Efficacy, Safety and Pharmacokinetics of QAV680 in Asthma Patients

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

37 participants

Study Classification

INTERVENTIONAL

Study Start Date

2008-12-31

Brief Summary

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This study aims to study the efficacy (as measured by change in FEV1) and safety of two-week administration of oral QAV680 in the treatment of patients with asthma.'

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Detailed Description

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Conditions

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Asthma

Study Design

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Allocation Method

RANDOMIZED

Intervention Model

CROSSOVER

Primary Study Purpose

TREATMENT

Blinding Strategy

QUADRUPLE

Participants Caregivers Investigators Outcome Assessors

Study Groups

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QAV680

Group Type EXPERIMENTAL

QAV680

Intervention Type DRUG

Placebo

Group Type PLACEBO_COMPARATOR

Matching placebo for QAV680

Intervention Type DRUG

Fluticasone Propionate Inhaler

Group Type ACTIVE_COMPARATOR

Fluticasone Propionate

Intervention Type DRUG

Interventions

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QAV680

Intervention Type DRUG

Matching placebo for QAV680

Intervention Type DRUG

Fluticasone Propionate

Intervention Type DRUG

Eligibility Criteria

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Inclusion Criteria

* Mild to moderate persistent asthma for at least 6 months.

Exclusion Criteria

* Past or recent history of significant medical illness and/or lab abnormalities including but not limited to ECG abnormalities, abnormal LFT, HIV, Hep B/C,
* Allergic disorders, pancreatic disease, serious underlying respiratory diseases, life threatening asthma, renal disease etc
* Surgical and/or medical conditions which significantly effect ADME of the drug.
* Prior use of asthma medications (except SABA's) prior to 2 weeks of dosing

Minimum Eligible Age

18 Years

Maximum Eligible Age

65 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No