AsthmaPhase 2NCT01057927
Safety and Efficacy Study of OC000459 Dosed Twice Daily for 28 Days in Asthmatic Subjects
A Phase 2 study testing OC000459 in people with Asthma, run by Oxagen Ltd at 16 sites in Russia.
Trial summary
The purpose of the study is to investigate the clinical effects of multiple (28 day) twice-daily doses of OC000459 in comparison to placebo on clinic lung function (FEV1) in mild to moderate asthmatics with an FEV1 of 60-80% of predicted and requiring only short acting inhaled B2-adrenergic agonists for symptomatic… Read more about this study
- Who is it for?
- Ages 18 to 55 years
- Conditions the study is for
- Asthma
- What is being tested?
- OC000459
- Type of treatment
- Pill or oral medicine
- Could I receive a placebo?
- Yes, some participants may receive a placebo
- How many people
- 132 participants
- Where
- 16 sitesRussia
- Study dates
- Jan 2007to Nov 2007
- 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 55 years
- All sexes
- No healthy volunteers
- Adult
Who may be able to join
- Male or female asthmatics, any racial group. Females of childbearing potential must practise two forms of contraception
- Non smokers
- Mild to moderate asthmatics according to GINA guidelines for at least 12 months.
- History of asthma symptoms increasing in response to external allergens.
- Testing positive on skin prick test to an allergen associated with the subject's asthma
Who cannot join
- Use of inhaled or local corticosteroids in the period from 28 days prior to screening.
- Receipt of prescribed or over the counter medication within 14 days of the first study day.
Trial locations and contacts
16 sites in 1 country.
16 sites in 1 country
Russia16 sites
Research Institute of Pulmonology
Moscow, 105077
Burdenko Main Military Hospital
Moscow, 105229
City Hospital #23
Moscow, 109240
City Hospital #7
Moscow, 115446
Vishnevsky Central Military Hospital #3
Moscow, 194354
Leningrad Regional Hospital
Saint Petersbrug, 194291
St George City Hospital
Saint Petersbrug, 194354
St Petersburg Medical Academy of Postgraduate Education
Saint Petersburg, 190068
St Petersburg Medical Academy
Saint Petersburg, 190068
Outpatient Clinic #94
Saint Petersburg, 193231
St Petersbrug Hospital of the Russian Academy of Science
Saint Petersburg, 194017
Russian Center of Emergency and Radiology Medicine
Saint Petersburg, 194044
St Petersburg State Pediatrics Academy
Saint Petersburg, 194100
Central Medical Unit #122
Saint Petersburg, 194291
St George City Hospital
Saint Petersburg, 194354
Sverdlovsk Regional Hospital #1
Yekaterinburg, 620102
About this study
Official title: Parallel Group, Randomised, Placebo Controlled, Double Blind Oral Assessment of OC000459 Dosed Twice Daily for 28 Days in Asthmatic Subjects
The purpose of the study is to investigate the clinical effects of multiple (28 day) twice-daily doses of OC000459 in comparison to placebo on clinic lung function (FEV1) in mild to moderate asthmatics with an FEV1 of 60-80% of predicted and requiring only short acting inhaled B2-adrenergic agonists for symptomatic control.
- Conditions
- Asthma
- Being tested
- OC000459, Placebo
- Medical subject headings
- Asthma
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
OC000459Drug
OC000459 capsules 2x100mg BID for 28 days
PlaceboDrug
Placebo capsules to match OC000459 100mg capsules, 2 tablets BID
| Study group | Role | What they receive |
|---|---|---|
| OC000459 | Experimental | Not described Receives: Drug: OC000459 |
| Placebo | Placebo comparator | Not described Receives: Drug: Placebo |
What is being measured
The primary outcome is the main question the study is designed to answer.
Forced expiratory volume in one second (FEV1)
Measured: 28 days
Secondary outcomes (3)
Clinic peak expiratory flow, diary peak expiratory flow, diary asthma symptoms, diary salbutamol use, Asthma Quality of Life Questionnaire (AQLQ(S))
Measured: 28 days
Sputum eosinophilia (subset of patients) and serum IgE
Measured: 28 days
Safety and tolerability assessed by adverse events, chest examination, concomitant medication and laboratory safety parameters
Measured: 28 days
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted28 Jan 2010 (estimated)
- Study startJan 2007
- Primary completionNov 2007
- Study completionNov 2007
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (1)Papers the sponsor has linked to this study.
