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

Primary Purpose

Perennial Allergic Rhinitis

Status

Completed

Phase

Phase 3

Locations

Study Type

Interventional

Intervention

Mometasone furoate

About this trial

This is an interventional treatment trial for Perennial Allergic Rhinitis

Eligibility Criteria

16 Years - undefined (Child, Adult, Older Adult)All SexesDoes not accept healthy volunteers

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.)

Sites / Locations

Arms of the Study

Arm 1

Arm Type

Experimental

Arm Label

Mometasone Nasal Spray

Arm Description

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.

Outcomes

Primary Outcome Measures

Change from Baseline in 4 nasal symptom score.

Secondary Outcome Measures

Individual nasal symptom scores (sneezing, attack, rhinorrhea, nasal congestion, and nasal itching)

Overall improvement (combination of nasal symptoms and rhinoscopic nasal findings)

Adverse events

Laboratory tests

Full Information

NCT ID

NCT00732368

First Posted

August 8, 2008

Last Updated

February 7, 2022

Sponsor

Organon and Co

1. Study Identification

Unique Protocol Identification Number

NCT00732368

Brief Title

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

Official Title

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

Study Type

Interventional

2. Study Status

Record Verification Date

February 2022

Overall Recruitment Status

Completed

Study Start Date

May 1, 2005 (Actual)

Primary Completion Date

January 1, 2006 (Actual)

Study Completion Date

January 1, 2006 (Actual)

3. Sponsor/Collaborators

Responsible Party, by Official Title

Sponsor

Name of the Sponsor

Organon and Co

4. Oversight

Data Monitoring Committee

5. Study Description

Brief Summary

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.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study

Perennial Allergic Rhinitis

7. Study Design

Primary Purpose

Treatment

Study Phase

Phase 3

Interventional Study Model

Single Group Assignment

Masking

None (Open Label)

Allocation

N/A

Enrollment

98 (Actual)

8. Arms, Groups, and Interventions

Arm Title

Mometasone Nasal Spray

Arm Type

Experimental

Arm Description

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.

Intervention Type

Drug

Intervention Name(s)

Mometasone furoate

Other Intervention Name(s)

SCH 032088, Nasonex

Intervention Description

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.

Primary Outcome Measure Information:

Title

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

Secondary Outcome Measure Information:

Title

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

Title

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)

Title

Adverse events

Time Frame

Throughout the study once initial treatment has started and until 5 to 9 days after last administration of treatment.

Title

Laboratory tests

Time Frame

At baseline, and 4, 12, and 24 weeks after treatment

10. Eligibility

Sex

All

Minimum Age & Unit of Time

16 Years

Accepts Healthy Volunteers

Eligibility Criteria

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.)

12. IPD Sharing Statement

Citations:

Citation

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

Results Reference

result

Available IPD and Supporting Information:

Available IPD/Information Type

CSR Synopsis

Available IPD/Information URL

http://www.merck.com/clinical-trials/policies-perspectives.html

Learn more about this trial

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

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