Phase 4 Fluticasone Furoate Nasal Spray (VERAMYST) Long Term Pediatric Growth Study.

This study has been completed.
Sponsor:
Information provided by (Responsible Party):
GlaxoSmithKline
ClinicalTrials.gov Identifier:
NCT00570492
First received: December 6, 2007
Last updated: May 16, 2013
Last verified: June 2012
Results First Received: November 3, 2011  
Study Type: Interventional
Study Design: Allocation: Randomized;   Endpoint Classification: Safety Study;   Intervention Model: Parallel Assignment;   Masking: Double Blind (Subject, Caregiver, Investigator, Outcomes Assessor);   Primary Purpose: Treatment
Condition: Rhinitis, Allergic, Perennial
Interventions: Drug: Fluticasone furoate nasal spray
Drug: Placebo nasal spray

  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
After screening and a 16-week Baseline Period (Pd.), participants (par.) were randomized 1:1 to each treatment arm during the 52-week Treatment Pd. After the Treatment Pd., par. entered an 8-week Follow-up (FU) Pd. during which all par. received placebo nasal spray. Par. completing at least 12 weeks of treatment were to complete the FU Pd.

Reporting Groups
  Description
Placebo: Baseline Period Placebo nasal spray administered once daily (OD) as 2 sprays per nostril to all enrolled participants during the 16-week Single-blind Baseline period, to assess the baseline growth velocity
Placebo: Double-blind Treatment Period Participants were randomized to receive matching placebo nasal spray OD as 2 sprays per nostril during the 52-week Double-blind Treatment Period
FFNS 110 Mcg: Double-blind Treatment Period Participants were randomized to receive fluticasone furoate nasal spray (FFNS) 110 micrograms (mcg) OD as 2 sprays per nostril during the 52-week Double-blind Treatment Period

Participant Flow for 2 periods

Period 1:   16-week Single-blind Baseline Period
    Placebo: Baseline Period     Placebo: Double-blind Treatment Period     FFNS 110 Mcg: Double-blind Treatment Period  
STARTED     910     0     0  
COMPLETED     474     0     0  
NOT COMPLETED     436     0     0  
Didn't Meet Inclusion/Exclusion Criteria                 98                 0                 0  
Didn't Meet Randomization Criteria                 263                 0                 0  
Withdrawal by Subject                 56                 0                 0  
Protocol Violation                 15                 0                 0  
Lost to Follow-up                 2                 0                 0  
Adverse Event                 1                 0                 0  
Randomized but Did'nt Receive Treatment                 1                 0                 0  

Period 2:   52-week Double-blind Treatment Period
    Placebo: Baseline Period     Placebo: Double-blind Treatment Period     FFNS 110 Mcg: Double-blind Treatment Period  
STARTED     0     237     237  
COMPLETED     0     187     186  
NOT COMPLETED     0     50     51  
Withdrawal by Subject                 0                 20                 20  
Protocol Violation                 0                 12                 15  
Lost to Follow-up                 0                 5                 7  
Adverse Event                 0                 5                 5  
Physician Decision                 0                 2                 4  
Lack of Efficacy                 0                 3                 0  
Reached Protocol-defined Stop Criteria                 0                 3                 0  



  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
Placebo Participants received matching placebo nasal spray OD (as 2 sprays per nostril at each time point) in the 16-week Single-blind Baseline Period, in the following 52-week Double-blind Treatment Period (after randomization), and then in the 8-week Single-blind Follow-up Period.
FFNS 110 Mcg Participants received placebo nasal spray OD (as 2 sprays per nostril at each time point) in the 16-week Single-blind Baseline Period, and then received FFNS 110 mcg OD in the following 52-week Double-blind Treatment Period. Participants again received placebo nasal spray OD in the 8-week Single-blind Follow-up Period.
Total Total of all reporting groups

Baseline Measures
    Placebo     FFNS 110 Mcg     Total  
Number of Participants  
[units: participants]
  237     237     474  
Age [1]
[units: Years]
Mean ± Standard Deviation
  6.61  ± 0.969     6.64  ± 0.933     6.63  ± 0.950  
Gender [1]
[units: Participants]
     
Female     73     75     148  
Male     164     162     326  
Race/Ethnicity, Customized [1]
[units: participants]
     
African American (Amc)/African Heritage     16     12     28  
Amc Indian or Alaska Native (Alk N)     19     18     37  
Asian     7     5     12  
Native Hawaiian or Other Pacific Islander     1     0     1  
White     189     199     388  
African Amc/African and Amc Indian or Alk N     1     0     1  
African Amc/African Heritage and White     1     2     3  
Amc Indian or Alk N and White     1     0     1  
Asian and White     1     1     2  
Native Hawaiian/ Other Pacific Islander and White     1     0     1  
[1] Baseline characteristics were collected for the Intent-to-Treat (ITT) Population, which included all participants who had been randomized to and received at least one dose of Double-blind study medication.



