AsthmaPhase 2NCT00859404
A Clinical Study of Oglemilast in Patients With Mild to Moderate Persistent Asthma
A Phase 2 study testing oglemilast in people with Asthma, run by Glenmark Pharmaceuticals Europe Ltd. (R&D) at 1 site in India.
Trial summary
The study is aimed at evaluating efficacy and safety of oglemilast in the treatment of stable mild to moderate persistent asthma. The study involves two weeks of run in period. This is a placebo controlled study. One of the four treatment arms is placebo. The duration of treatment is 12 weeks. Read more about this study
- Who is it for?
- Ages 18 to 65 years
- Conditions the study is for
- Asthma
- 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
- 282 participants
- Where
- 1 siteIndia
- Study dates
- Oct 2008to Jan 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 18 to 65 years
- All sexes
- No healthy volunteers
- Adult, Older adult
Eligibility Criteria:
- Adult patients with a physician-documented diagnosis of chronic, stable, persistent, mild to moderate asthma (clinical symptoms and documented reversibility of airway obstruction, with an FEV1 of 60% to 85% of the predicted value).
The following criteria must be met at the randomisation visit:
- At least 80% compliance during the single-blind placebo run-in period
- FEV1 between 60% and 85% of the predicted value
- Without asthma exacerbation during the run-in period
- Reversibility: patients are required to demonstrate a ≥ 12% increase in FEV1 (with an absolute improvement in FEV1 of at least 200mL) ≥ 10 min and up to 15 minutes after inhalation of 400 μg salbutamol via a spacer
- Any symptom score being ≥ 1 for at least 4 out of the last 7 days of the run-in
- Use of salbutamol for symptom relief on > 2 occasions on at least 4 out of the last 7 days of the run-in
Trial locations and contacts
1 site in 1 country.
About this study
Official title: A 12-week Randomized, Double-blind, Parallel Group, Placebo-controlled Dose Range Finding Study to Evaluate the Efficacy of Oglemilast in the Treatment of Stable Mild to Moderate Persistent Asthma
The study is aimed at evaluating efficacy and safety of oglemilast in the treatment of stable mild to moderate persistent asthma. The study involves two weeks of run in period. This is a placebo controlled study. One of the four treatment arms is placebo. The duration of treatment is 12 weeks.
- Conditions
- Asthma
- Being tested
- oglemilast
- Keywords
- Mild to moderate persistent asthma
- Medical subject headings
- Asthma
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
oglemilastDrug
Tablet oglemilast or placebo once a day, for 12 weeks
| Study group | Role | What they receive |
|---|---|---|
| 1. oglemilast | Experimental | Not described Receives: Drug: oglemilast |
| 2. oglemilast | Experimental | Not described Receives: Drug: oglemilast |
| 3. oglemilast | Experimental | Not described Receives: Drug: oglemilast |
| 4. placebo | Placebo comparator | Not described Receives: Drug: oglemilast |
What is being measured
The primary outcome is the main question the study is designed to answer.
