Efficacy and Safety of QGE031versus Placebo and Omalizumab in Patients Aged 18-75 Years With Asthma

Asthma Clinical Trial

Official title:

A Multi-center, Randomized, Double-blind, Placebo and Active-controlled Study With Exploratory Dose-ranging to Investigate the Efficacy and Safety of 16 Weeks Treatment With Subcutaneous (s.c.) QGE031 in Asthma Patients Not Adequately Controlled With High-dose Inhaled Corticosteroids and Long Acting β2-agonists

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT01716754
• Other study ID #: CQGE031B2201
• Secondary ID: 2012-002298-69
• Status: Completed
• Phase: Phase 2
• First received: October 19, 2012
• Last updated: August 7, 2017
• Start date: December 2012
• Est. completion date: January 2016

Study information

• Verified date: August 2017
• Source: Novartis
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial Summary

This study assessed the effect on asthma control of different dose levels and regimens of QGE031 in asthma patients that are inadequately controlled with inhaled steroid and beta-2 agonist medication. Safety was assessed also. Comparison was to placebo and omalizumab. Information from this study was planned to support the design of future studies.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 471
• Est. completion date: January 2016
• Est. primary completion date: January 2016
• Accepts healthy volunteers: No
• Gender: All
• Age group: 18 Years to 75 Years

Eligibility

Key Inclusion Criteria:

• A diagnosis of allergic asthma , uncontrolled on current medication.

• History of at least 1 asthma exacerbation during the last 1 year

• Forced Expiratory Volume in one second (FEV1) of = 40% and = 80% of the predicted normal value; reversibility following administration of bronchodilator must also be demonstrated (historical positive reversibility or bronchoprovocation result can be used).

Key Exclusion Criteria:

• Baseline IgE levels or body weight outside the omalizumab dosing table.

• Use of tobacco products within the previous 6 months (Social occasional smokers may be included).

• Recent asthma attack/exacerbation or asthma worsening/ respiratory infection.

Related Conditions & MeSH terms

• Asthma

Intervention

Drug:
• QGE031
QGE031 was supplied as 120 mg liquid in vial per 1 mL
• Omalizumab
Omalizumab was supplied as 150 mg lyophilisate in vial
• Placebo
Placebo to QGE031 and Omalizumab was supplied as QGE031 0 mg in vial per 1 mL

