A Randomized, Placebo Controlled Study to Determine the Efficacy and Speed of a Nasal Spray in Allergen Induced Seasonal Allergic Rhinitis
NCT ID: NCT00561717
Last Updated: 2013-05-07
Study Results
The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.
Basic Information
Get a concise snapshot of the trial, including recruitment status, study phase, enrollment targets, and key timeline milestones.
COMPLETED
PHASE4
70 participants
INTERVENTIONAL
2007-10-31
2008-02-29
Brief Summary
Review the sponsor-provided synopsis that highlights what the study is about and why it is being conducted.
Related Clinical Trials
Explore similar clinical trials based on study characteristics and research focus.
Study to Find Out How Long it Takes Azelastine Hydrochloride 0.15% Nasal Spray to Relieve Symptoms in Patients Suffering From Allergic Rhinitis
NCT04264637
A Study to Evaluate the Safety and Effectiveness of a Nasal Spray to Treat Seasonal Allergies
NCT00660517
A Study to Evaluate the Safety & Effectiveness of a Nasal Spray to Treat Seasonal Allergies
NCT00719862
A Study to Evaluate the Safety and Effectiveness of a Nasal Spray to Treat Perennial Allergies
NCT00712920
A Study to Evaluate the Safety and Effectiveness of a Nasal Spray to Treat Seasonal Allergies
NCT00651118
Detailed Description
Dive into the extended narrative that explains the scientific background, objectives, and procedures in greater depth.
Conditions
See the medical conditions and disease areas that this research is targeting or investigating.
Study Design
Understand how the trial is structured, including allocation methods, masking strategies, primary purpose, and other design elements.
RANDOMIZED
CROSSOVER
TREATMENT
TRIPLE
Study Groups
Review each arm or cohort in the study, along with the interventions and objectives associated with them.
Arm 1
Azelastine and placebo
One Astelin spray per nostril plus one placebo tablet. In Cross-Over-Design with other arms.
Arm 2
Loratadine and Placebo
One placebo spray per nostril plus one Loratadine 10 mg tablet. In Cross-Over-Design with other arms.
Arm 3
Cetirizine and Placebo
One placebo spray per nostril plus one 10 mg Cetirizine tablet. In Cross-Over-Design with other arms.
Arm 4
Placebo and Placebo (spray and Tablet)
One placebo spray per nostril plus one placebo tablet. In Cross-Over-Design with other arms.
Interventions
Learn about the drugs, procedures, or behavioral strategies being tested and how they are applied within this trial.
Azelastine and placebo
One Astelin spray per nostril plus one placebo tablet. In Cross-Over-Design with other arms.
Loratadine and Placebo
One placebo spray per nostril plus one Loratadine 10 mg tablet. In Cross-Over-Design with other arms.
Cetirizine and Placebo
One placebo spray per nostril plus one 10 mg Cetirizine tablet. In Cross-Over-Design with other arms.
Placebo and Placebo (spray and Tablet)
One placebo spray per nostril plus one placebo tablet. In Cross-Over-Design with other arms.
Eligibility Criteria
Check the participation requirements, including inclusion and exclusion rules, age limits, and whether healthy volunteers are accepted.
Inclusion Criteria
* Positive response to skin prick test to ragweed allergen at screening;
* Be willing to participate in the trial.
Exclusion Criteria
* 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.
18 Years
65 Years
ALL
No
Sponsors
Meet the organizations funding or collaborating on the study and learn about their roles.
Kingston Health Sciences Centre
OTHER
Bayer
INDUSTRY
Responsible Party
Identify the individual or organization who holds primary responsibility for the study information submitted to regulators.
Bayer Consumer Care Inc.
Principal Investigators
Learn about the lead researchers overseeing the trial and their institutional affiliations.
Bayer Study Director
Role: STUDY_DIRECTOR
Bayer
Locations
Explore where the study is taking place and check the recruitment status at each participating site.
Kingston, Ontario, Canada
Countries
Review the countries where the study has at least one active or historical site.
References
Explore related publications, articles, or registry entries linked to this study.
Tenn MW, Steacy LM, Ng CC, Ellis AK. Onset of action for loratadine tablets for the symptomatic control of seasonal allergic rhinitis in adults challenged with ragweed pollen in the Environmental Exposure Unit: a post hoc analysis of total symptom score. Allergy Asthma Clin Immunol. 2018 Jan 16;14:5. doi: 10.1186/s13223-017-0227-4. eCollection 2018.
Other Identifiers
Review additional registry numbers or institutional identifiers associated with this trial.
9427-B2171-22C (CR Number)
Identifier Type: OTHER
Identifier Source: secondary_id
12962
Identifier Type: -
Identifier Source: org_study_id
More Related Trials
Additional clinical trials that may be relevant based on similarity analysis.