Trial · NCT01687296
Nebulized Fluticasone Propionate VS Oral Prednisone in Chinese Pediatric and Adolescent Subjects With an Acute Exacerbation of Asthma
NCT01687296, Phase 3, Completed, GlaxoSmithKline; results first posted 2018-01-30
3 sourcestrials-2026-11-12-0.5.0
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ConductScience Library. Nebulized Fluticasone Propionate VS Oral Prednisone in Chinese Pediatric and Adolescent Subjects With an Acute Exacerbation of Asthma. Trials, record NCT01687296. Release trials-2026-11-12-0.5.0, 12 Nov 2026. https://conductscience.org/library/trials/NCT01687296
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Trial
As registered on ClinicalTrials.gov, in the graph's capture of the registry.
- Title
- Nebulized Fluticasone Propionate VS Oral Prednisone in Chinese Pediatric and Adolescent Subjects With an Acute Exacerbation of Asthma
- NCT number
- NCT01687296
- Status
- Completed
- Phases
- Phase 3
- Enrollment
- 261 participants, actual
- Lead sponsor
- GlaxoSmithKline
- Conditions
- Asthma
- Interventions
- fluticasone propionate inhalation solution, oral prednisone, placebo inhalation solution, placebo tablet, salbutamol
- First posted
- 2012-09-18
- Last updated
- 2018-06-20
- Results first posted
- 2018-01-30
Source ClinicalTrials.gov
Registered outcomes8
Each outcome the trial registered, primary first, in ClinicalTrials.gov's words.
| List | Outcome | Time frame | Description |
|---|---|---|---|
| Primary | Mean Morning Peak Expiratory Flow (AM PEF) on Diary Card Over the Treatment Assessment Period in Intent-to-Treat (ITT) Population | Days 2 to 8 | PEF is the maximum flow generated during a forceful exhalation, starting from full lung inflation. Participants (if needed with the help of parents or guardian) recorded on diary card the best of three PEF measurements, using a mini-Wright peak flow meter in the morning before taking any study drug. Only data that was drawn from Days 2 to 8 after randomization and on or before one day after the end date of study drug was used for analysis. The outcome measure was considered missing if less than 2 days were recorded in the given treatment assessment period. Two participants from fluticasone propionate group and 4 participants from prednisone group had the missing outcome measure. Analysis was performed using an analysis of covariance (ANCOVA) model with effects due to gender, age, centre and treatment group. |
| Primary | Mean Morning PEF on Diary Card Over the Treatment Assessment Period in Per Protocol (PP) Population | Days 2 to 8 | PEF is the maximum flow generated during a forceful exhalation, starting from full lung inflation. Participants (if needed with the help of parents or guardian) recorded on diary card the best of three PEF measurements, using a mini-Wright peak flow meter in the morning before talking any study drug. Only data that was drawn from Days 2 to 8 after randomization and on or before one day after the end date of study drug was used for analysis. The outcome measure was considered missing if less than 2 days were recorded in the given treatment assessment period. Two participants from fluticasone propionate group and 5 participants from prednisone group had the missing outcome measure. Analysis was performed using ANCOVA model with effects due to gender, age ,centre and treatment group. |
| Secondary | Mean Evening PEF on Diary Card Over the Treatment Assessment Period | Days 1/2 to 8 | PEF is the maximum flow generated during a forceful exhalation, starting from full lung inflation. Participants recorded on diary card the best of three PEF measurements, using a mini-Wright peak flow meter in the evening (6:00-9:00 post meridiem \[PM\]) before taking any study drug. Only data that was drawn from Days 1/2 to 8 after randomization and before or on the end date of study drug was used for analysis. If participants started to take the study drug in the morning (early or on 12:00 PM), only then the evening PEF on the date of randomization was used. The outcome measure was considered missing if less than 2 days was recorded in the given treatment assessment period. Two participants from fluticasone propionate group and 5 participants from prednisone group had the missing outcome measure. Analysis was performed using an ANCOVA model with effects due to gender, age, centre and treatment group. |
| Secondary | Median Day-time and Night-time Symptom Scores Over the Treatment Assessment Period | Days 2 to 8 | The symptoms of cough, sputum production, wheeze and dyspnoea were assessed in morning and evening, and recorded on participant diary cards. Day-time symptoms were scored while retiring to bed on a scale of 0 (no symptoms) to 5 (severe). Night-time symptoms were scored while waking in the morning on a scale of 0 (no symptoms) to 4 (severe). For day-time score, only data that was from Days 2 to 8 after randomization and before or on the end date of study drug was used. For night-time score, only data that are from Days 2 to 8 after randomization and on or before one day after the end date of study drug was used. The outcome measure was considered missing if less than 2 days were recorded in the given treatment assessment period. The analysis only includes participants with at least 2 days of non-missing symptom scores in the given treatment assessment period. |
