allergic rhinitis MedDRA version: 15.0 Level: LLT Classification code 10001723 Term: Allergic rhinitis System Organ Class: 10038738 - Respiratory, thoracic and mediastinal disorders
Conditions
Sponsors
Novartis Pharma Services AG
Eligibility
Sex/Gender
All
Inclusion criteria
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
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.
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Main Objective: To evaluate the efficacy of QAW039 225 mg b.i.d and Montelukast 10 mg q.d administered together as a free combination compared to QAW039 225 mg b.i.d monotherapy in patients with grass pollen-induced intermittent allergic rhinitis in an EEC challenge model. This will be assessed by the Total Nasal Symptom Score (TNSS) averaged over the last two hours (2-4h) of exposure following 14 days treatment with QAW039 and/or Montelukast or matched placebo.;Secondary Objective: • Assess the safety and tolerability of QAW039 and the free combination of QAW039 and Montelukast in patients with allergic rhinitis. • Evaluate additional clinical endpoints related to allergic rhinitis following 14 days of treatment with QAW039 and the free combination of QAW039 and Montelukast or matched placebo: • Total Ocular Symptom Score (TOSS) measured during exposure in an EEC. • Nasal flow assessed by rhinomanometry during exposure in an EEC • Nasal Secretion weight during Exposure in an EEC • Assess pharmacokinetics of QAW039 and Montelukast in patients with allergic rhinitis. • Lung Function assessed before, during and after exposure in an EEC.;Primary end point(s): Total Nasal Symptom Score (TNSS);Timepoint(s) of evaluation of this end point: averaged over the last two hours (2-4h) on day 14 | — |
Secondary
| Measure | Time frame |
|---|---|
| Secondary end point(s): - safety and tolerability of QAW039 and the free combination of QAW039 and Montelukast - Total Ocular Symptom Score (TOSS) - Nasal flow assessed by rhinomanometry - Nasal secretion weight - pharmacokinetics - Lung Function ;Timepoint(s) of evaluation of this end point: - over 14 days - day 14. - during exposure in an EEC day 14 - during exposure in an EEC day 14 - day 7 - before, during and after exposure in an EEC day 14 | — |
Countries
Germany
Contacts
Public ContactMedizinischer Infoservice
Novartis Pharma GmbH
Outcome results
None listed