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Note: This record shows only 22 elements of the WHO Trial Registration Data Set. To view changes that have been made to the source record, or for additional information about this trial, click on the URL below to go to the source record in the primary register.
Register: EUCTR
Last refreshed on: 3 February 2014
Main ID:  EUCTR2011-001062-18-GR
Date of registration: 11/07/2011
Prospective Registration: Yes
Primary sponsor: Novartis Pharma Services AG
Public title: A clinical trial looking at the effect of different doses of QAW039 in patients with moderate or severe allergic asthma
Scientific title: A randomized, placebo-controlled, dose-ranging, multi-centre trial of QAW039 (1-450 mg p.o.), to investigate the effect on FEV1 and ACQ in patients with moderate-to-severe, persistent, allergic asthma, inadequately controlled with ICS therapy
Date of first enrolment: 02/09/2011
Target sample size: 950
Recruitment status: Not Recruiting
URL:  https://www.clinicaltrialsregister.eu/ctr-search/search?query=eudract_number:2011-001062-18
Study type:  Interventional clinical trial of medicinal product
Study design:  Controlled: yes Randomised: yes Open: no Single blind: no Double blind: yes Parallel group: yes Cross over: no Other: no If controlled, specify comparator, Other Medicinial Product: yes Placebo: yes Other: no Number of treatment arms in the trial: 15  
Phase: 
Countries of recruitment
Argentina Austria Bulgaria Colombia Greece Guatemala Hungary India
Japan Mexico Netherlands Peru Poland South Africa United Kingdom United States
Venezuela, Bolivarian Republic of
Contacts
Name: Clinical Trial Information Desk   
Address:  Forum 1, Novartis Campus 4056 Basel Switzerland
Telephone: 41613241111
Email: clinicaltrial.enquiries@novartis.com
Affiliation:  Novartis Pharma AG
Name: Clinical Trial Information Desk   
Address:  Forum 1, Novartis Campus 4056 Basel Switzerland
Telephone: 41613241111
Email: clinicaltrial.enquiries@novartis.com
Affiliation:  Novartis Pharma AG
Key inclusion & exclusion criteria
Inclusion criteria:
1. Written informed consent must be obtained before any assessment is performed
2. Males and females of any race who are between 18 and 65 years old at the time informed
consent is obtained.
3. Physician diagnosis of asthma, as per GINA (2009) guidelines, and currently prescribed ICS therapy.
4. Patients with a pre-bronchodilator FEV1 value of 40% to 80% of individual predicted value at screening and at randomization, and the value at the randomization should be within 15% of the screening FEV1. The results of spirometry should meet the ATS/ERS criteria for acceptability and repeatability.
5. Patients should be allergic or atopic, as diagnosed historically or prior to entry into the study by either a skin prick test (= 3mm diameter above background) or a positive specific IgE (e.g. RAST/CAP) test (>0.35 IU eq./ml).
6. Patients who are demonstrated to have reversible airway obstruction or airways hyperreactivity or have shown either of such responses in previous test(s) within the last year.
• Reversible airway obstruction is defined as an increase of =12% and =200 ml in FEV1 over the patient’s pre-bronchodilator value in litres within 10-15 minutes after inhaling a total of 360 µg of albuterol or 400 µg salbutamol via MDI (reversibility test). The administration of albuterol or salbutamol for the reversibility test is to be within 30 minutes after pre-bronchodilator spirometry.
• A positive airways hyper-reactivity (AHR) test result is defined as a provoked fall in FEV1 of 20% (PC20) by methacholine at =8 mg/ml when not on ICS or =16 mg/ml on ICS therapy.
7. An ACQ score = 1.5 at randomisation.
Are the trial subjects under 18? no
Number of subjects for this age range:
F.1.2 Adults (18-64 years) yes
F.1.2.1 Number of subjects for this age range 950
F.1.3 Elderly (>=65 years) no
F.1.3.1 Number of subjects for this age range

Exclusion criteria:
1. Use of other investigational drugs at the time of enrollment, or within 30 days or 5 halflives
of enrollment, whichever is longer.
2. History of hypersensitivity to any of the study drugs or to drugs of similar chemical
classes (CRTh2 antagonists).
3. History of long QT syndrome or whose QTc interval (Fridericia’s) is prolonged > 450 msec for males and females at screening as assessed by central ECG interpretation.
4. History of malignancy of any organ system (other than localized basal cell carcinoma of the skin), treated or untreated, within the past 5 years, regardless of whether there is evidence of local recurrence or metastases.
5. Pregnant or nursing (lactating) women, where pregnancy is defined as the state of a female after conception and until the termination of gestation, confirmed by a positive hCG laboratory test (> 5 mIU/mL).
6. Women of child-bearing potential, defined as all women physiologically capable of becoming pregnant, must use effective contraception during the study and for 4 days (5
half-lives) after treatment. Effective contraception methods are defined in the protocol.
7. Patients with serious co-morbidities including uncontrolled diabetes (HbA1c =8%), heart
failure, cancer, neurodegenerative diseases, rheumatoid arthritis and other autoimmune
diseases, other lung diseases including chronic bronchitis, chronic obstructive pulmonary
disease or emphysema or other conditions characterised by eosinophilia and pulmonary
symptoms (i.e. Churg-Strauss syndrome, allergic bronchopulmonary aspergillosis,
eosinophilic pneumonia, etc.).
8. Acute illness other than asthma at the start of the study
9. History of life-threatening asthma, including a history of significant hypercarbia (pCO2>45mmHg), prior intubation, respiratory arrest, or seizures as a result of asthma.
10. History of alcohol or other substance abuse.
11. Patients who have had a respiratory tract infection within 4 weeks of the screening visit.
Patients who develop a respiratory tract infection between screening and the randomization visit must be screen failed, and may be permitted to re-enroll at a later date.
12. Patients who have been hospitalized due to their asthma, or that have required treatment
with systemic steroids, within 6 weeks of the screening visit.
13. Patients with clinically significant laboratory abnormalities (not associated with the study
indication) at screening including (but not limited to):
• Total white blood cell count <2500 cells/µL at screening.
• AST or ALT>2.0 X ULN or total bilirubin >1.3 X ULN at screening.
• Estimated Glomerular Filtration Rate (eGFR) by the MDRD equation <55 mL/minute/1.73 m2 at screening.
14. Patients who have a clinically significant abnormality on a 12-lead ECG recorded within
one month prior to or at screening.
15. Current smokers or ex-smokers who stopped smoking within 6 months prior to screening or have a smoking history of = 10 pack years.
16. Patients with a body mass index (BMI) < 17 or > 40 kg/m2.


