AsthmaPhase 2NCT01551147
A Placebo and Active Controlled Study of ONO-6950 Following Allergen Challenge in Patients With Asthma
A Phase 2 study testing ONO-6950 and Montelukast in people with Asthma, run by Ono Pharma USA Inc at 5 sites in Canada.
Trial summary
The primary objectives are to determine the effect of ONO-6950 200 mg QD versus placebo administered for 8 days on early asthmatic response (EAR) and late asthmatic response (LAR) induced by inhaled allergen to determine the safety and tolerability of ONO-6950 200 mg QD administered for 8 days in patients with asthma… Read more about this study
- Who is it for?
- Ages 18 to 60 years
- Conditions the study is for
- Asthma
- What is being tested?
- ONO-6950 and Montelukast
- Type of treatment
- Pill or oral medicine
- Could I receive a placebo?
- Yes, some participants may receive a placebo
- How many people
- 25 participants
- Where
- 5 sitesCanada
- Study dates
- Jun 2012to Apr 2013
- 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 60 years
- All sexes
- No healthy volunteers
- Adult
Who may be able to join
- Patients of both genders, between 18 to 60 years of age, with bronchial asthma symptoms for at least 6 months
- Patients with FEV1 ≥ 70% of predicted after withholding short-acting β agonists for at least 8 hours prior to testing
- Screening allergen challenge demonstrates that the patient experiences both an early and late asthmatic response
- Sensitivity to methacholine resulting in a ≥ 20% fall in FEV1 (PC20 methacholine)
- Non-smokers with free from the usage of nicotine-containing products at least for a year prior to screening
Who cannot join
- Previous history of life-threatening asthma, respiratory tract infection and/or exacerbation of asthma within 6 weeks prior to the first screening visit
- Past or present disorders and diseases including, but are not limited to, cardiovascular, malignancy, hepatic, renal, hematological, neurological, psychiatric, endocrine, or pulmonary other than asthma
- Significant safety laboratory, ECG, or vital sign abnormalities that would place the patient at undue disk during the study procedures
- History of clinically significant multiple drug or food allergy
Trial locations and contacts
5 sites in 1 country.
5 sites in 1 country
Canada5 sites
Calgary Clinical Site 540
Alberta, T2N4N1
Hamilton Clinical Site 550
Ontario, L8N3Z5
Quebec Clinical Site 510
Québec, G1V4GS
Saskatoon Clinical Site 520
Saskatoon, S7N0W8
Vancouver Clinical Site 530
Vancouver, British Columbia, V6T2B5
About this study
Official title: A Double-blind, Placebo-controlled, Three-way Crossover Study to Compare the Safety and Efficacy of 8 Days of Therapy With ONO-6950 Versus Placebo and Montelukast (Singulair®) on Asthmatic Responses and Airway Hypersensitivity Following Allergen Challenge in Patients With Asthma
The primary objectives are
- to determine the effect of ONO-6950 200 mg QD versus placebo administered for 8 days on early asthmatic response (EAR) and late asthmatic response (LAR) induced by inhaled allergen
- to determine the safety and tolerability of ONO-6950 200 mg QD administered for 8 days in patients with asthma
The secondary objectives are:
- to compare the effect of ONO-6950 versus montelukast on the % decrease of FEV1 following allergen exposure, and
- to determine the effect of ONO-6950 versus placebo and montelukast on allergen-induced airway hyperresponsiveness (AHR) as measured by methacholine challenge
Read the detailed description
The study will examine if ONO-6950 could alleviate EAR and LAR caused by an allergen challenge in subjects with asthma. Patients will be required to have EAR and LAR after standardized allergen challenges during the screening. Eligible patients will complete a randomized, double-blind, three-way crossover study. During each of three evaluation periods, patients will be administered either 200 mg ONO-6950, 10 mg Montelukast, or placebo for 8 days. Each evaluation period will occur over 8 days and will include various assessments following allergen challenge and methacholine challenge. The study does not require an overnight stay at the clinical research center.