- 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
- Double blind
- Who is masked
- Participant, Investigator
- Enrolment
- 132 participants (actual)
Sponsor and investigators
- Lead sponsor
- Oxagen Ltd
- Sponsor type
- Industry (pharma, biotech, devices)
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT01057927
- Sponsor's protocol ID
- OC000459/006/06
- Status last verified
- Jan 2010
- First submitted
- 25 Jan 2010
- Last updated
- 28 Jan 2010
- Results posted
- No
- Data monitoring committee
- Yes
Publications
Barnes N, Pavord I, Chuchalin A, Bell J, Hunter M, Lewis T, Parker D, Payton M, Collins LP, Pettipher R, Steiner J, Perkins CM. A randomized, double-blind, placebo-controlled study of the CRTH2 antagonist OC000459 in moderate persistent asthma. Clin Exp Allergy. 2012 Jan;42(1):38-48. doi: 10.1111/j.1365-2222.2011.03813.x. Epub 2011 Jul 15.
PubMed 21762224
Study at a glance
From the registry record, last updated by the sponsor on 28 Jan 2010. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Parallel Group, Randomised, Placebo Controlled, Double Blind Oral Assessment of OC000459 Dosed Twice Daily for 28 Days in Asthmatic Subjects
- ClinicalTrials.gov ID
- NCT01057927
- Acronym / sponsor ID
- OC000459/006/06
- Conditions
- Asthma
- Phase
- Phase 2
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 132 participants (actual)
- Lead sponsor
- Oxagen LtdIndustry (pharma, biotech, devices)
- Study start
- Jan 2007
- Primary completion
- Nov 2007 (actual)
- Study completion
- Nov 2007 (actual)
- First posted
- 28 Jan 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 the study is to investigate the clinical effects of multiple (28 day) twice-daily doses of OC000459 in comparison to placebo on clinic lung function (FEV1) in mild to moderate asthmatics with an FEV1 of 60-80% of predicted and requiring only short acting inhaled B2-adrenergic agonists for symptomatic control.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Double blind (participant, investigator)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| OC000459 | Experimental | Drug: OC000459 |
| Placebo | Placebo comparator | Drug: Placebo |
Who may qualify
- Ages
- 18 to 55 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult
Key inclusion criteria (5 listed)
- Male or female asthmatics, any racial group. Females of childbearing potential must practise two forms of contraception
- Non smokers
- Mild to moderate asthmatics according to GINA guidelines for at least 12 months.
- History of asthma symptoms increasing in response to external allergens.
- Testing positive on skin prick test to an allergen associated with the subject's asthma
Key exclusion criteria (2 listed)
- Use of inhaled or local corticosteroids in the period from 28 days prior to screening.
- Receipt of prescribed or over the counter medication within 14 days of the first study day.
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 |
|---|---|---|
| OC000459OC000459 capsules 2x100mg BID for 28 days | Drug | OC000459 |
| PlaceboPlacebo capsules to match OC000459 100mg capsules, 2 tablets BID | Drug | Placebo |
Primary outcome
Forced expiratory volume in one second (FEV1)
Time frame: 28 days
3 secondary outcomes
Clinic peak expiratory flow, diary peak expiratory flow, diary asthma symptoms, diary salbutamol use, Asthma Quality of Life Questionnaire (AQLQ(S))
Time frame: 28 days
Sputum eosinophilia (subset of patients) and serum IgE
Time frame: 28 days
Safety and tolerability assessed by adverse events, chest examination, concomitant medication and laboratory safety parameters
Time frame: 28 days
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 28 Jan 2010.
- Derived from this study: PubMed 21762224Barnes N, Pavord I, Chuchalin A, Bell J, Hunter M, Lewis T, Parker D, Payton M, Collins LP, Pettipher R, Steiner J, Perkins CM. A randomized, double-blind, placebo-controlled study of the CRTH2 antagonist OC000459 in moderate persistent asthma. Clin Exp Allergy. 2012 Jan;42(1):38-48. doi: 10.1111/j.1365-2222.2011.03813.x. Epub 2011 Jul 15.
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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.
16 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 OC000459 in people with Asthma, run by Oxagen Ltd at 16 sites in Russia.
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 5 inclusion and 2 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 28 Jan 2010. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 16 sites in Russia. 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?
Forced expiratory volume in one second (FEV1) (time frame: 28 days). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT01057927, which also lists 1 linked publication.
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 28 Jan 2010.