Trial · NCT02889809
Effects of a Orally Inhaled Fluticasone Furoate on Growth Velocity in Prepubertal, Paediatric Subjects With Asthma Over a Year
NCT02889809, Phase 4, Completed, GlaxoSmithKline; results first posted 2022-01-04
3 sourcestrials-2026-11-12-0.5.0
Download JSON
Cite this record
ConductScience Library. Effects of a Orally Inhaled Fluticasone Furoate on Growth Velocity in Prepubertal, Paediatric Subjects With Asthma Over a Year. Trials, record NCT02889809. Release trials-2026-11-12-0.5.0, 12 Nov 2026. https://conductscience.org/library/trials/NCT02889809
On this page
Trial
As registered on ClinicalTrials.gov, in the graph's capture of the registry.
- Title
- Effects of a Orally Inhaled Fluticasone Furoate on Growth Velocity in Prepubertal, Paediatric Subjects With Asthma Over a Year
- NCT number
- NCT02889809
- Status
- Completed
- Phases
- Phase 4
- Enrollment
- 477 participants, actual
- Lead sponsor
- GlaxoSmithKline
- Conditions
- Asthma
- Interventions
- Fluticasone furoate, Placebo, Montelukast, Short Acting Beta 2 Agonist
- First posted
- 2016-09-07
- Last updated
- 2024-01-17
- Results first posted
- 2022-01-04
Source ClinicalTrials.gov
Registered outcomes7
Each outcome the trial registered, primary first, in ClinicalTrials.gov's words.
| List | Outcome | Time frame | Description |
|---|---|---|---|
| Primary | Growth Velocity (Centimeter Per Year) Over the Double-blind Treatment Period, as Determined by Stadiometry | Up to 52 weeks | Three reproducible height measurements were taken using a stadiometer at each visit and were recorded to nearest 1/10th of centimeter. Each set of triplicate measurements was averaged to derive one estimated height per participant per visit. Growth velocity was calculated for each participant over double-blind treatment period (up to 52 weeks \[wk\]) by fitting a regression line to averaged height measurements at each visit for that participant during period. Slope of this regression line was participant's growth velocity for double-blind treatment period. Treatment policy estimand was assessed, including all on- and post-treatment data. Baseline was included as covariate which was calculated based on stadiometric height measurements recorded at Visits 1(wk -16), 3(wk-8), and 5(wk0), data from at least two of these visits were used to fit a simple linear regression line against time and the slope of the fitted regression line was the participant's Baseline growth velocity. |
| Secondary | Percentage of Participants Below the Third Percentile of Growth Velocity During Double-blind Treatment Period | Up to 52 weeks | Three reproducible height measurements were taken using stadiometer at each visit\&were recorded to nearest 1/10th of a centimeter.Each set of triplicate measurements was averaged to derive one estimated height per participant per visit.Growth velocity(GV)was calculated for each participant over double-blind treatment(up to 52 weeks)period by fitting regression line to height measurements recorded for that participant during period.Each participant's double-blind(DB) treatment period GV was calculated based on all on \&off treatment height data \&was programmatically compared to data values from Standards from Birth to Maturity for Height,Weight,Height Velocity, established in British Children(1965)\&further updated for North American children(1985)using 3rd percentile value of age closest to participant's age at end of endpoint(i.e.either end of participant's DB treatment period \[Visit18 Wk 52\]/withdrawal from study\[Early Withdrawal Visit\]).Percentage values presented is rounded off. |
| Secondary | Percentage of Participants With Change in Growth Velocity Quartiles From Baseline to Endpoint | Baseline and Endpoint (Week 28[Visit 12] up to and including Week 52 [Visit 18]) | Growth velocity(GV) quartile(defined as 1st quartile(1Q)=1st-25th percentile,2Q=26th-50th percentile,3Q=51st-75th percentile,4Q=76th-100th percentile) was determined at Baseline\&endpoint.Endpoint was defined as slope of simple linear regression of average stadiometric height recorded at week 28\& upto wk52.Baseline growth velocity was calculated as slope from simple linear regression of average stadiometric height recorded at wk-16,-8\&0.Baseline GV was programmatically compared to reference for standard height data using participant's estimated age at wk0\& age in reference data closest to actual age of participant to determine Baseline GV quartile.Endpoint GV was programmatically compared to reference data using participant's age at endpoint \& age in reference data that was closest to actual age of participant to determine endpoint GV quartile. Any increase/decrease indicates any increase/decrease in quartiles with reference to Baseline. Percentage values presented is rounded off. |
| Secondary | Growth Velocity Over the First 12 Weeks of Double-blind Treatment Period | Up to 12 weeks (Visit 8) of double-blind treatment period | Growth velocity was calculated for each participant over double blind period by fitting regression line to height measurements recorded for that participant during period.Slope of this regression line was participant's growth velocity for double-blind treatment period.In order to be included in this analysis,participant must have data from Visit8(Wk 12) stadiometric height assessment.Baseline was included as covariate which was calculated based on stadiometric height measurements recorded at Visits 1(wk -16),3(wk-8),\& 5(wk0),data from at least two of these visits were used to fit simple linear regression line against time\&slope of fitted regression line was participant's Baseline growth velocity.All available height data collected during double-blind treatment period upto Visit8(Wk12) while participant was on randomized double-blind treatment was considered.ANCOVA model was used to estimate mean treatment difference in growth velocity over 1st 12weeks of double-blind treatment period. |
