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

Johns Hopkins University logo

Johns Hopkins University

Status and phase

Terminated
Phase 4

Conditions

Patients With Nasal Polyps

Treatments

Drug: fluticasone furoate
Other: placebo

Study type

Interventional

Funder types

Other
Industry

Identifiers

NCT01013701
NA_00029405

Details and patient eligibility

About

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.

Enrollment

7 patients

Sex

All

Ages

18 to 70 years old

Volunteers

Accepts Healthy Volunteers

Inclusion criteria

  1. Male and female patients 18-70 years of age, in general good health.
  2. 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.

Exclusion criteria

  1. Are pregnant and/or breast-feeding.

  2. History of alcohol or drug abuse in the past year.

  3. Signs and symptoms suggestive of fulminant bacterial sinusitis (fever >101 F, persistent severe unilateral facial or tooth pain, facial swelling).

  4. Allergies to nasal corticosteroids

  5. .Other chronic significant medical illnesses 6) Maintenance oral prednisone therapy for other chronic medical conditions.

Trial design

Primary purpose

Treatment

Allocation

Randomized

Interventional model

Parallel Assignment

Masking

Triple Blind

7 participants in 2 patient groups, including a placebo group

Fluticasone Furoate
Active Comparator group
Description:
nasal steroid
Treatment:
Drug: fluticasone furoate
Placebo
Placebo Comparator group
Description:
nasal spray vehicle without drug
Treatment:
Other: placebo

Trial contacts and locations

0

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Data sourced from clinicaltrials.gov

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