Skip to main content
OpenTrials
Completed

NCT Number: NCT00732368

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

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.

Completed

Looking for future studies?

Notify Me

Key information

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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.)

Treatment and study plan

Mometasone furoate

Drug

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

Primary outcomes

  1. 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 outcomes

  1. 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

  2. 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)

  3. Adverse events

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

  4. Laboratory tests

    Time frame: At baseline, and 4, 12, and 24 weeks after treatment

Sponsors and collaborators

Lead sponsor

Organon and Co

Industry

Registry information

Official study title

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

Important dates

Study start
2005
Primary completion
2006
Study completion
2006
First posted
Aug 12, 2008
Registry last updated
Aug 15, 2024

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

Published trials that share one or more normalized conditions with this study.