Morning pre-dose FEV1 at day 85 compared with pre-dose FEV1 value at day 1
Measured: 12 weeks
Secondary outcomes (11)
Change from baseline at days 8, 36 and 64 in morning pre-dose FEV1
Measured: Days 8, 36, 64
Change from baseline at days 8, 36 and 64 in morning pre-dose vital capacity (FVC), peak expiratory flow (PEF), forced expiratory flow 25-75% (FEF25-75%)
Measured: days 8, 36 and 64
Change from baseline in morning and evening PEF (based on patient diary)
Measured: 12 weeks
Change in asthma day time symptom score from baseline at day 85
Measured: 12 weeks
Change in asthma night time symptom score from baseline at day 85
Measured: 12 weeks
Change in number of night time awakenings from baseline at day 85
Measured: 12 weeks
Frequency and the use of rescue (reliever) medication (salbutamol)
Measured: 12 weeks
Frequency and severity of asthma exacerbations
Measured: 12 weeks
Investigator global impression of change from baseline to day 85
Measured: 12 weeks
Patient global impression of change from baseline to day 85
Measured: 12 weeks
Pharmacokinetic parameters of oglemilast
Measured: 12 weeks
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted11 Mar 2009 (estimated)
- Study startOct 2008
- Primary completionDec 2009 (estimated)
- Study completionJan 2010 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for AsthmaStudies 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
- Quadruple blind
- Who is masked
- Participant, Care provider, Investigator, Outcomes assessor
- Enrolment
- 282 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Glenmark Pharmaceuticals Europe Ltd. (R&D)
- Sponsor type
- Industry (pharma, biotech, devices)
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT00859404
- Sponsor's protocol ID
- GRC 3886-201
- Status last verified
- Sep 2009
- First submitted
- 10 Mar 2009
- Last updated
- 24 Sep 2009
- Results posted
- No
- Data monitoring committee
- Yes
Study at a glance
From the registry record, last updated by the sponsor on 24 Sep 2009. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- A 12-week Randomized, Double-blind, Parallel Group, Placebo-controlled Dose Range Finding Study to Evaluate the Efficacy of Oglemilast in the Treatment of Stable Mild to Moderate Persistent Asthma
- ClinicalTrials.gov ID
- NCT00859404
- Acronym / sponsor ID
- GRC 3886-201
- Conditions
- Asthma
- Keywords
- Mild to moderate persistent asthma
- Phase
- Phase 2
- Study type
- Interventional
- Recruitment status
- Unknown status
- Enrolment
- 282 participants (estimated)
- Lead sponsor
- Glenmark Pharmaceuticals Europe Ltd. (R&D)Industry (pharma, biotech, devices)
- Study start
- Oct 2008
- Primary completion
- Dec 2009 (estimated)
- Study completion
- Jan 2010 (estimated)
- First posted
- 11 Mar 2009 (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 study is aimed at evaluating efficacy and safety of oglemilast in the treatment of stable mild to moderate persistent asthma. The study involves two weeks of run in period. This is a placebo controlled study. One of the four treatment arms is placebo. The duration of treatment is 12 weeks.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Quadruple blind (participant, care provider, investigator, outcomes assessor)
- Number of arms
- 4
| Arm | Type | Receives |
|---|---|---|
| 1. oglemilast | Experimental | Drug: oglemilast |
| 2. oglemilast | Experimental | Drug: oglemilast |
| 3. oglemilast | Experimental | Drug: oglemilast |
| 4. placebo | Placebo comparator | Drug: oglemilast |
Who may qualify
- Ages
- 18 to 65 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
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 |
|---|---|---|
| oglemilastTablet oglemilast or placebo once a day, for 12 weeks | Drug | 1. oglemilast, 2. oglemilast, 3. oglemilast, 4. placebo |
Primary outcome
Morning pre-dose FEV1 at day 85 compared with pre-dose FEV1 value at day 1
Time frame: 12 weeks
11 secondary outcomes
Change from baseline at days 8, 36 and 64 in morning pre-dose FEV1
Time frame: Days 8, 36, 64
Change from baseline at days 8, 36 and 64 in morning pre-dose vital capacity (FVC), peak expiratory flow (PEF), forced expiratory flow 25-75% (FEF25-75%)
Time frame: days 8, 36 and 64
Change from baseline in morning and evening PEF (based on patient diary)
Time frame: 12 weeks
Change in asthma day time symptom score from baseline at day 85
Time frame: 12 weeks
Change in asthma night time symptom score from baseline at day 85
Time frame: 12 weeks
Change in number of night time awakenings from baseline at day 85
Time frame: 12 weeks
Frequency and the use of rescue (reliever) medication (salbutamol)
Time frame: 12 weeks
Frequency and severity of asthma exacerbations
Time frame: 12 weeks
Investigator global impression of change from baseline to day 85
Time frame: 12 weeks
Patient global impression of change from baseline to day 85
Time frame: 12 weeks
Pharmacokinetic parameters of oglemilast
Time frame: 12 weeks
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 24 Sep 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.
1 site 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 Asthma, run by Glenmark Pharmaceuticals Europe Ltd. (R&D) at 1 site in India.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
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: status not confirmed, as of the sponsor's last update on 24 Sep 2009. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in India. 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?
Results are not available in the source record.
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?
Morning pre-dose FEV1 at day 85 compared with pre-dose FEV1 value at day 1 (time frame: 12 weeks). 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 24 Sep 2009.