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

Novartis

Status and phase: Completed; Phase 2

Conditions: Allergic Rhinitis

Treatments: Drug: QAW039; Drug: Montelukast; Drug: Placebo

Study type: Interventional

Funder types: Industry

Identifiers

NCT01804400

2012-001389-14 (EudraCT Number)

CQAW039A2212

Details and patient eligibility

About

This study will assess the safety and efficacy of QAW039 alone and in combination with Montelukast in patients with allergic rhinitis (hay fever) using an environmental exposure chamber.

Enrollment: 188 patients

Sex: All

Ages: 18 to 65 years old

Volunteers: No Healthy Volunteers

Inclusion criteria

• 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.
• 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.
• 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.
• TNSS score ≥6 on at least one assessment during the 2h EEC challenge at Screening.

Exclusion criteria

• 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.
• Pregnant or nursing (lactating) women,
• 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.

Trial design

Primary purpose: Treatment

Allocation: Randomized

Interventional model: Crossover Assignment

Masking: Double Blind

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188 participants in 5 patient groups, including a placebo group

QAW039 + Montelukast

Experimental group

Treatment:

Drug: QAW039

Drug: Placebo

Drug: Montelukast

QAW039 Once a day (q.d.)

Experimental group

Treatment:

Drug: QAW039

Drug: Placebo

QAW039 Twice a day (b.i.d.)

Experimental group

Treatment:

Drug: QAW039

Drug: Placebo

Montelukast

Active Comparator group

Treatment:

Drug: Placebo

Drug: Montelukast

Placebo

Placebo Comparator group

Treatment:

Drug: Placebo