- Conditions
- Asthma
- Being tested
- ONO-6950, Placebo, Montelukast
- Keywords
- asthma, ONO-6950, asthma in adult patients
- Medical subject headings
- Asthma
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
ONO-6950Drug
200 mg QD for 8 days
PlaceboDrug
Placebo to match ONO-6950 tablets or over-encapsulated Montelukast tablets dosed in a similar manner
MontelukastDrug
10 mg Montelukast QD for 8 days
| Study group | Role | What they receive |
|---|---|---|
| Experimental 200 mg dose | Experimental | Not described Receives: Drug: ONO-6950 |
| Active Comparator | Active comparator | Not described Receives: Drug: Montelukast |
| Placebo Comparator | Placebo comparator | Not described Receives: Drug: Placebo |
What is being measured
The primary outcome is the main question the study is designed to answer.
Late Asthmatic Response (3-7 hours after allergen challenge) as measured by the AUC in FEV1
Measured: Day 7
Early Asthmatic Response as measured by the AUC in FEV1
Measured: Day 7
Late Asthmatic Response as measured by the Maximum Fall in FEV1
Measured: Day 7
Early Asthmatic Response as measured by the Maximum Fall in FEV1
Measured: Day 7
Secondary outcomes (2)
Differences in PC20 pre-post treatment as measured by methacholine challenge
Measured: Day 6
Differences in PC20 pre-post allergen challenge as measured by methacholine challenge
Measured: Day 8
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted12 Mar 2012 (estimated)
- Study startJun 2012
- Primary completionApr 2013
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
- Crossover
- Masking
- Double blind
- Who is masked
- Participant, Investigator
- Enrolment
- 25 participants (actual)
Sponsor and investigators
- Lead sponsor
- Ono Pharma USA Inc
- Sponsor type
- Industry (pharma, biotech, devices)
- Collaborators
- Ono Pharmaceutical Co., Ltd.
- Responsible party
- Sponsor
- Investigators
- Ono Pharma USA, Inc., Study director, Ono Pharmaceutical Co., Ltd.
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT01551147
- Sponsor's protocol ID
- ONO-6950POU005
- Status last verified
- Apr 2013
- First submitted
- 8 Mar 2012
- Last updated
- 30 Apr 2013
- Results posted
- No
- Data monitoring committee
- No
Publications
Gauvreau GM, Boulet LP, FitzGerald JM, Cockcroft DW, Davis BE, Leigh R, Tanaka M, Fourre JA, Tanaka M, Nabata T, O'Byrne PM. A dual CysLT1/2 antagonist attenuates allergen-induced airway responses in subjects with mild allergic asthma. Allergy. 2016 Dec;71(12):1721-1727. doi: 10.1111/all.12987. Epub 2016 Aug 9.
PubMed 27444660
Study at a glance
From the registry record, last updated by the sponsor on 30 Apr 2013. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- A Double-blind, Placebo-controlled, Three-way Crossover Study to Compare the Safety and Efficacy of 8 Days of Therapy With ONO-6950 Versus Placebo and Montelukast (Singulair®) on Asthmatic Responses and Airway Hypersensitivity Following Allergen Challenge in Patients With Asthma
- ClinicalTrials.gov ID
- NCT01551147
- Acronym / sponsor ID
- ONO-6950POU005
- Conditions
- Asthma
- Keywords
- asthma, ONO-6950, asthma in adult patients
- Phase
- Phase 2
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 25 participants (actual)
- Lead sponsor
- Ono Pharma USA IncIndustry (pharma, biotech, devices)
- Collaborators
- Ono Pharmaceutical Co., Ltd.
