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

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
Conditions:	Rhinitis, Allergic, Perennial Perennial Allergic Rhinitis
Interventions:	Drug: Fluticasone furoate nasal spray Drug: Placebo nasal spray

Participant Flow

Recruitment Details

Key information relevant to the recruitment process for the overall study, such as dates of the recruitment period and locations
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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: Double-blind Treatment Period	FFNS 110 Mcg: Double-blind Treatment Period
STARTED	237	237
COMPLETED	187	186
NOT COMPLETED	50	51
Withdrawal by Subject	20	20
Protocol Violation	12	15
Lost to Follow-up	5	7
Adverse Event	5	5
Physician Decision	2	4
Lack of Efficacy	3	0
Reached Protocol-defined Stop Criteria	3	0

Baseline Characteristics

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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.

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) ]

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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) ]

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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) ]

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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) ]

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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) ]

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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) ]

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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) ]

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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) ]

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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) ]

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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) ]

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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) ]

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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) ]

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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) ]

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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) ]

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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) ]

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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) ]

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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) ]

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Serious Adverse Events

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Other Adverse Events

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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:

	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.
	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.
	Other disclosure agreement that restricts the right of the PI to discuss or publish trial results after the trial is completed. Restriction Description: GSK agreements may vary with individual investigators, but will not prohibit any investigator from publishing. GSK supports the publication of results from all centers of a multi-center trial but requests that reports based on single-site data not precede the primary publication of the entire clinical trial.

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
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Results Point of Contact:

Name/Title: GSK Response Center
Organization: GlaxoSmithKline
phone: 866-435-7343

No publications provided

Responsible Party:	Cheri Hudson; Clinical Disclosure Advisor, GSK Clinical Disclosure
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:	January 5, 2012
Health Authority:	United States: Food and Drug Administration