| Secondary | Median Number of Use of Rescue Medications During Day and Night Over the Treatment Assessment Period | Days 2 to 8 | The use of nebulized salbutamol (doses/puffs and frequency) were recorded on diary card in the morning and evening. The median numbers of times of use of rescue medication during day and night was calculated for each participant over the treatment assessment period. In each case, only data that was from Days 2 to 8 after randomization and before or on the end date of study drug was used. The outcome measure was considered missing if less than 2 days (that is., 24-hour periods) were recorded in the given treatment assessment period. The analysis only includes participants who have at least 2 days of non-missing numbers of times rescue medication (including zero) in the given treatment assessment period. |
| Secondary | Clinical Assessment of Lung Function of Forced Expiratory Volume in 1 Second (FEV1) and Forced Vital Capacity (FVC) During the Treatment Period | During the treatment period at Day 5, Day 8 | Spirometric assessments of FEV1 and FVC were assessed at clinic visit 1 (Screening), 2 (Day 5) and 3 (Day 8). Lung function tests were performed at the approximately same time at each visit in the morning. Participants were instructed to withhold salbutamol therapy for at least 4 hour, and the highest of three FEV1 and FVC measurements were recorded. If participants discontinued before or on Day 5, then the FEV1 and FVC collected at the early withdrawal visit is included in the Visit 2. Otherwise, the FEV1, FVC collected at the early withdrawal visit was included in the Visit 3. Analysis was performed using ANCOVA with covariates of gender, centre, age and treatment. |
| Secondary | Mean Change From Baseline in Clinical Scoring Index at Day 5 and Day 8 | Baseline, Day 5 and Day 8 | The clinical scoring index was assessed at Baseline (Visit 1), Day 5 and Day 8. The score assigned represented the sum of the score for each of four signs: respiratory rate, wheezing, inspiration/expiration ratio, and accessory muscle use. Each of these parameters were scored on a 4-point scale of 0 to 3 where 0=none, 1=mild, 2=moderate and 3=severe. The total score ranged from 0 to 12, where 0 indicated absence of symptoms and 12 indicated most severe symptoms. The Baseline value was the last non-missing value prior to randomization. Change from Baseline was calculated/defined as value at the indicated visit minus value at the Baseline. A negative value of change in score from Baseline indicated improvement in severity of symptoms. If participants discontinued before or on Day 5, then the clinical scoring index collected at the early withdrawal visit was included in the Visit 2. Otherwise, the clinical scoring index collected at the early withdrawal visit was included in the Visit 3 |
| Secondary | Mean Global Evaluation for Efficacy by Participant/Parent and Investigator | Day 8 | At Visit 3 (Day 8), participant/parent and investigator were asked to evaluate efficacy globally as very beneficial=1, beneficial=2, no effect=3 or worse=4. The global evaluation collected at the early withdrawal visit was included in the Visit 3. If participants were discontinued at Visit 2, then the global evaluation collected at the Visit 2 is also included in the Visit 3 for summary and analysis. |
Source ClinicalTrials.gov
Outcomes8
Each outcome the trial posted results for, in ClinicalTrials.gov's words.
| Type | Outcome | Time frame | Population | Units | Measured as |
|---|---|---|---|---|---|
| PRIMARY | Mean Morning Peak Expiratory Flow (AM PEF) on Diary Card Over the Treatment Assessment Period in Intent-to-Treat (ITT) Population | Days 2 to 8 | ITT Population comprised of all participants randomized to treatment and who received at least one dose of study drug. Data is presented for the participants available at the time of assessment. | Litres per minute (L/min) | LEAST_SQUARES_MEAN |
| PRIMARY | Mean Morning PEF on Diary Card Over the Treatment Assessment Period in Per Protocol (PP) Population | Days 2 to 8 | PP Population comprised of all participants in the ITT Population who did not have any full protocol violations which could impact treatment effect. Data is presented for the participants available at the time of assessment. | L/min | LEAST_SQUARES_MEAN |
| SECONDARY | Mean Evening PEF on Diary Card Over the Treatment Assessment Period | Days 1/2 to 8 | ITT Population. Data is presented for the participants available at the time of assessment. | L/min | LEAST_SQUARES_MEAN |
| SECONDARY | Median Day-time and Night-time Symptom Scores Over the Treatment Assessment Period | Days 2 to 8 | ITT Population. Only those participants available at the specified time points were analyzed. | Scores on a scale | MEDIAN |
| SECONDARY | Median Number of Use of Rescue Medications During Day and Night Over the Treatment Assessment Period | Days 2 to 8 | ITT Population. Data is presented for the participants available at the time of assessment. | Number of use of rescue medication | MEDIAN |
| SECONDARY | Clinical Assessment of Lung Function of Forced Expiratory Volume in 1 Second (FEV1) and Forced Vital Capacity (FVC) During the Treatment Period | During the treatment period at Day 5, Day 8 | ITT Population. Only those participants available at the specified time points were analyzed. | Litres | LEAST_SQUARES_MEAN |
| SECONDARY | Mean Change From Baseline in Clinical Scoring Index at Day 5 and Day 8 | Baseline, Day 5 and Day 8 | ITT Population. Only those participants available at the specified time points were analyzed. | Scores on a scale | MEAN |
| SECONDARY | Mean Global Evaluation for Efficacy by Participant/Parent and Investigator | Day 8 | ITT Population. Only those participants available at the specified time points were analyzed. | Scores on a scale | MEAN |
Source ClinicalTrials.gov
Results by group28
Each measurement the trial posted, group by group, in the words and numbers it posted.
