A Long-term Study of Mometasone Furoate in Patients With Perennial Allergic Rhinitis (Study P04459)

February 7, 2022 updated by: Organon and Co

A Long-term Study of Mometasone Furoate in Patients With Perennial Allergic Rhinitis

This study examined the safety and effectiveness of long-term administration of mometasone nasal spray in patients with perennial allergic rhinitis. Patients received mometasone for 12 weeks plus an additional 12 weeks if patient agreed to continue. Dose of mometasone could be decreased or increased during the study based on patient's response.

Study Overview

Status

Completed

Conditions

Intervention / Treatment

Study Type

Interventional

Enrollment (Actual)

98

Phase

  • Phase 3

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

14 years and older (Child, Adult, Older Adult)

Accepts Healthy Volunteers

No

Genders Eligible for Study

All

Description

Inclusion Criteria:

  • Moderate to severe perennial allergic rhinitis, >16 years of age

Exclusion Criteria:

  • Patients with coexisting tuberculous disease or lower respiratory tract infection and patients who have acute upper respiratory tract infection, acute pharyngolaryngitis, or acute tonsillitis judged by the investigator to require treatment
  • Patients with coexisting infections or systemic mycosis for which there are no effective treatment
  • Patients with coexisting mycosis in the nasal and paranasal cavities
  • Patients who are judged to require prohibited concomitant drugs during the clinical study
  • Patients who have experienced recent nasal septum ulcers, nasal surgery, or nasal trauma, which have not yet healed
  • Patients with a history of hypersensitivity to steroids or mometasone furoate
  • Patients who are pregnant or nursing or who may be pregnant and patients or whose partner desires to become pregnant during the study period
  • Patients with severe hepatic disorder, renal disorder, cardiac disease, diabetes mellitus, hypertension, or hematological disease or other serious coexisting diseases and whose general condition is poor as judged by the investigators.
  • Patients allergic to pollen and the pollen release season occurs in the 7 days before the start of treatment
  • Patients diagnosed with vasomotor rhinitis or eosinophilic rhinitis
  • Patients with nasal conditions which may interfere with efficacy evaluation of the study drug
  • Patients who develop a disease which may affect nasal symptoms in the 7 days before the start of treatment
  • Patients who are participating or have participated in a clinical trial of an investigational drug within 120 days before the day of obtaining informed consent
  • Patients for whom the period of discontinuation of previous treatment before the start of study drug administration indicated Table 2 is not adequate or who cannot avoid the use of these drugs
  • Patients undergoing specific desensitization therapy or nonspecific allassotherapy (Histaglobin, vaccine therapy, etc.) or who had discontinued such therapy within 90 days prior to obtaining informed consent. (However, patients need not be excluded if therapy has been ongoing for at least 180 days before obtaining informed consent and maintenance therapy is now being conducted.)

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: Treatment
  • Allocation: N/A
  • Interventional Model: Single Group Assignment
  • Masking: None (Open Label)

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
Experimental: Mometasone Nasal Spray
Open-label. Two sprays per nostril once daily (200 mcg/day). After 4 weeks, dose can be decreased to one spray per nostril daily or increased to 4 sprays per nostril daily.
Drug: Mometasone furoate
Two sprays mometasone nasal spray per nostril once daily (200 mcg/day). After 4 weeks, dose can be decreased to one spray per nostril daily or increased to 4 sprays per nostril daily.
Other Names:
  • Nasonex
  • SCH 032088

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Time Frame
Change from Baseline in 4 nasal symptom score.
Time Frame: All visits starting 2 weeks prior to treatment until 5 to 9 days after last administration of treatment
All visits starting 2 weeks prior to treatment until 5 to 9 days after last administration of treatment

Secondary Outcome Measures

Outcome Measure
Time Frame
Individual nasal symptom scores (sneezing, attack, rhinorrhea, nasal congestion, and nasal itching)
Time Frame: All visits starting 2 weeks prior to treatment until 5 to 9 days after last administration of treatment
All visits starting 2 weeks prior to treatment until 5 to 9 days after last administration of treatment
Overall improvement (combination of nasal symptoms and rhinoscopic nasal findings)
Time Frame: All visits during which patient is receiving drug (includes the 12 week drug administration period plus the 12 week additional drug administration period)
All visits during which patient is receiving drug (includes the 12 week drug administration period plus the 12 week additional drug administration period)
Adverse events
Time Frame: Throughout the study once initial treatment has started and until 5 to 9 days after last administration of treatment.
Throughout the study once initial treatment has started and until 5 to 9 days after last administration of treatment.
Laboratory tests
Time Frame: At baseline, and 4, 12, and 24 weeks after treatment
At baseline, and 4, 12, and 24 weeks after treatment

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Organon and Co

Publications and helpful links

The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.

General Publications

  • T. Ishikawa et. al; Practica otologica. Suppl. 122 Page1-17(2008.11) -Japanese language journal

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (Actual)

May 1, 2005

Primary Completion (Actual)

January 1, 2006

Study Completion (Actual)

January 1, 2006

Study Registration Dates

First Submitted

August 8, 2008

First Submitted That Met QC Criteria

August 8, 2008

First Posted (Estimate)

August 12, 2008

Study Record Updates

Last Update Posted (Actual)

February 16, 2022

Last Update Submitted That Met QC Criteria

February 7, 2022

Last Verified

February 1, 2022

More Information

Terms related to this study

Additional Relevant MeSH Terms

Other Study ID Numbers

  • P04459

Plan for Individual participant data (IPD)

Study Data/Documents

  1. CSR Synopsis

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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