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

August 7, 2017 updated by: Novartis Pharmaceuticals

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

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.

Study Overview

Status

Status

Indicates the current recruitment status or the expanded access status.
Completed

Conditions

Conditions

The disease, disorder, syndrome, illness, or injury that is being studied. On ClinicalTrials.gov, conditions may also include other health-related issues, such as lifespan, quality of life, and health risks.

Intervention / Treatment

Intervention / Treatment

A process or action that is the focus of a clinical study. Interventions include drugs, medical devices, procedures, vaccines, and other products that are either investigational or already available. Interventions can also include noninvasive approaches, such as education or modifying diet and exercise.

Study Type

Study Type

Describes the nature of a clinical study. Study types include interventional studies (also called clinical trials), observational studies (including patient registries), and expanded access.
Interventional

Enrollment (Actual)

Enrollment

The number of participants in a clinical study. The "anticipated" enrollment is the target number of participants that the researchers need for the study.
471

Phase

Phase

The stage of a clinical trial studying a drug or biological product, based on definitions developed by the U.S. Food and Drug Administration (FDA). The phase is based on the study's objective, the number of participants, and other characteristics. There are five phases: Early Phase 1 (formerly listed as Phase 0), Phase 1, Phase 2, Phase 3, and Phase 4. Not Applicable is used to describe trials without FDA-defined phases, including trials of devices or behavioral interventions.
  • Phase 2

