Trial · NCT00570492
Phase 4 Fluticasone Furoate Nasal Spray (VERAMYST) Long Term Pediatric Growth Study.
NCT00570492, Phase 4, Completed, GlaxoSmithKline; results first posted 2012-02-07
3 sourcestrials-2026-11-12-0.5.0
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ConductScience Library. Phase 4 Fluticasone Furoate Nasal Spray (VERAMYST) Long Term Pediatric Growth Study. Trials, record NCT00570492. Release trials-2026-11-12-0.5.0, 12 Nov 2026. https://conductscience.org/library/trials/NCT00570492
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Trial
As registered on ClinicalTrials.gov, in the graph's capture of the registry.
- Title
- Phase 4 Fluticasone Furoate Nasal Spray (VERAMYST) Long Term Pediatric Growth Study.
- NCT number
- NCT00570492
- Status
- Completed
- Phases
- Phase 4
- Enrollment
- 474 participants, actual
- Lead sponsor
- GlaxoSmithKline
- Conditions
- Rhinitis, Allergic, Perennial
- Interventions
- Fluticasone furoate nasal spray, Placebo nasal spray
- First posted
- 2007-12-11
- Last updated
- 2017-09-15
- Results first posted
- 2012-02-07
Source ClinicalTrials.gov
Registered outcomes17
Each outcome the trial registered, primary first, in ClinicalTrials.gov's words.
| List | Outcome | Time frame | Description |
|---|---|---|---|
| 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 | Baseline Period (Weeks -16 to 0) and DB Treatment Period (Weeks 1 to 52) | Height was measured (triplicate measurements) in pre-pubescent pediatric participants via stadiometry at each clinic visit during the entire 76-week study period (16-week Baseline Period, 52-week DB Treatment Period and 8-week Follow-up Period). Growth velocity was calculated by fitting a regression line to all height measurements recorded for the participant during the period and was determined by the slope of the fitted regression line. Change from Baseline was calculated as the value over the 52-week Treatment Period minus the value over the 16-week Baseline Period. |
| Secondary | Mean 24-hour Urinary Free Cortisol Excretion | 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) | Hypothalamic-pitiutary-adrenal (HPA) axis function was assessed by the measurement of urinary free cortisol, using urine samples collected over the course of 24 hours by the parent/guardian in the participants' home on an out-patient basis within 7 days prior to the indicated time points. Detailed verbal instructions and a take-home instruction card on how to conduct the 24-hour urine collection were provided to the parent/guardian before each collection interval. |
| Secondary | Number of Participants With the Indicated Shifts From Baseline in Nasal Examination (NE) Results | Baseline Period (Weeks -16 to 0) and DB Treatment Period (Weeks 1 to 52) | NE included the evaluation of the size of ulcers/polyps (of nasal turbinates/septa) and assessment for mucosal bleeding (MB) at all study visits. Polyps are non-cancerous growths; ulcers are breaks in the skin/mucous membrane with loss of surface tissue, disintegration, and necrosis of epithelial tissue. For MB, Improved=shift from present (\>=1 nostril) to absent (both nostrils); Worsened=shift from absent (both nostrils) to present (\>=1 nostril). For polyps/ulcers, Improved=shift from large to small or from small to none; Worsened=shift from none to small or from small to none (\>=1 nostril). |
| Secondary | Mean Values for the Laboratory Parameters of Alkaline (Alk) Phosphatase (P), Alanine Aminotransferase (ALT), and Aspartate Aminotransferase (AST) | Baseline Period (Weeks -16 to 0), DB Treatment Period (Weeks 1 to 52), and Follow-up Period (Weeks 53 to 60) | Participants in the study were evaluated for the following clinical laboratory parameters at the indicated time points: Alk P, ALT, and AST. |
| Secondary | Mean Values for the Laboratory Parameters if Albumin and Total Protein | Baseline Period (Weeks -16 to 0), DB Treatment Period (Weeks 1 to 52), and Follow-up Period (Weeks 53 to 60) | Participants in the study were evaluated for the following clinical laboratory parameters at the indicated time points: Albumin and Total Protein. |
