Mometasone Furoate Nasal Spray for Treatment of Nasal Polyposis After Surgery (Study P03218)(COMPLETED) - Full Text View

Sponsor:	Schering-Plough
Information provided by:	Schering-Plough
ClinicalTrials.gov Identifier:	NCT00731185

Purpose

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	Intervention	Phase
Nasal Polyps	Drug: Mometasone Furoate Nasal Spray Drug: Placebo	Phase III

Study Type:	Interventional
Study Design:	Allocation: Randomized Control: Placebo Control Endpoint Classification: Efficacy Study Intervention Model: Parallel Assignment Masking: Double Blind (Subject, Caregiver, 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

Resource links provided by NLM:

MedlinePlus related topics: Surgery

Drug Information available for: Mometasone furoate

U.S. FDA Resources

Further study details as provided by Schering-Plough:

Primary Outcome Measures:

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) ] [ Designated as safety issue: No ]

Secondary Outcome Measures:

Signs and symptom scores [ Time Frame: All study visits (up to 24 weeks of treatment) ] [ Designated as safety issue: No ]
Quality of life, peak nasal inspiratory flow, olfaction threshold [ Time Frame: Measured starting 1 week after treatment up to 24 weeks of treatment ] [ Designated as safety issue: No ]
Adverse events [ Time Frame: Throughout the whole study after the Screening period. ] [ Designated as safety issue: Yes ]

Enrollment:	162
Study Start Date:	September 2003
Study Completion Date:	September 2005
Primary Completion Date:	September 2005 (Final data collection date for primary outcome measure)

Arms	Assigned Interventions
Mometasone Furoate Nasal Spray (MFNS): Experimental 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
Placebo: Placebo Comparator Placebo nasal spray (2 sprays of 50 mcg in each nostril) once daily in the morning	Drug: Placebo

Eligibility

Ages Eligible for Study:	18 Years and older
Genders Eligible for Study:	Both
Accepts Healthy Volunteers:	No

Criteria

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

Contacts and Locations

No Contacts or Locations Provided

More Information

No publications provided by Schering-Plough

Additional publications automatically indexed to this study by National Clinical Trials Identifier (NCT ID):

Stjärne P, Olsson P, Alenius M. Use of mometasone furoate to prevent polyp relapse after endoscopic sinus surgery. Arch Otolaryngol Head Neck Surg. 2009 Mar;135(3):296-302.

Responsible Party:	Schering-Plough ( Head, Clinical Trials Registry & Results Disclosure Group )
Study ID Numbers:	P03218
Study First Received:	August 5, 2008
Last Updated:	August 7, 2008
ClinicalTrials.gov Identifier:	NCT00731185 History of Changes
Health Authority:	Sweden: Medical Products Agency

Keywords provided by Schering-Plough:

functional
endoscopic
sinus
surgery

Additional relevant MeSH terms:

Anti-Inflammatory Agents
Pathological Conditions, Anatomical
Nasal Polyps
Otorhinolaryngologic Diseases
Therapeutic Uses

Mometasone furoate
Polyps
Anti-Allergic Agents
Pharmacologic Actions
Nose Diseases

ClinicalTrials.gov processed this record on March 18, 2010