Trial · NCT01462344
6-month Safety and Benefit Study of ADVAIR in Children 4-11 Years Old
NCT01462344, Phase 4, Completed, GlaxoSmithKline; results first posted 2016-10-05
3 sourcestrials-2026-11-12-0.5.0
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ConductScience Library. 6-month Safety and Benefit Study of ADVAIR in Children 4-11 Years Old. Trials, record NCT01462344. Release trials-2026-11-12-0.5.0, 12 Nov 2026. https://conductscience.org/library/trials/NCT01462344
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Trial
As registered on ClinicalTrials.gov, in the graph's capture of the registry.
- Title
- 6-month Safety and Benefit Study of ADVAIR in Children 4-11 Years Old
- NCT number
- NCT01462344
- Status
- Completed
- Phases
- Phase 4
- Enrollment
- 6,250 participants, actual
- Lead sponsor
- GlaxoSmithKline
- Conditions
- Asthma
- Interventions
- ADVAIR 100/50mcg, ADVAIR 250/50mcg, FLOVENT 100mcg, FLOVENT 250mcg
- First posted
- 2011-10-31
- Last updated
- 2018-08-06
- Results first posted
- 2016-10-05
Source ClinicalTrials.gov
Registered outcomes8
Each outcome the trial registered, primary first, in ClinicalTrials.gov's words.
| List | Outcome | Time frame | Description |
|---|---|---|---|
| Primary | Number of Participants Experiencing an Event in the Composite Safety Endpoint of Serious Asthma Outcomes ( Asthma-related Hospitalization, Asthma-related Endotracheal Intubation, or Asthma-related Death) | From Day 1 up to 6 months | Composite endpoint was defined as clinically relevant endpoint that is constructed from combinations of other clinically relevant endpoints of serious asthma outcomes (i.e., asthma-related hospitalization, asthma-related endotracheal intubation, or asthma-related death). Hospitalization was defined as an inpatient stay or a \>=24-hour stay in an observation area in an emergency department or other equivalent facility. Time to first event in the composite endpoint of serious asthma-related outcomes over the 6-month study treatment period was analyzed using a Cox proportional hazards regression model. An estimate of absolute risk difference and its corresponding 95% confidence interval (CI) were also included. The Intent-to-Treat (ITT) Population included all participants randomized to study drug and who took study treatment. |
| Primary | Number of Participants With at Least One Asthma Exacerbation Over the 6-month Study Treatment Period | From Day 1 up to 6 months | Number of participants with asthma exacerbation over the 6-month study treatment period are presented. Participants from mITT population with screening childhood asthma control test (C-ACT) scores of 20 or higher, one exacerbation in the previous year, and either low-dose inhaled corticosteroid (ICS) + one or more adjunctive therapy or medium-dose ICS monotherapy or medium-dose ICS and one or more adjunctive therapy as prior asthma therapy were included for this endpoint. Time to first exacerbation analyzed using a cox proportional hazards regression model. The number of asthma exacerbations were compared between treatments using a negative binomial regression model. The modified Intent-to-Treat (mITT) Population consisted of the ITT participants with a different data cut-off for supportive analyses of the primary composite safety endpoint. |
| Secondary | Number of Participants Experiencing Asthma-related Deaths Over the 6-month Study Treatment Period. | From Day 1 up to 6 months | Number of participants experiencing asthma-related death over the 6-month study treatment period are presented. |
| Secondary | Number of Participants Experiencing Asthma-related Endotracheal Intubations Over the 6-month Study Treatment Period | From Day 1 up to 6 months | Intubation is defined as endotracheal intubation with ventilation (mechanical or by hand). The number of participants experiencing asthma-related endotracheal intubations over the 6-month study treatment period are presented. |
