AsthmaPhase 2NCT01536041
A Placebo and Active Controlled Study of ONO-6950 in Asthmatic Patients
A Phase 2 study testing ONO-6950 and Montelukast in people with Asthma, run by Ono Pharma USA Inc at 9 sites in United States.
Trial summary
The primary objectives of this study are: i. to determine the effect of single oral doses (20 and 200 mg) of ONO-6950 versus placebo on exercise induced bronchoconstriction (EIB) as percent attenuation in the decrease of forced expiratory volume in 1 second (FEV1) after exercise challenge ii. 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
- 59 participants
- Where
- 9 sitesUnited States
- Study dates
- Mar 2012to Nov 2012
- 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 for at least 6 months and history of exercise induced bronchospasm
- Patients with FEV1 ≥ 70% of predicted after withholding short-acting β agonists for at least 8 hours prior to testing
- Screening exercise challenge demonstrates that the patient experiences a fall in FEV1 of ≥ 20%
- 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
- History of being unable to tolerate or complete an exercise challenge and clinically significant multiple drug or food allergies
- 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
- Patients with Seasonal Allergic Rhinitis (SAR) or seasonal allergic asthma,with significant symptoms that may confound study assessment
- Significant safety laboratory, ECG, or vital sign abnormalities that would place the patient at undue risk during the study procedures
Trial locations and contacts
9 sites in 1 country.
9 sites in 1 country
United States9 sites
Denver Clinical Site 160
Denver, Colorado, 80230
Los Angeles Clinical Site 110
Los Angeles, California, 90025
Minneapolis Clinical Site 190
Minneapolis, Minnesota, 55402
New Braunfeis Clinical Site 120
New Braunfels, Texas, 78130
North Dartmouth Clincial Site 150
North Dartmouth, Massachusetts, 02747
Princeton Clinical Site 170
Princeton, New Jersey, 08558
Raleigh Clinical Site 130
Raleigh, North Carolina, 27607
San Antonio Clinical Site 180
San Antonio, Texas, 78229
San Diego Clinical Site 140
San Diego, California, 92123
About this study
Official title: A Double-blind, Placebo-controlled, Four-way Crossover Study to Compare the Safety and Efficacy of ONO-6950 20 mg and 200 mg QD Versus Placebo and Montelukast (Singulair) in Asthmatic Patients Who Experience Exercise-induced Bronchoconstriction
The primary objectives of this study are:
- to determine the effect of single oral doses (20 and 200 mg) of ONO-6950 versus placebo on exercise induced bronchoconstriction (EIB) as percent attenuation in the decrease of forced expiratory volume in 1 second (FEV1) after exercise challenge ii. to determine the safety and tolerability of single dose administrations of 20 and 200 mg of ONO-6950 in asthmatic patients.
Read more
The secondary objectives of this study are:
- to compare the effect of different (20 and 200 mg) single oral doses of ONO-6950 versus montelukast (10 mg) on EIB as percent attenuation in the decrease of FEV1 after exercise challenge ii. to determine the ratio of responders/non-responders in FEV1 for different (20 and 200 mg) single oral doses of ONO-6950 in comparison to montelukast (10 mg) and placebo.
Read the detailed description
The study will examine if ONO-6950 could alleviate EIB in asthmatic patients. Eligible patients will complete a randomized, double-blind, four-way crossover study. During each of four evaluation periods, patients will be administered a single dose of either 20 or 200 mg ONO-6950, 10 mg Montelukast, or placebo. Each evaluation period include various assessments following exercise challenge in an ambulatory setting.
- Conditions
- Asthma
- Being tested
- ONO-6950, Montelukast, Placebo
- Keywords
- asthma, Adult
- 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, single dose
ONO-6950Drug
20 mg QD, single dose
MontelukastDrug
10 mg Montelukast, QD single dose
PlaceboDrug
Placebo to match ONO-6950 tablets or leukotriene receptor antagonist (LTRA) tablets dosed in a similar manner
| Study group | Role | What they receive |
|---|---|---|
| Experimental 200 mg dose | Experimental | Not described Receives: Drug: ONO-6950 |
| Experimental 20 mg dose | Experimental | Not described Receives: Drug: ONO-6950 |
| Active Comparator Montelukast | 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.
