Patients With Nasal Polyps
Conditions
Keywords
nasal polyps, nasal steroid, fluticasone furoate
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.
Interventions
DRUGfluticasone furoate
nasal steroid spray
OTHERplacebo
nasal steroid vehicle without drug
Sponsors
GlaxoSmithKline
Johns Hopkins University
Study design
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
TREATMENT
Masking
TRIPLE (Subject, Caregiver, Investigator)
Eligibility
Sex/Gender
ALL
Age
18 Years to 70 Years
Healthy volunteers
Yes
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. \- \-
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| 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
| Measure | Time frame |
|---|---|
| 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 |
Participant flow
Pre-assignment details
The PI has left the institution and neither he, nor the data if any, is available. All information provided has been obtained from the Johns Hopkins University School of Medicine Institutional Review Board and was only available as one arm.
Participants by arm
| Arm | Count |
|---|---|
| All Participants nasal steroid fluticasone furoate: nasal steroid spray
OR
nasal spray vehicle without drug placebo: nasal steroid vehicle without drug | 7 |
| Total | 7 |
Withdrawals & dropouts
| Period | Reason | FG000 |
|---|---|---|
| Overall Study | study prematurely terminated | 7 |
Baseline characteristics
| Characteristic | All Participants |
|---|---|
| Age, Customized >=18, <=70, years | 7 Participants |
| Region of Enrollment United States | 7 participants |
| Sex: Female, Male Female | 4 Participants |
| Sex: Female, Male Male | 3 Participants |
Adverse events
| Event type | EG000 affected / at risk |
|---|---|
| deaths Total, all-cause mortality | 0 / 0 |
| other Total, other adverse events | 0 / 0 |
| serious Total, serious adverse events | 0 / 0 |
Outcome results
Primary
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.
Time frame: 18 weeks
Population: The PI has left the institution and neither he, nor the data if any, is available. All information provided has been obtained from the Johns Hopkins University School of Medicine Institutional Review Board.
Secondary
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.
Time frame: 18 weeks
Population: No data was collected/is available for the study as it was terminated prematurely and the PI has since left the institution.