| Outcome | Group | Category | Value | Spread | Units |
|---|---|---|---|---|---|
| Mean Morning Peak Expiratory Flow (AM PEF) on Diary Card Over the Treatment Assessment Period in Intent-to-Treat (ITT) Population | Fluticasone Propionate | 188.77 | Standard Error 3.774 | Litres per minute (L/min) | |
| Mean Morning Peak Expiratory Flow (AM PEF) on Diary Card Over the Treatment Assessment Period in Intent-to-Treat (ITT) Population | Prednisone | 188.31 | Standard Error 3.790 | Litres per minute (L/min) | |
| Mean Morning PEF on Diary Card Over the Treatment Assessment Period in Per Protocol (PP) Population | Fluticasone Propionate | 189.46 | Standard Error 3.724 | L/min | |
| Mean Morning PEF on Diary Card Over the Treatment Assessment Period in Per Protocol (PP) Population | Prednisone | 188.96 | Standard Error 3.712 | L/min | |
| Mean Evening PEF on Diary Card Over the Treatment Assessment Period | Fluticasone Propionate | 195.79 | Standard Error 3.723 | L/min | |
| Mean Evening PEF on Diary Card Over the Treatment Assessment Period | Prednisone | 194.63 | Standard Error 3.751 | L/min | |
| Median Day-time and Night-time Symptom Scores Over the Treatment Assessment Period | Fluticasone Propionate | Day-time symptom score | 0.5 | Full Range 0 to 3 | Scores on a scale |
| Median Day-time and Night-time Symptom Scores Over the Treatment Assessment Period | Prednisone | Day-time symptom score | 1.0 | Full Range 0 to 3 | Scores on a scale |
| Median Day-time and Night-time Symptom Scores Over the Treatment Assessment Period | Fluticasone Propionate | Night-time symptom score | 0.0 | Full Range 0 to 3 | Scores on a scale |
| Median Day-time and Night-time Symptom Scores Over the Treatment Assessment Period | Prednisone | Night-time symptom score | 0.0 | Full Range 0 to 4 | Scores on a scale |
1 to 10 of 28Source ClinicalTrials.gov
See all 28 results by groupParticipant flow6
How many started, completed or left each group, period by period.
| Period | Milestone | Group | Participants | Units counted |
|---|---|---|---|---|
| Overall Study | STARTED | Fluticasone Propionate | 123 | |
| Overall Study | STARTED | Prednisone | 128 | |
| Overall Study | COMPLETED | Fluticasone Propionate | 116 | |
| Overall Study | COMPLETED | Prednisone | 123 | |
| Overall Study | NOT COMPLETED | Fluticasone Propionate | 7 | |
| Overall Study | NOT COMPLETED | Prednisone | 5 |
Source ClinicalTrials.gov
Adverse events4
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 | White blood cell count increased | Investigations | Fluticasone Propionate | 1 | 123 | |
| other | White blood cell count increased | Investigations | Prednisone | 10 | 128 | |
| serious | Upper respiratory tract infection | Infections and infestations | Fluticasone Propionate | 1 | 123 | |
| serious | Upper respiratory tract infection | Infections and infestations | Prednisone | 2 | 128 |
Source ClinicalTrials.gov
Adverse event totals6
The totals the trial posted for each group.
| Total | Group | Affected | At risk |
|---|---|---|---|
| Total, all-cause mortality | Fluticasone Propionate | 0 | 123 |
| Total, all-cause mortality | Prednisone | 0 | 128 |
| Total, other adverse events | Fluticasone Propionate | 1 | 123 |
| Total, other adverse events | Prednisone | 10 | 128 |
| Total, serious adverse events | Fluticasone Propionate | 1 | 123 |
| Total, serious adverse events | Prednisone | 2 | 128 |
Source ClinicalTrials.gov
Papers0
The papers the trial lists on ClinicalTrials.gov.
None in this release.
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 comparisons2
Comparisons of the trial's two groups, calculated by ConductScience from the counts it posted.
| Comparison | Source |
|---|---|
| Fluticasone Propionate vs Prednisone: deaths from any cause | Trial comparisons |
| Fluticasone Propionate vs Prednisone: 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.
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