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Completed

NCT Number: NCT00561717

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

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

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Key information

Conditions

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

Age range

18 year–65 year

Sex eligibility

All sexes

Study type

Interventional

Phase

Phase 4

Primary location

Kingston, Ontario, K7L 2V7, Canada

Who can participate

Healthy volunteers accepted: No

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

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.

Treatment and study plan

Azelastine and placebo

Drug

One Astelin spray per nostril plus one placebo tablet. In Cross-Over-Design with other arms.

Loratadine and Placebo

Drug

One placebo spray per nostril plus one Loratadine 10 mg tablet. In Cross-Over-Design with other arms.

Cetirizine and Placebo

Drug

One placebo spray per nostril plus one 10 mg Cetirizine tablet. In Cross-Over-Design with other arms.

Placebo and Placebo (spray and Tablet)

Drug

One placebo spray per nostril plus one placebo tablet. In Cross-Over-Design with other arms.

Primary outcomes

  1. 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

Secondary outcomes

  1. Change from baseline for individual symptoms of allergic seasonal rhinitis; overall assessment of efficacy

    Time frame: Effect over 6 hours

Sponsors and collaborators

Lead sponsor

Bayer

Industry

Collaborators

  • Kingston Health Sciences Centre

Registry information

Official study 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

Acronym: GEYSER

Important dates

Study start
2007
Primary completion
2007
Study completion
2008
First posted
Nov 21, 2007
Registry last updated
May 7, 2013

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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