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CompletedNCT01551147Updated Apr 30, 2013

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

A Phase 2 interventional study of ONO-6950 and Placebo in Asthma, sponsored by Ono Pharma USA Inc. Completed at 5 sites in Canada. Open to participants aged 18 Years to 60 Years. Per ClinicalTrials.gov, last updated 2013-04-30.

Sponsored by Ono Pharma USA Inc · Phase 2, Interventional, and Treatment

Phase
Phase 2
Study type
Interventional
Enrollment
25
Allocation
Randomized
Ages
18 Years to 60 Years
Sex
All
01

Study 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
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.

02

Conditions studied

  • Asthma

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Keywords

  • asthma
  • ONO-6950
  • asthma in adult patients
03

In context

Asthma

3,921 studies on the registry are indexed under Asthma; 506 are open to participants now.

This study's enrollment of 25 is below the median of 83 across 2,752 interventional studies indexed under Asthma.

Browse Asthma studies →

Lead sponsor

Ono Pharma USA Inc is the lead sponsor of 21 studies on the registry; none are open to participants now.

Counted across the registry records on this site, refreshed daily.

04

Who can participate

Ages eligible
18 Years to 60 Years
Sexes eligible
All
Accepts healthy volunteers
No

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

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
05

Study design

Phase
Phase 2
Primary purpose
Treatment
Allocation
Randomized
Intervention model
Crossover assignment
Masking
Double (Participant, Investigator)
Enrollment
25 participants (actual)

Study arms

  • Experimental
    Experimental 200 mg dose

    Drug: ONO-6950

  • Active comparator
    Active Comparator

    Drug: Montelukast

  • Placebo comparator
    Placebo Comparator

    Drug: Placebo

Interventions

  • DrugONO-6950

    200 mg QD for 8 days

  • DrugPlacebo

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

  • DrugMontelukast

    10 mg Montelukast QD for 8 days

06

What researchers measure

Primary outcomes

  1. Late Asthmatic Response (3-7 hours after allergen challenge) as measured by the AUC in FEV1

    Time frame: Day 7

  2. Early Asthmatic Response as measured by the AUC in FEV1

    Time frame: Day 7

  3. Late Asthmatic Response as measured by the Maximum Fall in FEV1

    Time frame: Day 7

  4. Early Asthmatic Response as measured by the Maximum Fall in FEV1

    Time frame: Day 7

Secondary outcomes

  1. Differences in PC20 pre-post treatment as measured by methacholine challenge

    Time frame: Day 6

  2. Differences in PC20 pre-post allergen challenge as measured by methacholine challenge

    Time frame: Day 8

07

Study locations

5 sites
  • Vancouver Clinical Site 530
    Vancouver, British Columbia V6T2B5, Canada
  • Calgary Clinical Site 540
    Alberta, T2N4N1, Canada
  • Hamilton Clinical Site 550
    Ontario, L8N3Z5, Canada
  • Quebec Clinical Site 510
    Quebec City, G1V4GS, Canada
  • Saskatoon Clinical Site 520
    Saskatoon, S7N0W8, Canada
08

References and documents

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 ↗
09

Updates

Tracking since Sep 25, 2026
No changes since tracking began. The registry record was last updated on Apr 30, 2013, before this site started recording changes on Sep 25, 2026. Its history is on ClinicalTrials.gov ↗
10

Registry details

Key details

Study ID
NCT01551147
Lead sponsor
Ono Pharma USA Inc
Collaborators
Ono Pharmaceutical Co. Ltd
Responsible party
Sponsor
First posted
Mar 12, 2012
Start date
Jun 2012
Primary completion
Apr 2013
Last update
Apr 30, 2013

Study contacts

Ono Pharma USA, Inc.
study director · Ono Pharmaceutical Co. Ltd

Oversight

Data monitoring committee
No
View the source record on ClinicalTrials.gov ↗

Not currently enrolling

This study is completed, as verified in Apr 2013. You cannot join it, but the record below documents what was studied.

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