Locations

Country	Name	City	State
Argentina	Novartis Investigative Site	Buenos Aires
Argentina	Novartis Investigative Site	Buenos Aires
Argentina	Novartis Investigative Site	Caba	Buenos Aires
Argentina	Novartis Investigative Site	Caba	Buenos Aires
Argentina	Novartis Investigative Site	Caba	Capital Federal
Argentina	Novartis Investigative Site	Mar del Plata	Buenos Aires
Argentina	Novartis Investigative Site	Mendoza
Argentina	Novartis Investigative Site	Mendoza
Argentina	Novartis Investigative Site	Rosario	Santa Fe
Argentina	Novartis Investigative Site	Rosario	Santa Fe
Argentina	Novartis Investigative Site	San Miguel de Tucuman	Tucuman
Argentina	Novartis Investigative Site	Santa Fe
Argentina	Novartis Investigative Site	Santa Fe	Rosario
Canada	Novartis Investigative Site	Montreal	Quebec
Canada	Novartis Investigative Site	Ottawa	Ontario
Canada	Novartis Investigative Site	Quebec
Canada	Novartis Investigative Site	St-Charles-Borromée	Quebec
Czechia	Novartis Investigative Site	Breclav
Czechia	Novartis Investigative Site	Brno
Czechia	Novartis Investigative Site	Brno	Czech Republic
Czechia	Novartis Investigative Site	Tabor
Czechia	Novartis Investigative Site	Teplice	CZE
Czechia	Novartis Investigative Site	Trutnov	Czech Republic
Finland	Novartis Investigative Site	Helsinki
Finland	Novartis Investigative Site	Tampere
Finland	Novartis Investigative Site	Turku
France	Novartis Investigative Site	Le Kremlin Bicetre
France	Novartis Investigative Site	Marseille
France	Novartis Investigative Site	Montpellier
France	Novartis Investigative Site	Strasbourg
Germany	Novartis Investigative Site	Frankfurt
Germany	Novartis Investigative Site	Hamburg
Germany	Novartis Investigative Site	Homburg
Germany	Novartis Investigative Site	Leipzig
Germany	Novartis Investigative Site	Leipzig
Germany	Novartis Investigative Site	Mainz
Germany	Novartis Investigative Site	Roth
Germany	Novartis Investigative Site	Rüdersdorf
Guatemala	Novartis Investigative Site	Guatemala City	GTM
Guatemala	Novartis Investigative Site	Guatemala City	GTM
Guatemala	Novartis Investigative Site	Guatemala City
Hungary	Novartis Investigative Site	Budapest
Hungary	Novartis Investigative Site	Debrecen
Hungary	Novartis Investigative Site	Pecs
Hungary	Novartis Investigative Site	Torokbalint
India	Novartis Investigative Site	Dhantoli	Nagpur
India	Novartis Investigative Site	Karamsad	Gujrat
India	Novartis Investigative Site	Panjim	Goa
Israel	Novartis Investigative Site	Haifa
Israel	Novartis Investigative Site	Jerusalem
Israel	Novartis Investigative Site	Jerusalem
Israel	Novartis Investigative Site	Kfar-Saba
Israel	Novartis Investigative Site	Petach Tikva
Israel	Novartis Investigative Site	Rehovot
Italy	Novartis Investigative Site	Messina	ME
Italy	Novartis Investigative Site	Milano	MI
Italy	Novartis Investigative Site	Padova	PD
Italy	Novartis Investigative Site	Pisa	PI
Italy	Novartis Investigative Site	Reggio Emilia	RE
Italy	Novartis Investigative Site	Verona	VR
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, Republic of	Novartis Investigative Site	Seoul
Korea, Republic of	Novartis Investigative Site	Seoul	Korea
Korea, Republic of	Novartis Investigative Site	Suwon	Gyeonggi-do
Mexico	Novartis Investigative Site	Guadalajara	Jalisco
Mexico	Novartis Investigative Site	México, D.F.	Distrito Federal
Panama	Novartis Investigative Site	Panama City
Poland	Novartis Investigative Site	Bialystok
Poland	Novartis Investigative Site	Lodz
Portugal	Novartis Investigative Site	Coimbra
Portugal	Novartis Investigative Site	Lisboa
Portugal	Novartis Investigative Site	Lisboa
Portugal	Novartis Investigative Site	Porto
Portugal	Novartis Investigative Site	Vila Nova de Gaia
Romania	Novartis Investigative Site	Brasov
Romania	Novartis Investigative Site	Brasov
Romania	Novartis Investigative Site	Brasov
Romania	Novartis Investigative Site	Bucharest	District 3
