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Completed

NCT Number: NCT00731185

Mometasone Furoate Nasal Spray for Treatment of Nasal Polyposis After Surgery (Study P03218)

This study was conducted to evaluate the effectiveness of mometasone nasal spray in preventing polyp relapse/symptom worsening in patients after surgical treatment of nasal polyps. Patients who met Screening eligibility underwent endoscopic sino-nasal surgery (FESS) on visit 2. Mometasone nasal spray or placebo was started about 2 weeks after surgery and continued for up to 24 weeks or until relapse.

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Key information

Conditions

Nasal Polyps Fistula Nose Diseases Otorhinolaryngologic Diseases Pathological Conditions, Anatomical Pathological Conditions, Signs and Symptoms Polyps Respiratory Tract Diseases

Age range

18 year and older

Sex eligibility

All sexes

Study type

Interventional

Phase

Phase 3

Who can participate

Healthy volunteers accepted: No

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

Inclusion criteria

  • At least 18 years of age
  • Bilateral nasal polyps
  • Fulfill criteria for polypectomy (be indicated for surgical - FESS - treatment)

Exclusion criteria

  • Polypectomy within the last 6 months
  • Unhealed nasal surgery/trauma
  • >5 previous polypectomies
  • Female of childbearing age who is pregnant, lactating, or not using active contraceptive methods
  • Nasal infection
  • Pulmonary tuberculosis
  • Cystic fibrosis, glaucoma, clinically significant cardiovascular, pulmonary, renal, hepatic, metabolic, hematological, or neurological disease
  • Immunocompromised
  • Rhinitis medicamentosa (rebound congestion following misuse of nasal decongestants)
  • Known hereditary mucociliary dysfunction
  • Significant nasal structure abnormalities
  • Asthmatic attack within the past 30 days
  • Asthmatic patients requiring >1000 mcg beclomethasone or equivalent
  • Asthmatic patients not stable on corticosteroid therapy

Treatment and study plan

Mometasone Furoate Nasal spray

Drug

MFNS 200 mcg (2 sprays of 50 mcg in each nostril) once daily in the morning for up to 24 weeks or until relapse

Other names: Nasonex, SCH 032088

Placebo

Drug

Other names: Placebo (2 sprays of 50 mcg in each nostril) once daily in the morning for up to 24 weeks or until relapse

Primary outcomes

  1. Time to relapse in polyp score after surgery

    Time frame: Assessment for relapse was performed at every study visit (up to 24 weeks of treatment)

Secondary outcomes

  1. Signs and symptom scores

    Time frame: All study visits (up to 24 weeks of treatment)

  2. Quality of life, peak nasal inspiratory flow, olfaction threshold

    Time frame: Measured starting 1 week after treatment up to 24 weeks of treatment

  3. Adverse events

    Time frame: Throughout the whole study after the Screening period.

Sponsors and collaborators

Lead sponsor

Organon and Co

Industry

Registry information

Official study title

A Multi-center, Randomized, Double-blind, Placebo-controlled Study on Efficacy and Safety of Mometasone Furoate Nasal Spray (MFNS) in the Post Surgical Treatment of Nasal Polyposis

Important dates

Study start
2003
Primary completion
2005
Study completion
2005
First posted
Aug 8, 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.

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