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

  • Argentina
      • Buenos Aires, Argentina, B1842DID
        • Novartis Investigative Site
      • Buenos Aires, Argentina, C1125ABE
        • Novartis Investigative Site
      • Mendoza, Argentina, M5500CBA
        • Novartis Investigative Site
      • Mendoza, Argentina, M5500FIK
        • Novartis Investigative Site
      • Santa Fe, Argentina, S3000FIL
        • Novartis Investigative Site
    • Buenos Aires
      • Caba, Buenos Aires, Argentina, C1122AAK
        • Novartis Investigative Site
      • Caba, Buenos Aires, Argentina, C1426ABP
        • Novartis Investigative Site
      • Mar del Plata, Buenos Aires, Argentina, 7600
        • Novartis Investigative Site
    • Capital Federal
      • Caba, Capital Federal, Argentina, C1430CKE
        • Novartis Investigative Site
    • Rosario
      • Santa Fe, Rosario, Argentina, S2000DBS
        • Novartis Investigative Site
    • Santa Fe
      • Rosario, Santa Fe, Argentina, S2000CXH
        • Novartis Investigative Site
      • Rosario, Santa Fe, Argentina, S2000AII
        • Novartis Investigative Site
    • Tucuman
      • San Miguel de Tucuman, Tucuman, Argentina, 4000
        • Novartis Investigative Site
  • Canada
      • Quebec, Canada, G1V 4W2
        • Novartis Investigative Site
    • Ontario
      • Ottawa, Ontario, Canada, K1Y 4G2
        • Novartis Investigative Site
    • Quebec
      • Montreal, Quebec, Canada, H3G 1L5
        • Novartis Investigative Site
      • St-Charles-Borromée, Quebec, Canada, J6E 2B4
        • Novartis Investigative Site
  • Czechia
      • Breclav, Czechia, 690 02
        • Novartis Investigative Site
      • Brno, Czechia, 615 00
        • Novartis Investigative Site
      • Tabor, Czechia, 390 01
        • Novartis Investigative Site
    • CZE
      • Teplice, CZE, Czechia, 415 01
        • Novartis Investigative Site
    • Czech Republic
      • Brno, Czech Republic, Czechia, 639 00
        • Novartis Investigative Site
      • Trutnov, Czech Republic, Czechia, 541 01
        • Novartis Investigative Site
  • Finland
      • Helsinki, Finland, 00290
        • Novartis Investigative Site
      • Tampere, Finland, 33520
        • Novartis Investigative Site
      • Turku, Finland, 20521
        • Novartis Investigative Site
  • France
      • Le Kremlin Bicetre, France, 94275
        • Novartis Investigative Site
      • Marseille, France, 13915
        • Novartis Investigative Site
      • Montpellier, France, 34059
        • Novartis Investigative Site
      • Strasbourg, France, 67091
        • Novartis Investigative Site
  • Germany
      • Frankfurt, Germany, 60596
        • Novartis Investigative Site
      • Hamburg, Germany, 20354
        • Novartis Investigative Site
      • Homburg, Germany, 66421
        • Novartis Investigative Site
      • Leipzig, Germany, 04103
        • Novartis Investigative Site
      • Leipzig, Germany, 04275
        • Novartis Investigative Site
      • Mainz, Germany, 55131
        • Novartis Investigative Site
      • Roth, Germany, 91154
        • Novartis Investigative Site
      • Rüdersdorf, Germany, 15562
        • Novartis Investigative Site
  • Guatemala
      • Guatemala City, Guatemala, 01011
        • Novartis Investigative Site
    • GTM
      • Guatemala City, GTM, Guatemala, 01010
        • Novartis Investigative Site
      • Guatemala City, GTM, Guatemala, 01011
        • Novartis Investigative Site
  • Hungary
      • Budapest, Hungary, 1121
        • Novartis Investigative Site
      • Debrecen, Hungary, 4032
        • Novartis Investigative Site
      • Pecs, Hungary, 7635
        • Novartis Investigative Site
      • Torokbalint, Hungary, 2045
        • Novartis Investigative Site
  • India
    • Goa
      • Panjim, Goa, India, 403 002
        • Novartis Investigative Site
    • Gujrat
      • Karamsad, Gujrat, India, 388325
        • Novartis Investigative Site
    • Nagpur
      • Dhantoli, Nagpur, India, 12
        • Novartis Investigative Site
  • Israel
      • Haifa, Israel, 3436212
        • Novartis Investigative Site
      • Jerusalem, Israel, 91031
        • Novartis Investigative Site
      • Jerusalem, Israel, 9112001
        • Novartis Investigative Site
      • Kfar-Saba, Israel, 4428164
        • Novartis Investigative Site
