Pulmonary Disease, Chronic ObstructivePhase 2NCT00671073
Study To Assess Efficacy and Safety of Oglemilast in Patients With Chronic Obstructive Pulmonary Disease (COPD)
A Phase 2 study testing Oglemilast in people with Pulmonary Disease, Chronic Obstructive, run by Forest Laboratories at 47 sites in United States.
Trial summary
This study will assess the safety and efficacy of a range of oglemilast doses. The study will be 14 weeks in duration. All patients meeting the eligibility criteria will be randomized to one of three doses of oglemilast or placebo. Read more about this study
- Who is it for?
- Ages 40 to 80 years
- Conditions the study is for
- Pulmonary Disease, Chronic Obstructive
- What is being tested?
- Oglemilast
- Type of treatment
- Pill or oral medicine
- Could I receive a placebo?
- Yes, some participants may receive a placebo
- How many people
- 427 participants
- Where
- 47 sitesUnited States
- Study dates
- 5 May 2008to 15 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 to 80 years
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- Presence of COPD as defined by GOLD criteria (2006); post-bronchodilator FEV1/FVC <70%, and post-bronchodilator FEV1 >30% and < 80% predicted
- Current or former cigarette smoker
Who cannot join
- Long-term oxygen use of > 15 hours a day
- Symptoms consistent with a significant asthmatic component (e.g. atopic disease, allergic symptoms)
- Any COPD exacerbations within 30 days prior to study entry or during run-in
- History of chronic or recurrent gastrointestinal disorder associated with bleeding in previous 12 months
- Presence of clinical significant pulmonary disease other than COPD
Trial locations and contacts
47 sites in 1 country.
47 sites in 1 country
United States47 sites
Forest Investigative Site
Bethlehem, Pennsylvania, 18020
Forest Investigative Site
Birmingham, Alabama, 35215
Forest Investigative Site
Buena Park, California, 90620
Forest Investigative Site
Centennial, Colorado, 80112
Forest Investigative Site
Charleston, South Carolina, 29406
Forest Investigative Site
Charlotte, North Carolina, 28207
Forest Investigative Site
Cherry Hill, New Jersey, 08003
Forest Investigative Site
Cincinnati, Ohio, 45231
Forest Investigative Site
Cincinnati, Ohio, 45242
Forest Investigative Site
Edina, Minnesota, 55437
Forest Investigative Site
El Paso, Texas, 79902
Forest Investigative Site
Elmira, New York, 14901
Forest Investigative Site
Encinitas, California, 92024
Forest Investigative Site
Evansville, Indiana, 47713
Forest Investigative Site
Fort Lauderdale, Florida, 33316
Forest Investigative Site
Fredericksburg, Virginia, 22401
Forest Investigative Site
Fullerton, California, 92835
Forest Investigative Site
Greenville, South Carolina, 29615
Forest Investigative Site
Livonia, Michigan, 48152
Forest Investigative Site
Los Angeles, California, 90095
Forest Investigative Site
Medford, Oregon, 97504
Forest Investigative Site
Miami, Florida, 33155
Forest Investigative Site
Miami, Florida, 33169
Forest Investigative Site
Mineola, New York, 11501
Forest Investigative Site
Minneapolis, Minnesota, 55407
Forest Investigative Site
North Dartmouth, Massachusetts, 02747
Forest Investigative Site
Orange, California, 92868
Forest Investigative Site
Ormond Beach, Florida, 32174
Forest Investigative Site
Papillion, Nebraska, 68046
Forest Investigative Site
Philadelphia, Pennsylvania, 19140
Forest Investigative Site
Phoenix, Arizona, 85006
Forest Investigative Site
Portland, Oregon, 97213
Forest Investigative Site
Rancho Mirage, California, 92270
Forest Investigative Site
Rochester, New York, 14618
Forest Investigative Site
San Antonio, Texas, 78229
Forest Investigative Site
San Diego, California, 92120
Forest Investigative Site
San Diego, California, 92134
Forest Investigative Site
Skokie, Illinois, 60076
Forest Investigative Site
Spartanburg, South Carolina, 29303
Forest Investigative Site
Stockton, California, 95207
Forest Investigative Site
Tacoma, Washington, 98405
Forest Investigative Site
Tamarac, Florida, 33321
Forest Investigative Site
Toledo, Ohio, 43614
Forest Investigative Site
Tucson, Arizona, 85715
Forest Investigative Site
Waterbury, Connecticut, 06708
Forest Investigative Site WR1
Wheat Ridge, Colorado, 80033
Forest Investigative Site WR2
Wheat Ridge, Colorado, 80033
About this study
Official title: Phase II Dose-Ranging Study of the Efficacy and Safety of Oglemilast in Patients With COPD
This study will assess the safety and efficacy of a range of oglemilast doses. The study will be 14 weeks in duration. All patients meeting the eligibility criteria will be randomized to one of three doses of oglemilast or placebo.
- Conditions
- Pulmonary Disease, Chronic Obstructive
- Being tested
- Oglemilast, Placebo
- Keywords
- Airflow Obstruction, Chronic, Chronic Airflow Obstruction, Chronic Obstructive Pulmonary Disease, Chronic Obstructive Airway Disease, Chronic Obstructive Lung Disease, COPD, COAD
- 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.
