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

This study has been completed.
Sponsor:
Information provided by:
Novartis
ClinicalTrials.gov Identifier:
NCT01103050
First received: April 12, 2010
Last updated: January 6, 2011
Last verified: January 2011
History of Changes
  Purpose

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: Double Blind (Subject, Caregiver, 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:

U.S. FDA Resources

Further study details as provided by Novartis:

Primary Outcome Measures:
  • Total Nasal Symptom Score measured during allergen exposure [ Time Frame: 14 Days ] [ Designated as safety issue: No ]

Secondary Outcome Measures:
  • Nasal airway patency assessed by acoustic rhinometry during allergen exposure [ Time Frame: 14 days ] [ Designated as safety issue: No ]
  • Nasal secretion weight during allergen exposure [ Time Frame: 14 days ] [ Designated as safety issue: No ]
  • Total Nasal Symptom Score & Total Ocular Symptom Score measured during allergen exposure [ Time Frame: 14 days ] [ Designated as safety issue: No ]

Enrollment: 60
Study Start Date: March 2010
Primary Completion Date: July 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

  Eligibility

Ages Eligible for Study:   18 Years to 65 Years
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   No
Criteria

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
Please refer to this study by its ClinicalTrials.gov identifier: NCT01103050

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

Additional Information:
Related Info  This link exits the ClinicalTrials.gov site

No publications provided

Responsible Party: External Affairs, Novartis Pharmaceuticals
ClinicalTrials.gov Identifier: NCT01103050     History of Changes
Other Study ID Numbers: CQAV680A2204
Study First Received: April 12, 2010
Last Updated: January 6, 2011
Health Authority: Canada: Health Canada

Keywords provided by Novartis:
Allergic inflammation
Seasonal rhinitis

Additional relevant MeSH terms:
Rhinitis
Nose Diseases
Respiratory Tract Diseases
Respiratory Tract Infections
Otorhinolaryngologic Diseases
Cetirizine
Anti-Allergic Agents
Therapeutic Uses
 Pharmacologic Actions
Histamine H1 Antagonists, Non-Sedating
Histamine H1 Antagonists
Histamine Antagonists
Histamine Agents
Neurotransmitter Agents
Molecular Mechanisms of Pharmacological Action
Physiological Effects of Drugs

ClinicalTrials.gov processed this record on June 17, 2013