Romania	Novartis Investigative Site	Bucharest	District 3
Romania	Novartis Investigative Site	Bucharest	ROM
Romania	Novartis Investigative Site	Bucuresti	District 1
Romania	Novartis Investigative Site	Bucuresti
Romania	Novartis Investigative Site	Bucuresti
Romania	Novartis Investigative Site	Cluj Napoca
Romania	Novartis Investigative Site	Cluj-Napoca
Romania	Novartis Investigative Site	Constanta	Jud. Constanta
Romania	Novartis Investigative Site	Pitesti
Russian Federation	Novartis Investigative Site	Barnaul
Russian Federation	Novartis Investigative Site	Chelyabinsk
Russian Federation	Novartis Investigative Site	Chelyabinsk
Russian Federation	Novartis Investigative Site	Moscow
Russian Federation	Novartis Investigative Site	Moscow
Russian Federation	Novartis Investigative Site	Moscow
Russian Federation	Novartis Investigative Site	N.Novgorod
Russian Federation	Novartis Investigative Site	Nizhny Novgorod
Russian Federation	Novartis Investigative Site	Penza
Russian Federation	Novartis Investigative Site	Ryazan
Russian Federation	Novartis Investigative Site	Saint Petersburg
Russian Federation	Novartis Investigative Site	Saratov
Russian Federation	Novartis Investigative Site	St-Petersburg
Russian Federation	Novartis Investigative Site	St. Petersburg
Russian Federation	Novartis Investigative Site	Yaroslavl
Singapore	Novartis Investigative Site	Singapore
Singapore	Novartis Investigative Site	Singapore
Slovakia	Novartis Investigative Site	Bardejov
Slovakia	Novartis Investigative Site	Bratislava
Slovakia	Novartis Investigative Site	Bratislava	Slovak Republic
Slovakia	Novartis Investigative Site	Kosice
Slovakia	Novartis Investigative Site	Nitra	Slovak Republic
Slovakia	Novartis Investigative Site	Prievidza
Slovakia	Novartis Investigative Site	Ruzomberok
Slovakia	Novartis Investigative Site	Trencin
South Africa	Novartis Investigative Site	Cape Town
South Africa	Novartis Investigative Site	Cape Town
South Africa	Novartis Investigative Site	Durban
Turkey	Novartis Investigative Site	Aydin
Turkey	Novartis Investigative Site	Fatih / Istanbul
Turkey	Novartis Investigative Site	Istanbul
Turkey	Novartis Investigative Site	Istanbul
Turkey	Novartis Investigative Site	Izmir
Turkey	Novartis Investigative Site	Mersin
United Kingdom	Novartis Investigative Site	Birmingham
United Kingdom	Novartis Investigative Site	Bradford	West Yorkshire
United Kingdom	Novartis Investigative Site	East Yorkshire
United Kingdom	Novartis Investigative Site	Southampton
United States	Novartis Investigative Site	Brooklyn	New York
United States	Novartis Investigative Site	Cincinnati	Ohio
United States	Novartis Investigative Site	Columbia	Maryland
United States	Novartis Investigative Site	Evansville	Indiana
United States	Novartis Investigative Site	Everett	Washington
United States	Novartis Investigative Site	Fairfax	Virginia
United States	Novartis Investigative Site	Fresno	California
United States	Novartis Investigative Site	Hawaiian Gardens	California
United States	Novartis Investigative Site	Lincoln	Rhode Island
United States	Novartis Investigative Site	Mineola	New York
United States	Novartis Investigative Site	Minneapolis	Minnesota
United States	Novartis Investigative Site	Mount Pleasant	South Carolina
United States	Novartis Investigative Site	Novi	Michigan
United States	Novartis Investigative Site	Omaha	Nebraska
United States	Novartis Investigative Site	Owensboro	Kentucky
United States	Novartis Investigative Site	Papillion	Nebraska
United States	Novartis Investigative Site	Riverside	California
United States	Novartis Investigative Site	Salt Lake City	Utah
United States	Novartis Investigative Site	San Jose	California
United States	Novartis Investigative Site	Summerville	South Carolina
United States	Novartis Investigative Site	Vista	California
United States	Novartis Investigative Site	Waldorf	Maryland

