A Clinical Trial to test how well two drugs, QAW039 and Montelukast work both individually and together, to target allergic rhinitis using an environmental exposure chamber.

• Conditions: allergic rhinitis; MedDRA version: 15.0Level: LLTClassification code 10001723Term: Allergic rhinitisSystem Organ Class: 10038738 - Respiratory, thoracic and mediastinal disorders; Therapeutic area: Diseases [C] - Respiratory Tract Diseases [C08]

• Registration Number: EUCTR2012-001389-14-DE
• Lead Sponsor: ovartis Pharma Services AG

Brief Summary

Not available

Detailed Description

Not available

Study Timeline

• Study Start: 2012-08-27
• Last Update Posted: 27 October 2014

Recruitment & Eligibility

• Status: ot Recruiting
• Sex: All
• Target Recruitment: Not specified

Inclusion Criteria

1. Male or female aged 18-65 years inclusive, with a clinical history of intermittent allergic rhinitis
with seasonal onset and offset of nasal allergy symptoms during each of the last two grass
pollen allergy seasons.
2. A positive skin prick test at Visit 1 to dactylis glomerata with a wheal diameter equal to or
greater than 3 mm and a negative control with a wheal diameter of zero. A positive skin prick
test within 12 months prior to Visit 1 is also acceptable.
3. FEV1 measured by spirometry must be =80% of their predicted value at screening. If the
patient does not achieve =80% of their predicted value this may be repeated prior to the EEC
challenge at visit 2.
4. TNSS score =6 on at least one assessment during the 2h EEC challenge at Screening.
5. Non-smokers and ex-smokers (=10 pack years and >6 months of smoking abstinence)
Pack years = the number of cigarettes smoked on average per day divided by 20 over the
period of 1 year (e.g. 20 cigarettes per day for 1 year = 1 pack year).
6. Urine cotinine levels will be measured during screening and at each baseline for all
patients. Smokers will be defined as any subject with a positive urine cotinine test as
defined by the local laboratory without confirmed use of nicotine replacement therapy.
7. Patients must weigh at least 50 kg to participate in the study, and must have a body mass
index (BMI) within the range of 18 to 35 kg/m2.
8. Able to communicate well with the Investigator/designee, to understand and comply with
the requirements of the study. Understand and sign the written informed consent.
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 190
F.1.3 Elderly (>=65 years) yes
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 half-lives of
enrollment, whichever is longer; or longer if required by local regulations, and for any other
limitation of participation in an investigational trial based on local regulations.
2. History of hypersensitivity to any of the study drugs or to drugs of similar chemical
classes (CRTh2 antagonists)
3. 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.
4. Pregnant or nursing (lactating) women,
5. Women of child-bearing potential, defined as all women physiologically capable of becoming
pregnant, unless they are using effective methods of contraception during dosing of study
treatment. Women of child-bearing potential, defined as all women physiologically capable of
becoming pregnant, unless they are using effective methods of contraception during dosing of
study treatment.

Study & Design

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