AsthmaPhase 2NCT00322686
Study of Oglemilast for the Treatment of Asthma
A Phase 2 study testing Oglemilast in people with Asthma, run by Forest Laboratories at 1 site in United States.
Trial summary
The purpose of this study is to determine whether oglemilast is safe and effective in the treatment of allergen-induced asthma. Read more about this study
- Who is it for?
- Ages 18 to 50 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
- 6 participants
- Where
- 1 siteUnited States
- Study dates
- May 2006to Dec 2006
- 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 50 years
- All sexes
- No healthy volunteers
- Adult
Who may be able to join
- Mild atopic asthma
- Hyperreactivity to methacholine
- Exhibit positive response to standard allergen skin prick test
Who cannot join
- Pulmonary disease other than asthma
- Asthma exacerbation within 4 weeks
- History of substance abuse
- Active cardiac disease
Trial locations and contacts
1 site in 1 country.
United States1 site
Forest Investigative Site
Los Angeles, California, 90025
About this study
Official title: Efficacy and Safety of Oglemilast in the Prevention of Allergen-induced Bronchospasm
The purpose of this study is to determine whether oglemilast is safe and effective in the treatment of allergen-induced asthma.
- Conditions
- Asthma
- Being tested
- Oglemilast, Placebo then Oglemilast
- Keywords
- oglemilast, asthma, allergen, prevention, prophylaxis, Allergen-Induced 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
Oglemilast, 15mg oral administration, once per day and then dose-matched placebo
Placebo then OglemilastDrug
Dose-matched placebo and then Oglemilast, 15mg, oral administration, once per day.
| Study group | Role | What they receive |
|---|---|---|
| Oglemilast followed by placebo | Experimental | Not described Receives: Drug: Oglemilast |
| Placebo followed by Oglemilast | Experimental | Not described Receives: Drug: Placebo then Oglemilast |
What is being measured
The primary outcome is the main question the study is designed to answer.
To determine the effect of oglemilast in the prevention of bronchoconstriction after the administration of allergen, in comparison with placebo in patients with mild asthma
Measured: From Baseline to Day 7
Secondary outcomes (1)
To evaluate the safety of oglemilast over 2 weeks as determined by adverse events,physical examinations, vital signs, electrocardiograms, and laboratory examinations
Measured: From Baseline to Day 14
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted8 May 2006 (estimated)
- Study startMay 2006
- Primary completionDec 2006
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
- Prevention
- Allocation
- Randomised
- Intervention model
- Crossover
- Masking
- Triple blind
- Who is masked
- Participant, Investigator, Outcomes assessor
- Enrolment
- 6 participants (actual)
Sponsor and investigators
- Lead sponsor
- Forest Laboratories
- Sponsor type
- Industry (pharma, biotech, devices)
- Responsible party
- Sponsor
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT00322686
- Sponsor's protocol ID
- GRC-MD-03
- Status last verified
- Mar 2012
- First submitted
- 4 May 2006
- Last updated
- 20 Mar 2012
- Results posted
- No
- Data monitoring committee
- No
Study at a glance
From the registry record, last updated by the sponsor on 20 Mar 2012. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Efficacy and Safety of Oglemilast in the Prevention of Allergen-induced Bronchospasm
- ClinicalTrials.gov ID
- NCT00322686
- Acronym / sponsor ID
- GRC-MD-03
- Conditions
- Asthma
- Keywords
- oglemilast, asthma, allergen, prevention, prophylaxis, Allergen-Induced Asthma
- Phase
- Phase 2
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 6 participants (actual)
- Lead sponsor
- Forest LaboratoriesIndustry (pharma, biotech, devices)
- Study start
- May 2006
- Primary completion
- Dec 2006 (actual)
- First posted
- 8 May 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 this study is to determine whether oglemilast is safe and effective in the treatment of allergen-induced asthma.
Study design
- Primary purpose
- Prevention
- Allocation
- Randomised
- Intervention model
- Crossover
- Masking
- Triple blind (participant, investigator, outcomes assessor)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Oglemilast followed by placebo | Experimental | Drug: Oglemilast |
| Placebo followed by Oglemilast | Experimental | Drug: Placebo then Oglemilast |
Who may qualify
- Ages
- 18 to 50 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult
Key inclusion criteria (3 listed)
- Mild atopic asthma
- Hyperreactivity to methacholine
- Exhibit positive response to standard allergen skin prick test
Key exclusion criteria (4 listed)
- Pulmonary disease other than asthma
- Asthma exacerbation within 4 weeks
- History of substance abuse
- Active cardiac disease
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 |
|---|---|---|
| OglemilastOglemilast, 15mg oral administration, once per day and then dose-matched placebo | Drug | Oglemilast followed by placebo |
| Placebo then OglemilastDose-matched placebo and then Oglemilast, 15mg, oral administration, once per day. | Drug | Placebo followed by Oglemilast |
Primary outcome
To determine the effect of oglemilast in the prevention of bronchoconstriction after the administration of allergen, in comparison with placebo in patients with mild asthma
Time frame: From Baseline to Day 7
1 secondary outcome
To evaluate the safety of oglemilast over 2 weeks as determined by adverse events,physical examinations, vital signs, electrocardiograms, and laboratory examinations
Time frame: From Baseline to Day 14
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 Mar 2012.
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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 Forest Laboratories at 1 site 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 3 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 20 Mar 2012. 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 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?
To determine the effect of oglemilast in the prevention of bronchoconstriction after the administration of allergen, in comparison with placebo in patients with mild asthma (time frame: From Baseline to Day 7). 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 Mar 2012.