Inhibition of maximum fall in Forced Expiratory Volume in One Second (FEV1) after exercise
Measured: 60 minutes following the exercise challenge
Secondary outcomes (5)
AUC (0-30 min)
area under the concentration time curve integrating fall in FEV1 following exercise over the 30 minute interval immediately following exercise
Measured: 30 minutes following the exercise challenge
AUC (0-60 min)
area under the concentration time curve integrating fall in FEV1 following exercise over the 60 minute interval immediately following exercise
Measured: 60 minutes following the exercise challenge
Time to recovery of FEV1 to within 5% of the pre-exercise baseline
Measured: 90 minutes following the exercise challenge
Proportion of patients using a short acting beta agonist (rescue medication)
Measured: 90 minutes following the exercise challenge
Ratio of responder/non-responder in FEV1
Measured: 60 minutes following the exercise challenge
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted20 Feb 2012 (estimated)
- Study startMar 2012
- Primary completionNov 2012
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
- Crossover
- Masking
- Double blind
- Who is masked
- Participant, Investigator
- Enrolment
- 59 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
- NCT01536041
- Sponsor's protocol ID
- ONO-6950POU006
- Status last verified
- Jan 2014
- First submitted
- 15 Feb 2012
- Last updated
- 14 Feb 2014
- Results posted
- No
- Data monitoring committee
- No
Study at a glance
From the registry record, last updated by the sponsor on 14 Feb 2014. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- A Double-blind, Placebo-controlled, Four-way Crossover Study to Compare the Safety and Efficacy of ONO-6950 20 mg and 200 mg QD Versus Placebo and Montelukast (Singulair) in Asthmatic Patients Who Experience Exercise-induced Bronchoconstriction
- ClinicalTrials.gov ID
- NCT01536041
- Acronym / sponsor ID
- ONO-6950POU006
- Conditions
- Asthma
- Keywords
- asthma, Adult
- Phase
- Phase 2
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 59 participants (actual)
- Lead sponsor
- Ono Pharma USA IncIndustry (pharma, biotech, devices)
- Collaborators
- Ono Pharmaceutical Co., Ltd.
- Study start
- Mar 2012
- Primary completion
- Nov 2012 (actual)
- First posted
- 20 Feb 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 of this study are:
- to determine the effect of single oral doses (20 and 200 mg) of ONO-6950 versus placebo on exercise induced bronchoconstriction (EIB) as percent attenuation in the decrease of forced expiratory volume in 1 second (FEV1) after exercise challenge ii. to determine the safety and tolerability of single dose administrations of 20 and 200 mg of ONO-6950 in asthmatic patients.
The secondary objectives of this study are:
- to compare the effect of different (20 and 200 mg) single oral doses of ONO-6950 versus montelukast (10 mg) on EIB as percent attenuation in the decrease of FEV1 after exercise challenge ii. to determine the ratio of responders/non-responders in FEV1 for different (20 and 200 mg) single oral doses of ONO-6950 in comparison to montelukast (10 mg) and placebo.
Detailed description
The study will examine if ONO-6950 could alleviate EIB in asthmatic patients. Eligible patients will complete a randomized, double-blind, four-way crossover study. During each of four evaluation periods, patients will be administered a single dose of either 20 or 200 mg ONO-6950, 10 mg Montelukast, or placebo. Each evaluation period include various assessments following exercise challenge in an ambulatory setting.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Crossover
- Masking
- Double blind (participant, investigator)
- Number of arms
- 4
| Arm | Type | Receives |
|---|---|---|
| Experimental 200 mg dose | Experimental | Drug: ONO-6950 |
| Experimental 20 mg dose | Experimental | Drug: ONO-6950 |
| Active Comparator Montelukast | 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 (4 listed)
- Patients of both genders, between 18 to 60 years of age, with bronchial asthma for at least 6 months and history of exercise induced bronchospasm
- Patients with FEV1 ≥ 70% of predicted after withholding short-acting β agonists for at least 8 hours prior to testing
- Screening exercise challenge demonstrates that the patient experiences a fall in FEV1 of ≥ 20%
- Non-smokers with free from the usage of nicotine-containing products at least for a year prior to screening
Key exclusion criteria (5 listed)
- Previous history of life-threatening asthma, respiratory tract infection and/or exacerbation of asthma within 6 weeks prior to the first screening visit
- History of being unable to tolerate or complete an exercise challenge and clinically significant multiple drug or food allergies
- 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
- Patients with Seasonal Allergic Rhinitis (SAR) or seasonal allergic asthma,with significant symptoms that may confound study assessment
- Significant safety laboratory, ECG, or vital sign abnormalities that would place the patient at undue risk during the study procedures
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, single dose | Drug | Experimental 200 mg dose |
| ONO-695020 mg QD, single dose | Drug | Experimental 20 mg dose |
| Montelukast10 mg Montelukast, QD single dose | Drug | Active Comparator Montelukast |
| PlaceboPlacebo to match ONO-6950 tablets or leukotriene receptor antagonist (LTRA) tablets dosed in a similar manner | Drug | Placebo Comparator |
Primary outcome
Inhibition of maximum fall in Forced Expiratory Volume in One Second (FEV1) after exercise
Time frame: 60 minutes following the exercise challenge
5 secondary outcomes
AUC (0-30 min)
Time frame: 30 minutes following the exercise challenge
AUC (0-60 min)
Time frame: 60 minutes following the exercise challenge
Time to recovery of FEV1 to within 5% of the pre-exercise baseline
Time frame: 90 minutes following the exercise challenge
Proportion of patients using a short acting beta agonist (rescue medication)
Time frame: 90 minutes following the exercise challenge
Ratio of responder/non-responder in FEV1
Time frame: 60 minutes following the exercise challenge
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 14 Feb 2014.
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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.
9 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 9 sites 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 4 inclusion and 5 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 14 Feb 2014. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 9 sites 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. 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?
Inhibition of maximum fall in Forced Expiratory Volume in One Second (FEV1) after exercise (time frame: 60 minutes following the exercise challenge). 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 14 Feb 2014.