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:
Information provided by (Responsible Party):
Merck Sharp & Dohme Corp.
ClinicalTrials.gov Identifier:
NCT00834119
First received: October 30, 2008
Last updated: April 25, 2014
Last verified: April 2014
  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
Endpoint Classification: Efficacy Study
Intervention Model: Parallel Assignment
Masking: 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 ] [ Designated as safety issue: No ]

Secondary Outcome Measures:
  • Patient satisfaction with intranasal steroid monotherapy. [ Time Frame: Day 28 ] [ Designated as safety issue: No ]
  • Potential benefit of an oral antihistamine in combination with an intranasal steroid [ Time Frame: Day 56 ] [ Designated as safety issue: No ]

Enrollment: 72
Study Start Date: September 2003
Study Completion Date: April 2004
Primary Completion Date: April 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

Ages Eligible for Study:   18 Years to 65 Years
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 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
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: NCT00834119     History of Changes
Other Study ID Numbers: P03270
Study First Received: October 30, 2008
Last Updated: April 25, 2014
Health Authority: Portugal: INFARMED - Autoridade Nacional do Medicamento e Produtos de Saúde, I.P.

Additional relevant MeSH terms:
Rhinitis
Nose Diseases
Respiratory Tract Diseases
Respiratory Tract Infections
Otorhinolaryngologic Diseases
Histamine Antagonists
Histamine H1 Antagonists
Mometasone furoate
Histamine Agents
Neurotransmitter Agents
Molecular Mechanisms of Pharmacological Action
Pharmacologic Actions
Physiological Effects of Drugs
Anti-Inflammatory Agents
Therapeutic Uses
Anti-Allergic Agents

ClinicalTrials.gov processed this record on September 11, 2014