A randomized, placebo-controlled, parallel group study to assess the efficacy, safety, and pharmacokinetics of QAW039 in steroid-free patients with mild to moderate persistent asthma

• Conditions: Mild to moderate persistent asthma; MedDRA version: 12.1Level: LLTClassification code 10003553Term: Asthma

• Registration Number: EUCTR2010-020177-16-DE
• Lead Sponsor: OVARTIS PHARMA SERVICES AG

Brief Summary

Not available

Detailed Description

Not available

Study Timeline

• Study Start: 2010-12-27
• Last Update Posted: 22 October 2012

Recruitment & Eligibility

• Status: ot Recruiting
• Sex: All
• Target Recruitment: 220

Inclusion Criteria

• Male and female asthma patients 18 to 65 years of age inclusive.
• Patients with a medical history of mild to moderate persistent allergic asthma, diagnosed according to (GINA 2009) guidelines.
• Women must be postmenopausal or surgically sterilized at the time of participation.
• Postmenopausal females must have 12 months of natural (spontaneous) amenorrhea prior to dosing OR 6 months of spontaneous amenorrhea with serum FSH levels >40 IU/L at screening.
• Female patients who report surgical sterilization must have had the procedure at least 6 months prior to initial dosing.
• Surgical sterilization procedures should be supported with clinical documentation made available to the sponsor and noted in the Relevant Medical History / Current Medical Conditions section of the eCRF.
• All female patients must have negative pregnancy test results at screening and at baseline.
• Patients must demonstrate an increase of =12% AND 200 mL in FEV1 over their pre-bronchodilator value within 30 minutes after inhaling a total of 400/360 µg of salbutamol/albuterol (the reversibility test). Reversibility will have to be demonstrated after an appropriate washout period of at least 6 hrs for a short-acting ß2-agonist and at least 48 hours for LABAs. The administration of salbutamol/albuterol for the reversibility test is to be within 30 minutes after pre-bronchodilator spirometry. Reversibility has to be determined at screening or during the weaning period (up until visit 5).
• Patients must have an FEV1 of = 60% and = 85% of the predicted normal value for the patient when LABA and steroid-weaned. This criterion for FEV1 will have to be demonstrated after a washout period of at least 6 hours during which no short acting ß2-agonist has been inhaled.
• Patients must be symptomatic after weaning of their asthma medication which will be assessed by a mean rescue medication usage of at least 1 puff per day (average of 7 days prior to baseline visit).
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
F.1.3 Elderly (>=65 years) no
F.1.3.1 Number of subjects for this age range

Exclusion Criteria

• Patients with severe persistent asthma according to (GINA 2009) guidelines.
• History of life-threatening asthma, defined as an asthma episode that required intubation and/or was associated with hypercapnoea, respiratory arrest and/or hypoxic seizures. History of asthma exacerbation in the past 6 months that required hospitalization or emergency unit visit. Use of parenteral steroids within 6 months of screening.
• Any disease or illness, other than asthma, that may require the use of systemic corticosteroids during the study period.
• Any occupational exposure to allergens/ irritants that may have a potential to worsen the asthma symptoms during the trial.
• Respiratory tract infection and/or exacerbation of asthma within 4 weeks prior to the first dose of study medication. Patients with other serious underlying diseases (i.e. tuberculosis, bronchiectasis, pulmonary fibrosis, pulmonary hypertension, emphysema, chronic bronchitis, a-1-antitrypsin deficiency). Note: When patient has upper respiratory signs and symptoms due to common cold post screening and prior to dosing, baseline evaluation should be delayed until symptoms resolve.
• Smokers defined as history of smoking in the previous 6 months or a smoking history of more than 10 pack years, a pack year being defined as smoking the equivalent of 20 cigarettes – a pack – every day for the period of 1 year.

Study & Design

• Study Type: Interventional clinical trial of medicinal product
• Study Design: Not specified