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Completed

NCT Number: NCT01804400

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

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.

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Key information

Age range

18 year–65 year

Sex eligibility

All sexes

Study type

Interventional

Phase

Phase 2

Primary location

Novartis Investigative Site

Hanover, 30625, Germany

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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.

Treatment and study plan

QAW039

Drug

Montelukast

Drug

Placebo

Drug

Primary outcomes

  1. Change in Total Nasal Symptom Score from baseline at 14 days

    Time frame: Baseline, Day 14

    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 outcomes

  1. Change in Total Ocular Symptom score from Baseline at 14 days

    Time frame: Baseline, Day 14

    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

  2. Change in Nasal Flow from baseline at 14 days

    Time frame: Prior to, and every 60 min during allergen exposure period

    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

  3. Change in Nasal excretion weight from baseline at 14 days

    Time frame: Baseline, Day 14

    Total weight of tissues (before and after use)

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

    Time frame: Baseline, Day 14

    Change in FEV1 from Baseline

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

    Time frame: Baseline, Day 14

    Change in FVC from Baseline

  6. Change in FEV1/FVC at from baseline at 14 days

    Time frame: Baseline, Day 14

    Change in FEV1/FVC from Baseline

  7. Plasma Concentration maximum (Cmax)

    Time frame: Day 1-14

    Determined at steady state in plasma

  8. Plasma Concentration Minimum (Cmin)

    Time frame: Day 1-14

    Determined at steady state in plasma

  9. Plasma Concentration Average (Cav)

    Time frame: Day 1-14

    Determined at steady state in plasma

  10. Time of Cmax (Tmax)

    Time frame: Day 1-14

    Determined at steady state in plasma

  11. Area Under Curve (AUCtau)

    Time frame: Day 1-14

    Determined at steady state in plasma

Sponsors and collaborators

Lead sponsor

Novartis Pharmaceuticals

Industry

Registry information

Official study 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

Important dates

Study start
2012
Primary completion
2013
Study completion
2013
First posted
Mar 5, 2013
Registry last updated
Nov 18, 2016

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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