| Secondary | Number of Participants Experiencing Asthma-related Hospitalizations Over the 6-month Study Treatment Period | From Day 1 up to 6 months | Hospitalization is defined as a \>=24-hour stay as an inpatient or in an observation ward. The number of participants experiencing asthma-related hospitalizations over the 6-month study treatment period are presented. |
| Secondary | Number of Participants Withdrawn From Study Treatment Due to Asthma Exacerbation Over the 6-month Study Treatment Period | From Day 1 up to 6 months | An exacerbation is defined as deterioration of asthma requiring the use of systemic corticosteroids (tablets, suspension, or injection) for at least 3 days (up to 10 days) or a single depot corticosteroid injection. Number of participants experiencing at least one exacerbation from mITT population were included for this endpoint. The number of participants withdrawn from study treatment due to asthma exacerbation over the 6-month study treatment period are presented. |
| Secondary | Percentage of Rescue-free Days Over the 6-month Study Treatment Period | From Day 1 up to 6 months | Rescue-free days were days without use of rescue albuterol/salbutamol (other than pre-exercise treatment) over the 6-month study treatment period. The mean percentages of rescue-free days over the months 1-6 (defined as treatment days 2-182) are summarized. Number of participants over treatment days 2-182 from mITT Population were included for this endpoint. |
| Secondary | Percentage of Asthma Control Days Over the 6-month Study Treatment Period | From Day 1 up to 6 months | An asthma control day is one on which rescue albuterol/salbutamol use was recorded as 0, no night time awakenings were recorded, no asthma exacerbations were recorded, no work, school, or daycare days were missed by caregiver or participant due to asthma, coughing symptom score was \<=1 and wheezing symptom score was 0. The mean percentages of asthma control days over the months 1-6 (defined as treatment days 2-182) are summarized. Number of participants over treatment days 2-182 from mITT Population were included for this endpoint. |
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 | Number of Participants Experiencing an Event in the Composite Safety Endpoint of Serious Asthma Outcomes ( Asthma-related Hospitalization, Asthma-related Endotracheal Intubation, or Asthma-related Death) | From Day 1 up to 6 months | ITT Population | Participants | NUMBER |
| PRIMARY | Number of Participants With at Least One Asthma Exacerbation Over the 6-month Study Treatment Period | From Day 1 up to 6 months | mITT Population | Participants | NUMBER |
| SECONDARY | Number of Participants Experiencing Asthma-related Deaths Over the 6-month Study Treatment Period. | From Day 1 up to 6 months | ITT Population | Participants | NUMBER |
| SECONDARY | Number of Participants Experiencing Asthma-related Endotracheal Intubations Over the 6-month Study Treatment Period | From Day 1 up to 6 months | ITT Population | Participants | NUMBER |
| SECONDARY | Number of Participants Experiencing Asthma-related Hospitalizations Over the 6-month Study Treatment Period | From Day 1 up to 6 months | ITT Population | Participants | NUMBER |
| SECONDARY | Number of Participants Withdrawn From Study Treatment Due to Asthma Exacerbation Over the 6-month Study Treatment Period | From Day 1 up to 6 months | mITT Population | Participants | NUMBER |
| SECONDARY | Percentage of Rescue-free Days Over the 6-month Study Treatment Period | From Day 1 up to 6 months | mITT Population | Percentage of rescue-free days | MEAN |
| SECONDARY | Percentage of Asthma Control Days Over the 6-month Study Treatment Period | From Day 1 up to 6 months | mITT Population | Percentage of asthma control days | MEAN |
Source ClinicalTrials.gov
Results by group16
Each measurement the trial posted, group by group, in the words and numbers it posted.
