Trial Outcomes & Findings for Compare the Effects of Fluticasone Furoate Nasal Spray vs Placebo in Patients With Nasal Polypoid Disease (NCT NCT01013701)

Results Overview

Recruitment status

TERMINATED

Study phase

PHASE4

Target enrollment

7 participants

Primary outcome timeframe

18 weeks

Results posted on

2017-09-13

Participant Flow

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.

Participant milestones

Participant milestones
Measure	All Participants nasal steroid fluticasone furoate: nasal steroid spray OR nasal spray vehicle without drug placebo: nasal steroid vehicle without drug
Overall Study STARTED	7
Overall Study COMPLETED	0
Overall Study NOT COMPLETED	7

Reasons for withdrawal

Reasons for withdrawal
Measure	All Participants nasal steroid fluticasone furoate: nasal steroid spray OR nasal spray vehicle without drug placebo: nasal steroid vehicle without drug
Overall Study study prematurely terminated	7

Baseline Characteristics

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

Baseline characteristics by cohort

Baseline characteristics by cohort
Measure	All Participants n=7 Participants nasal steroid fluticasone furoate: nasal steroid spray OR nasal spray vehicle without drug placebo: nasal steroid vehicle without drug
Age, Customized >=18, <=70, years	7 Participants n=5 Participants
Sex: Female, Male Female	4 Participants n=5 Participants
Sex: Female, Male Male	3 Participants n=5 Participants
Region of Enrollment United States	7 participants n=5 Participants

PRIMARY outcome

Timeframe: 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.

Outcome measures

Outcome data not reported

SECONDARY outcome

Timeframe: 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.

Outcome measures

Outcome data not reported

Adverse Events

All Participants

Serious events: 0 serious events

Other events: 0 other events

Deaths: 0 deaths

Serious adverse events

Adverse event data not reported

Other adverse events

Adverse event data not reported

Additional Information

Johns Hopkins University Clinical Trials Program

Johns Hopkins University School of Medicine

Phone: 410-550-6484

Email: [email protected]

Results disclosure agreements

Principal investigator is a sponsor employee
Publication restrictions are in place