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Completed

NCT Number: NCT01103050

A Cross Over Study to Compare the Effect of Combined Treatment With QAV680 and Cetirizine

This study will determine the capacity of more frequent dosing of QAV680 to suppress allergic inflammation. The study will investigate the paradigm of multiple receptor antagonism in allergic disease by combining QAV680 with a second generation H1 histamine receptor antagonist to assess possible additive or synergistic anti-allergic effects of the two compound classes.

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Key information

Conditions

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

Age range

18 year–65 year

Sex eligibility

All sexes

Study type

Interventional

Phase

Phase 2

Primary location

Novartis Investigative Site

Ontario, Canada

Who can participate

Healthy volunteers accepted: No

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

Inclusion criteria

  • Patients with clinical history of intermittent allergic rhinitis with seasonal onset and offset of nasal allergy symptoms during each of the last two ragweed allergy seasons
  • positive skin prick test to ragweed allergen within twelve months of screening

Exclusion criteria

  • Use of any medication used to treat allergy (administered via any route), such as: pseudoephedrine, antihistamines, ipratropium bromide, cromoglycates, corticosteroids, immunotherapy or other antiinflammatory or immunosuppressive agents, or any other medication administered via the nasal or ocular routes)
  • Within the last three years a recurrent history of acute or chronic bronchospastic disease including moderate-severe asthma or chronic obstructive pulmonary disease
  • Nasal conditions such as nasal septal perforations,nasal polyps, sinus disease, chronic nasal obstruction

Other protocol-defined inclusion/exclusion criteria may apply

Treatment and study plan

QAV680 + Cetirizine Placebo

Drug

QAV680 + Cetirizine

Drug

Cetirizine + QAV680 Placebo

Drug

QAV680 Placebo + Cetirizine Placebo

Drug

Primary outcomes

  1. Total Nasal Symptom Score measured during allergen exposure

    Time frame: 14 Days

Secondary outcomes

  1. Nasal airway patency assessed by acoustic rhinometry during allergen exposure

    Time frame: 14 days

  2. Nasal secretion weight during allergen exposure

    Time frame: 14 days

  3. Total Nasal Symptom Score & Total Ocular Symptom Score measured during allergen exposure

    Time frame: 14 days

Sponsors and collaborators

Lead sponsor

Novartis Pharmaceuticals

Industry

Registry information

Official study title

A Randomized, Double-blind, Double-dummy, Placebo Controlled Three-period Incomplete Cross Over Study to Compare the Effect of Combined Treatment With QAV680 and Cetirizine on Total Nasal Symptom Score in Allergic Rhinitis Patients in an Environmental Exposure Chamber

Important dates

Study start
2010
Primary completion
2010
Study completion
2010
First posted
Apr 13, 2010
Registry last updated
Feb 23, 2017

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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