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Effectiveness and Safety of Desloratadine in Patients With Allergic Airway Disease During the Pollen Season (Study P03284) | Clinical Trials | Clareo Health

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Effectiveness and Safety of Desloratadine in Patients With Allergic Airway Disease During the Pollen Season (Study P03284)

Efficacy and Safety of Desloratadine 10 mg Daily vs. Placebo in Subjects With Allergic Airway Disease During the Pollen Season

NCT00779636•Organon and Co

View on ClinicalTrials.gov

Summary

This was a placebo controlled study designed to evaluate the effectiveness of desloratadine in relieving symptoms of allergic airway disease during the pollen season. Patients received desloratadine 10 mg or placebo once daily for 28 days, and had their allergy symptoms and side effects to medication measured on Day 1, Day 15, and Day 29 (one day after stopping study drug).

Eligibility

Age

18 - 65 years

Sex

ALL

Healthy Volunteers

Inclusion Criteria

•18 - 65 years old
•at least a two-year history of seasonal allergic rhinitis and the presence of chest symptoms (cough, wheezing, difficulty breathing) associated with the allergy season
•FEV1 was greater than or equal to 70% of predicted
•skin test positive (skin prick test)
•Total Nasal Symptom Severity Score of \>= 6 at the Screening Visit.
•Total Chest Symptom Severity Score of \>= 3 at the Screening Visit.
•Total Frequency of Chest Symptoms and/or Total Frequency of Bronchodilator Use of at least 2 at the Screening Visit
•Total Nasal Symptom Severity Score was \>= 6 on 7 of the 15 run-in diary timepoints.
•Total Chest Symptom Severity Score was \>= 3 on 7 of the 15 run-in diary timepoints
•Free of any clinically significant disease that would interfere with the study evaluations.

Exclusion Criteria

•Subjects who:
•demonstrated a change in FEV1 of \>= 20% between Visit 2 and Visit 3.
•used \>12 puffs of Proventil® HFA (or other beta-2-agonist) on any 2 consecutive days or treatment with nebulized beta-2 agonists during the screening period - between Visit 2 and Visit 3.
•required chronic use of inhaled or systemic corticosteroids.
•required regular treatment with nebulized beta2-agonists.
•required short acting beta-2 agonists use before every exercise session or exposure to an animal.
•have current or history of frequent (2 or more episodes per year for the past 2 years), clinically significant sinusitis or chronic purulent postnasal drip.
•have rhinitis medicamentosa or chronic obstructive pulmonary disease (COPD).
•had an upper or lower respiratory tract or sinus infection that required antibiotic therapy with the last dose 14 days prior to Screening, or who have had a upper or lower viral respiratory infection within 7 days prior to Screening.
•had nasal structural abnormalities, including large nasal polyps and marked septal deviation that significantly interfered with nasal air flow.
+7 more criteria

Key Dates

Start Date

July 1, 2003

Primary Completion Date

November 1, 2004

Completion Date

November 1, 2004

Last Updated

August 15, 2024

Enrollment

506

ACTUAL participants

Conditions

Allergic Airway Disease

Interventions

Desloratadine

DRUG

Placebo

DRUG

Classical Conditioning to Treat Allergic Airway Diseases

NCT00032526

Allergic Airway Disease

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Data Source & Attribution

This clinical trial information is sourced from ClinicalTrials.gov, a service of the U.S. National Institutes of Health.

ClinicalTrials.gov last update: August 15, 2024Data synced to Clareo: March 29, 2026

Modifications: This data has been reformatted for display purposes. Eligibility criteria have been parsed into inclusion/exclusion sections. Location data has been geocoded to enable distance-based search. For the authoritative and most current information, please visit ClinicalTrials.gov.

Neither the United States Government nor Clareo Health make any warranties regarding the data. Check ClinicalTrials.gov frequently for updates.

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