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A Placebo and Active Controlled Study of ONO-6950 Following Allergen Challenge in Patients With Asthma

NCT ID: NCT01551147

Last Updated: 2013-04-30

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

COMPLETED

Clinical Phase

PHASE2

Total Enrollment

25 participants

Study Classification

INTERVENTIONAL

Study Start Date

2012-06-30

Brief Summary

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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

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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

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Asthma

Keywords

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asthma ONO-6950 asthma in adult patients

Study Design

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Allocation Method

RANDOMIZED

Intervention Model

CROSSOVER

Primary Study Purpose

TREATMENT

Blinding Strategy

DOUBLE

Participants Investigators

Study Groups

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Experimental 200 mg dose

Group Type EXPERIMENTAL

ONO-6950

Intervention Type DRUG

200 mg QD for 8 days

Active Comparator

Group Type ACTIVE_COMPARATOR

Montelukast

Intervention Type DRUG

10 mg Montelukast QD for 8 days

Placebo Comparator

Group Type PLACEBO_COMPARATOR

Placebo

Intervention Type DRUG

Placebo to match ONO-6950 tablets or over-encapsulated Montelukast tablets dosed in a similar manner

Interventions

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ONO-6950

200 mg QD for 8 days

Intervention Type DRUG

Placebo

Placebo to match ONO-6950 tablets or over-encapsulated Montelukast tablets dosed in a similar manner

Intervention Type DRUG

Montelukast

10 mg Montelukast QD for 8 days

Intervention Type DRUG

Eligibility Criteria

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Inclusion Criteria

* 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

Exclusion Criteria

* 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
Minimum Eligible Age

18 Years

Maximum Eligible Age

60 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No

Sponsors

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Ono Pharmaceutical Co. Ltd

INDUSTRY

Sponsor Role collaborator

Ono Pharma USA Inc

INDUSTRY

Sponsor Role lead

Responsible Party

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Responsibility Role SPONSOR

Principal Investigators

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Ono Pharma USA, Inc.

Role: STUDY_DIRECTOR

Ono Pharmaceutical Co. Ltd

Locations

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Vancouver Clinical Site 530

Vancouver, British Columbia, Canada

Site Status

Calgary Clinical Site 540

Alberta, , Canada

Site Status

Hamilton Clinical Site 550

Ontario, , Canada

Site Status

Quebec Clinical Site 510

Québec, , Canada

Site Status

Saskatoon Clinical Site 520

Saskatoon, , Canada

Site Status

Countries

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Canada

References

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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.

Reference Type DERIVED
PMID: 27444660 (View on PubMed)

Other Identifiers

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ONO-6950POU005

Identifier Type: -

Identifier Source: org_study_id