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

Allergic Rhinitis Clinical Trial

Official title:

A Randomized, Double-blind, Placebo-controlled Three-period Incomplete Cross Over Study to Compare the Efficacy of QAW039 Alone and in Combination With Montelukast in Patients With Allergic Rhinitis Using an Environmental Exposure Chamber

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT01804400
• Other study ID #: CQAW039A2212
• Secondary ID: 2012-001389-14
• Status: Completed
• Phase: Phase 2
• First received: October 4, 2012
• Last updated: November 16, 2016
• Start date: October 2012
• Est. completion date: October 2013

Study information

• Verified date: November 2016
• Source: Novartis
• Contact: n/a
• Is FDA regulated: No
• Health authority: Germany: Federal Institute for Drugs and Medical Devices
• Study type: Interventional

Clinical Trial 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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 188
• Est. completion date: October 2013
• Est. primary completion date: October 2013
• Accepts healthy volunteers: No
• Gender: Both
• Age group: 18 Years to 65 Years

Eligibility

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.

Study Design

Allocation: Randomized, Endpoint Classification: Safety/Efficacy Study, Intervention Model: Crossover Assignment, Masking: Double Blind (Subject, Investigator), Primary Purpose: Treatment

Related Conditions & MeSH terms

• Allergic Rhinitis
• Rhinitis
• Rhinitis, Allergic

Intervention

Drug:
• QAW039

• Montelukast

• Placebo

Locations

Country	Name	City	State
Germany	Novartis Investigative Site	Hannover

Sponsors (1)

Lead Sponsor	Collaborator
Novartis Pharmaceuticals

Country where clinical trial is conducted

Germany, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	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	No
Secondary	Change in Total Ocular Symptom score from Baseline at 14 days	Total Ocular Symptom Score (TOSS), defined as the sum of ocular symptoms of eye tearing, itching, watery eyes and redness, each of which is scored on a scale from 0 and 3	Baseline, Day 14	No
Secondary	Change in Nasal Flow from baseline at 14 days	Measured using rhinomanometry Flow rates at 150 Pa will be obtained separately for the right and left nostrils (cm^3/second). The sum of the flow rates of both nostrils will be calculated from the two measurements	Prior to, and every 60 min during allergen exposure period	No
Secondary	Change in Nasal excretion weight from baseline at 14 days	Total weight of tissues (before and after use)	Baseline, Day 14	No
Secondary	Change in Forced Expiratory Volume in 1 Second (FEV1) from baseline at 14 days	Change in FEV1 from Baseline	Baseline, Day 14	No
Secondary	Change in Forced Vital Capacity (FVC) from baseline at 14 days	Change in FVC from Baseline	Baseline, Day 14	No
Secondary	Change in FEV1/FVC at from baseline at 14 days	Change in FEV1/FVC from Baseline	Baseline, Day 14	No
Secondary	Plasma Concentration maximum (Cmax)	Determined at steady state in plasma	Day 1-14	No
Secondary	Plasma Concentration Minimum (Cmin)	Determined at steady state in plasma	Day 1-14	No
Secondary	Plasma Concentration Average (Cav)	Determined at steady state in plasma	Day 1-14	No
Secondary	Time of Cmax (Tmax)	Determined at steady state in plasma	Day 1-14	No
Secondary	Area Under Curve (AUCtau)	Determined at steady state in plasma	Day 1-14	No

External Links

•   Results for CQAW039A2212 from the Novartis Clinical Trials Website