A Randomized, Placebo Controlled Study to Determine the Efficacy and Speed of a Nasal Spray in Allergen Induced Seasonal Allergic Rhinitis - Full Text View

Sponsor:	Bayer
Collaborator:	Kingston General Hospital
Information provided by:	Bayer
ClinicalTrials.gov Identifier:	NCT00561717

Purpose

Finding out how fast azelastine nasal spray works in subjects with hay fever.

Condition	Intervention	Phase
Seasonal Allergic Rhinitis	Drug: Azelastine and placebo Drug: Loratadine and Placebo Drug: Cetirizine and Placebo Drug: Placebo and Placebo (spray and Tablet)	Phase IV

Study Type:	Interventional
Study Design:	Allocation: Randomized Endpoint Classification: Efficacy Study Intervention Model: Crossover Assignment Masking: Double Blind (Subject, Caregiver, Investigator) Primary Purpose: Treatment
Official Title:	A Four-Way Double-Blind, Randomized, Placebo Controlled Study to Determine the Efficacy and Speed of Azelastine Nasal Spray and Antihistaminic Agents in Adult Subjects With Allergen Induced Seasonal Allergic Rhinitis

Resource links provided by NLM:

MedlinePlus related topics: Hay Fever Methamphetamine

Drug Information available for: Azelastine Azelastine hydrochloride Loratadine Cetirizine Cetirizine hydrochloride

U.S. FDA Resources

Further study details as provided by Bayer:

Primary Outcome Measures:

Onset of action measured by change in total nasal symptom score Until "Onset of action" = until drug demonstrates and maintains a change greater than placebo compared to baseline [ Time Frame: Up to 6 hours ] [ Designated as safety issue: No ]

Secondary Outcome Measures:

Change from baseline for individual symptoms of allergic seasonal rhinitis; overall assessment of efficacy [ Time Frame: Effect over 6 hours ] [ Designated as safety issue: No ]

Enrollment:	70
Study Start Date:	October 2007
Study Completion Date:	February 2008
Primary Completion Date:	December 2007 (Final data collection date for primary outcome measure)

Arms	Assigned Interventions
Experimental: Arm 1	Drug: Azelastine and placebo One Astelin spray per nostril plus one placebo tablet. In Cross-Over-Design with other arms.
Active Comparator: Arm 2	Drug: Loratadine and Placebo One placebo spray per nostril plus one Loratadine 10 mg tablet. In Cross-Over-Design with other arms.
Active Comparator: Arm 3	Drug: Cetirizine and Placebo One placebo spray per nostril plus one 10 mg Cetirizine tablet. In Cross-Over-Design with other arms.
Placebo Comparator: Arm 4	Drug: Placebo and Placebo (spray and Tablet) One placebo spray per nostril plus one placebo tablet. In Cross-Over-Design with other arms.

Eligibility

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

Criteria

Inclusion Criteria:

History of seasonal allergic rhinitis to ragweed pollen for last 2 consecutive seasons;
Positive response to skin prick test to ragweed allergen at screening;
Be willing to participate in the trial.

Exclusion Criteria:

History of hypersensitivity to azelastine;
Females who are pregnant or lactating;
Relative chronic sinusitis or nasal structural abnormalities causing greater than 50% obstruction;
Asthma that requires other than occasional use of inhaled short-acting beta-2 antagonist;
Known non-responsiveness to antihistamines;
Alcoholism or drug abuse within 2 yrs. of screening;
Current or regular use within 6 months of any type of tobacco product;
Evidence of any clinically significant hematological, renal, endocrine, pulmonary, gastrointestinal, cardiovascular, hepatic, psychiatric, neurologic or malignancies within the last 5 years;
History of a positive test to HIV, TB, hepatitis B or C.

Contacts and Locations

Please refer to this study by its ClinicalTrials.gov identifier: NCT00561717

Locations

Canada, Ontario

Kingston, Ontario, Canada, K7L 2V7

Sponsors and Collaborators

Bayer

Kingston General Hospital

Investigators

Study Director:

Bayer Study Director

Bayer

More Information

Additional Information:

Click here and search for drug information provided by the FDA. This link exits the ClinicalTrials.gov site

Click here and search for information on any recalls, market or product safety alerts by the FDA which might have occurred with this product. This link exits the ClinicalTrials.gov site

No publications provided

Responsible Party:	Medical Affairs Therapeutic Area Head, Bayer Consumer Care Inc.
ClinicalTrials.gov Identifier:	NCT00561717 History of Changes
Other Study ID Numbers:	12962, 9427-B2171-22C (CR Number)
Study First Received:	November 20, 2007
Last Updated:	May 24, 2011
Health Authority:	Canada: Health Canada

Keywords provided by Bayer:

Seasonal Allergic Rhinitis
Ragweed
Pollen
Allergy

Additional relevant MeSH terms:

Rhinitis, Allergic, Seasonal
Rhinitis
Nose Diseases
Respiratory Tract Diseases
Respiratory Hypersensitivity
Otorhinolaryngologic Diseases
Hypersensitivity, Immediate
Hypersensitivity
Immune System Diseases
Respiratory Tract Infections
Azelastine
Cetirizine
Loratadine
Histamine H1 Antagonists, Non-Sedating
Histamine H1 Antagonists

Histamine Antagonists
Histamine Agents
Neurotransmitter Agents
Molecular Mechanisms of Pharmacological Action
Pharmacologic Actions
Physiological Effects of Drugs
Lipoxygenase Inhibitors
Enzyme Inhibitors
Anti-Allergic Agents
Therapeutic Uses
Bronchodilator Agents
Autonomic Agents
Peripheral Nervous System Agents
Anti-Asthmatic Agents
Respiratory System Agents

ClinicalTrials.gov processed this record on February 09, 2012