A Study of the Effectiveness and Safety of Mometasone Furoate Nasal Spray (MFNS, SCH 032088) for the Treatment of Nasal Polyps (P05604)

NCT ID: NCT01386125

Last Updated: 2024-05-21

Basic Information

• Recruitment Status: COMPLETED
• Clinical Phase: PHASE3
• Total Enrollment: 748 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2011-06-30
• Study Completion Date: 2013-02-28

Brief Summary

This study will evaluate the effectiveness and safety of MFNS in improving nasal congestion/obstruction and in reducing bilateral nasal polyps.

Conditions

Nasal Polyps

Study Design

• Allocation Method: RANDOMIZED
• Intervention Model: PARALLEL
• Primary Study Purpose: TREATMENT
• Blinding Strategy: DOUBLE

Study Groups

Mometasone Furoate Nasal Spray (MFNS)

Participants receive mometasone furoate nasal spray (MFNS) 200 mcg twice daily (BID) for 16 weeks

Group Type: EXPERIMENTAL

Mometasone Furoate Nasal Spray (MFNS)

Intervention Type: DRUG

MFNS, 200 mcg BID administered as two 50 mcg sprays in each nostril BID for up to 16 weeks

Placebo

Participants receive matching placebo nasal spray BID for 16 weeks

Group Type: PLACEBO_COMPARATOR

Placebo for MFNS

Intervention Type: DRUG

Two sprays in each nostril BID for up to 16 weeks

Interventions

Mometasone Furoate Nasal Spray (MFNS)

MFNS, 200 mcg BID administered as two 50 mcg sprays in each nostril BID for up to 16 weeks

Intervention Type: DRUG

Placebo for MFNS

Two sprays in each nostril BID for up to 16 weeks

Intervention Type: DRUG

Eligibility Criteria

Inclusion Criteria

• Must be Chinese
• Must have a diagnosis of bilateral nasal polyps
• Clinically significant nasal congestion/obstruction must be present
• Must be in good health, free of any clinically significant disease that would interfere with the study schedule or procedures, or compromise the participant's safety
• Must have negative urine pregnancy test
• Must be using or agree to use a medically accepted method of contraception prior to Screening and during the study

Exclusion Criteria

• Have a history of seasonal allergic rhinitis within the last two years
• Have had sinus or nasal surgery within the past six months
• Have presumed fibrotic nasal polyps
• Have had three or more nasal surgeries
• Have had any surgical procedure that prevents an accurate grading of the polyps
• Complete (or near complete) nasal obstruction
• Have acute sinusitis, concurrent nasal infection or have had a nasal infection within two weeks
• Have ongoing rhinitis medicamentosa
• Have Churg Strauss syndrome (vasculitis, asthma, fever, and eosinophilia)
• Have dyskinetic ciliary syndromes, eg, Young's syndrome (sinopulmonary infections and obstructive azoospermia) or Kartagener's syndrome (immobile cilia)
• Have been treated within the last 4 weeks with intranasal steroids
• Have used any investigational drug in the last 30 days
• Have a hypersensitivity to corticosteroids or are allergic to aspirin
• Have an ongoing upper respiratory tract infection or had an upper respiratory tract infection within two weeks
• Have a nasal septal deviation needing corrective surgery
• Have a nasal septal perforation
• Have asthma that required in-patient hospitalization for asthma control within six months, required ventilator support for respiratory failure secondary to their asthma within the last five years, required admission to the hospital for management of airway obstruction on two or more occasions within the past year, or required use of more than 14 days of systemic steroid use in previous six months

• Minimum Eligible Age: 18 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: No

Sponsors

Organon and Co

INDUSTRY

Sponsor Role: lead

Responsible Party

Responsibility Role: SPONSOR

References

Zhou B, He G, Liang J, Cheng L, Mehta A, Liu S, Yu W, Wang Z, Han D. Mometasone furoate nasal spray in the treatment of nasal polyposis in Chinese patients: a double-blind, randomized, placebo-controlled trial. Int Forum Allergy Rhinol. 2016 Jan;6(1):88-94. doi: 10.1002/alr.21650. Epub 2015 Nov 17.

Reference Type: RESULT

PMID: 26575524 (View on PubMed)

Other Identifiers

P05604

Identifier Type: -

Identifier Source: org_study_id