoterol Fumarate and Foradil Aerolizer in people with Chronic Obstructive Pulmonary Disease (COPD), run by Dey at 4 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 6 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 27 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 4 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?
Forced expiratory volume at one second (FEV1) measured (in liters) by serial spirometry to compare dosing effect and characterize pharmacodynamic profile of Formoterol Fumarate and Foradil (time frame: 12 hours on Day 1 and Day 7 of dosing during each treatment period). 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 27 May 2013.