OglemilastDrug
Also called GRC 3886
Oglemilast low dose, oral administration, once daily for 12 weeks
PlaceboDrug
Placebo, oral administration, once daily for 12 weeks
OglemilastDrug
Also called GRC 3886
Oglemilast middle dose, oral administration, once daily for 12 weeks
OglemilastDrug
Also called GRC 3886
Oglemilast high dose, oral administration, once daily for 12 weeks
| Study group | Role | What they receive |
|---|---|---|
| 1 | Active comparator | Oglemilast low dose, oral administration once daily for 12 weeks Receives: Drug: Oglemilast |
| 2 | Active comparator | Oglemilast middle dose, oral administration, once daily for 12 weeks Receives: Drug: Oglemilast |
| 3 | Active comparator | Oglemilast high dose, oral administration, once daily for 12 weeks. Receives: Drug: Oglemilast |
| 4 | Placebo comparator | Placebo Receives: Drug: Placebo |
What is being measured
The primary outcome is the main question the study is designed to answer.
Pre-bronchodilator morning (trough) forced expiratory volume in 1 second (FEV1)
Measured: After 12 weeks of treatment
Secondary outcomes (1)
Pre-bronchodilator forced vital capacity (FVC)
Measured: After 12 weeks of treatment
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted2 May 2008 (estimated)
- Study start5 May 2008
- Primary completion15 May 2009
- Study completion15 May 2009
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Pulmonary Disease, Chronic ObstructiveStudies 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
- Who is masked
- Participant, Investigator
- Enrolment
- 427 participants (actual)
Sponsor and investigators
- Lead sponsor
- Forest Laboratories
- Sponsor type
- Industry (pharma, biotech, devices)
- Responsible party
- Sponsor
- Investigators
- Brian T Maurer, MS, Study director, Forest Laboratories
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT00671073
- Sponsor's protocol ID
- GRC-MD-50
- Status last verified
- Sep 2019
- First submitted
- 29 Apr 2008
- Last updated
- 19 Sep 2019
- Results posted
- No
- Data monitoring committee
- No
Study at a glance
From the registry record, last updated by the sponsor on 19 Sep 2019. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Phase II Dose-Ranging Study of the Efficacy and Safety of Oglemilast in Patients With COPD
- ClinicalTrials.gov ID
- NCT00671073
- Acronym / sponsor ID
- GRC-MD-50
- Conditions
- Pulmonary Disease, Chronic Obstructive
- Keywords
- Airflow Obstruction, Chronic, Chronic Airflow Obstruction, Chronic Obstructive Pulmonary Disease, Chronic Obstructive Airway Disease, Chronic Obstructive Lung Disease, COPD, COAD
- Phase
- Phase 2
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 427 participants (actual)
- Lead sponsor
- Forest LaboratoriesIndustry (pharma, biotech, devices)
- Study start
- 5 May 2008
- Primary completion
- 15 May 2009 (actual)
- Study completion
- 15 May 2009 (actual)
- First posted
- 2 May 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.
This study will assess the safety and efficacy of a range of oglemilast doses. The study will be 14 weeks in duration. All patients meeting the eligibility criteria will be randomized to one of three doses of oglemilast or placebo.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Double blind (participant, investigator)
- Number of arms
- 4
| Arm | Type | Receives |
|---|---|---|
| 1 | Active comparator | Drug: OglemilastOglemilast low dose, oral administration once daily for 12 weeks |
| 2 | Active comparator | Drug: OglemilastOglemilast middle dose, oral administration, once daily for 12 weeks |
| 3 | Active comparator | Drug: OglemilastOglemilast high dose, oral administration, once daily for 12 weeks. |
| 4 | Placebo comparator | Drug: PlaceboPlacebo |
Who may qualify
- Ages
- 40 to 80 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (2 listed)
- Presence of COPD as defined by GOLD criteria (2006); post-bronchodilator FEV1/FVC <70%, and post-bronchodilator FEV1 >30% and < 80% predicted
- Current or former cigarette smoker
Key exclusion criteria (5 listed)
- Long-term oxygen use of > 15 hours a day
- Symptoms consistent with a significant asthmatic component (e.g. atopic disease, allergic symptoms)
- Any COPD exacerbations within 30 days prior to study entry or during run-in
- History of chronic or recurrent gastrointestinal disorder associated with bleeding in previous 12 months
- Presence of clinical significant pulmonary disease other than COPD
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 |
|---|---|---|
| OglemilastAlso: GRC 3886Oglemilast low dose, oral administration, once daily for 12 weeks | Drug | 1 |
| PlaceboPlacebo, oral administration, once daily for 12 weeks | Drug | 4 |
| OglemilastAlso: GRC 3886Oglemilast middle dose, oral administration, once daily for 12 weeks | Drug | 2 |
| OglemilastAlso: GRC 3886Oglemilast high dose, oral administration, once daily for 12 weeks | Drug | 3 |
Primary outcome
Pre-bronchodilator morning (trough) forced expiratory volume in 1 second (FEV1)
Time frame: After 12 weeks of treatment
1 secondary outcome
Pre-bronchodilator forced vital capacity (FVC)
Time frame: After 12 weeks of treatment
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 19 Sep 2019.
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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.
Brian T Maurer, MS study director
Forest Laboratories
47 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 Oglemilast in people with Pulmonary Disease, Chronic Obstructive, run by Forest Laboratories at 47 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 2 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 19 Sep 2019. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 47 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?
Pre-bronchodilator morning (trough) forced expiratory volume in 1 second (FEV1) (time frame: After 12 weeks of treatment). 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 19 Sep 2019.