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A Study to Assess the Effect of QAW039 in Non-atopic Asthmatic Patients

NCT ID: NCT01836471

Last Updated: 2017-03-20

Study Results

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Basic Information

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Recruitment Status

COMPLETED

Clinical Phase

PHASE2

Total Enrollment

345 participants

Study Classification

INTERVENTIONAL

Study Start Date

2013-05-31

Study Completion Date

2016-02-29

Brief Summary

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The purpose of the study was to assess the clinical effect of QAW039 in non-atopic asthmatics taking low dose Inhaled Corticosteroid (ICS) as background therapy.

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Detailed Description

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This was a multi-centre, randomised, placebo-controlled, double blind, 3-arm study designed to compare the efficacy and safety of a once daily dose of QAW039 with placebo in non-atopic and atopic asthmatics both inadequately controlled despite receiving a low dose ICS background therapy, over a 12 week treatment period. Efficacy and safety of a once daily dose of QAW039 was also compared with an increased dose of ICS in atopic asthmatics taking low dose ICS as background therapy.

Conditions

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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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QAW039 450 mg qd Non-atopic

QAW039 450 mg (3 capsules of QAW039 150 mg) qd combined with background ICS (100 μg fluticasone, bid). Non-atopic patients randomized in ratio of approximately 1:1.

Group Type EXPERIMENTAL

QAW039

Intervention Type DRUG

QAW039 supplied as hard gelatin capsule in unit dose strength of 150 mg. Patient took 450 mg once daily (3 capsules taken with food in the morning) for the approximate period of the study (12 weeks)

Fluticasone 100 mcg

Intervention Type DRUG

Background therapy - fluticasone was supplied in inhalers with dose strength of 100 mcg. All patients in the study other than the Atopic Fluticasone 150 mcg arm were given the 100 mcg dose strength inhalers and took fluticasone 100 mcg bid (taken morning and evening with approximately 12 hours between doses) as background therapy for the approximate period of the study (12 weeks).

Placebo Non-atopic

Placebo to QAW039 (3 capsules of Placebo of QAW039 150 mg) combined with background ICS (100 μg fluticasone, bid). Non-atopic randomized in ratio of approximately 1:1.

Group Type PLACEBO_COMPARATOR

Placebo QAW039

Intervention Type DRUG

Matching placebo for QAW039 supplied as hard gelatin capsule were identical in appearance to their active counterparts. Patients took 3 QAW039 matching placebo capsules once a day ( taken with food in the morning) for the approximate period of the study (12 weeks)

Fluticasone 100 mcg

Intervention Type DRUG

Background therapy - fluticasone was supplied in inhalers with dose strength of 100 mcg. All patients in the study other than the Atopic Fluticasone 150 mcg arm were given the 100 mcg dose strength inhalers and took fluticasone 100 mcg bid (taken morning and evening with approximately 12 hours between doses) as background therapy for the approximate period of the study (12 weeks).

QAW039 450 mg qd Atopic

QAW039 450 mg (3 capsules of QAW039 150 mg) qd combined with background ICS (100 μg fluticasone, bid). Atopic patients randomized in a ratio of approximate 1:1:1

Group Type EXPERIMENTAL

QAW039

Intervention Type DRUG

QAW039 supplied as hard gelatin capsule in unit dose strength of 150 mg. Patient took 450 mg once daily (3 capsules taken with food in the morning) for the approximate period of the study (12 weeks)

Fluticasone 100 mcg

Intervention Type DRUG

Background therapy - fluticasone was supplied in inhalers with dose strength of 100 mcg. All patients in the study other than the Atopic Fluticasone 150 mcg arm were given the 100 mcg dose strength inhalers and took fluticasone 100 mcg bid (taken morning and evening with approximately 12 hours between doses) as background therapy for the approximate period of the study (12 weeks).

Fluticasone 150 mcg bid Atopic

Placebo to QAW039 (3 capsules of Placebo of QAW039 150 mg) combined with 150 μg ICS and with background ICS (100 μg fluticasone, bid). As a consequence total ICS was 250 μg fluticasone bid. Atopic patients randomized in ratio of approximately 1:1:1

Group Type ACTIVE_COMPARATOR

Placebo QAW039

Intervention Type DRUG

Matching placebo for QAW039 supplied as hard gelatin capsule were identical in appearance to their active counterparts. Patients took 3 QAW039 matching placebo capsules once a day ( taken with food in the morning) for the approximate period of the study (12 weeks)

Fluticasone 250 mcg

Intervention Type DRUG

Fluticasone was supplied in inhalers with dose strength of 250 mcg. Patients took 250 mcg bid (morning and evening approximately 12 hours between doses) for a total dose of 500 mcg daily for the approximate period of the study (12 weeks).

Placebo Atopic

Placebo to QAW039 (3 capsules of Placebo of QAW039 150 mg) combined with background ICS (100 μg fluticasone, bid). Atopic patients andomized in ratio of approximately 1:1:1

Group Type PLACEBO_COMPARATOR

Placebo QAW039

Intervention Type DRUG

Matching placebo for QAW039 supplied as hard gelatin capsule were identical in appearance to their active counterparts. Patients took 3 QAW039 matching placebo capsules once a day ( taken with food in the morning) for the approximate period of the study (12 weeks)

Fluticasone 100 mcg

Intervention Type DRUG

Background therapy - fluticasone was supplied in inhalers with dose strength of 100 mcg. All patients in the study other than the Atopic Fluticasone 150 mcg arm were given the 100 mcg dose strength inhalers and took fluticasone 100 mcg bid (taken morning and evening with approximately 12 hours between doses) as background therapy for the approximate period of the study (12 weeks).

