We updated the design of this site on December 18, 2017. Learn more.
ClinicalTrials.gov
ClinicalTrials.gov Menu
IMPORTANT: Due to the lapse in government funding, the information on this web site may not be up to date, transactions submitted via the web site may not be processed, and the agency may not be able to respond to inquiries until appropriations are enacted. Updates regarding government operating status and resumption of normal operations can be found at opm.gov.

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

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details.
ClinicalTrials.gov Identifier: NCT01716754
Recruitment Status : Completed
First Posted : October 30, 2012
Results First Posted : March 8, 2017
Last Update Posted : August 11, 2017
Sponsor:
Information provided by (Responsible Party):

Study Description
Brief 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.

Condition or disease Intervention/treatment Phase
Asthma Drug: QGE031 Drug: Omalizumab Drug: Placebo Phase 2

Study Design

Study Type : Interventional  (Clinical Trial)
Actual Enrollment : 471 participants
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Double (Participant, Investigator)
Primary Purpose: Treatment
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
Study Start Date : December 2012
Primary Completion Date : January 2016
Study Completion Date : January 2016

Resource links provided by the National Library of Medicine

MedlinePlus related topics: Asthma
Drug Information available for: Omalizumab
U.S. FDA Resources

Arms and Interventions

Arm Intervention/treatment
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 Name: 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


Outcome Measures

Primary Outcome Measures :
  1. 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.


Secondary Outcome Measures :
  1. 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.

  2. 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.

  3. 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.

  4. 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.


Eligibility Criteria

Information from the National Library of Medicine

Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the contacts provided below. For general information, Learn About Clinical Studies.


Ages Eligible for Study:   18 Years to 75 Years   (Adult, Senior)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
Criteria

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.
Contacts and Locations

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT01716754


  Show 150 Study Locations
Sponsors and Collaborators
Novartis Pharmaceuticals
Investigators
Study Director: Novartis Pharmaceuticals Novartis Pharmaceuticals
More Information

Additional Information:
Responsible Party: Novartis Pharmaceuticals
ClinicalTrials.gov Identifier: NCT01716754     History of Changes
Other Study ID Numbers: CQGE031B2201
2012-002298-69 ( EudraCT Number )
First Posted: October 30, 2012    Key Record Dates
Results First Posted: March 8, 2017
Last Update Posted: August 11, 2017
Last Verified: August 2017

Keywords provided by Novartis ( Novartis Pharmaceuticals ):
asthma
asthma control
allergy
atopic
IgE
double-blind
placebo
omalizumab

Additional relevant MeSH terms:
Asthma
Bronchial Diseases
Respiratory Tract Diseases
Lung Diseases, Obstructive
Lung Diseases
Respiratory Hypersensitivity
Hypersensitivity, Immediate
Hypersensitivity
Immune System Diseases
Omalizumab
Anti-Allergic Agents
Anti-Asthmatic Agents
Respiratory System Agents