      • Petach Tikva, Israel, 49100
        • Novartis Investigative Site
      • Rehovot, Israel, 7610001
        • Novartis Investigative Site
  • Italy
    • ME
      • Messina, ME, Italy, 98125
        • Novartis Investigative Site
    • MI
      • Milano, MI, Italy, 20123
        • Novartis Investigative Site
    • PD
      • Padova, PD, Italy, 35128
        • Novartis Investigative Site
    • PI
      • Pisa, PI, Italy, 56124
        • Novartis Investigative Site
    • RE
      • Reggio Emilia, RE, Italy, 42123
        • Novartis Investigative Site
    • VR
      • Verona, VR, Italy, 37126
        • Novartis Investigative Site
  • Korea, Republic of
      • Gwangju, Korea, Republic of, 501-757
        • Novartis Investigative Site
      • Seoul, Korea, Republic of, 120-752
        • Novartis Investigative Site
      • Seoul, Korea, Republic of, 156-755
        • Novartis Investigative Site
    • Chungcheongbuk-do
      • Cheongju-si, Chungcheongbuk-do, Korea, Republic of, 28644
        • Novartis Investigative Site
    • Gyeonggi-Do
      • Bucheon-Si, Gyeonggi-Do, Korea, Republic of, 14584
        • Novartis Investigative Site
    • Gyeonggi-do
      • Suwon, Gyeonggi-do, Korea, Republic of, 16499
        • Novartis Investigative Site
    • Korea
      • Seoul, Korea, Korea, Republic of, 08308
        • Novartis Investigative Site
  • Mexico
    • Distrito Federal
      • México, D.F., Distrito Federal, Mexico, 06700
        • Novartis Investigative Site
    • Jalisco
      • Guadalajara, Jalisco, Mexico, 44130
        • Novartis Investigative Site
  • Panama
      • Panama City, Panama
        • Novartis Investigative Site
  • Poland
      • Bialystok, Poland, 15-276
        • Novartis Investigative Site
      • Lodz, Poland, 90-153
        • Novartis Investigative Site
  • Portugal
      • Coimbra, Portugal, 3041-853
        • Novartis Investigative Site
      • Lisboa, Portugal, 1749-035
        • Novartis Investigative Site
      • Lisboa, Portugal, 1169-024
        • Novartis Investigative Site
      • Porto, Portugal, 4100-180
        • Novartis Investigative Site
      • Vila Nova de Gaia, Portugal, 4434-502
        • Novartis Investigative Site
  • Romania
      • Brasov, Romania, 500112
        • Novartis Investigative Site
      • Brasov, Romania, 500281
        • Novartis Investigative Site
      • Brasov, Romania, 500086
        • Novartis Investigative Site
      • Bucuresti, Romania, 011461
        • Novartis Investigative Site
      • Bucuresti, Romania, 050159
        • Novartis Investigative Site
      • Cluj Napoca, Romania, 400139
        • Novartis Investigative Site
      • Cluj-Napoca, Romania, 400371
        • Novartis Investigative Site
      • Pitesti, Romania, 110114
        • Novartis Investigative Site
    • District 1
      • Bucuresti, District 1, Romania, 10457
        • Novartis Investigative Site
    • District 3
      • Bucharest, District 3, Romania, 030303
        • Novartis Investigative Site
      • Bucharest, District 3, Romania, 030317
        • Novartis Investigative Site
    • Jud. Constanta
      • Constanta, Jud. Constanta, Romania, 900002
        • Novartis Investigative Site
    • ROM
      • Bucharest, ROM, Romania, 12071
        • Novartis Investigative Site
  • Russian Federation
      • Barnaul, Russian Federation, 656045
        • Novartis Investigative Site
      • Chelyabinsk, Russian Federation, 454021
        • Novartis Investigative Site
      • Chelyabinsk, Russian Federation, 454000
        • Novartis Investigative Site
      • Moscow, Russian Federation, 127018
        • Novartis Investigative Site
      • Moscow, Russian Federation, 119992
        • Novartis Investigative Site
      • Moscow, Russian Federation, 125315
        • Novartis Investigative Site
      • N.Novgorod, Russian Federation, 603126
        • Novartis Investigative Site
      • Nizhny Novgorod, Russian Federation, 603018
        • Novartis Investigative Site
      • Penza, Russian Federation, 440026
        • Novartis Investigative Site
      • Ryazan, Russian Federation, 390026
        • Novartis Investigative Site
      • Saint Petersburg, Russian Federation, 197022
        • Novartis Investigative Site
      • Saratov, Russian Federation, 410012
        • Novartis Investigative Site
