Bronchial AsthmaPhase 2NCT01056692
OC000459 Bronchial Allergen Challenge
A Phase 2 study testing OC000459 in people with Bronchial Asthma, run by Oxagen Ltd at 2 sites in United Kingdom.
Trial summary
OC0000459 reduces inflammation in the tissues in response to allergic stimuli in patients with asthma. This clinical trial, in mildly asthmatic patients, studies the effects of OC000459 and placebo on the asthmatic response to two known stimulants of the asthmatic response in the lungs, namely cat hair, pollen or… Read more about this study
- Who is it for?
- Ages 18 to 45 years
- Conditions the study is for
- Bronchial 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
- 20 participants
- Where
- 2 sitesUnited Kingdom
- Study dates
- Feb 2006to not given
- 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 45 years
- All sexes
- No healthy volunteers
- Adult
Who may be able to join
- Known history of asthma (intermittent wheezing, cough, dyspnoea responsive to inhaled short acting beta agonists).
- FEV1 >65% of predicted on at least two occasions at screening.
- At the screening allergen challenge, a decrease in FEV1 of ≥20% in the early asthmatic reaction and of ≥15% in the LAR to allergen on 3 separate occasions between 3-10hrs post allergen, 2 of which must be consecutive.
- No steroid usage in the past 12 weeks.
- Testing positive to skin prick challenge with at least one of the following allergens: house dust mite, pollen or cat hair within the previous 12 months.
- Non smokers for a minimum of 6 months; less than 10 pack year history.
Who cannot join
- Respiratory tract pathology other than allergic asthma.
- Lower respiratory tract infection within 4 weeks prior to an allergen challenge.
- Receipt of prescribed or OTC medication other than paracetamol or short acting inhaled beta agonists within 14 days of screening or of the first day of each dosing period.
Trial locations and contacts
2 sites in 1 country.
United Kingdom2 sites
King's College London School of Medicine
London, London, SE5 9PJ
Medicines Evaluation Unit
Manchester, Manchester, M23 9LT
About this study
Official title: A Phase II Study of oc000459 in Subjects With Allergic Asthma; a Randomised, Double Blind, Two Way Balanced Crossover Comparing oc000459 With Placebo
OC0000459 reduces inflammation in the tissues in response to allergic stimuli in patients with asthma. This clinical trial, in mildly asthmatic patients, studies the effects of OC000459 and placebo on the asthmatic response to two known stimulants of the asthmatic response in the lungs, namely cat hair, pollen or house dust mite and methacholine.
- Conditions
- Bronchial Asthma
- Being tested
- OC000459, Placebo
- Keywords
- Asthma, bronchial allergen challenge, sputum eosinophiilia
- Medical subject headings
- Asthma
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
OC000459Drug
Capsules twice daily for 15 days
PlaceboDrug
Capsules twice daily for 15 days
| Study group | Role | What they receive |
|---|---|---|
| Active compound | Active comparator | OC000459 orally Receives: Drug: OC000459 |
| Placebo | Placebo comparator | Placebo given orally Receives: Drug: Placebo |
What is being measured
The primary outcome is the main question the study is designed to answer.
The primary endpoint is the diminution in the late asthmatic response to bronchial allergen challenge as measured by the AUC and the maximum of percentage reductions in FEV1 between 3 and 10 hours after allergen challenge.
Measured: Primary outcome is measured after 15 days of treatment with active or placebo
Secondary outcomes (1)
Secondary biological activity endpoints include the diminution of the early asthmatic response to bronchial allergen challenge sputum eosinophilia, the methacholine PC20 after allergen challenge and exhaled NO pre- and post-allergen.
Measured: These measures are examined after 15 days of treatment with either active or placebo
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted26 Jan 2010 (estimated)
- Study startFeb 2006
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 Bronchial 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
- Crossover
- Masking
- Double blind
- Enrolment
- 20 participants (actual)
Sponsor and investigators
- Lead sponsor
- Oxagen Ltd
- Sponsor type
- Industry (pharma, biotech, devices)
- Collaborators
- Medicines Evaluation Unit, Manchester, UK, King's College Hospital NHS Trust
- Investigators
- David Singh, MD, Principal investigator, Medicines Evaluation Unit, Manchester, UK
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT01056692
- Sponsor's protocol ID
- OC000459/004/05
- Status last verified
- Jan 2010
- First submitted
- 21 Dec 2009
- Last updated
- 26 Jan 2010
- Results posted
- No
- Data monitoring committee
- No
Publications
Singh D, Cadden P, Hunter M, Pearce Collins L, Perkins M, Pettipher R, Townsend E, Vinall S, O'Connor B. Inhibition of the asthmatic allergen challenge response by the CRTH2 antagonist OC000459. Eur Respir J. 2013 Jan;41(1):46-52. doi: 10.1183/09031936.00092111. Epub 2012 Apr 10.
