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

October 30, 2008
April 25, 2014
September 2003
April 2004   (final data collection date for primary outcome measure)
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 ]
Same as current
Complete list of historical versions of study NCT00834119 on ClinicalTrials.gov Archive Site
  • 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 ]
Same as current
Not Provided
Not Provided
 
Assessment of Intranasal Steroids in Allergic Rhinitis When Used Alone or in Combination With an Oral Antihistamine (Study P03270)
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

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.

Not Provided
Interventional
Phase 4
Allocation: Non-Randomized
Endpoint Classification: Efficacy Study
Intervention Model: Parallel Assignment
Masking: Open Label
Primary Purpose: Treatment
Rhinitis, Allergic
  • Drug: Mometasone furoate
    Mometasone furoate 200 mcg (2 puffs in each nostril) once a day for 28 days
    Other Names:
    • Nasonex
    • SCH 32088
  • 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
  • Experimental: Mometasone furoate
    Intervention: Drug: Mometasone furoate
  • Experimental: Mometasone furoate plus an oral antihistamine
    Intervention: Drug: Mometasone furoate
Not Provided

*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Completed
72
April 2004
April 2004   (final data collection date for primary outcome measure)

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.
Both
18 Years to 65 Years
No
Contact information is only displayed when the study is recruiting subjects
Not Provided
 
NCT00834119
P03270
No
Merck Sharp & Dohme Corp.
Merck Sharp & Dohme Corp.
Not Provided
Not Provided
Merck Sharp & Dohme Corp.
April 2014

ICMJE     Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP