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

Asthma Clinical Trial

Official title:

A Double-blind, Placebo-controlled, Study Examining the Effect of Orally Administered QAW039 (450 mg QD) on FEV1 and ACQ in Non-atopic, Asthmatic Patients With a Baseline, Pre-bronchodilator FEV1 of 40-80% Predicted, Inadequately Controlled With Low Dose ICS Therapy

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT01836471
• Other study ID #: CQAW039A2214
• Status: Completed
• Phase: Phase 2
• First received: April 17, 2013
• Last updated: March 10, 2016
• Start date: May 2013
• Est. completion date: February 2016

Study information

• Verified date: March 2016
• Source: Novartis
• Contact: n/a
• Is FDA regulated: No
• Health authority: United States: Food and Drug Administration
• Study type: Interventional

Clinical Trial Summary

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

Description:

This is 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 is also compared with an increased dose of ICS in atopic asthmatics taking low dose ICS as background therapy.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 345
• Est. completion date: February 2016
• Est. primary completion date: February 2016
• Accepts healthy volunteers: No
• Gender: Both
• Age group: 18 Years and older

Eligibility

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

Study Design

Allocation: Randomized, Endpoint Classification: Safety/Efficacy Study, Intervention Model: Parallel Assignment, Masking: Double Blind (Subject, Caregiver, Investigator, Outcomes Assessor), Primary Purpose: Treatment

Related Conditions & MeSH terms

• Asthma

Intervention

Drug:
• QAW039
QAW039 for 12 weeks plus Placebo for 2 weeks
• Placebo
Placebo for 14 weeks
• Inhaled corticosteroid (ICS)
ICS for 12 weeks plus Placebo for 2 weeks

Locations

Country	Name	City	State
Belgium	Novartis Investigative Site	Erpent
Belgium	Novartis Investigative Site	Liege
Colombia	Novartis Investigative Site	Barranquilla	Atlantico
Colombia	Novartis Investigative Site	Barranquilla
Colombia	Novartis Investigative Site	Bogotá	Cundinamarca
Colombia	Novartis Investigative Site	Medellín
Czech Republic	Novartis Investigative Site	Hradec Kralove	CZE
Czech Republic	Novartis Investigative Site	Karlovy Vary-Stara Rokle	CZE
Czech Republic	Novartis Investigative Site	Teplice	CZE
Czech Republic	Novartis Investigative Site	Trutnov
Germany	Novartis Investigative Site	Berlin
Germany	Novartis Investigative Site	Frankfurt
Germany	Novartis Investigative Site	Leipzig
Germany	Novartis Investigative Site	Lübeck
Germany	Novartis Investigative Site	Marburg
Germany	Novartis Investigative Site	Wiesbaden
Germany	Novartis Investigative Site	Witten
India	Novartis Investigative Site	Coimbatore	Tamil Nadu
India	Novartis Investigative Site	Hyderabad	Andhra Pradesh
India	Novartis Investigative Site	Nagpur	Maharashtra
India	Novartis Investigative Site	Nagpur	Maharashtra
India	Novartis Investigative Site	Panjim	Goa
Korea, Republic of	Novartis Investigative Site	Bucheon-Si	Gyeonggi-Do
Korea, Republic of	Novartis Investigative Site	Cheongju-si	Chungcheongbuk-do
Korea, Republic of	Novartis Investigative Site	Gwangju
Korea, Republic of	Novartis Investigative Site	Seoul	Korea
Korea, Republic of	Novartis Investigative Site	Suwon	Gyeonggi-do
Poland	Novartis Investigative Site	Bialystok
Poland	Novartis Investigative Site	Bialystok
Poland	Novartis Investigative Site	Lodz
Poland	Novartis Investigative Site	Wroclaw
Romania	Novartis Investigative Site	Arad
Romania	Novartis Investigative Site	Bucharest	District 3
Romania	Novartis Investigative Site	Bucharest	District 3
Romania	Novartis Investigative Site	Bucuresti	District 1
Romania	Novartis Investigative Site	Craiova	Dolj
Romania	Novartis Investigative Site	Craiova
Romania	Novartis Investigative Site	Deva
Romania	Novartis Investigative Site	Timisoara
South Africa	Novartis Investigative Site	Cape Town
South Africa	Novartis Investigative Site	Cape Town
South Africa	Novartis Investigative Site	Cape Town
South Africa	Novartis Investigative Site	Cape Town
South Africa	Novartis Investigative Site	Durban
South Africa	Novartis Investigative Site	Gatesville
South Africa	Novartis Investigative Site	Pretoria
United States	Novartis Investigative Site	Charleston	South Carolina
United States	Novartis Investigative Site	Charlotte	North Carolina
United States	Novartis Investigative Site	Cincinnati	Ohio
United States	Novartis Investigative Site	Colorado Springs	Colorado
United States	Novartis Investigative Site	Denver	Colorado
United States	Novartis Investigative Site	Denver	Colorado
United States	Novartis Investigative Site	Encinitas	California
United States	Novartis Investigative Site	Huntington Beach	California
United States	Novartis Investigative Site	Lincoln	Rhode Island
United States	Novartis Investigative Site	Los Angeles	California
United States	Novartis Investigative Site	Los Angeles	California
United States	Novartis Investigative Site	Medford	Oregon
United States	Novartis Investigative Site	Minneapolis	Minnesota
United States	Novartis Investigative Site	Mission Viejo	California
United States	Novartis Investigative Site	North Dartmouth	Massachusetts
United States	Novartis Investigative Site	Orange	California
United States	Novartis Investigative Site	Owensboro	Kentucky
United States	Novartis Investigative Site	Palmdale	California
United States	Novartis Investigative Site	Papillion	Nebraska
United States	Novartis Investigative Site	Portland	Oregon
United States	Novartis Investigative Site	Riverside	California
United States	Novartis Investigative Site	Rolling Hills Estates	California
United States	Novartis Investigative Site	San Diego	California
United States	Novartis Investigative Site	San Jose	California
United States	Novartis Investigative Site	Sarasota	Florida
United States	Novartis Investigative Site	Seattle	Washington
United States	Novartis Investigative Site	Skillman	New Jersey
United States	Novartis Investigative Site	St. Louis	Missouri
United States	Novartis Investigative Site	St. Louis	Missouri
United States	Novartis Investigative Site	Stockton	California

