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

NCT01836471 | Completed Phase 2 Results

• 2 other identifiers: CQAW039A22142012-003995-38
• Study Type: interventional
• Target: 345
• Locations: 10 countries
• Sites: 76

Brief Summary

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.

Conditions

Asthma

Outcome Measures

Primary Outcomes (1)

• Change From Baseline in Trough FEV1 (L) in Non-atopic Patients at Week 12 - Full Analysis Set

  Forced Expiratory Volume in one second (FEV1) is calculated as the volume of air forcibly exhaled in one second as measured by a spirometer. Baseline is defined as the last available FEV1 measurement taken prior to the first dose of randomized study drug. Data within 6 hr of rescue medication use is excluded from this analysis. For subjects with missing trough FEV1 (L) at Week 12, the last post baseline observation were used (LOCF). Estimates are from a mixed effects model with treatment, subject population (non-atopic vs. atopic), treatment by subject population interaction, baseline trough FEV1 and region as fixed effects and center nested within region as random effects. Full analysis set included all randomized subjects who received at least one dose of study drug.

  baseline,12 weeks

Secondary Outcomes (4)

• Change From Baseline in Trough FEV1 (L) in Atopic Patients at Week 12 - Full Analysis Set

  baseline,12 weeks

• Change From Baseline in Trough FEV1 (L) in Non-atopic Compared to Atopic Patients at Week 12 - Full Analysis Set

  baseline,12 weeks

• Change From Baseline in ACQ-6 Score at Week 12 Non-atopic and Atopic Patients at Week 12 - Full Analysis Set

  baseline,12 weeks

• Change From Baseline in ACQ-6 Score at Week 12 Non-atopic Compared to Atopic Patients at Week 12 - Full Analysis Set

  baseline,12 weeks

Study Arms (5)

QAW039 450 mg qd Non-atopic

EXPERIMENTAL

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.

Drug: QAW039; Drug: Fluticasone 100 mcg

Placebo Non-atopic

PLACEBO COMPARATOR

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.

Drug: Placebo QAW039; Drug: Fluticasone 100 mcg

QAW039 450 mg qd Atopic

EXPERIMENTAL

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

Drug: QAW039; Drug: Fluticasone 100 mcg

Fluticasone 150 mcg bid Atopic

ACTIVE COMPARATOR

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

Drug: Placebo QAW039; Drug: Fluticasone 250 mcg

Placebo Atopic

PLACEBO COMPARATOR

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

Drug: Placebo QAW039; Drug: Fluticasone 100 mcg

Interventions

QAW039 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)

QAW039 450 mg qd Atopic; QAW039 450 mg qd Non-atopic

Placebo QAW039 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 150 mcg bid Atopic; Placebo Atopic; Placebo Non-atopic

Fluticasone 250 mcg 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).

Fluticasone 150 mcg bid Atopic

Fluticasone 100 mcg 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 Atopic; Placebo Non-atopic; QAW039 450 mg qd Atopic; QAW039 450 mg qd Non-atopic

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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

You may not qualify if:

• 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

Sponsors & Collaborators

• Novartis Pharmaceuticals: lead

Study Sites (76)

Novartis Investigative Site

Encinitas, California, 92024, United States

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Novartis Investigative Site

Huntington Beach, California, 92647, United States

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Los Angeles, California, 90025, United States

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Los Angeles, California, 90048, United States

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Novartis Investigative Site

Mission Viejo, California, 92691, United States

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Novartis Investigative Site

Orange, California, 92868, United States

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Palmdale, California, 93551, United States

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Riverside, California, 92506, United States

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Rolling Hills Estates, California, 90274, United States

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San Diego, California, 92123, United States

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San Jose, California, 95117, United States

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Novartis Investigative Site

Stockton, California, 95207, United States

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Colorado Springs, Colorado, 80907, United States

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Novartis Investigative Site

Denver, Colorado, 80206, United States

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Novartis Investigative Site

Denver, Colorado, 80230, United States

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Sarasota, Florida, 34233, United States

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Owensboro, Kentucky, 42301, United States

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North Dartmouth, Massachusetts, 02747, United States

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Minneapolis, Minnesota, 55402, United States

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St Louis, Missouri, 63128, United States

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Novartis Investigative Site

St Louis, Missouri, 63141, United States

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Novartis Investigative Site

Papillion, Nebraska, 68046, United States

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Novartis Investigative Site

Skillman, New Jersey, 08558, United States

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Novartis Investigative Site

Charlotte, North Carolina, 28207, United States

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Cincinnati, Ohio, 45231, United States

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Novartis Investigative Site

Medford, Oregon, 97504-8741, United States

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Novartis Investigative Site

Portland, Oregon, 97213, United States

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Lincoln, Rhode Island, 02865, United States

