Clinical Trial Results:
A 26-week randomized, double-blind, placebo-controlled, multi-center study to evaluate the effect of omalizumab on markers of asthma impairment in patients with persistent allergic asthma
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Summary
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EudraCT number |
2017-001799-41 |
Trial protocol |
Outside EU/EEA |
Global end of trial date |
17 Mar 2010
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Results information
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Results version number |
v1(current) |
This version publication date |
25 Oct 2017
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First version publication date |
25 Oct 2017
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Other versions |
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Trial Information
Subject Disposition
Baseline Characteristics
End Points
Adverse Events
More Information
Subject Disposition
Baseline Characteristics
End Points
Adverse Events
More Information
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Trial identification
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Sponsor protocol code |
CIGE025AUS33
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Additional study identifiers
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ISRCTN number |
- | ||
US NCT number |
NCT00870584 | ||
WHO universal trial number (UTN) |
- | ||
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Sponsors
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Sponsor organisation name |
Novartis Pharma AG
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Sponsor organisation address |
CH-4002, Basel, Switzerland,
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Public contact |
Clinical Disclosure Office, Novartis Pharma, 41 613241111,
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Scientific contact |
Clinical Disclosure Office, Novartis Pharma AG, 41 613241111,
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Paediatric regulatory details
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Is trial part of an agreed paediatric investigation plan (PIP) |
No
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Does article 45 of REGULATION (EC) No 1901/2006 apply to this trial? |
No
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Does article 46 of REGULATION (EC) No 1901/2006 apply to this trial? |
Yes
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Results analysis stage
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Analysis stage |
Final
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Date of interim/final analysis |
17 Mar 2010
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Is this the analysis of the primary completion data? |
No
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Global end of trial reached? |
Yes
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Global end of trial date |
17 Mar 2010
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Was the trial ended prematurely? |
No
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General information about the trial
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Main objective of the trial |
The primary objective was to evaluate the effect of omalizumab on markers of impairment, as measured by the Asthma Control Test (ACT) scores at Week 24 of treatment, in patients with inadequately controlled persistent allergic asthma on Step 4 or above therapy, as defined
in the 2007 National Heart, Lung, and Blood Institute (NHLBI) guidelines. Inadequately controlled was defined as not well controlled or very poorly controlled.
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Protection of trial subjects |
The study was in compliance with the ethical principles derived from the Declaration of Helsinki and the International Conference on Harmonization (ICH) Good Clinical Practice (GCP) guidelines. All the local regulatory requirements pertinent to safety of trial subjects were also followed during the conduct of the trial.
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Background therapy |
- | ||
Evidence for comparator |
- | ||
Actual start date of recruitment |
09 Mar 2009
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Long term follow-up planned |
No
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Independent data monitoring committee (IDMC) involvement? |
No
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Population of trial subjects
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Number of subjects enrolled per country |
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Country: Number of subjects enrolled |
United States: 271
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Worldwide total number of subjects |
271
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EEA total number of subjects |
0
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Number of subjects enrolled per age group |
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In utero |
0
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Preterm newborn - gestational age < 37 wk |
0
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Newborns (0-27 days) |
0
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Infants and toddlers (28 days-23 months) |
0
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Children (2-11 years) |
0
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Adolescents (12-17 years) |
19
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Adults (18-64 years) |
239
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From 65 to 84 years |
13
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85 years and over |
0
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Recruitment
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Recruitment details |
- | ||||||||||||||||||||||||
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Pre-assignment
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Screening details |
Approximately 266 patients from an estimated 50 centers were to be randomized to receive omalizumab or placebo, in a 1:1 ratio (133 patients per treatment group), as add-on therapy to their current asthma maintenance therapy. | ||||||||||||||||||||||||
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Period 1
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Period 1 title |
Overall Study (overall period)
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Is this the baseline period? |
Yes | ||||||||||||||||||||||||
Allocation method |
Randomised - controlled
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Blinding used |
Double blind | ||||||||||||||||||||||||
Roles blinded |
Investigator, Subject | ||||||||||||||||||||||||
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Arms
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Are arms mutually exclusive |
Yes
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Arm title
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Omalizumab | ||||||||||||||||||||||||
Arm description |
The determined dose (at least 0.016 mg/kg/IgE (IU/mL) was administered subcutaneously every 2 weeks or every 4 weeks. Dose and dosing interval were determined based on patient body weight and pre-treatment serum IgE level; a dosing table was used. | ||||||||||||||||||||||||
Arm type |
Experimental | ||||||||||||||||||||||||
Investigational medicinal product name |
Omalizumab
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Investigational medicinal product code |
IGE025
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Other name |
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Pharmaceutical forms |
Powder for injection
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Routes of administration |
Subcutaneous use
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Dosage and administration details |
Omalizumab was supplied as a lyophilized, sterile powder in a single-use, 5 mL vial. The vial was designed to deliver 150 mg (1.2 mL) of omalizumab for subcutaneous (s.c.) administration after reconstitution with 1.4 mL sterile water for injection. Doses of more than 150 mg were divided among multiple injection sites to limit injections to not more than 150 mg per site
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Arm title
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Placebo | ||||||||||||||||||||||||
Arm description |
Placebo was administered subcutaneously every 2 weeks or every 4 weeks depending on the dosing schedule in the protocol. | ||||||||||||||||||||||||
Arm type |
Placebo | ||||||||||||||||||||||||
Investigational medicinal product name |
Placebo
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Investigational medicinal product code |
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Other name |
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Pharmaceutical forms |