      • St-Petersburg, Russian Federation, 193312
        • Novartis Investigative Site
      • St. Petersburg, Russian Federation, 194354
        • Novartis Investigative Site
      • Yaroslavl, Russian Federation, 150003
        • Novartis Investigative Site
  • Singapore
      • Singapore, Singapore, 169608
        • Novartis Investigative Site
      • Singapore, Singapore, 308433
        • Novartis Investigative Site
  • Slovakia
      • Bardejov, Slovakia, 085 01
        • Novartis Investigative Site
      • Bratislava, Slovakia, 826 06
        • Novartis Investigative Site
      • Kosice, Slovakia, 04001
        • Novartis Investigative Site
      • Prievidza, Slovakia, 97101
        • Novartis Investigative Site
      • Ruzomberok, Slovakia, 034 26
        • Novartis Investigative Site
      • Trencin, Slovakia, 91101
        • Novartis Investigative Site
    • Slovak Republic
      • Bratislava, Slovak Republic, Slovakia, 831 03
        • Novartis Investigative Site
      • Nitra, Slovak Republic, Slovakia, 949 01
        • Novartis Investigative Site
  • South Africa
      • Cape Town, South Africa, 7531
        • Novartis Investigative Site
      • Cape Town, South Africa, 7505
        • Novartis Investigative Site
      • Durban, South Africa, 4001
        • Novartis Investigative Site
  • Turkey
      • Aydin, Turkey, 09100
        • Novartis Investigative Site
      • Fatih / Istanbul, Turkey, 34098
        • Novartis Investigative Site
      • Istanbul, Turkey, 34093
        • Novartis Investigative Site
      • Istanbul, Turkey, 34854
        • Novartis Investigative Site
      • Izmir, Turkey, 35040
        • Novartis Investigative Site
      • Mersin, Turkey, 33079
        • Novartis Investigative Site
  • United Kingdom
      • Birmingham, United Kingdom, B9 5SS
        • Novartis Investigative Site
      • East Yorkshire, United Kingdom, HU16 5JQ
        • Novartis Investigative Site
      • Southampton, United Kingdom, SO16 6YD
        • Novartis Investigative Site
    • West Yorkshire
      • Bradford, West Yorkshire, United Kingdom, BD9 6RJ
        • Novartis Investigative Site
  • United States
    • California
      • Fresno, California, United States, 93720
        • Novartis Investigative Site
      • Hawaiian Gardens, California, United States, 90716
        • Novartis Investigative Site
      • Riverside, California, United States, 92506
        • Novartis Investigative Site
      • San Jose, California, United States, 95117
        • Novartis Investigative Site
      • Vista, California, United States, 92083
        • Novartis Investigative Site
    • Indiana
      • Evansville, Indiana, United States, 47713
        • Novartis Investigative Site
    • Kentucky
      • Owensboro, Kentucky, United States, 42301
        • Novartis Investigative Site
    • Maryland
      • Columbia, Maryland, United States, 21044
        • Novartis Investigative Site
      • Waldorf, Maryland, United States, 20602
        • Novartis Investigative Site
    • Michigan
      • Novi, Michigan, United States, 48375
        • Novartis Investigative Site
    • Minnesota
      • Minneapolis, Minnesota, United States, 55402
        • Novartis Investigative Site
    • Nebraska
      • Omaha, Nebraska, United States, 68130
        • Novartis Investigative Site
      • Papillion, Nebraska, United States, 68046
        • Novartis Investigative Site
    • New York
      • Brooklyn, New York, United States, 11229
        • Novartis Investigative Site
      • Mineola, New York, United States, 11501
        • Novartis Investigative Site
    • Ohio
      • Cincinnati, Ohio, United States, 45231
        • Novartis Investigative Site
    • Rhode Island
      • Lincoln, Rhode Island, United States, 02865
        • Novartis Investigative Site
    • South Carolina
      • Mount Pleasant, South Carolina, United States, 29464
        • Novartis Investigative Site
      • Summerville, South Carolina, United States, 29485
        • Novartis Investigative Site
    • Utah
      • Salt Lake City, Utah, United States, 84108
        • Novartis Investigative Site
    • Virginia
      • Fairfax, Virginia, United States, 22030
        • Novartis Investigative Site
    • Washington
      • Everett, Washington, United States, 98208
        • Novartis Investigative Site

