Efficacy, Safety, and Pharmacokinetics of QAW039

NCT ID: NCT01253603

Last Updated: 2020-12-19

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

170 participants

Study Classification

INTERVENTIONAL

Study Start Date

2010-11-30

Study Completion Date

2011-09-30

Brief Summary

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This study will assess the safety, efficacy and pharmacokinetics of QAW039 in steroid-free patients with mild to moderate persistent asthma.

Detailed Description

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Conditions

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Persistent Asthma

Keywords

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Asthma

Study Design

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Allocation Method

RANDOMIZED

Intervention Model

PARALLEL

Primary Study Purpose

TREATMENT

Blinding Strategy

QUADRUPLE

Participants Caregivers Investigators Outcome Assessors

Study Groups

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1

QAW039 capsules once daily for 28 days

Group Type EXPERIMENTAL

QAW039 capsules once daily for 28 days

Intervention Type DRUG

2

Placebo to QAW039 capsules once daily for 28 days

Group Type EXPERIMENTAL

Placebo to QAW039 capsules once daily for 28 days

Intervention Type DRUG

3

Fluticasone propionate inhaler twice daily for 28 days

Group Type EXPERIMENTAL

Fluticasone propionate inhaler twice daily for 28 days

Intervention Type DRUG

Interventions

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QAW039 capsules once daily for 28 days

Intervention Type DRUG

Placebo to QAW039 capsules once daily for 28 days

Intervention Type DRUG

Fluticasone propionate inhaler twice daily for 28 days

Intervention Type DRUG

Eligibility Criteria

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Inclusion Criteria

* Patients with a medical history of mild to moderate persistent allergic asthma.
* Patients must weigh at least 45 kg to participate in the study, and must have abody mass index (BMI) of \>17 kg/m2.
* Female patients must be surgically sterilized, postmenopausal or using a double-barrier method of contraception

Exclusion Criteria

* Women of child-bearing potential.
* Smokers defined as history of smoking in the previous 6 months or a smoking history of more than 10 pack years, a pack year being defined as smoking the equivalent of 20 cigarettes - a pack - every day for the period of 1 year
* Patients with severe persistent asthma
Minimum Eligible Age

18 Years

Maximum Eligible Age

65 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No

Sponsors

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Novartis Pharmaceuticals

INDUSTRY

Sponsor Role lead

Responsible Party

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Responsibility Role SPONSOR

Principal Investigators

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Novartis Pharmaceuticals

Role: STUDY_DIRECTOR

Novartis Pharmaceuticals

Locations

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Novartis Investigative Site

Encinitas, California, United States

Site Status

Novartis Investigative Site

Huntington Beach, California, United States

Site Status

Novartis Investigative Site

Los Angeles, California, United States

Site Status

Novartis Investigative Site

Los Angeles, California, United States

Site Status

Novartis Investigative Site

Mission Viejo, California, United States

Site Status

Novartis Investigative Site

San Diego, California, United States

Site Status

Novartis Investigative Site

San Diego, California, United States

Site Status

Novartis Investigative Site

San Jose, California, United States

Site Status

Novartis Investigative Site

Stockton, California, United States

Site Status

Novartis Investigative Site

Stockbridge, Georgia, United States

Site Status

Novartis Investigative Site

North Dartmouth, Massachusetts, United States

Site Status

Novartis Investigative Site

Bellevue, Nebraska, United States

Site Status

Novartis Investigative Site

Berlin, New Jersey, United States

Site Status

Novartis Investigative Site

Skillman, New Jersey, United States

Site Status

Novartis Investigative Site

Raleigh, North Carolina, United States

Site Status

Novartis Investigative Site

Medford, Oregon, United States

Site Status

Novatis Investigative Site

Upland, Pennsylvania, United States

Site Status

Novartis Investigative Site

Dallas, Texas, United States

Site Status

Novartis Investigative Site

Jambes, , Belgium

Site Status

Novartis Investigative Site

Berlin, , Germany

Site Status

Novartis Investigative Site

Cologne, , Germany

Site Status

Novartis Investigative Site

Frankfurt, , Germany

Site Status

Novartis Investigative Site

Hamburg, , Germany

Site Status

Novartis Investigative Site

Wiesbaden, , Germany

Site Status

Novartis Investigative Site

Bucharest, , Romania

Site Status

Novartis Investigative Site

Seoul, , South Korea

Site Status

Countries

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United States Belgium Germany Romania South Korea

References

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Erpenbeck VJ, Popov TA, Miller D, Weinstein SF, Spector S, Magnusson B, Osuntokun W, Goldsmith P, Weiss M, Beier J. The oral CRTh2 antagonist QAW039 (fevipiprant): A phase II study in uncontrolled allergic asthma. Pulm Pharmacol Ther. 2016 Aug;39:54-63. doi: 10.1016/j.pupt.2016.06.005. Epub 2016 Jun 21.

Reference Type DERIVED
PMID: 27354118 (View on PubMed)

Related Links

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https://www.novctrd.com/ctrdweb/trialresult/trialresults/pdf?trialResultId=10283

Results for CQAW039A2201 from the Novartis Clinical Trials website

Other Identifiers

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2010-020177-16

Identifier Type: EUDRACT_NUMBER

Identifier Source: secondary_id

CQAW039A2201

Identifier Type: -

Identifier Source: org_study_id