Sponsors (1)

Lead Sponsor	Collaborator
Novartis Pharmaceuticals

Countries where clinical trial is conducted

United States,  Belgium,  Colombia,  Czech Republic,  Germany,  India,  Korea, Republic of,  Poland,  Romania,  South Africa, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Lung Function Assessed by trough Forced Expiratory Volume for 1 Second (FEV1) in non-atopic asthmatics	Forced Expiratory Volume in one second (FEV1) is calculated as the volume of air forcibly exhaled in one second as measured by a spirometer.	12 weeks	No
Secondary	Asthma Control assessed by Asthma Control Questionnaire (ACQ) score in non-atopic asthmatics	The Asthma Control Questionnaire (ACQ) has six questions answered by the patient, each with a 7 point scale (0=good control, 6=poor control), and one question expressing the actual pre-bronchodilator FEV1 value in % of predicted FEV1 is classified to scores from 0 (> 95% of predicted) to 6 (< 50% of predicted). The overall score is the average of the 7 questions; a score of 0 = good control of asthma; a score of 6 = poor control of asthma. A negative change in score indicates improvement in symptoms.	12 weeks	No
Secondary	ACQ score in atopic asthmatics	The Asthma Control Questionnaire (ACQ) has six questions answered by the patient, each with a 7 point scale (0=good control, 6=poor control), and one question expressing the actual pre-bronchodilator FEV1 value in % of predicted FEV1 is classified to scores from 0 (> 95% of predicted) to 6 (< 50% of predicted). The overall score is the average of the 7 questions; a score of 0 = good control of asthma; a score of 6 = poor control of asthma. A negative change in score indicates improvement in symptoms.	12 weeks	No
Secondary	Comparison of ACQ score between non-atopic and atopic asthmatics	The Asthma Control Questionnaire (ACQ) has six questions answered by the patient, each with a 7 point scale (0=good control, 6=poor control), and one question expressing the actual pre-bronchodilator FEV1 value in % of predicted FEV1 is classified to scores from 0 (> 95% of predicted) to 6 (< 50% of predicted). The overall score is the average of the 7 questions; a score of 0 = good control of asthma; a score of 6 = poor control of asthma. A negative change in score indicates improvement in symptoms.	12 weeks	No
Secondary	Trough FEV1 in atopic asthmatics	Forced expiratory Volume in one second (FEV1) is the amount of air which can be forcibly exhaled from the lungs in the first second of a forced exhalation, measured through spirometry testing. The trough in FEV1 is defined as the mean of two measurements.	12 weeks	No
Secondary	Comparison of trough FEV1 between non-atopic and atopic asthmatics	Forced expiratory Volume in one second (FEV1) is the amount of air which can be forcibly exhaled from the lungs in the first second of a forced exhalation, measured through spirometry testing. The trough in FEV1 is defined as the mean of two measurements.	12 weeks	No