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

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details. Identifier: NCT00731185
Recruitment Status : Completed
First Posted : August 8, 2008
Last Update Posted : March 23, 2017
Information provided by (Responsible Party):
Merck Sharp & Dohme Corp.

Brief Summary:
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.

Condition or disease Intervention/treatment Phase
Nasal Polyps Drug: Mometasone Furoate Nasal Spray Drug: Placebo Phase 3

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Study Type : Interventional  (Clinical Trial)
Actual Enrollment : 162 participants
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)
Primary Purpose: Treatment
Official 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
Actual Study Start Date : September 1, 2003
Actual Primary Completion Date : September 1, 2005
Actual Study Completion Date : September 1, 2005

Resource links provided by the National Library of Medicine

Arm Intervention/treatment
Experimental: Mometasone Furoate Nasal Spray (MFNS)
MFNS 200 mcg (2 sprays of 50 mcg in each nostril) once daily in the morning
Drug: Mometasone Furoate Nasal Spray
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 Comparator: Placebo
Placebo nasal spray (2 sprays of 50 mcg in each nostril) once daily in the morning
Drug: Placebo
Other Name: Placebo (2 sprays of 50 mcg in each nostril) once daily in the morning for up to 24 weeks or until relapse

Primary Outcome Measures :
  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 Outcome Measures :
  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. ]

Information from the National Library of Medicine

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Ages Eligible for Study:   18 Years and older   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No

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
Study Data/Documents: CSR Synopsis  This link exits the site

Publications automatically indexed to this study by Identifier (NCT Number):
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Responsible Party: Merck Sharp & Dohme Corp. Identifier: NCT00731185    
Other Study ID Numbers: P03218
First Posted: August 8, 2008    Key Record Dates
Last Update Posted: March 23, 2017
Last Verified: March 2017
Keywords provided by Merck Sharp & Dohme Corp.:
Additional relevant MeSH terms:
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Nasal Polyps
Nose Diseases
Respiratory Tract Diseases
Otorhinolaryngologic Diseases
Pathological Conditions, Anatomical
Mometasone Furoate
Anti-Inflammatory Agents
Dermatologic Agents
Anti-Allergic Agents