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

This study has been terminated.
(Terminated based on mutual agreement between PI and sponsor (Glaxo Smith Kline))
Sponsor:
ClinicalTrials.gov Identifier:
NCT01013701
First Posted: November 16, 2009
Last Update Posted: September 13, 2017
The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details.
Collaborator:
GlaxoSmithKline
Information provided by (Responsible Party):
Johns Hopkins University
Results First Submitted: July 17, 2017  
Study Type: Interventional
Study Design: Allocation: Randomized;   Intervention Model: Parallel Assignment;   Masking: Triple (Participant, Care Provider, Investigator);   Primary Purpose: Treatment
Condition: Patients With Nasal Polyps
Interventions: Drug: fluticasone furoate
Other: placebo

  Participant Flow
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Recruitment Details
Key information relevant to the recruitment process for the overall study, such as dates of the recruitment period and locations
No text entered.

Pre-Assignment Details
Significant events and approaches for the overall study following participant enrollment, but prior to group assignment
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.

Reporting Groups
  Description
All Participants

nasal steroid fluticasone furoate: nasal steroid spray

OR

nasal spray vehicle without drug placebo: nasal steroid vehicle without drug


Participant Flow:   Overall Study
    All Participants
STARTED   7 
COMPLETED   0 
NOT COMPLETED   7 
study prematurely terminated                7 



  Baseline Characteristics
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Population Description
Explanation of how the number of participants for analysis was determined. Includes whether analysis was per protocol, intention to treat, or another method. Also provides relevant details such as imputation technique, as appropriate.
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.

Reporting Groups
  Description
All Participants

nasal steroid fluticasone furoate: nasal steroid spray

OR

nasal spray vehicle without drug placebo: nasal steroid vehicle without drug


Baseline Measures
   All Participants 
Overall Participants Analyzed 
[Units: Participants]
 7 
Age, Customized 
[Units: Participants]
Count of Participants
 
>=18, <=70, years   7 
Sex: Female, Male 
[Units: Participants]
Count of Participants
 
Female      4  57.1% 
Male      3  42.9% 
Region of Enrollment 
[Units: Participants]
 
United States   7 


  Outcome Measures
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1.  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 ]

2.  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 ]


  Serious Adverse Events


  Other Adverse Events


  Limitations and Caveats
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Limitations of the study, such as early termination leading to small numbers of participants analyzed and technical problems with measurement leading to unreliable or uninterpretable data
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  More Information
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Certain Agreements:  
All Principal Investigators ARE employed by the organization sponsoring the study.


Results Point of Contact:  
Name/Title: Johns Hopkins University Clinical Trials Program
Organization: Johns Hopkins University School of Medicine
phone: 410-550-6484
e-mail: registerclinicaltrials@jhmi.edu



Responsible Party: Johns Hopkins University
ClinicalTrials.gov Identifier: NCT01013701     History of Changes
Other Study ID Numbers: NA_00029405
First Submitted: November 13, 2009
First Posted: November 16, 2009
Results First Submitted: July 17, 2017
Results First Posted: September 13, 2017
Last Update Posted: September 13, 2017