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Charleston, South Carolina, 29407, United States

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Novartis Investigative Site

Seattle, Washington, 98104, United States

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Novartis Investigative Site

Erpent, 5100, Belgium

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Novartis Investigative Site

Liège, 4000, 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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Novartis Investigative Site

Medellín, Colombia

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Novartis Investigative Site

Trutnov, Czech Republic, 541 01, Czechia

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Hradec Králové, CZE, 500 05, Czechia

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Novartis Investigative Site

Karlovy Vary-Stara Rokle, CZE, 360 17, Czechia

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Teplice, CZE, 415 01, Czechia

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Novartis Investigative Site

Marburg, Germany, D-35037, Germany

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Wiesbaden, Germany, 65187, Germany

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Berlin, 10717, Germany

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Frankfurt, 60596, Germany

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Leipzig, 04357, Germany

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Lübeck, 23552, Germany

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Novartis Investigative Site

Witten, 58452, Germany

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Novartis Investigative Site

Hyderabad, Andhra Pradesh, 500 068, India

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Novartis Investigative Site

Panjim, Goa, 403 002, India

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Novartis Investigative Site

Nagpur, Maharashtra, 400 012, India

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Novartis Investigative Site

Nagpur, Maharashtra, 440010, India

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Novartis Investigative Site

Coimbatore, Tamil Nadu, 641 045, India

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Novartis Investigative Site

Bialystok, 15-010, Poland

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Bialystok, 15-044, Poland

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Novartis Investigative Site

Lodz, 90-153, Poland

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Novartis Investigative Site

Wroclaw, 50-349, Poland

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Novartis Investigative Site

Bucharest, District 1, 10457, Romania

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Novartis Investigative Site

Bucharest, District 3, 030303, Romania

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Novartis Investigative Site

Bucharest, District 3, 030317, Romania

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Novartis Investigative Site

Craiova, Dolj, 200515, Romania

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Novartis Investigative Site

Timișoara, Romania, 300736, Romania

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Novartis Investigative Site

Arad, 310013, Romania

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Novartis Investigative Site

Craiova, 200515, Romania

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Novartis Investigative Site

Deva, 330162, Romania

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Novartis Investigative Site

Durban, South Africa, 4001, South Africa

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Novartis Investigative Site

Cape Town, 7500, South Africa

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Novartis Investigative Site

Cape Town, 7531, South Africa

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Novartis Investigative Site

Cape Town, 7925, South Africa

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Novartis Investigative Site

Cape Town, 8001, South Africa

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Novartis Investigative Site

Gatesville, 7764, South Africa

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Novartis Investigative Site

Pretoria, 0181, South Africa

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Novartis Investigative Site

Gwangju, Gwangju, 501-757, South Korea

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Novartis Investigative Site

Bucheon-si, Gyeonggi-do, 14584, South Korea

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Novartis Investigative Site

Suwon, Gyeonggi-do, 443-721, South Korea

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Novartis Investigative Site

Seoul, Korea, 06591, South Korea

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Novartis Investigative Site

Cheongju-si, North Chungcheong, 28644, South Korea

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MeSH Terms

Conditions

Asthma

Interventions

fevipiprant; Fluticasone

Condition Hierarchy (Ancestors)

Bronchial Diseases; Respiratory Tract Diseases; Lung Diseases, Obstructive; Lung Diseases; Respiratory Hypersensitivity; Hypersensitivity, Immediate; Hypersensitivity; Immune System Diseases

Intervention Hierarchy (Ancestors)

Androstadienes; Androstenes; Androstanes; Steroids; Fused-Ring Compounds; Polycyclic Compounds

Results Point of Contact

• Title: Study Director
• Organization: Novaratis Pharmaceuticals

862-778-8300

Study Officials

• Richard Kay

  Novartis Pharmaceuticals

  STUDY DIRECTOR

Publication Agreements

• PI is Sponsor Employee: No
• Restriction Type: OTHER
• Restrictive Agreement: Yes

Study Design

• Study Type: interventional
• Phase: phase 2
• Allocation: RANDOMIZED
• Masking: QUADRUPLE
• Who Masked: PARTICIPANT, CARE PROVIDER, INVESTIGATOR, OUTCOMES ASSESSOR
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: INDUSTRY
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: April 17, 2013
• First Posted: April 22, 2013
• Study Start: May 1, 2013
• Primary Completion: February 1, 2016
• Study Completion: February 1, 2016
• Last Updated: March 20, 2017
• Results First Posted: March 20, 2017

Record last verified: 2017-01

Data Sharing

• IPD Sharing: Will not share

Locations

BE (2); US (30); DE (7); IN (5); KR (5); RO (8); CZ (4); CO (4); PL (4); ZA (7)