Compare the Effects of Fluticasone Furoate Nasal Spray vs Placebo in Patients With Nasal Polypoid Disease

NCT01013701 | Terminated Phase 4 Results DMC

• 1 other identifier: NA_00029405
• Study Type: interventional
• Target: 7
• Locations: 0 countries
• Sites: N/A

Brief Summary

Fluticasone furoate is being studied to determine whether treatment with a topical nasal steroid, in patients with existing nasal polyps , can not only improve symptoms but also suppress the recurrence of clinically significant nasal polyp obstruction and prevent surgical intervention.

Conditions

Patients With Nasal Polyps

Keywords

nasal polyps; nasal steroid; fluticasone furoate

Outcome Measures

Primary Outcomes (1)

• To Evaluate the Effect of Once Daily Nasal Steroid Therapy With Fluticasone Furoate Nasal Spray (110 mcg/Day) in Suppressing Nasal Polyp-induced Symptoms Over the Course of 16 Weeks in Patients Presenting to the Clinic With Active Nasal Polypoid Disease.

  18 weeks

Secondary Outcomes (1)

• To Evaluate the Efficacy and Safety of Once Daily Nasal Steroid Therapy With Fluticasone Furoate Nasal Spray in Suppressing the Signs of Recurrence of Nasal Polyps Over the Course of 16 Weeks.

  18 weeks

Study Arms (2)

Fluticasone Furoate

ACTIVE COMPARATOR

nasal steroid

Drug: fluticasone furoate

Placebo

PLACEBO COMPARATOR

nasal spray vehicle without drug

Other: placebo

Interventions

fluticasone furoate DRUG

nasal steroid spray

Fluticasone Furoate

placebo OTHER

nasal steroid vehicle without drug

Placebo

Eligibility Criteria

• Age: 18 Years - 70 Years
• Sex: all
• Healthy Volunteers: Yes
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• Male and female patients 18-70 years of age, in general good health.
• Current evidence of nasal polyps on physical exam. 3) Able to understand the protocol and comply with instructions. 4) Have a negative urine pregnancy test in women of childbearing potential. 5) Women of childbearing potential must be on an acceptable method of birth control or willing to remain abstinent through the duration of the study.

You may not qualify if:

• Are pregnant and/or breast-feeding.
• History of alcohol or drug abuse in the past year.
• Signs and symptoms suggestive of fulminant bacterial sinusitis (fever \>101 F, persistent severe unilateral facial or tooth pain, facial swelling).
• Allergies to nasal corticosteroids
• Other chronic significant medical illnesses 6) Maintenance oral prednisone therapy for other chronic medical conditions.

Sponsors & Collaborators

• Johns Hopkins University: lead
• GlaxoSmithKline: collaborator

MeSH Terms

Conditions

Nasal Polyps

Interventions

fluticasone furoate

Condition Hierarchy (Ancestors)

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

Results Point of Contact

• Title: Johns Hopkins University Clinical Trials Program
• Organization: Johns Hopkins University School of Medicine

registerclinicaltrials@jhmi.edu

410-550-6484

Publication Agreements

• PI is Sponsor Employee: Yes

Study Design

• Study Type: interventional
• Phase: phase 4
• Allocation: RANDOMIZED
• Masking: TRIPLE
• Who Masked: PARTICIPANT, CARE PROVIDER, INVESTIGATOR
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: November 13, 2009
• First Posted: November 16, 2009
• Study Start: November 1, 2009
• Primary Completion: July 29, 2010
• Study Completion: July 29, 2010
• Last Updated: September 13, 2017
• Results First Posted: September 13, 2017

Record last verified: 2017-08