Powder for injection
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Routes of administration |
Subcutaneous use
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Dosage and administration details |
Placebo was supplied as a lyophilized, sterile powder in a single-use, 5 mL vial. The vial was designed to deliver 150 mg (1.2 mL) of omalizumab for subcutaneous (s.c.) administration after reconstitution with 1.4 mL sterile water for injection. Doses of more than 150 mg were divided among multiple injection sites to limit injections to not more than 150 mg per site
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Baseline characteristics reporting groups
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Reporting group title |
Omalizumab
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Reporting group description |
The determined dose (at least 0.016 mg/kg/IgE (IU/mL) was administered subcutaneously every 2 weeks or every 4 weeks. Dose and dosing interval were determined based on patient body weight and pre-treatment serum IgE level; a dosing table was used. | ||||||||||||||||||||||||||||||||||||||||||||||||||||||||
Reporting group title |
Placebo
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Reporting group description |
Placebo was administered subcutaneously every 2 weeks or every 4 weeks depending on the dosing schedule in the protocol. | ||||||||||||||||||||||||||||||||||||||||||||||||||||||||
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End points reporting groups
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Reporting group title |
Omalizumab
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Reporting group description |
The determined dose (at least 0.016 mg/kg/IgE (IU/mL) was administered subcutaneously every 2 weeks or every 4 weeks. Dose and dosing interval were determined based on patient body weight and pre-treatment serum IgE level; a dosing table was used. | ||
Reporting group title |
Placebo
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Reporting group description |
Placebo was administered subcutaneously every 2 weeks or every 4 weeks depending on the dosing schedule in the protocol. | ||
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End point title |
Change from baseline in Asthma Control Test (ACT) after 24 weeks of treatment | ||||||||||||
End point description |
The Asthma Control Test (ACT) is a validated tool to assess overall asthma control over the last 4 weeks in patients aged >= 12 years old. It is a 1 page questionnaire consisting of 5 simple questions assessing: asthma symptoms, use of rescue medications, and the impact of asthma on everyday functioning. All questions are scored on a 5-point Likert scale, with a higher score indicating better control. All scores are added together to calculate a total score. Total score ranges from 5 to 25. A positive change indicates improvement.
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End point type |
Primary
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End point timeframe |
Baseline and 24 weeks
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Statistical analysis title |
Change in ACT total score from baseline | ||||||||||||
Comparison groups |
Omalizumab v Placebo
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Number of subjects included in analysis |
241
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Analysis specification |
Post-hoc
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Analysis type |
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P-value |
= 0.1779 | ||||||||||||
Method |
ANCOVA | ||||||||||||
Confidence interval |
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95% | ||||||||||||
sides |
2-sided
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lower limit |
-0.3 | ||||||||||||
upper limit |
1.59 | ||||||||||||
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End point title |
Investigator Global Evaluation of Treatment Effectiveness (IGETE) at 24 weeks | |||||||||||||||||||||||||||
End point description |
The IGETE is an assessment of asthma symptom control in response to asthma treatment. It consists of the question "What is the investigator's overall impression of the study medication and its effect on the typical symptoms of allergic asthma during the study?" The scale is: excellent, good, moderate, poor, and worsening. A good or excellent response is suggested as a means of defining a patient who has responded to treatment.
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End point type |
Secondary
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End point timeframe |
24 weeks
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Adverse events information
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Timeframe for reporting adverse events |
Timeframe for AE
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Adverse event reporting additional description |
AE additional description
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Assessment type |
Systematic | ||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||
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Dictionary used for adverse event reporting
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Dictionary name |
MedDRA | ||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||
Dictionary version |
12.1
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Reporting groups
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Reporting group title |
Omalizumab
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Reporting group description |
Omalizumab | ||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||
Reporting group title |
Placebo
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Reporting group description |
Placebo | ||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||
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| Frequency threshold for reporting non-serious adverse events: 5% | |||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||
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Substantial protocol amendments (globally) |
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| Were there any global substantial amendments to the protocol? Yes | |||
Date |
Amendment |
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18 Dec 2008 |
Amendment 1 -issued prior to study start included the following key changes:-Specified that inclusion criteria events documenting uncontrolled asthma should have occurred, on average, during the 4 weeks preceding screening.
-Deleted duplicate exclusion criterion for patients who had previously received anti-IgE therapy.
-Clarified patient number assignment and IVRS randomization process.
-Clarified that patients were required to remain on their current asthma maintenance therapy throughout study participation, with no changes in this therapy during the study.
-Added a definition for asthma exacerbation.
-Changed the administration of the ACT from every scheduled visit to Visits 1, 6, 10, and 14.
-Changed the administration of the WPAI-A from Visits 2 through 14 to Visits 2, 6, 10, and 14.
-Included a review of concomitant medications at all study visits (assessment added to Visits 3-5, 7-9, and 11-13).
-Eliminated urinalysis from the end-of-study visit (Visit 14).
-In keeping with the International Conference on Harmonisation E9 guidance, changed the terminology for the safety and intent-to-treat populations to the Safety and Full Analysis Sets, respectively, and added a Randomized Set. |
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21 Jul 2009 |
Amendment 2 issues prior to database lock, clarified how health care utilization was captured. All health care utilization resulting from an asthma exacerbation, rather than only outpatient or inpatient hospitalization, was captured on the Health Care Utilization CRF. Amendment 2 also clarified that if an exacerbation occurred within the double-blind treatment period, patients were to attend their regularly scheduled study visit and receive study medication. Efficacy assessments, including administration of the ACT, were not to be performed until at least 28 days after the last dose of systemic steroid burst. The changes in Amendments 1 and 2 were not felt to affect the interpretation of study results, as the changes in Amendment 1 occurred before the first patient entered the study and the changes in Amendment 2 occurred before database lock and were minor. |
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Interruptions (globally) |
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| Were there any global interruptions to the trial? No | |||
Limitations and caveats |
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| Limitations of the trial such as small numbers of subjects analysed or technical problems leading to unreliable data. | |||
| None reported | |||
