Study Of RV-39 In Patients Who Also Have Asthma

This study has been terminated.
(lack of data)
Sponsor:
Information provided by (Responsible Party):
GlaxoSmithKline
ClinicalTrials.gov Identifier:
NCT00503009
First received: July 17, 2007
Last updated: May 31, 2012
Last verified: February 2011
Results First Received: July 6, 2009  
Study Type: Interventional
Study Design: Allocation: Randomized;   Endpoint Classification: Safety/Efficacy Study;   Intervention Model: Parallel Assignment;   Masking: Double Blind (Subject, Investigator);   Primary Purpose: Treatment
Condition: Asthma
Interventions: Drug: fluticasone propionate/salmeterol
Drug: fluticasone propionate
Drug: 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
Eligible subjects were randomized to one of two sputum induction groups (sputum induction, no sputum induction) and then stratified at a second randomization to one of three treatment groups (Fluticasone Propionate/Salmeterol [FSC 250/50] mcg twice a day [BID], Fluticasone Propionate [FP] 250 mcg BID, or Placebo BID).

Reporting Groups
  Description
FSC 250/50 Mcg BID Fluticasone Propionate/Salmeterol (FSC) (250/50 microgram) twice daily
FP 250 Mcg BID Fluticasone Propionate (FP) (250 microgram) twice daily
Placebo Diskus BID Placebo twice daily

Participant Flow:   Overall Study
    FSC 250/50 Mcg BID     FP 250 Mcg BID     Placebo Diskus BID  
STARTED     5     5     6  
COMPLETED     4     3     3  
NOT COMPLETED     1     2     3  
Protocol Violation                 1                 0                 1  
Withdrawal by Subject                 0                 1                 1  
Physician Decision                 0                 1                 1  



  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.
No text entered.

Reporting Groups
  Description
FSC 250/50 Mcg BID Fluticasone Propionate/Salmeterol (FSC) (250/50 microgram) twice daily
FP 250 Mcg BID Fluticasone Propionate (FP) (250 microgram) twice daily
Placebo Diskus BID Placebo twice daily
Total Total of all reporting groups

Baseline Measures
    FSC 250/50 Mcg BID     FP 250 Mcg BID     Placebo Diskus BID     Total  
Number of Participants  
[units: participants]
  5     5     6     16  
Age  
[units: years]
Mean ± Standard Deviation
  20.4  ± 2.07     20.0  ± 1.00     23.0  ± 5.83     21.25  ± 3.8  
Gender  
[units: participants]
       
Female     0     2     3     5  
Male     5     3     3     11  
Race/Ethnicity, Customized  
[units: participants]
       
White     5     2     4     11  
African American/African Heritage     0     2     0     2  
American Indian/Alaskan Native/Native Hawaiian/Pac     0     0     1     1  
Asian     0     1     1     2  



  Outcome Measures
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1.  Primary:   Change From Baseline in the Cumulative Lower Respiratory Symptom Score Averaged Over Days 1-4   [ Time Frame: Days 1 through 4 ]

2.  Secondary:   Change From Baseline in the Morning Peak Expiratory Flow (PEF) Averaged Over Days 1-4   [ Time Frame: Days 1 through 4 ]

3.  Secondary:   Change From Baseline in the Morning Forced Expiratory Volume in One Second (FEV1) Averaged Over Days 1-4   [ Time Frame: Days 1 through 4 ]

4.  Secondary:   Change From Baseline in Exhaled Nitric Oxide (eNO) Averaged Over Days 1-4   [ Time Frame: Days 1 through 4 ]


  Serious Adverse Events


  Other Adverse Events


  More Information
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Certain Agreements:  
Principal Investigators are NOT employed by the organization sponsoring the study.
There IS an agreement between Principal Investigators and the Sponsor (or its agents) that restricts the PI's rights to discuss or publish trial results after the trial is completed.
The agreement is:
unchecked The only disclosure restriction on the PI is that the sponsor can review results communications prior to public release and can embargo communications regarding trial results for a period that is less than or equal to 60 days. The sponsor cannot require changes to the communication and cannot extend the embargo.
unchecked The only disclosure restriction on the PI is that the sponsor can review results communications prior to public release and can embargo communications regarding trial results for a period that is more than 60 days but less than or equal to 180 days. The sponsor cannot require changes to the communication and cannot extend the embargo.


Limitations and Caveats
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
Due to the small sample size, efficacy measures were not analyzed.  


Results Point of Contact:  
Name/Title: GSK Response Center
Organization: GlaxoSmithKline
phone: 866-435-7343


No publications provided


Responsible Party: GlaxoSmithKline
ClinicalTrials.gov Identifier: NCT00503009     History of Changes
Other Study ID Numbers: HZA109895
Study First Received: July 17, 2007
Results First Received: July 6, 2009
Last Updated: May 31, 2012
Health Authority: United States: Food and Drug Administration