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Assessment of Intranasal Steroids in Allergic Rhinitis When Used Alone or in Combination With an Oral Antihistamine (Study P03270)

This study has been completed.
Sponsor:
ClinicalTrials.gov Identifier:
NCT00834119
First Posted: February 3, 2009
Last Update Posted: March 23, 2017
The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details.
Information provided by (Responsible Party):
Merck Sharp & Dohme Corp.
  Purpose
This is a Phase 4, non-comparative, open-label, multi-center study. It is designed to determine the effectiveness of regular intranasal steroid use in alleviating allergic rhinitis nasal symptoms, when used alone or in combination with an oral antihistamine. Subjects will receive 200 mcg (2 puffs in each nostril) of mometasone furoate once a day. An oral antihistamine at the discretion of the physician may be added at Day 28 (Visit 2), if patients fail to improve nasal symptoms.

Condition Intervention Phase
Rhinitis, Allergic Drug: Mometasone furoate Phase 4

Study Type: Interventional
Study Design: Allocation: Non-Randomized
Intervention Model: Parallel Assignment
Masking: None (Open Label)
Primary Purpose: Treatment
Official Title: Assessment of the Effectiveness of Regular Use of Intranasal Steroids in Alleviating Nasal Symptoms in Allergic Rhinitis When Used Alone or in Combination With Oral Antihistamine

Resource links provided by NLM:


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

Primary Outcome Measures:
  • To assess the mean change in total nasal symptom score from Baseline to the Final Visit of regular intranasal steroid use (mometasone furoate) in allergic rhinitis patients when used alone or in combination with an oral antihistamine. [ Time Frame: Day 28 and Day 56 ]

Secondary Outcome Measures:
  • Patient satisfaction with intranasal steroid monotherapy. [ Time Frame: Day 28 ]
  • Potential benefit of an oral antihistamine in combination with an intranasal steroid [ Time Frame: Day 56 ]

Enrollment: 72
Actual Study Start Date: September 1, 2003
Study Completion Date: April 1, 2004
Primary Completion Date: April 1, 2004 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
Experimental: Mometasone furoate Drug: Mometasone furoate
Mometasone furoate 200 mcg (2 puffs in each nostril) once a day for 28 days
Other Names:
  • Nasonex
  • SCH 32088
Experimental: Mometasone furoate plus an oral antihistamine Drug: Mometasone furoate
Mometasone furoate 200 mcg (2 puffs in each nostril) once a day plus an oral antihistamine added at Day 28 (Visit 2) at the discretion of the physician
Other Names:
  • Nasonex
  • SCH 32088

  Eligibility

Information from the National Library of Medicine

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Ages Eligible for Study:   18 Years to 65 Years   (Adult)
Sexes Eligible for Study:   All
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 form
  • Subjects must be between 18-65 years of age, of either sex and any race
  • Subjects must be diagnosed by the physician to have moderate to severe allergic rhinitis according to ARIA guidelines.
  • Subjects must be mometasone furoate naïve.

Exclusion Criteria:

  • Significant comorbid medical condition.
  • Respiratory tract infection.
  • Any contraindications according to mometasone furoate product monograph.
  • Patients who have received antihistamine treatment within the last 5 days.
  • Patients who have received corticosteroid treatment within the last 30 days.
  • Patients who are likely to require the administration of systemic steroids during the course of this program.
  • Any condition which in the doctor's opinion could interfere with the patient completion of this program.
  • Pregnant or lactating patients.
  • Patients with local infections involving the nasal mucosa.
  • Patients with structural abnormalities or who have undergone nasal surgery or trauma in the past 6 months.
  • Patients with hypersensitivity to mometasone furoate or are allergic to corticosteroids.
  • Patients who are prone to nose bleeding.
  Contacts and Locations
No Contacts or Locations Provided
  More Information

Study Data/Documents: CSR Synopsis  This link exits the ClinicalTrials.gov site

Responsible Party: Merck Sharp & Dohme Corp.
ClinicalTrials.gov Identifier: NCT00834119     History of Changes
Other Study ID Numbers: P03270
First Submitted: October 30, 2008
First Posted: February 3, 2009
Last Update Posted: March 23, 2017
Last Verified: March 2017

Additional relevant MeSH terms:
Rhinitis
Rhinitis, Allergic
Nose Diseases
Respiratory Tract Diseases
Respiratory Tract Infections
Otorhinolaryngologic Diseases
Respiratory Hypersensitivity
Hypersensitivity, Immediate
Hypersensitivity
Immune System Diseases
Mometasone Furoate
Histamine Antagonists
Histamine H1 Antagonists
Anti-Inflammatory Agents
Dermatologic Agents
Anti-Allergic Agents
Histamine Agents
Neurotransmitter Agents
Molecular Mechanisms of Pharmacological Action
Physiological Effects of Drugs


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