A Placebo and Active Controlled Study of ONO-6950 Followi... | NCT01551147

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

NCT01551147

Sponsor

Ono Pharma USA Inc

Status

Completed

Last Update Posted

Apr 30, 2013Estimated

Enrollment

25Actual

Phase

Phase 2

Conditions

Asthma

Interventions

ONO-6950
Placebo
Montelukast

Countries

Canada

Protocol Section

Identification Module Status Module Sponsor/Collaborators Module Oversight Module Description Module Conditions Module Design Module Arms/Interventions Module Outcomes Module Eligibility Module Contacts/Locations Module References Module IPD Sharing Statement Module

Results Section

Participant Flow Module Baseline Characteristics Module Outcome Measures Module Adverse Events Module More Info Module

Annotation Section

Annotation Module

Document Section

Large Document Module

Derived Section

Miscellaneous Info Module Condition Browse Module Intervention Browse Module

Protocol Section

Identification Module

NCT ID

Results Section

No data available

No data is available for this block.

Annotation Section

No data available

No data is available for this block.

Document Section

No data available

No data is available for this block.

Derived Section

Miscellaneous Info Module

Version Holder

Status Module

Record Verification Date

Apr 2013

Overall Recruitment Status or Expanded Access Status

Completed

Last Known Status

Not provided

Delayed Posting

Not provided

Why Stopped

Not provided

Expanded Access Info

Start Date

Jun 2012

Primary Completion Date

Apr 2013Actual

Completion Date

Not provided

First Submitted Date

Mar 8, 2012

First Submission Date that Met QC Criteria

Mar 9, 2012

First Posted Date

Mar 12, 2012Estimated

Results Waived

Not provided

Results First Submitted Date

Not provided

Results First Submitted that Met QC Criteria

Not provided

Results First Posted Date

Not provided

Certification/Extension (aka Delayed Results) First Submitted Date

Not provided

Certification/Extension First Submitted that Passed QC Review

Not provided

Certification/Extension First Posted Date

Not provided

Last Update Submitted Date

Apr 29, 2013

Last Update Posted Date

Apr 30, 2013Estimated

Name	Class
Ono Pharmaceutical Co., Ltd.	INDUSTRY

Oversight Module

Has Data Monitoring Committee (DMC)

Is FDA Regulated Drug

Not provided

Is FDA Regulated Device

Not provided

Is Unapproved Device

Not provided

Pediatric Postmarket Surveillance of a Device Product

Not provided

Product Exported from US

Not provided

FDAAA801 Violation

Not provided

Description Module

Brief 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

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.

Design Module

Study Type

Interventional

Number of References to an Expanded Access Study

Not provided

Expanded Access Types

Not provided

Patient Registry

Not provided

Target Follow-Up Duration

Not provided

Phases

Phase 2

Interventional Study Design

Allocation

Biospecimen

No data available

No data is available for this block.

Enrollment

25Actual

Arms/Interventions Module

Arm Groups

Label	Type	Intervention Names
Experimental 200 mg dose	Experimental	Drug: ONO-6950
Active Comparator	Active Comparator	Drug: Montelukast
Placebo Comparator	Placebo Comparator	Drug: Placebo

Interventions

Name	Type	Description	Arm Group Labels	Other Names
ONO-6950	Drug	200 mg QD for 8 days	Experimental 200 mg dose
Placebo

Outcomes Module

Primary Outcomes

Measure	Description	Time Frame
Late Asthmatic Response (3-7 hours after allergen challenge) as measured by the AUC in FEV1		Day 7
Early Asthmatic Response as measured by the AUC in FEV1		Day 7
Late Asthmatic Response as measured by the Maximum Fall in FEV1		Day 7
Early Asthmatic Response as measured by the Maximum Fall in FEV1		Day 7

Secondary Outcomes

Measure	Description	Time Frame
Differences in PC20 pre-post treatment as measured by methacholine challenge		Day 6
Differences in PC20 pre-post allergen challenge as measured by methacholine challenge		Day 8

Other Outcomes

Not provided

Eligibility Module

Eligibility Criteria

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

Accepts Healthy Volunteers

Sex

All

Sex/Gender Based

Not provided

Sex/Gender Description

Not provided

Minimum Age

18 Years

Maximum Age

60 Years

Standard Ages

Adult

Study Population

Not provided

Sampling Method

Not provided

Contacts/Locations Module

Central Contacts

Not provided

Overall Officials

Name	Affiliation	Role
Ono Pharma USA, Inc.	Ono Pharmaceutical Co., Ltd.	Study Director

Locations

Facility	Status	City	State	ZIP	Country	Contacts
Vancouver Clinical Site 530		Vancouver	British Columbia	V6T2B5	Canada
Calgary Clinical Site 540

References Module

Citations

PubMed Identifier	Type	Citation	Retractions
27444660	Derived	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.

ID	Term
D001982	Bronchial Diseases
D012140	Respiratory Tract Diseases
D008173	Lung Diseases, Obstructive
D008171	Lung Diseases

ID	Term
C000603360	gemilukast
C093875	montelukast