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

This study has been completed.
Sponsor:
Information provided by (Responsible Party):
Novartis ( Novartis Pharmaceuticals )
ClinicalTrials.gov Identifier:
NCT01716754
First received: October 19, 2012
Last updated: January 18, 2017
Last verified: January 2017
  Purpose
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 Intervention Phase
Asthma
Drug: QGE031
Drug: Omalizumab
Drug: Placebo
Phase 2

Study Type: Interventional
Study Design: Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: 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

Resource links provided by NLM:


Further study details as provided by Novartis:

Primary Outcome Measures:
  • 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:
  • 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.

  • 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.

  • 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.

  • 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.


Enrollment: 471
Study Start Date: December 2012
Study Completion Date: January 2016
Primary Completion Date: January 2016 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
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

  Eligibility

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
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, see Learn About Clinical Studies.

Please refer to this study by its ClinicalTrials.gov identifier: NCT01716754

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

Responsible Party: Novartis Pharmaceuticals
ClinicalTrials.gov Identifier: NCT01716754     History of Changes
Other Study ID Numbers: CQGE031B2201
2012-002298-69 ( EudraCT Number )
Study First Received: October 19, 2012
Results First Received: January 18, 2017
Last Updated: January 18, 2017

Keywords provided by Novartis:
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

ClinicalTrials.gov processed this record on April 28, 2017