| Secondary | Mean Values for the Laboratory Parameters of Total Bilirubin and Creatinine | Baseline Period (Weeks -16 to 0), DB Treatment Period (Weeks 1 to 52), and Follow-up Period (Weeks 53 to 60) | Participants in the study were evaluated for the following clinical laboratory parameters at the indicated time points: Total Bilirubin and Creatinine. |
| Secondary | Mean Values for the Laboratory Parameters of Glucose, Calcium, Potassium, Sodium, and Urea/Blood Urea Nitrogen (BUN) | Baseline Period (Weeks -16 to 0), DB Treatment Period (Weeks 1 to 52), and Follow-up Period (Weeks 53 to 60) | Participants in the study were evaluated for the following clinical laboratory parameters at the indicated time points: Glucose, Calcium, Potassium, Sodium, and Urea/BUN. |
| Secondary | Mean Hematology Values for Basophil, Eosinophil, Lymphocyte, White Blood Cell (WBC), Monocyte, Segmented Neutrophil (Neu), and Platelet Counts | Baseline Period (Weeks -16 to 0), DB Treatment Period (Weeks 1 to 52), and Follow-up Period (Weeks 53 to 60) | Participants in the study were evaluated for the following hematology laboratory parameters at the indicated time points: Basophil, Eosinophil, Lymphocyte, White Blood Cell (WBC), Monocyte, Segmented Neutrophil (Neu), and Platelet counts. |
| Secondary | Mean Values for Hemoglobin | Baseline Period (Weeks -16 to 0), DB Treatment Period (Weeks 1 to 52), and Follow-up Period (Weeks 53 to 60) | Hemoglobin was assessed in participants at the indicated time points. |
| Secondary | Mean Values for Hematocrit | Baseline Period (Weeks -16 to 0), DB Treatment Period (Weeks 1 to 52), and Follow-up Period (Weeks 53 to 60) | Hematocrit was assessed in participants at indicated the time points. Hematocrit is the percentage of blood volume (BV) that is occupied by red blood cells (RBCs). |
1 to 10 of 17Source ClinicalTrials.gov
See all 17 registered outcomesOutcomes17
Each outcome the trial posted results for, in ClinicalTrials.gov's words.
| Type | Outcome | Time frame | Population | Units | Measured as |
|---|---|---|---|---|---|
| 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 | Baseline Period (Weeks -16 to 0) and DB Treatment Period (Weeks 1 to 52) | Growth Population: all randomized participants with height assessments via stadiometry from at least three post-randomization clinic visits during the DB Treatment Period | Centimeters per year (cm/year) | LEAST_SQUARES_MEAN |
| SECONDARY | Mean 24-hour Urinary Free Cortisol Excretion | 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) | Urine Cortisol Population: all randomized participants excluding those whose urine samples were considered to have confounding factors affecting the interpretation of the 24-hour urinary cortisol results. One participant in each arm had a Baseline value \<1.0 and was not analyzed. Some participants had samples that were not acceptable for analysis. | Micrograms per 24 hours (mcg/24 hours) | MEAN |
| SECONDARY | Number of Participants With the Indicated Shifts From Baseline in Nasal Examination (NE) Results | Baseline Period (Weeks -16 to 0) and DB Treatment Period (Weeks 1 to 52) | Intent-to-Treat (ITT) Population: all participants who had been randomized to and received at least one dose of double-blind study medication. Most participants received examinations at each visit; however, on some occasions, some assessments were not completed for various reasons. | participants | NUMBER |
| SECONDARY | Mean Values for the Laboratory Parameters of Alkaline (Alk) Phosphatase (P), Alanine Aminotransferase (ALT), and Aspartate Aminotransferase (AST) | Baseline Period (Weeks -16 to 0), DB Treatment Period (Weeks 1 to 52), and Follow-up Period (Weeks 53 to 60) | ITT Population. Only those participants remaining in the study and contributing viable samples at the various time points were analyzed. | International Units per liter (IU/L) | MEAN |
| SECONDARY | Mean Values for the Laboratory Parameters if Albumin and Total Protein | Baseline Period (Weeks -16 to 0), DB Treatment Period (Weeks 1 to 52), and Follow-up Period (Weeks 53 to 60) | ITT Population. Only those participants remaining in the study and contributing viable samples at the various time points were analyzed. | Grams per liter (g/L) | MEAN |