| Secondary | Change in Height Standard Deviation Scores (SDS) From Baseline to Endpoint | Baseline (Week 0 [Visit 5]) and up to Endpoint (Week 52 [Visit 18]) | Each participant's SDS for each of three required stadiometric height measurements was calculated as:(observed height measurement-standard median height for age at Visit \[week-16\]) divided by (/) (\[standard 95th height percentile for age at visit-standard 5th height percentile for age at visit\]/\[2\*1.645\]).Standard median, 95th percentile, \& 5th percentile values were obtained from standard tables (Guidance for Industry Orally Inhaled \& Intranasal Corticosteroid). SDS for each height stadiometric measurement at each visit was calculated using percentiles from standard tables \& averaged for each participant before being summarized by treatment group. A reduction in SDS over time indicates growth deceleration \& an increase in SDS over time means growth acceleration.Baseline was defined as height SD score at Visit 5 (week 0). Endpoint was defined as height SD score at Visit 18 (week52) (on- \& off-treatment data). Change from Baseline was calculated as Endpoint value minus Baseline value. |
| Secondary | Number of Participants With Non-serious Adverse Events (AEs) and Serious Adverse Events (SAEs) | Up to 76 weeks | An AE is any untoward medical occurrence in a participant or clinical investigation participant, temporally associated with the use of a medicinal product, whether or not considered related to the medicinal product. A SAE is defined as any untoward medical occurrence that, at any dose which results in death, is life-threatening, requires hospitalization or prolongation of existing hospitalization, results in disability/incapacity, is a congenital anomaly/birth defect, other situations as per investigator's judgement. |
| Secondary | Number of Participants With On-treatment Asthma Exacerbations Over Double-blind Treatment Period | Up to 52 weeks | An exacerbation is defined as deterioration of asthma requiring the use of systemic corticosteroids (tablets, suspension, or injection) for at least 3 days or a single depot corticosteroid injection, or an in-patient hospitalization or emergency department (ED) visit due to asthma that required systemic corticosteroids. Number of participants with on-treatment asthma exacerbations during double-blind treatment period is presented. |
Source ClinicalTrials.gov
Outcomes7
Each outcome the trial posted results for, in ClinicalTrials.gov's words.
| Type | Outcome | Time frame | Population | Units | Measured as |
|---|---|---|---|---|---|
| PRIMARY | Growth Velocity (Centimeter Per Year) Over the Double-blind Treatment Period, as Determined by Stadiometry | Up to 52 weeks | Growth Population comprised of all Intent to Treat (ITT) participants who have stadiometric height assessments from at least three post-randomization, on-treatment clinic visits (i.e., including all available height measurements after Visit 5 \[wk 0\] up to and including Visit 18 \[wk 52\], without exclusion) during the double-blind treatment period. | Centimeter per year | LEAST_SQUARES_MEAN |
| SECONDARY | Percentage of Participants Below the Third Percentile of Growth Velocity During Double-blind Treatment Period | Up to 52 weeks | Growth Population | Percentage of participants | NUMBER |
| SECONDARY | Percentage of Participants With Change in Growth Velocity Quartiles From Baseline to Endpoint | Baseline and Endpoint (Week 28[Visit 12] up to and including Week 52 [Visit 18]) | Growth Population. Only those participants with data available at the specified data points were analyzed. | Percentage of Participants | NUMBER |
| SECONDARY | Growth Velocity Over the First 12 Weeks of Double-blind Treatment Period | Up to 12 weeks (Visit 8) of double-blind treatment period | Growth Population. Only those participants with data available at the specified data points were analyzed. | Centimeter per year | LEAST_SQUARES_MEAN |
| SECONDARY | Change in Height Standard Deviation Scores (SDS) From Baseline to Endpoint | Baseline (Week 0 [Visit 5]) and up to Endpoint (Week 52 [Visit 18]) | Growth Population. Only those participants with data available at the specified data points were analyzed | Standard Deviation Score | MEAN |
| SECONDARY | Number of Participants With Non-serious Adverse Events (AEs) and Serious Adverse Events (SAEs) | Up to 76 weeks | Intent-to-Treat Population comprised of all randomized participants who received at least one dose of study treatment. | Participants | COUNT_OF_PARTICIPANTS |
| SECONDARY | Number of Participants With On-treatment Asthma Exacerbations Over Double-blind Treatment Period | Up to 52 weeks | Intent-to-Treat Population. | Participants | COUNT_OF_PARTICIPANTS |
Source ClinicalTrials.gov
Results by group18
Each measurement the trial posted, group by group, in the words and numbers it posted.
