Clinical trial NCT01551147: A Placebo and Active Controlled Study of ONO-6950 Following Allergen Challenge in Patients With Asthma
Official title: A Double-blind, Placebo-controlled, Three-way Crossover Study to Compare the Safety and Efficacy of 8 Days of Therapy With ONO-6950 Versus Placebo and Montelukast (Singulair®) on Asthmatic Responses and Airway Hypersensitivity Following Allergen Challenge in Patients With Asthma
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: PHASE2
Conditions: Asthma
Keywords: asthma
ONO-6950
asthma in adult patients
Lead sponsor: Ono Pharmaceutical Co. Ltd
Sponsor class: INDUSTRY
Collaborators: name: Ono Pharmaceutical Co. Ltd
First posted: 2012-03-12
Enrollment: 25
Sex: ALL
Minimum age (years): 18
Maximum age (years): 60
Standard ages: ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: CROSSOVER
Primary purpose: TREATMENT

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.

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

Primary outcomes:
measure: Late Asthmatic Response (3-7 hours after allergen challenge) as measured by the AUC in FEV1
timeFrame: Day 7
measure: Early Asthmatic Response as measured by the AUC in FEV1
timeFrame: Day 7
measure: Late Asthmatic Response as measured by the Maximum Fall in FEV1
timeFrame: Day 7
measure: Early Asthmatic Response as measured by the Maximum Fall in FEV1
timeFrame: Day 7
Secondary outcomes:
measure: Differences in PC20 pre-post treatment as measured by methacholine challenge
timeFrame: Day 6
measure: Differences in PC20 pre-post allergen challenge as measured by methacholine challenge
timeFrame: Day 8
Other outcomes:
Locations:
city: Vancouver
country: Canada
facility: Vancouver Clinical Site 530
state: British Columbia
city: Alberta
country: Canada
facility: Calgary Clinical Site 540
city: Ontario
country: Canada
facility: Hamilton Clinical Site 550
city: Quebec City
country: Canada
facility: Quebec Clinical Site 510
city: Saskatoon
country: Canada
facility: Saskatoon Clinical Site 520
Study officials:
affiliation: Ono Pharmaceutical Co. Ltd
name: Ono Pharma USA, Inc.
role: STUDY_DIRECTOR
References:
citation: 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.