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Eligibility Criteria

The key requirements that people who want to participate in a clinical study must meet or the characteristics they must have. Eligibility criteria consist of both inclusion criteria (which are required for a person to participate in the study) and exclusion criteria (which prevent a person from participating). Types of eligibility criteria include whether a study accepts healthy volunteers, has age or age group requirements, or is limited by sex.

Ages Eligible for Study

18 years to 75 years (ADULT, OLDER_ADULT)

Accepts Healthy Volunteers

No

Genders Eligible for Study

All

Description

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.

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: TREATMENT
  • Allocation: RANDOMIZED
  • Interventional Model: PARALLEL
  • Masking: DOUBLE

Arms and Interventions

Participant Group / Arm

Participant Group / Arm

A group or subgroup of participants in a clinical trial that receives a specific intervention/treatment, or no intervention, according to the trial's protocol.
Intervention / Treatment

Intervention / Treatment

A process or action that is the focus of a clinical study. Interventions include drugs, medical devices, procedures, vaccines, and other products that are either investigational or already available. Interventions can also include noninvasive approaches, such as education or modifying diet and exercise.
EXPERIMENTAL: QGE031 240 mg every 2 weeks (q2w)
Participants received QGE031 240 mg subcutaneously (s.c.) q2w for 16 weeks.
Drug: QGE031
QGE031 was supplied as 120 mg liquid in vial per 1 mL
EXPERIMENTAL: QGE031 240 mg q4w
Participants received QGE031 240 mg s.c. q4w for 16 weeks.
Drug: QGE031
QGE031 was supplied as 120 mg liquid in vial per 1 mL
EXPERIMENTAL: QGE031 180 mg q2w
Participants received QGE031 180 mg s.c. q2w for 16 weeks.
Drug: QGE031
QGE031 was supplied as 120 mg liquid in vial per 1 mL
EXPERIMENTAL: QGE031 120 mg q2w
Participants received QGE031 120 mg s.c. q2w for 16 weeks.
Drug: QGE031
QGE031 was supplied as 120 mg liquid in vial per 1 mL
EXPERIMENTAL: QGE031 36 mg q2w
Participants received QGE031 36 mg s.c. q2w for 16 weeks.
Drug: QGE031
QGE031 was supplied as 120 mg liquid in vial per 1 mL
EXPERIMENTAL: QGE031 12 mg q2w
Participants received QGE031 12 mg s.c. q2w for 16 weeks.
Drug: QGE031
QGE031 was supplied as 120 mg liquid in vial per 1 mL
ACTIVE_COMPARATOR: Omalizumab (as per locally approved dosing table)
Participants received omalizumab as per locally approved dosing table s.c. q2w or q4w for 16 weeks.
Drug: Omalizumab
Omalizumab was supplied as 150 mg lyophilisate in vial
Other Names:
  • Xolair
PLACEBO_COMPARATOR: Placebo to QGE031 240 mg q2w
Participants received matching placebo to QGE031 240 mg s.c. q2w for 16 weeks.
Drug: Placebo
Placebo to QGE031 and Omalizumab was supplied as QGE031 0 mg in vial per 1 mL
PLACEBO_COMPARATOR: Placebo to QGE031 240 mg q4w
Participants received placebo to QGE031 240 mg s.c. q2w for 16 weeks.
Drug: Placebo
Placebo to QGE031 and Omalizumab was supplied as QGE031 0 mg in vial per 1 mL
PLACEBO_COMPARATOR: Placebo to QGE031 180 mg q2w
Participants received QGE031 180 mg s.c. q2w for 16 weeks.
Drug: Placebo
Placebo to QGE031 and Omalizumab was supplied as QGE031 0 mg in vial per 1 mL
PLACEBO_COMPARATOR: Placebo to QGE031 120 mg q2w
Participants received QGE031 120 mg s.c. q2w for 16 weeks.
Drug: Placebo
Placebo to QGE031 and Omalizumab was supplied as QGE031 0 mg in vial per 1 mL
PLACEBO_COMPARATOR: Placebo to QGE031 36 mg q2w
Participants received QGE031 36 mg s.c. q2w for 16 weeks.
Drug: Placebo
Placebo to QGE031 and Omalizumab was supplied as QGE031 0 mg in vial per 1 mL
PLACEBO_COMPARATOR: Placebo to QGE031 12 mg q2w
Participants received QGE031 12 mg s.c. q2w for 16 weeks.
Drug: Placebo
Placebo to QGE031 and Omalizumab was supplied as QGE031 0 mg in vial per 1 mL
PLACEBO_COMPARATOR: Placebo to omalizumab
Participants received placebo to omalizumab s.c. q2w or q4w for 16 weeks.
Drug: Placebo
Placebo to QGE031 and Omalizumab was supplied as QGE031 0 mg in vial per 1 mL

What is the study measuring?

Primary Outcome Measures

Primary Outcome Measures

In a clinical study's protocol, the planned outcome measure that is the most important for evaluating the effect of an intervention/treatment. Most clinical studies have one primary outcome measure, but some have more than one.
Outcome Measure
Measure Description
Time Frame
Percentage of QGE031 Participants With Clinically Important Improvement of <= -0.5 in the Asthma Control Questionnaire 7 (ACQ-7) Score Compared to Placebo
Time Frame: Week 16
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 Outcome Measures

Secondary Outcome Measures

In a clinical study's protocol, a planned outcome measure that is not as important as the primary outcome measure for evaluating the effect of an intervention but is still of interest. Most clinical studies have more than one secondary outcome measure.
Outcome Measure
Measure Description
Time Frame
Change From Baseline in ACQ-7 Score
Time Frame: Baseline, Weeks 4, 8, 12, 16 and 28
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
Percentage of Participants With a Change From Baseline in ACQ-7 Score Less Than -1.1
Time Frame: Week 16
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
Change From Baseline in Asthma Quality of Life Questionnaire (AQLQ) Score
Time Frame: Baseline, Week 16, Week 28
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
Change From Baseline in Mean Number of Puffs of Morning, Evening and Total Daily Asthma Rescue Medication
Time Frame: Baseline, Week 16
Participants recorded their use of rescue medication into an electronic diary (eDiary). A negative change from baseline indicates improvement.
Baseline, Week 16