- Study start
- Jun 2012
- Primary completion
- Apr 2013 (actual)
- First posted
- 12 Mar 2012 (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 primary objectives are
- to determine the effect of ONO-6950 200 mg QD versus placebo administered for 8 days on early asthmatic response (EAR) and late asthmatic response (LAR) induced by inhaled allergen
- to determine the safety and tolerability of ONO-6950 200 mg QD administered for 8 days in patients with asthma
The secondary objectives are:
- to compare the effect of ONO-6950 versus montelukast on the % decrease of FEV1 following allergen exposure, and
- to determine the effect of ONO-6950 versus placebo and montelukast on allergen-induced airway hyperresponsiveness (AHR) as measured by methacholine challenge
Detailed description
The study will examine if ONO-6950 could alleviate EAR and LAR caused by an allergen challenge in subjects with asthma. Patients will be required to have EAR and LAR after standardized allergen challenges during the screening. Eligible patients will complete a randomized, double-blind, three-way crossover study. During each of three evaluation periods, patients will be administered either 200 mg ONO-6950, 10 mg Montelukast, or placebo for 8 days. Each evaluation period will occur over 8 days and will include various assessments following allergen challenge and methacholine challenge. The study does not require an overnight stay at the clinical research center.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Crossover
- Masking
- Double blind (participant, investigator)
- Number of arms
- 3
| Arm | Type | Receives |
|---|---|---|
| Experimental 200 mg dose | Experimental | Drug: ONO-6950 |
| Active Comparator | Active comparator | Drug: Montelukast |
| Placebo Comparator | Placebo comparator | Drug: Placebo |
Who may qualify
- Ages
- 18 to 60 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult
Key inclusion criteria (5 listed)
- Patients of both genders, between 18 to 60 years of age, with bronchial asthma symptoms for at least 6 months
- Patients with FEV1 ≥ 70% of predicted after withholding short-acting β agonists for at least 8 hours prior to testing
- Screening allergen challenge demonstrates that the patient experiences both an early and late asthmatic response
- Sensitivity to methacholine resulting in a ≥ 20% fall in FEV1 (PC20 methacholine)
- Non-smokers with free from the usage of nicotine-containing products at least for a year prior to screening
Key exclusion criteria (4 listed)
- Previous history of life-threatening asthma, respiratory tract infection and/or exacerbation of asthma within 6 weeks prior to the first screening visit
- Past or present disorders and diseases including, but are not limited to, cardiovascular, malignancy, hepatic, renal, hematological, neurological, psychiatric, endocrine, or pulmonary other than asthma
- Significant safety laboratory, ECG, or vital sign abnormalities that would place the patient at undue disk during the study procedures
- History of clinically significant multiple drug or food allergy
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 |
|---|---|---|
| ONO-6950200 mg QD for 8 days | Drug | Experimental 200 mg dose |
| PlaceboPlacebo to match ONO-6950 tablets or over-encapsulated Montelukast tablets dosed in a similar manner | Drug | Placebo Comparator |
| Montelukast10 mg Montelukast QD for 8 days | Drug | Active Comparator |
Primary outcome
Late Asthmatic Response (3-7 hours after allergen challenge) as measured by the AUC in FEV1
Time frame: Day 7
Early Asthmatic Response as measured by the AUC in FEV1
Time frame: Day 7
Late Asthmatic Response as measured by the Maximum Fall in FEV1
Time frame: Day 7
Early Asthmatic Response as measured by the Maximum Fall in FEV1
Time frame: Day 7
2 secondary outcomes
Differences in PC20 pre-post treatment as measured by methacholine challenge
Time frame: Day 6
Differences in PC20 pre-post allergen challenge as measured by methacholine challenge
Time frame: Day 8
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 30 Apr 2013.
- Derived from this study: PubMed 27444660Gauvreau GM, Boulet LP, FitzGerald JM, Cockcroft DW, Davis BE, Leigh R, Tanaka M, Fourre JA, Tanaka M, Nabata T, O'Byrne PM. A dual CysLT1/2 antagonist attenuates allergen-induced airway responses in subjects with mild allergic asthma. Allergy. 2016 Dec;71(12):1721-1727. doi: 10.1111/all.12987. Epub 2016 Aug 9.
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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.
Ono Pharma USA, Inc. study director
Ono Pharmaceutical Co., Ltd.
5 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 ONO-6950 and Montelukast in people with Asthma, run by Ono Pharma USA Inc at 5 sites in Canada.
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 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 30 Apr 2013. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 5 sites in Canada. 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?
Late Asthmatic Response (3-7 hours after allergen challenge) as measured by the AUC in FEV1 (time frame: Day 7). The study lists 4 primary outcomes in all. 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 NCT01551147, 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 30 Apr 2013.