Interventions

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QAW039

QAW039 supplied as hard gelatin capsule in unit dose strength of 150 mg. Patient took 450 mg once daily (3 capsules taken with food in the morning) for the approximate period of the study (12 weeks)

Intervention Type DRUG

Placebo QAW039

Matching placebo for QAW039 supplied as hard gelatin capsule were identical in appearance to their active counterparts. Patients took 3 QAW039 matching placebo capsules once a day ( taken with food in the morning) for the approximate period of the study (12 weeks)

Intervention Type DRUG

Fluticasone 250 mcg

Fluticasone was supplied in inhalers with dose strength of 250 mcg. Patients took 250 mcg bid (morning and evening approximately 12 hours between doses) for a total dose of 500 mcg daily for the approximate period of the study (12 weeks).

Intervention Type DRUG

Fluticasone 100 mcg

Background therapy - fluticasone was supplied in inhalers with dose strength of 100 mcg. All patients in the study other than the Atopic Fluticasone 150 mcg arm were given the 100 mcg dose strength inhalers and took fluticasone 100 mcg bid (taken morning and evening with approximately 12 hours between doses) as background therapy for the approximate period of the study (12 weeks).

Intervention Type DRUG

Eligibility Criteria

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Inclusion Criteria

* Written informed consent must be obtained before any assessment is performed
* Patients with a diagnosis of persistent asthma (according to Global Initiative for Asthma 2011) for a period of at least 6 months prior to screening
* Patients with a pre-bronchodilator Forced Expiratory Volume In One Second (FEV1) value of 40% to 80% of individual predicted value at screening and prior to treatment
* An Asthma Control Questionnaire score ≥ 1.5 prior to treatment
* Demonstration of reversible airway obstruction

Exclusion Criteria

* Pregnant or nursing (lactating) women
* Acute illness other than asthma at the start of the study
* Patients with clinically significant laboratory abnormalities at screening
* Patients with clinically significant condition which may compromise subject safety or interfere with study evaluation
* Use of other investigational drugs at the time of enrollment
Minimum Eligible Age

18 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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Richard Kay

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

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Novartis Investigative Site

Los Angeles, California, United States

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Novartis Investigative Site

Los Angeles, California, United States

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Novartis Investigative Site

Mission Viejo, California, United States

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Novartis Investigative Site

Orange, California, United States

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Novartis Investigative Site

Palmdale, California, United States

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Novartis Investigative Site

Riverside, California, United States

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Novartis Investigative Site

Rolling Hills Estates, California, United States

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Novartis Investigative Site

San Diego, California, United States

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San Jose, California, United States

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Novartis Investigative Site

Stockton, California, United States

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Colorado Springs, Colorado, United States

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Denver, Colorado, United States

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Denver, Colorado, United States

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Sarasota, Florida, United States

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Owensboro, Kentucky, United States

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North Dartmouth, Massachusetts, United States

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Minneapolis, Minnesota, United States

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St Louis, Missouri, United States

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St Louis, Missouri, United States

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Papillion, Nebraska, United States

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Skillman, New Jersey, United States

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Charlotte, North Carolina, United States

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Cincinnati, Ohio, United States

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Medford, Oregon, United States

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Portland, Oregon, United States

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Lincoln, Rhode Island, United States

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Charleston, South Carolina, United States

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Seattle, Washington, United States

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Novartis Investigative Site

Erpent, , Belgium

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Novartis Investigative Site

Liège, , Belgium

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Novartis Investigative Site

Barranquilla, Atlántico, Colombia

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Novartis Investigative Site

Bogotá, Cundinamarca, Colombia

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Barranquilla, , Colombia

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Medellín, , Colombia

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Trutnov, Czech Republic, Czechia

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Hradec Králové, CZE, Czechia

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Karlovy Vary-Stara Rokle, CZE, Czechia

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Teplice, CZE, Czechia

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Marburg, Germany, Germany

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Wiesbaden, Germany, Germany

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Berlin, , Germany

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Frankfurt, , Germany

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Leipzig, , Germany

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Lübeck, , Germany

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Witten, , Germany

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Hyderabad, Andhra Pradesh, India

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Panjim, Goa, India

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Nagpur, Maharashtra, India

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Nagpur, Maharashtra, India

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Coimbatore, Tamil Nadu, India

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Bialystok, , Poland

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Bialystok, , Poland

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Lodz, , Poland

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Wroclaw, , Poland

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Bucharest, District 1, Romania

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Bucharest, District 3, Romania

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Bucharest, District 3, Romania

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Craiova, Dolj, Romania

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Timișoara, Romania, Romania

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Arad, , Romania

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Craiova, , Romania

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Deva, , Romania

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Novartis Investigative Site

Durban, South Africa, South Africa

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Novartis Investigative Site

Cape Town, , South Africa

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Cape Town, , South Africa

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Cape Town, , South Africa

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Cape Town, , South Africa

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Novartis Investigative Site

Gatesville, , South Africa

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Pretoria, , South Africa

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Novartis Investigative Site

Gwangju, Gwangju, South Korea

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Novartis Investigative Site

Bucheon-si, Gyeonggi-do, South Korea

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Novartis Investigative Site

Suwon, Gyeonggi-do, South Korea

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Novartis Investigative Site

Seoul, Korea, South Korea

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Novartis Investigative Site

Cheongju-si, North Chungcheong, South Korea

Site Status

Countries

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United States Belgium Colombia Czechia Germany India Poland Romania South Africa South Korea

Other Identifiers

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2012-003995-38

Identifier Type: EUDRACT_NUMBER

Identifier Source: secondary_id

CQAW039A2214

Identifier Type: -

Identifier Source: org_study_id

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