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Sponsor

The organization or person who initiates the study and who has authority and control over the study.
Novartis Pharmaceuticals

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start

Study Start

The actual date on which the first participant was enrolled in a clinical study. The "anticipated" study start date is the date that the researchers think will be the study start date.
December 1, 2012

Primary Completion (ACTUAL)

Primary Completion

The date on which the last participant in a clinical study was examined or received an intervention to collect final data for the primary outcome measure. Whether the clinical study ended according to the protocol or was terminated does not affect this date. For clinical studies with more than one primary outcome measure with different completion dates, this term refers to the date on which data collection is completed for all the primary outcome measures. The "anticipated" primary completion date is the date that the researchers think will be the primary completion date for the study.
January 1, 2016

Study Completion (ACTUAL)

Study Completion

The date on which the last participant in a clinical study was examined or received an intervention/treatment to collect final data for the primary outcome measures, secondary outcome measures, and adverse events (that is, the last participant's last visit). The "anticipated" study completion date is the date that the researchers think will be the study completion date.
January 1, 2016

Study Registration Dates

First Submitted

First Submitted

The date on which the study sponsor or investigator first submitted a study record to ClinicalTrials.gov. There is typically a delay of a few days between the first submitted date and the record's availability on ClinicalTrials.gov (the first posted date).
October 19, 2012

First Submitted That Met QC Criteria

First Submitted That Met QC Criteria

The date on which the study sponsor or investigator first submits a study record that is consistent with National Library of Medicine (NLM) quality control (QC) review criteria. The sponsor or investigator may need to revise and submit a study record one or more times before NLM's QC review criteria are met. It is the responsibility of the sponsor or investigator to ensure that the study record is consistent with the NLM QC review criteria.
October 25, 2012

First Posted (ESTIMATE)

First Posted

The date on which the study record was first available on ClinicalTrials.gov after National Library of Medicine (NLM) quality control (QC) review has concluded. There is typically a delay of a few days between the date the study sponsor or investigator submitted the study record and the first posted date.
October 30, 2012

Study Record Updates

Last Update Posted (ACTUAL)

Last Update Posted

The most recent date on which changes to a study record were made available on ClinicalTrials.gov. There may be a delay between when the changes were submitted to ClinicalTrials.gov by the study's sponsor or investigator (the last update submitted date) and the last update posted date.
August 11, 2017

Last Update Submitted That Met QC Criteria

Last Update Submitted That Met QC Criteria

The most recent date on which the study sponsor or investigator submitted changes to a study record that are consistent with National Library of Medicine (NLM) quality control (QC) review criteria. It is the responsibility of the sponsor or investigator to ensure that the study record is consistent with the NLM QC review criteria.
August 7, 2017

Last Verified

Last Verified

The most recent date on which the study sponsor or investigator confirmed the information about a clinical study on ClinicalTrials.gov as accurate and current. If a study with a recruitment status of recruiting; not yet recruiting; or active, not recruiting has not been confirmed within the past 2 years, the study's recruitment status is shown as unknown.
August 1, 2017

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

Other Study ID Numbers

Identifiers or ID numbers other than the NCT number that are assigned to a clinical study by the study's sponsor, funders, or others. These numbers may include unique identifiers from other trial registries and National Institutes of Health grant numbers.
  • CQGE031B2201
  • 2012-002298-69 (EUDRACT_NUMBER)

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

Clinical Trials on Asthma

Clinical Trials on QGE031

Search Similar Trials

Sponsors and Collaborators

Medical Conditions

Drug Interventions

Conditions

Rare Diseases

Drug Interventions

Dietary Supplements

Sponsor/Collaborators

Locations

Cookie Settings

We use cookies to ensure that we give you the best experience on our website. For more details carefully read our Privacy and Cookies Policy. ...>>>You can change your preferences or withdraw your consent at any time by deleting the cookies from your website or computer as described in the policy. Please accept it and choose your preferences by ticking the corresponding boxes in the "Manage Settings" section below. Please carefully read our Terms of Service before you proceed with using any part of this website.
«Manage Settings