Sponsors (1)

Lead Sponsor	Collaborator
Novartis Pharmaceuticals

Countries where clinical trial is conducted

United States,  Argentina,  Canada,  Czechia,  Finland,  France,  Germany,  Guatemala,  Hungary,  India,  Israel,  Italy,  Korea, Republic of,  Mexico,  Panama,  Poland,  Portugal,  Romania,  Russian Federation,  Singapore,  Slovakia,  South Africa,  Turkey,  United Kingdom, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Percentage of QGE031 Participants With Clinically Important Improvement of <= -0.5 in the Asthma Control Questionnaire 7 (ACQ-7) Score Compared to Placebo	The ACQ-7 measures asthma symptom control and consisted of 7 items: 5 on symptom assessment, 1 on rescue bronchodilator use and 1 on airway caliber (FEV1 % predicted). All 7 questions of the ACQ were equally weighted. Items 1-6 scored along a 7-point response scale, where 0 = good controlled and 6 = poor controlled. The 7th item on % predicted FEV1 (pre-bronchodilator) was scored by clinic staff on a 7-point scale (0 - > 95%; 1 - 90-95%; 2 - 80-89%; 3 - 70-79%; 4 - 60-69%; 5 - 50-59%; 6 - < 50%). The average score of the 7 questions was calculated as the sum of scores divided by the number of questions that were answered by the participants, as long as there were at least 6 questions answered and the missing items were neither question 1 nor question 7.	Week 16
Secondary	Change From Baseline in ACQ-7 Score	The ACQ-7 measures asthma symptom control and consisted of 7 items: 5 on symptom assessment, 1 on rescue bronchodilator use and 1 on airway caliber (FEV1 % predicted). All 7 questions of the ACQ were equally weighted. Items 1-6 scored along a 7-point response scale, where 0 = good controlled and 6 = poor controlled. The 7th item on % predicted FEV1 (pre-bronchodilator) was scored by clinic staff on a 7-point scale (0 - > 95%; 1 - 90-95%; 2 - 80-89%; 3 - 70-79%; 4 - 60-69%; 5 - 50-59%; 6 - < 50%). The average score of the 7 questions was calculated as the sum of scores divided by the number of questions that were answered by the participants, as long as there were at least 6 questions answered and the missing items were neither question 1 nor question 7. A negative change from baseline indicates improvement.	Baseline, Weeks 4, 8, 12, 16 and 28
Secondary	Percentage of Participants With a Change From Baseline in ACQ-7 Score Less Than -1.1	The ACQ-7 measures asthma symptom control and consisted of 7 items: 5 on symptom assessment, 1 on rescue bronchodilator use and 1 on airway caliber (FEV1 % predicted). All 7 questions of the ACQ were equally weighted. Items 1-6 scored along a 7-point response scale, where 0 = good controlled and 6 = poor controlled. The 7th item on % predicted FEV1 (pre-bronchodilator) was scored by clinic staff on a 7-point scale (0 - > 95%; 1 - 90-95%; 2 - 80-89%; 3 - 70-79%; 4 - 60-69%; 5 - 50-59%; 6 - < 50%). The average score of the 7 questions was calculated as the sum of scores divided by the number of questions that were answered by the participants, as long as there were at least 6 questions answered and the missing items were neither question 1 nor question 7.	Week 16
Secondary	Change From Baseline in Asthma Quality of Life Questionnaire (AQLQ) Score	The AQLQ is a 32-item disease specific questionnaire designed to measure functional impairments that are most important to participants with asthma. The 32 items in the AQLQ were divided into four domain-specific scores and a total score as follows: Activity limitations = Mean of Items 1, 2, 3, 4, 5, 11, 19, 25, 28, 31, 32 (11 items); Symptoms = Mean of Items 6, 8, 10, 12, 14, 16, 18, 20, 22, 24, 29, 30 (12 items); Emotional function = Mean of Items 7, 13, 15, 21, 27 (5 items); Environmental stimuli = Mean of Items 9, 17, 23, 26 (4 items); and Overall Score = Mean of Items 1 to 32 (32 items). Each item of the AQLQ was equally weighted and scored along a 7-point scale, where 1 indicates maximal impairment and 7 indicates no impairment. Thus, higher scores indicate better asthma-related quality of life. The mean overall score ranged from 1 to 7. A positive change from baseline indicates improvement.	Baseline, Week 16, Week 28
Secondary	Change From Baseline in Mean Number of Puffs of Morning, Evening and Total Daily Asthma Rescue Medication	Participants recorded their use of rescue medication into an electronic diary (eDiary). A negative change from baseline indicates improvement.	Baseline, Week 16

External Links

•   Results for CQGE031B2201 from the Novartis Clinical Trial Results Website