Study of Nasal Symptom Relief and Side Effects in Hayfever Patients Treated With Aerius (Desloratadine)(P03442)

This study has been completed.
Sponsor:
Information provided by (Responsible Party):
Merck Sharp & Dohme Corp.
ClinicalTrials.gov Identifier:
NCT00805584
First received: December 5, 2008
Last updated: April 29, 2014
Last verified: April 2014
  Purpose

The purpose of this study was to test the effectiveness and side effects of desloratadine (Aerius) in patients with hayfever. Patients took desloratadine once a day for 15 days. At the end of therapy, they scored how severe their hayfever symptoms were and how they responded to therapy. Side effects were recorded.


Condition Intervention Phase
Rhinitis, Allergic, Seasonal
Drug: desloratadine
Phase 4

Study Type: Interventional
Study Design: Endpoint Classification: Safety/Efficacy Study
Intervention Model: Single Group Assignment
Masking: Open Label
Primary Purpose: Treatment
Official Title: A Multi-center, Open-label, Non-comparative Study of the Relief of Nasal Symptoms and Tolerability in Subjects With Seasonal Allergic Rhinitis (SAR) Treated With Aerius.

Resource links provided by NLM:


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

Primary Outcome Measures:
  • Relief of allergy symptoms [ Time Frame: Baseline and end of therapy ] [ Designated as safety issue: No ]

Secondary Outcome Measures:
  • Global therapeutic response [ Time Frame: End of therapy ] [ Designated as safety issue: No ]
  • Adverse events [ Time Frame: Baseline and end of therapy ] [ Designated as safety issue: Yes ]

Enrollment: 311
Study Start Date: May 2003
Study Completion Date: June 2003
Primary Completion Date: June 2003 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
Experimental: Arm 1 Drug: desloratadine
Aerius (desloratadine) tablets; 5mg orally once a day in the morning for 15 days
Other Name: Aerius, Clarinex, SCH 34117, descarboethoxyloratadine

  Eligibility

Ages Eligible for Study:   18 Years and older
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   No
Criteria

Inclusion Criteria:

  • Subjects must demonstrate their willingness to participate in the study and comply with its procedures by signing a written informed consent.
  • Subjects must be >=18 years of age, of either sex and any race.
  • Women of childbearing potential (includes women who are less than 1 year postmenopausal and women who become sexually active) must be using or agree to use an acceptable method of birth control. Women who are not currently sexually active must agree and consent to use some sort of contraception should they become sexually active while participating in the study.
  • Subjects must be in general good health, i.e., they must be free of any clinically significant disease (other than SAR) that would interfere with study evaluations.
  • Subjects must understand and be able to adhere to the dosing and visit schedules, and agree to report concomitant medications and adverse events to the Investigator or designee.
  • Subjects must have at least a positive history, self-reported history of signs and symptoms is acceptable, of recurring seasonal allergic rhinitis
  • Subjects must be clinically symptomatic with SAR at Visit 2 (Baseline): the total (nasal + non-nasal) symptom score must be >=8 points with a nasal congestion score of >=2, and the non-nasal symptom score must be >=2. Subjects may be rescheduled up two additional times for the qualifying visit if they do not meet the minimum symptom scores.
  • Women of childbearing potential must have be negative pregnancy history at Visit 1.

Exclusion Criteria:

  • Women who are pregnant or nursing.
  • Subjects who have not observed the designated washout periods for any of the prohibited medications.
  • Subjects with asthma who require chronic use of inhaled or systemic corticosteroids.
  • Subjects with current or history of frequent, clinically significant sinusitis or chronic purulent postnasal drip.
  • Subjects with rhinitis medicamentosa.
  • Subjects who have had an upper respiratory tract or sinus infection that required antibiotic therapy within 14 days prior to Visit 1 (Screening / Consent), or subjects who have had a viral upper respiratory infection within 7 days prior to Visit 1.
  • Subjects who have nasal structural abnormalities, including nasal polyps and marked septal deviation, that significantly interferes with nasal airflow.
  • Subjects who, in the opinion of the Investigator, are dependent upon nasal, oral or ocular decongestants, nasal topical antihistamines, or nasal steroids.
  • Subjects with a history of hypersensitivity to desloratadine or any of its excipients.
  • Subjects who are staff personnel directly involved with the administration of this study.
  • Subjects who have any current evidence of clinically significant hematopoetic, metabolic, cardiovascular, immunologic, neurologic, hematologic, gastrointestinal, hepatic, renal, psychiatric, cerebrovascular, or respiratory disease, or any other disorder which, in the judgment of the Investigator, may interfere with the study evaluations or affect subject safety.
  • Subject taking prohibited drugs listed in the study protocol are excluded from participation.
  Contacts and Locations
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

No Contacts or Locations Provided
  More Information

No publications provided

Responsible Party: Merck Sharp & Dohme Corp.
ClinicalTrials.gov Identifier: NCT00805584     History of Changes
Other Study ID Numbers: P03442
Study First Received: December 5, 2008
Last Updated: April 29, 2014
Health Authority: Lithuania: State Medicine Control Agency - Ministry of Health

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
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 28, 2014