A Long-Term Study of Mometasone Furoate in Patients With Perennial Allergic Rhinitis (Study P04459)(COMPLETED) - Full Text View

Purpose

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.

Condition	Intervention	Phase
Perennial Allergic Rhinitis	Drug: Mometasone furoate	Phase 3

Study Type:	Interventional
Study Design:	Endpoint Classification: Safety/Efficacy Study Intervention Model: Single Group Assignment Masking: Open Label Primary Purpose: Treatment
Official Title:	A Long-Term Study of Mometasone Furoate in Patients With Perennial Allergic Rhinitis

Resource links provided by NLM:

Drug Information available for: Mometasone furoate Mometasone furoate monohydrate

U.S. FDA Resources

Further study details as provided by Schering-Plough:

Primary Outcome Measures:

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 ] [ Designated as safety issue: No ]

Secondary Outcome Measures:

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 ] [ Designated as safety issue: No ]
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) ] [ Designated as safety issue: No ]
Adverse events [ Time Frame: Throughout the study once initial treatment has started and until 5 to 9 days after last administration of treatment. ] [ Designated as safety issue: Yes ]
Laboratory tests [ Time Frame: At baseline, and 4, 12, and 24 weeks after treatment ] [ Designated as safety issue: Yes ]

Enrollment:	98
Study Start Date:	May 2005
Study Completion Date:	January 2006
Primary Completion Date:	January 2006 (Final data collection date for primary outcome measure)

Arms	Assigned Interventions
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: SCH 032088 Nasonex

Eligibility

Ages Eligible for Study:	16 Years and older
Genders Eligible for Study:	Both
Accepts Healthy Volunteers:	No

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.)

Contacts and Locations

No Contacts or Locations Provided

More Information

No publications provided

Responsible Party:	Head, Clinical Trials Registry & Results Disclosure Group, Schering-Plough
ClinicalTrials.gov Identifier:	NCT00732368 History of Changes
Other Study ID Numbers:	P04459
Study First Received:	August 8, 2008
Last Updated:	October 23, 2008
Health Authority:	Japan: Pharmaceuticals and Medical Devices Agency

Additional relevant MeSH terms:

Rhinitis
Rhinitis, Allergic, Perennial
Nose Diseases
Respiratory Tract Diseases
Respiratory Tract Infections
Otorhinolaryngologic Diseases
Respiratory Hypersensitivity
Hypersensitivity, Immediate

Hypersensitivity
Immune System Diseases
Mometasone furoate
Anti-Allergic Agents
Therapeutic Uses
Pharmacologic Actions
Anti-Inflammatory Agents

ClinicalTrials.gov processed this record on May 21, 2013