PubMed 22496329
Study at a glance
From the registry record, last updated by the sponsor on 26 Jan 2010. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- A Phase II Study of oc000459 in Subjects With Allergic Asthma; a Randomised, Double Blind, Two Way Balanced Crossover Comparing oc000459 With Placebo
- ClinicalTrials.gov ID
- NCT01056692
- Acronym / sponsor ID
- OC000459/004/05
- Conditions
- Bronchial Asthma
- Keywords
- Asthma, bronchial allergen challenge, sputum eosinophiilia
- Phase
- Phase 2
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 20 participants (actual)
- Lead sponsor
- Oxagen LtdIndustry (pharma, biotech, devices)
- Collaborators
- Medicines Evaluation Unit, Manchester, UK, King's College Hospital NHS Trust
- Study start
- Feb 2006
- First posted
- 26 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.
OC0000459 reduces inflammation in the tissues in response to allergic stimuli in patients with asthma. This clinical trial, in mildly asthmatic patients, studies the effects of OC000459 and placebo on the asthmatic response to two known stimulants of the asthmatic response in the lungs, namely cat hair, pollen or house dust mite and methacholine.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Crossover
- Masking
- Double blind
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Active compound | Active comparator | Drug: OC000459OC000459 orally |
| Placebo | Placebo comparator | Drug: PlaceboPlacebo given orally |
Who may qualify
- Ages
- 18 to 45 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult
Key inclusion criteria (6 listed)
- Known history of asthma (intermittent wheezing, cough, dyspnoea responsive to inhaled short acting beta agonists).
- FEV1 >65% of predicted on at least two occasions at screening.
- At the screening allergen challenge, a decrease in FEV1 of ≥20% in the early asthmatic reaction and of ≥15% in the LAR to allergen on 3 separate occasions between 3-10hrs post allergen, 2 of which must be consecutive.
- No steroid usage in the past 12 weeks.
- Testing positive to skin prick challenge with at least one of the following allergens: house dust mite, pollen or cat hair within the previous 12 months.
Key exclusion criteria (3 listed)
- Respiratory tract pathology other than allergic asthma.
- Lower respiratory tract infection within 4 weeks prior to an allergen challenge.
- Receipt of prescribed or OTC medication other than paracetamol or short acting inhaled beta agonists within 14 days of screening or of the first day of each dosing period.
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 |
|---|---|---|
| OC000459Capsules twice daily for 15 days | Drug | Active compound |
| PlaceboCapsules twice daily for 15 days | Drug | Placebo |
Primary outcome
The primary endpoint is the diminution in the late asthmatic response to bronchial allergen challenge as measured by the AUC and the maximum of percentage reductions in FEV1 between 3 and 10 hours after allergen challenge.
Time frame: Primary outcome is measured after 15 days of treatment with active or placebo
1 secondary outcome
Secondary biological activity endpoints include the diminution of the early asthmatic response to bronchial allergen challenge sputum eosinophilia, the methacholine PC20 after allergen challenge and exhaled NO pre- and post-allergen.
Time frame: These measures are examined after 15 days of treatment with either active or placebo
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 26 Jan 2010.
- Derived from this study: PubMed 22496329Singh D, Cadden P, Hunter M, Pearce Collins L, Perkins M, Pettipher R, Townsend E, Vinall S, O'Connor B. Inhibition of the asthmatic allergen challenge response by the CRTH2 antagonist OC000459. Eur Respir J. 2013 Jan;41(1):46-52. doi: 10.1183/09031936.00092111. Epub 2012 Apr 10.
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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.
David Singh, MD principal investigator
Medicines Evaluation Unit, Manchester, UK
2 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 Bronchial Asthma, run by Oxagen Ltd at 2 sites in United Kingdom.
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 6 inclusion and 3 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 26 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 2 sites in United Kingdom. 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?
The primary endpoint is the diminution in the late asthmatic response to bronchial allergen challenge as measured by the AUC and the maximum of percentage reductions in FEV1 between 3 and 10 hours after allergen challenge. (time frame: Primary outcome is measured after 15 days of treatment with active or placebo). 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 NCT01056692, 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 26 Jan 2010.