| Outcome | Group | Category | Value | Spread | Units |
|---|---|---|---|---|---|
| Growth Velocity (Centimeter Per Year) Over the Double-blind Treatment Period, as Determined by Stadiometry | Placebo | 6.065 | Standard Error 0.1090 | Centimeter per year | |
| Growth Velocity (Centimeter Per Year) Over the Double-blind Treatment Period, as Determined by Stadiometry | FF 50 mcg | 5.905 | Standard Error 0.1078 | Centimeter per year | |
| Percentage of Participants Below the Third Percentile of Growth Velocity During Double-blind Treatment Period | Placebo | 9 | Percentage of participants | ||
| Percentage of Participants Below the Third Percentile of Growth Velocity During Double-blind Treatment Period | FF 50 mcg | 7 | Percentage of participants | ||
| Percentage of Participants With Change in Growth Velocity Quartiles From Baseline to Endpoint | Placebo | Any increase | 33 | Percentage of Participants | |
| Percentage of Participants With Change in Growth Velocity Quartiles From Baseline to Endpoint | FF 50 mcg | Any increase | 32 | Percentage of Participants | |
| Percentage of Participants With Change in Growth Velocity Quartiles From Baseline to Endpoint | Placebo | Any decrease | 34 | Percentage of Participants | |
| Percentage of Participants With Change in Growth Velocity Quartiles From Baseline to Endpoint | FF 50 mcg | Any decrease | 38 | Percentage of Participants | |
| Growth Velocity Over the First 12 Weeks of Double-blind Treatment Period | Placebo | 6.222 | Standard Error 0.1845 | Centimeter per year | |
| Growth Velocity Over the First 12 Weeks of Double-blind Treatment Period | FF 50 mcg | 6.281 | Standard Error 0.1841 | Centimeter per year |
1 to 10 of 18Source ClinicalTrials.gov
See all 18 results by groupParticipant flow6
How many started, completed or left each group, period by period.
| Period | Milestone | Group | Participants | Units counted |
|---|---|---|---|---|
| Overall Study | STARTED | Placebo | 239 | |
| Overall Study | STARTED | FF 50 mcg | 238 | |
| Overall Study | COMPLETED | Placebo | 196 | |
| Overall Study | COMPLETED | FF 50 mcg | 205 | |
| Overall Study | NOT COMPLETED | Placebo | 43 | |
| Overall Study | NOT COMPLETED | FF 50 mcg | 33 |
Source ClinicalTrials.gov
Adverse events50
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 | Pyrexia | General disorders | Placebo | 18 | 239 | 23 |
| other | Pyrexia | General disorders | FF 50 mcg | 13 | 238 | 15 |
| other | Bronchitis | Infections and infestations | Placebo | 12 | 239 | 13 |
| other | Bronchitis | Infections and infestations | FF 50 mcg | 9 | 238 | 11 |
| other | Influenza | Infections and infestations | Placebo | 7 | 239 | 8 |
| other | Influenza | Infections and infestations | FF 50 mcg | 11 | 238 | 11 |
| other | Nasopharyngitis | Infections and infestations | Placebo | 25 | 239 | 31 |
| other | Nasopharyngitis | Infections and infestations | FF 50 mcg | 23 | 238 | 26 |
| other | Pharyngitis | Infections and infestations | Placebo | 9 | 239 | 10 |
| other | Pharyngitis | Infections and infestations | FF 50 mcg | 3 | 238 | 3 |
1 to 10 of 50Source ClinicalTrials.gov
See all 50 adverse eventsAdverse event totals6
The totals the trial posted for each group.
| Total | Group | Affected | At risk |
|---|---|---|---|
| Total, all-cause mortality | Placebo | 0 | 239 |
| Total, all-cause mortality | FF 50 mcg | 0 | 238 |
| Total, other adverse events | Placebo | 105 | 239 |
| Total, other adverse events | FF 50 mcg | 99 | 238 |
| Total, serious adverse events | Placebo | 8 | 239 |
| Total, serious adverse events | FF 50 mcg | 6 | 238 |
Source ClinicalTrials.gov
Papers1
The papers the trial lists on ClinicalTrials.gov.
| PMID | Listed as |
|---|---|
| 37728224 | BACKGROUND |
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 comparisons3
Comparisons of the trial's two groups, calculated by ConductScience from the counts it posted.
| Comparison | Source |
|---|---|
| FF 50 mcg vs Placebo: Number of Participants With On-treatment Asthma Exacerbations Over Double-blind Treatment Period | Trial comparisons |
| FF 50 mcg vs Placebo: deaths from any cause | Trial comparisons |
| FF 50 mcg vs Placebo: serious adverse events | 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/NCT02889809
GET https://conductscience.org/api/trials/v1/NCT02889809/events?page=2