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

NCT01804400 | Completed Phase 2

• 2 other identifiers: CQAW039A22122012-001389-14
• Study Type: interventional
• Target: 188
• Locations: 1 country
• Sites: 1

Brief Summary

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.

Conditions

Allergic Rhinitis

Outcome Measures

Primary Outcomes (1)

• Change in Total Nasal Symptom Score from baseline at 14 days

  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

  Baseline, Day 14

Secondary Outcomes (11)

• Change in Total Ocular Symptom score from Baseline at 14 days

  Baseline, Day 14

• Change in Nasal Flow from baseline at 14 days

  Prior to, and every 60 min during allergen exposure period

• Change in Nasal excretion weight from baseline at 14 days

  Baseline, Day 14

• Change in Forced Expiratory Volume in 1 Second (FEV1) from baseline at 14 days

  Baseline, Day 14

• Change in Forced Vital Capacity (FVC) from baseline at 14 days

  Baseline, Day 14

Study Arms (5)

QAW039 + Montelukast

EXPERIMENTAL

Drug: QAW039; Drug: Montelukast; Drug: Placebo

QAW039 Once a day (q.d.)

EXPERIMENTAL

Drug: QAW039; Drug: Placebo

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

EXPERIMENTAL

Drug: QAW039; Drug: Placebo

Montelukast

ACTIVE COMPARATOR

Drug: Montelukast; Drug: Placebo

Placebo

PLACEBO COMPARATOR

Drug: Placebo

Interventions

QAW039 DRUG

QAW039 + Montelukast; QAW039 Once a day (q.d.); QAW039 Twice a day (b.i.d.)

Montelukast DRUG

Montelukast; QAW039 + Montelukast

Placebo DRUG

Montelukast; Placebo; QAW039 + Montelukast; QAW039 Once a day (q.d.); QAW039 Twice a day (b.i.d.)

Eligibility Criteria

• Age: 18 Years - 65 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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.

You may not qualify if:

• 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.

Sponsors & Collaborators

• Novartis Pharmaceuticals: lead

Study Sites (1)

Novartis Investigative Site

Hanover, 30625, Germany

Location

MeSH Terms

Conditions

Rhinitis, Allergic

Interventions

fevipiprant; montelukast

Condition Hierarchy (Ancestors)

Rhinitis; Nose Diseases; Respiratory Tract Diseases; Respiratory Hypersensitivity; Otorhinolaryngologic Diseases; Hypersensitivity, Immediate; Hypersensitivity; Immune System Diseases

Study Officials

• Novartis Pharmaceuticals

  Novartis Pharmaceuticals

  STUDY DIRECTOR

Study Design

• Study Type: interventional
• Phase: phase 2
• Allocation: RANDOMIZED
• Masking: DOUBLE
• Who Masked: PARTICIPANT, INVESTIGATOR
• Purpose: TREATMENT
• Intervention Model: CROSSOVER
• Sponsor Type: INDUSTRY
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: October 4, 2012
• First Posted: March 5, 2013
• Study Start: October 1, 2012
• Primary Completion: October 1, 2013
• Study Completion: October 1, 2013
• Last Updated: November 18, 2016

Record last verified: 2016-11

Locations

DE (1)