Age minimum:
Age maximum:
Gender:
Female: yes
Male: yes
Health Condition(s) or Problem(s) studied
Moderate-to-severe, persistent, allergic asthma, inadequately controlled with ICS therapy
MedDRA version: 14.0 Level: LLT Classification code 10001705 Term: Allergic asthma System Organ Class: 10038738 - Respiratory, thoracic and mediastinal disorders
Therapeutic area: Diseases [C] - Respiratory Tract Diseases [C08]
Intervention(s)

Product Code: QAW039
Pharmaceutical Form: Capsule
INN or Proposed INN: Not established
CAS Number: 872365-14-5
Current Sponsor code: QAW039
Other descriptive name: QAW039-NXA.001
Concentration unit: mg milligram(s)
Concentration type: equal
Concentration number: 1-
Pharmaceutical form of the placebo: Capsule
Route of administration of the placebo: Oral use

Product Code: QAW039
Pharmaceutical Form: Capsule
INN or Proposed INN: Not established
CAS Number: 872365-14-5
Current Sponsor code: QAW039
Other descriptive name: QAW039-NXA.001
Concentration unit: mg milligram(s)
Concentration type: equal
Concentration number: 10-
Pharmaceutical form of the placebo: Capsule
Route of administration of the placebo: Oral use

Product Code: QAW039
Pharmaceutical Form: Capsule
INN or Proposed INN: Not established
CAS Number: 872365-14-5
Current Sponsor code: QAW039
Other descriptive name: QAW039-NXA.001
Concentration unit: mg milligram(s)
Concentration type: equal
Concentration number: 25-
Pharmaceutical form of the placebo: Capsule
Route of administration of the placebo: Oral use

Product Code: QAW039
Pharmaceutical Form: Capsule
INN or Proposed INN: Not established
CAS Number: 872365-14-5
Current Sponsor code: QAW039
Other descriptive name: QAW039-NXA.001
Concentration unit: mg milligram(s)
Concentration type: equal
Concentration number: 150-
Pharmaceutical form of the placebo: Capsule
Route of administration of the placebo: Oral use

Trade Name: Singulair
Product Name: Singulair
Product Code: Montelukast
Pharmaceutical Form: Capsule, hard
INN or Proposed INN: MONTELUKAST SODIUM
CAS Number: 151767-02-1
Concentration unit: mg milligram(s)
Concentration type: equal
Concentration number: 10-
Pharmaceutical form of the placebo: Capsule
Route of administration of the placebo: Oral use

Primary Outcome(s)
Primary end point(s): Morning FEV1
Main Objective: To demonstrate a clinically significant improvement in morning FEV1 in moderate to severe
allergic asthmatics inadequately controlled by ICS therapy treated with QAW039 for 12
weeks compared to placebo.
Timepoint(s) of evaluation of this end point: Visit 2 to 10 included
Secondary Objective: - To demonstrate that QAW039 provides significantly superior control of asthmatic symptoms in these patients as measured by the ACQ, compared to placebo.
- To estimate the onset of efficacy as measured by spirometry assessments and the ACQ after 2, 4, 8 and 12 weeks of treatment.
- To characterize the dose response relationship among QAW039 doses with respect to trough FEV1 after 12 weeks of treatment.
- To assess safety and tolerability of QAW039 in a moderate to severe asthmatic population, particularly with regard to vital signs, ECG, heart rate, laboratory tests and adverse events, as compared to placebo.
- To compare the efficacy of QAW039 to that of montelukast as an add-on therapy to ICS in
inadequately controlled moderate-to-severe asthmatics.
- To assess the effect of QAW039 on asthma symptoms as measured by the Juniper asthma
diary.
Secondary Outcome(s)
Timepoint(s) of evaluation of this end point: - ACQ (visit 2 to 10 included)
- Trough FEV1 (visit 2 to 10 included)
- Jumper asthma diary (visit 3 to 10 included)
- Vital signs (visit 2 to 10 included)
Secondary end point(s): - ACQ
- Trough FEV1
- Jumper asthma diary
- Vital signs
Secondary ID(s)
CQAW039A2206
Source(s) of Monetary Support
Novartis Pharma Services AG
Secondary Sponsor(s)
Ethics review
Results
Results available:
Date Posted:
Date Completed:
URL:
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