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

This study has been completed.
Sponsor:
Information provided by (Responsible Party):
Merck Sharp & Dohme Corp.
ClinicalTrials.gov Identifier:
NCT00779636
First received: October 23, 2008
Last updated: April 25, 2014
Last verified: April 2014
  Purpose

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).


Condition Intervention Phase
Allergic Airway Disease
Drug: Desloratadine
Drug: Placebo
Phase 4

Study Type: Interventional
Study Design: Allocation: Randomized
Endpoint Classification: Efficacy Study
Intervention Model: Parallel Assignment
Masking: Double Blind (Subject, Caregiver, Investigator)
Primary Purpose: Treatment
Official Title: Efficacy and Safety of Desloratadine 10 mg Daily vs. Placebo in Subjects With Allergic Airway Disease During the Pollen Season

Resource links provided by NLM:


Further study details as provided by Merck Sharp & Dohme Corp.:

Primary Outcome Measures:
  • Change in FEV1 averaged over weeks 1 to 4. [ Time Frame: Over weeks 1 to 4 ] [ Designated as safety issue: No ]

Secondary Outcome Measures:
  • Change from Baseline in chest symptoms, nasal symptoms, and eye symptom scores [ Time Frame: Day 15 and Day 29 ] [ Designated as safety issue: No ]
  • Interference with sleep and daily activities [ Time Frame: Day 15 and Day 29 ] [ Designated as safety issue: No ]
  • Number of nocturnal awakenings due to chest symptoms [ Time Frame: Day 15 and Day 29 ] [ Designated as safety issue: No ]
  • Overall Therapeutic Response to therapy of allergic airway disease symptoms (investigator and joint evaluation) [ Time Frame: Day 15 and Day 29 ] [ Designated as safety issue: No ]
  • Change from Baseline in chest symptoms, nasal symptoms, and eye symptom scores [ Time Frame: ALL TREATMENT VISITS (Day 1, Day 15, and Day 29) ] [ Designated as safety issue: No ]
  • Change in FEV1, FVC, FEF(25%-75%), PEFR [ Time Frame: ALL TREATMENT VISITS (Day 1, Day 15, and Day 29) ] [ Designated as safety issue: No ]
  • Use of Proventil® HFA rescue medication [ Time Frame: ALL TREATMENT VISITS (Day 1, Day 15, and Day 29) ] [ Designated as safety issue: No ]
  • Interference with sleep and daily activities [ Time Frame: ALL TREATMENT VISITS (Day 1, Day 15, and Day 29) ] [ Designated as safety issue: No ]
  • Number of nocturnal awakenings due to chest symptoms [ Time Frame: ALL TREATMENT VISITS (Day 1, Day 15, and Day 29) ] [ Designated as safety issue: No ]

Enrollment: 506
Study Start Date: July 2003
Study Completion Date: November 2004
Primary Completion Date: November 2004 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
Experimental: Desloratadine 10 mg Drug: Desloratadine
Desloratadine 10 mg daily x 28 days
Other Name: Clarinex, SCH 034117
Placebo Comparator: Placebo Drug: Placebo
Placebo daily x 28 days

  Eligibility

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

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.
  • in the opinion of the Investigator, were dependent upon nasal, oral or ocular decongestants, nasal topical antihistamines, or nasal steroids.
  • are on immunotherapy (desensitization therapy), unless on a regular maintenance schedule prior to the Screening visit and staying on this schedule for the remainder of the study. Subjects could not receive desensitization treatment within 24 hours prior to a study visit.
  • smoke, or ex-smokers who had smoked within the previous six months.
  • had current evidence of clinically significant hematopoietic, cardiovascular, hepatic, immunologic, renal, neurologic, psychiatric, autoimmune disease, or other disease that precludes the subject's participation in the study or with the subject's ability to complete the diary cards.
  • were morbidly obese (BMI >= 35).
  • were night-shift workers and those who did not have a standard asleep at night / awake during the day cycle.
  • had any history of life threatening asthma attacks or subjects who had been treated in the emergency room or been admitted to the hospital for asthma control within the previous 3 months or more than once in the previous 6 months.
  Contacts and Locations
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No Contacts or Locations Provided
  More Information

No publications provided

Responsible Party: Merck Sharp & Dohme Corp.
ClinicalTrials.gov Identifier: NCT00779636     History of Changes
Other Study ID Numbers: P03284
Study First Received: October 23, 2008
Last Updated: April 25, 2014
Health Authority: United States: Food and Drug Administration

Additional relevant MeSH terms:
Desloratadine
Cholinergic Antagonists
Cholinergic Agents
Neurotransmitter Agents
Molecular Mechanisms of Pharmacological Action
Pharmacologic Actions
Physiological Effects of Drugs
Histamine H1 Antagonists, Non-Sedating
Histamine H1 Antagonists
Histamine Antagonists
Histamine Agents

ClinicalTrials.gov processed this record on August 19, 2014