| SECONDARY | Mean Values for the Laboratory Parameters of Total Bilirubin and Creatinine | Baseline Period (Weeks -16 to 0), DB Treatment Period (Weeks 1 to 52), and Follow-up Period (Weeks 53 to 60) | ITT Population. Only those participants remaining in the study and contributing viable samples at the various time points were analyzed. | Micromoles (µmol)/L | MEAN |
| SECONDARY | Mean Values for the Laboratory Parameters of Glucose, Calcium, Potassium, Sodium, and Urea/Blood Urea Nitrogen (BUN) | Baseline Period (Weeks -16 to 0), DB Treatment Period (Weeks 1 to 52), and Follow-up Period (Weeks 53 to 60) | ITT Population. Only those participants remaining in the study and contributing viable samples at the various time points were analyzed. | Millimoles (mmol)/L | MEAN |
| SECONDARY | Mean Hematology Values for Basophil, Eosinophil, Lymphocyte, White Blood Cell (WBC), Monocyte, Segmented Neutrophil (Neu), and Platelet Counts | Baseline Period (Weeks -16 to 0), DB Treatment Period (Weeks 1 to 52), and Follow-up Period (Weeks 53 to 60) | ITT Population. Only those participants remaining in the study and contributing viable samples at the various time points were analyzed. | Giga (10^9) cells (Gi)/L | MEAN |
| SECONDARY | Mean Values for Hemoglobin | Baseline Period (Weeks -16 to 0), DB Treatment Period (Weeks 1 to 52), and Follow-up Period (Weeks 53 to 60) | ITT Population. Only those participants remaining in the study and contributing viable samples at the various time points were analyzed. | g/L | MEAN |
| SECONDARY | Mean Values for Hematocrit | Baseline Period (Weeks -16 to 0), DB Treatment Period (Weeks 1 to 52), and Follow-up Period (Weeks 53 to 60) | ITT Population. Only those participants remaining in the study and contributing viable samples at the various time points were analyzed. | Percentage of BV occupied by RBCs | MEAN |
1 to 10 of 17Source ClinicalTrials.gov
See all 17 outcomesResults by group346
Each measurement the trial posted, group by group, in the words and numbers it posted.
| Outcome | Group | Category | Value | Spread | Units |
|---|---|---|---|---|---|
| Change From Baseline in the Growth Velocity of Pre-pubescent Pediatric Participants to the End of the 52-week Double-blind (DB) Treatment Period | Placebo | 5.46 | Standard Error 0.10 | Centimeters per year (cm/year) | |
| Change From Baseline in the Growth Velocity of Pre-pubescent Pediatric Participants to the End of the 52-week Double-blind (DB) Treatment Period | FFNS 110 mcg | 5.19 | Standard Error 0.10 | Centimeters per year (cm/year) | |
| Mean 24-hour Urinary Free Cortisol Excretion | Placebo | End of 16-week Baseline Period, n=168, 172 | 9.771 | Standard Deviation 6.0479 | Micrograms per 24 hours (mcg/24 hours) |
| Mean 24-hour Urinary Free Cortisol Excretion | FFNS 110 mcg | End of 16-week Baseline Period, n=168, 172 | 9.242 | Standard Deviation 5.5821 | Micrograms per 24 hours (mcg/24 hours) |
| Mean 24-hour Urinary Free Cortisol Excretion | Placebo | End of 52-week DB Treatment Period, n=163, 169 | 11.340 | Standard Deviation 9.6775 | Micrograms per 24 hours (mcg/24 hours) |
| Mean 24-hour Urinary Free Cortisol Excretion | FFNS 110 mcg | End of 52-week DB Treatment Period, n=163, 169 | 11.125 | Standard Deviation 9.2195 | Micrograms per 24 hours (mcg/24 hours) |
| Mean 24-hour Urinary Free Cortisol Excretion | Placebo | End of 8-week Follow-up Period, n=161, 167 | 10.615 | Standard Deviation 6.6903 | Micrograms per 24 hours (mcg/24 hours) |
| Mean 24-hour Urinary Free Cortisol Excretion | FFNS 110 mcg | End of 8-week Follow-up Period, n=161, 167 | 10.311 | Standard Deviation 5.9986 | Micrograms per 24 hours (mcg/24 hours) |
| Number of Participants With the Indicated Shifts From Baseline in Nasal Examination (NE) Results | Placebo | Mucosal Bleeding, Improved | 1 | participants | |
| Number of Participants With the Indicated Shifts From Baseline in Nasal Examination (NE) Results | FFNS 110 mcg | Mucosal Bleeding, Improved | 0 | participants |
1 to 10 of 346Source ClinicalTrials.gov
See all 346 results by groupParticipant flow18
How many started, completed or left each group, period by period.