  Outcome Measures
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1.  Primary:   Change From Baseline in the Growth Velocity of Pre-pubescent Pediatric Participants to the End of the 52-week Double-blind (DB) Treatment Period   [ Time Frame: Baseline Period (Weeks -16 to 0) and DB Treatment Period (Weeks 1 to 52) ]

2.  Secondary:   Mean 24-hour Urinary Free Cortisol Excretion   [ Time Frame: Randomization/end of 16-week Baseline Period (Week 0), End of 52-week DB Treatment Period (Week 52), and end of 8-week Follow-up Period (Week 60) ]

3.  Secondary:   Number of Participants With the Indicated Shifts From Baseline in Nasal Examination (NE) Results   [ Time Frame: Baseline Period (Weeks -16 to 0) and DB Treatment Period (Weeks 1 to 52) ]

4.  Secondary:   Mean Values for the Laboratory Parameters of Alkaline (Alk) Phosphatase (P), Alanine Aminotransferase (ALT), and Aspartate Aminotransferase (AST)   [ Time Frame: Baseline Period (Weeks -16 to 0), DB Treatment Period (Weeks 1 to 52), and Follow-up Period (Weeks 53 to 60) ]

5.  Secondary:   Mean Values for the Laboratory Parameters if Albumin and Total Protein   [ Time Frame: Baseline Period (Weeks -16 to 0), DB Treatment Period (Weeks 1 to 52), and Follow-up Period (Weeks 53 to 60) ]

6.  Secondary:   Mean Values for the Laboratory Parameters of Total Bilirubin and Creatinine   [ Time Frame: Baseline Period (Weeks -16 to 0), DB Treatment Period (Weeks 1 to 52), and Follow-up Period (Weeks 53 to 60) ]

7.  Secondary:   Mean Values for the Laboratory Parameters of Glucose, Calcium, Potassium, Sodium, and Urea/Blood Urea Nitrogen (BUN)   [ Time Frame: Baseline Period (Weeks -16 to 0), DB Treatment Period (Weeks 1 to 52), and Follow-up Period (Weeks 53 to 60) ]

8.  Secondary:   Mean Hematology Values for Basophil, Eosinophil, Lymphocyte, White Blood Cell (WBC), Monocyte, Segmented Neutrophil (Neu), and Platelet Counts   [ Time Frame: Baseline Period (Weeks -16 to 0), DB Treatment Period (Weeks 1 to 52), and Follow-up Period (Weeks 53 to 60) ]

9.  Secondary:   Mean Values for Hemoglobin   [ Time Frame: Baseline Period (Weeks -16 to 0), DB Treatment Period (Weeks 1 to 52), and Follow-up Period (Weeks 53 to 60) ]

10.  Secondary:   Mean Values for Hematocrit   [ Time Frame: Baseline Period (Weeks -16 to 0), DB Treatment Period (Weeks 1 to 52), and Follow-up Period (Weeks 53 to 60) ]

11.  Secondary:   Mean Hematology Values for Red Blood Cells (RBCs)   [ Time Frame: Baseline Period (Weeks -16 to 0), DB Treatment Period (Weeks 1 to 52), and Follow-up Period (Weeks 53 to 60) ]

12.  Secondary:   Mean Values for Urine pH   [ Time Frame: Baseline Period (Weeks -16 to 0), DB Treatment Period (Weeks 1 to 52), and Follow-up Period (Weeks 53 to 60) ]

13.  Secondary:   Mean Values for Urine Specific Gravity   [ Time Frame: Baseline Period (Weeks -16 to 0), DB Treatment Period (Weeks 1 to 52), and Follow-up Period (Weeks 53 to 60) ]

14.  Secondary:   Number of Participants With the Indicated Urinalysis Results for Urine Bilirubin and Urine Nitrite   [ Time Frame: Baseline Period (Weeks -16 to 0), DB Treatment Period (Weeks 1 to 52), and Follow-up Period (Weeks 53 to 60) ]

15.  Secondary:   Number of Participants With the Indicated Urinalysis Results for Urine Glucose, Urine Ketones, and Urine Proteins   [ Time Frame: Baseline Period (Weeks -16 to 0), DB Treatment Period (Weeks 1 to 52), and Follow-up Period (Weeks 53 to 60) ]

16.  Secondary:   Number of Participants With the Indicated Urinalysis Results for Urine Occult Blood (OB) and the Urine Leukocyte Esterase Test (LET)   [ Time Frame: Baseline Period (Weeks -16 to 0), DB Treatment Period (Weeks 1 to 52), and Follow-up Period (Weeks 53 to 60) ]

17.  Secondary:   Number of Participants With the Indicated Urinalysis Results for Urine Appearance (App.)/Clarity and Color   [ Time Frame: Baseline Period (Weeks -16 to 0), DB Treatment Period (Weeks 1 to 52), and Follow-up Period (Weeks 53 to 60) ]


  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:  
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.


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


No publications provided by GlaxoSmithKline

Publications automatically indexed to this study:

Responsible Party: GlaxoSmithKline
ClinicalTrials.gov Identifier: NCT00570492     History of Changes
Other Study ID Numbers: FFR101782
Study First Received: December 6, 2007
Results First Received: November 3, 2011
Last Updated: May 16, 2013
Health Authority: United States: Food and Drug Administration