NCT01551147

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

Trial Health

80
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
25

participants targeted

Target at below P25 for phase_2 asthma

Geographic Reach
1 country

5 active sites

Status
completed

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

First Submitted

Initial submission to the registry

March 8, 2012

Completed
4 days until next milestone

First Posted

Study publicly available on registry

March 12, 2012

Completed
3 months until next milestone

Study Start

First participant enrolled

June 1, 2012

Completed
10 months until next milestone

Primary Completion

Last participant's last visit for primary outcome

April 1, 2013

Completed
Last Updated

April 30, 2013

Status Verified

April 1, 2013

Enrollment Period

10 months

First QC Date

March 8, 2012

Last Update Submit

April 29, 2013

Conditions

Asthma

Keywords

asthmaONO-6950asthma in adult patients

Outcome Measures

Primary Outcomes (4)

  • 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 (2)

  • 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

Study Arms (3)

Experimental 200 mg dose

EXPERIMENTAL
Drug: ONO-6950

Active Comparator

ACTIVE COMPARATOR
Drug: Montelukast

Placebo Comparator

PLACEBO COMPARATOR
Drug: Placebo

Interventions

ONO-6950DRUG

200 mg QD for 8 days

Experimental 200 mg dose
PlaceboDRUG

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

Placebo Comparator
MontelukastDRUG

10 mg Montelukast QD for 8 days

Active Comparator

Eligibility Criteria

Age18 Years - 60 Years
Sexall
Healthy VolunteersNo
Age GroupsAdult (18-64)

You may qualify if:

  • 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

You may not qualify if:

  • 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

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (5)

Vancouver Clinical Site 530

Vancouver, British Columbia, V6T2B5, Canada

Location

Calgary Clinical Site 540

Alberta, T2N4N1, Canada

Location

Hamilton Clinical Site 550

Ontario, L8N3Z5, Canada

Location

Quebec Clinical Site 510

Québec, G1V4GS, Canada

Location

Saskatoon Clinical Site 520

Saskatoon, S7N0W8, Canada

Location

Related Publications (1)

  • 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.

    PMID: 27444660DERIVED

MeSH Terms

Conditions

Asthma

Interventions

gemilukastmontelukast

Condition Hierarchy (Ancestors)

Bronchial DiseasesRespiratory Tract DiseasesLung Diseases, ObstructiveLung DiseasesRespiratory HypersensitivityHypersensitivity, ImmediateHypersensitivityImmune System Diseases

Study Officials

  • Ono Pharma USA, Inc.

    Ono Pharmaceutical Co. Ltd

    STUDY DIRECTOR

Study Design

Study Type
interventional
Phase
phase 2
Allocation
RANDOMIZED
Masking
DOUBLE
Who Masked
PARTICIPANT, INVESTIGATOR
Purpose
TREATMENT
Intervention Model
CROSSOVER
Sponsor Type
INDUSTRY
Responsible Party
SPONSOR

Study Record Dates

First Submitted

March 8, 2012

First Posted

March 12, 2012

Study Start

June 1, 2012

Primary Completion

April 1, 2013

Last Updated

April 30, 2013

Record last verified: 2013-04

Locations

CA(5)