| Period | Milestone | Group | Participants | Units counted |
|---|---|---|---|---|
| 16-week Single-blind Baseline Period | STARTED | Placebo: Baseline Period | 910 | |
| 16-week Single-blind Baseline Period | STARTED | Placebo: Double-blind Treatment Period | 0 | |
| 16-week Single-blind Baseline Period | STARTED | FFNS 110 mcg: Double-blind Treatment Period | 0 | |
| 16-week Single-blind Baseline Period | COMPLETED | Placebo: Baseline Period | 474 | |
| 16-week Single-blind Baseline Period | COMPLETED | Placebo: Double-blind Treatment Period | 0 | |
| 16-week Single-blind Baseline Period | COMPLETED | FFNS 110 mcg: Double-blind Treatment Period | 0 | |
| 16-week Single-blind Baseline Period | NOT COMPLETED | Placebo: Baseline Period | 436 | |
| 16-week Single-blind Baseline Period | NOT COMPLETED | Placebo: Double-blind Treatment Period | 0 | |
| 16-week Single-blind Baseline Period | NOT COMPLETED | FFNS 110 mcg: Double-blind Treatment Period | 0 | |
| 52-week Double-blind Treatment Period | STARTED | Placebo: Baseline Period | 0 |
1 to 10 of 18Source ClinicalTrials.gov
See all 18 participant flowAdverse events48
Each adverse event the trial posted, group by group: the participants affected out of those at risk.
| Type | Event | Organ system | Group | Affected | At risk | Events |
|---|---|---|---|---|---|---|
| other | Nasopharyngitis | Infections and infestations | Placebo | 41 | 237 | |
| other | Nasopharyngitis | Infections and infestations | FFNS 110 mcg | 37 | 237 | |
| other | Bronchitis | Infections and infestations | Placebo | 24 | 237 | |
| other | Bronchitis | Infections and infestations | FFNS 110 mcg | 34 | 237 | |
| other | Pharyngitis | Infections and infestations | Placebo | 18 | 237 | |
| other | Pharyngitis | Infections and infestations | FFNS 110 mcg | 12 | 237 | |
| other | Respiratory Tract Infection Viral | Infections and infestations | Placebo | 17 | 237 | |
| other | Respiratory Tract Infection Viral | Infections and infestations | FFNS 110 mcg | 12 | 237 | |
| other | Sinusitis | Infections and infestations | Placebo | 14 | 237 | |
| other | Sinusitis | Infections and infestations | FFNS 110 mcg | 11 | 237 |
1 to 10 of 48Source ClinicalTrials.gov
See all 48 adverse eventsAdverse event totals6
The totals the trial posted for each group.
| Total | Group | Affected | At risk |
|---|---|---|---|
| Total, all-cause mortality | Placebo | ||
| Total, all-cause mortality | FFNS 110 mcg | ||
| Total, other adverse events | Placebo | 135 | 237 |
| Total, other adverse events | FFNS 110 mcg | 129 | 237 |
| Total, serious adverse events | Placebo | 4 | 237 |
| Total, serious adverse events | FFNS 110 mcg | 2 | 237 |
Source ClinicalTrials.gov
Papers1
The papers the trial lists on ClinicalTrials.gov.
| PMID | Listed as |
|---|---|
| 25017530 | DERIVED |
Source PubMed
Grants0
The grants NIH RePORTER links to the trial, newest funded first: NIH's, and some of AHRQ's, CDC's, FDA's and VA's. Each shows its title, principal investigators, organization and funder in its newest year.
None in this release.
Trial comparisons1
Comparisons of the trial's two groups, calculated by ConductScience from the counts it posted.
| Comparison |
|---|
| FFNS 110 mcg vs Placebo: serious adverse events |
Source Trial comparisons
Tests0
The ConductCognition tests this trial's registered outcomes name, as ScienceGraph matched them in trial-tests-2026-11-12-0.2.1.
None in this release.
Data dates
The day each source was copied for this release.
Sources 3
- ClinicalTrials.gov's posted results, through CTTI's AACTFreely available. Acknowledgement requested
- ClinicalTrials.govNo license stated
- NIH RePORTER's clinical studies and project filesPublic domain
Each source's terms
- ClinicalTrials.gov's posted results, through CTTI's AACTClinicalTrials.gov data via Aggregate Analysis of ClinicalTrials.gov (AACT), CTTI. CTTI makes its materials freely available and requests acknowledgement. https://aact.ctti-clinicaltrials.org/documentation/299
- ClinicalTrials.govnone stated
- NIH RePORTER's clinical studies and project filesPublic domain (NIH RePORTER)
ClinicalTrials.gov's data carry an international copyright outside the United States: https://clinicaltrials.gov/about-site/terms-conditions.
For software
Read this trial from software.
The record and each of its lists are JSON, twenty rows a page. No key.
GET https://conductscience.org/api/trials/v1/NCT00570492
GET https://conductscience.org/api/trials/v1/NCT00570492/results?page=2