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

This study has been completed.
Information provided by (Responsible Party):
Novartis ( Novartis Pharmaceuticals ) Identifier:
First received: April 12, 2010
Last updated: February 20, 2017
Last verified: February 2017
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.

Condition Intervention Phase
Allergic Rhinitis
Drug: QAV680 + Cetirizine Placebo
Drug: QAV680 + Cetirizine
Drug: Cetirizine + QAV680 Placebo
Drug: QAV680 Placebo + Cetirizine Placebo
Phase 2

Study Type: Interventional
Study Design: Allocation: Randomized
Intervention Model: Crossover Assignment
Masking: Participant, Care Provider, Investigator
Primary Purpose: Treatment
Official 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

Resource links provided by NLM:

Further study details as provided by Novartis ( Novartis Pharmaceuticals ):

Primary Outcome Measures:
  • Total Nasal Symptom Score measured during allergen exposure [ Time Frame: 14 Days ]

Secondary Outcome Measures:
  • Nasal airway patency assessed by acoustic rhinometry during allergen exposure [ Time Frame: 14 days ]
  • Nasal secretion weight during allergen exposure [ Time Frame: 14 days ]
  • Total Nasal Symptom Score & Total Ocular Symptom Score measured during allergen exposure [ Time Frame: 14 days ]

Enrollment: 60
Actual Study Start Date: March 22, 2010
Study Completion Date: July 28, 2010
Primary Completion Date: July 28, 2010 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
Active Comparator: QAV680 + Cetirizine Placebo Drug: QAV680 + Cetirizine Placebo
Experimental: QAV680 + Cetirizine Drug: QAV680 + Cetirizine
Active Comparator: Cetirizine + QAV680 Placebo Drug: Cetirizine + QAV680 Placebo
Placebo Comparator: QAV680 Placebo + Cetirizine Placebo Drug: QAV680 Placebo + Cetirizine Placebo


Ages Eligible for Study:   18 Years to 65 Years   (Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No

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

  Contacts and Locations
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Please refer to this study by its identifier: NCT01103050

Novartis Investigative Site
Ontario, Canada
Sponsors and Collaborators
Novartis Pharmaceuticals
Study Director: Novartis Pharmaceuticals Novartis Pharmaceuticals
  More Information

Additional Information:
Responsible Party: Novartis Pharmaceuticals Identifier: NCT01103050     History of Changes
Other Study ID Numbers: CQAV680A2204
Study First Received: April 12, 2010
Last Updated: February 20, 2017

Keywords provided by Novartis ( Novartis Pharmaceuticals ):
Allergic inflammation
Seasonal rhinitis

Additional relevant MeSH terms:
Rhinitis, Allergic
Nose Diseases
Respiratory Tract Diseases
Respiratory Tract Infections
Otorhinolaryngologic Diseases
Respiratory Hypersensitivity
Hypersensitivity, Immediate
Immune System Diseases
Anti-Allergic Agents
Histamine H1 Antagonists, Non-Sedating
Histamine H1 Antagonists
Histamine Antagonists
Histamine Agents
Neurotransmitter Agents
Molecular Mechanisms of Pharmacological Action
Physiological Effects of Drugs processed this record on May 25, 2017