| Outcome | Group | Category | Value | Spread | Units |
|---|---|---|---|---|---|
Number of Participants Experiencing an Event in the Composite Safety Endpoint of Serious Asthma Outcomes ( Asthma-related Hospitalization, Asthma-related Endotracheal Intubation, or Asthma-related Death) | FSC DPI | 27 | Participants | ||
Number of Participants Experiencing an Event in the Composite Safety Endpoint of Serious Asthma Outcomes ( Asthma-related Hospitalization, Asthma-related Endotracheal Intubation, or Asthma-related Death) | FP DPI | 21 | Participants | ||
| Number of Participants With at Least One Asthma Exacerbation Over the 6-month Study Treatment Period | FSC DPI | 265 | Participants | ||
| Number of Participants With at Least One Asthma Exacerbation Over the 6-month Study Treatment Period | FP DPI | 309 | Participants | ||
| Number of Participants Experiencing Asthma-related Deaths Over the 6-month Study Treatment Period. | FSC DPI | 0 | Participants | ||
| Number of Participants Experiencing Asthma-related Deaths Over the 6-month Study Treatment Period. | FP DPI | 0 | Participants | ||
| Number of Participants Experiencing Asthma-related Endotracheal Intubations Over the 6-month Study Treatment Period | FSC DPI | 0 | Participants | ||
| Number of Participants Experiencing Asthma-related Endotracheal Intubations Over the 6-month Study Treatment Period | FP DPI | 0 | Participants | ||
| Number of Participants Experiencing Asthma-related Hospitalizations Over the 6-month Study Treatment Period | FSC DPI | 27 | Participants | ||
| Number of Participants Experiencing Asthma-related Hospitalizations Over the 6-month Study Treatment Period | FP DPI | 21 | Participants |
1 to 10 of 16Source ClinicalTrials.gov
See all 16 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/Salmeterol Combination (FSC) | 3,107 | |
| Overall Study | STARTED | Fluticasone Propionate (FP) | 3,101 | |
| Overall Study | COMPLETED | Fluticasone Propionate/Salmeterol Combination (FSC) | 2,724 | |
| Overall Study | COMPLETED | Fluticasone Propionate (FP) | 2,751 | |
| Overall Study | NOT COMPLETED | Fluticasone Propionate/Salmeterol Combination (FSC) | 383 | |
| Overall Study | NOT COMPLETED | Fluticasone Propionate (FP) | 350 |
Source ClinicalTrials.gov
Adverse events176
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 | Asthma | Respiratory, thoracic and mediastinal disorders | FSC DPI | 15 | 3,107 | |
| other | Asthma | Respiratory, thoracic and mediastinal disorders | FP DPI | 23 | 3,101 | |
| other | Cough | Respiratory, thoracic and mediastinal disorders | FSC DPI | 2 | 3,107 | |
| other | Cough | Respiratory, thoracic and mediastinal disorders | FP DPI | 2 | 3,101 | |
| other | Wheezing | Respiratory, thoracic and mediastinal disorders | FSC DPI | 1 | 3,107 | |
| other | Wheezing | Respiratory, thoracic and mediastinal disorders | FP DPI | 1 | 3,101 | |
| other | Bronchospasm | Respiratory, thoracic and mediastinal disorders | FSC DPI | 1 | 3,107 | |
| other | Bronchospasm | Respiratory, thoracic and mediastinal disorders | FP DPI | 0 | 3,101 | |
| other | Dyspnoea | Respiratory, thoracic and mediastinal disorders | FSC DPI | 0 | 3,107 | |
| other | Dyspnoea | Respiratory, thoracic and mediastinal disorders | FP DPI | 1 | 3,101 |
1 to 10 of 176Source ClinicalTrials.gov
See all 176 adverse eventsAdverse event totals6
The totals the trial posted for each group.
| Total | Group | Affected | At risk |
|---|---|---|---|
| Total, all-cause mortality | FSC DPI | ||
| Total, all-cause mortality | FP DPI | ||
| Total, other adverse events | FSC DPI | 31 | 3,107 |
| Total, other adverse events | FP DPI | 39 | 3,101 |
| Total, serious adverse events | FSC DPI | 56 | 3,107 |
| Total, serious adverse events | FP DPI | 54 | 3,101 |
Source ClinicalTrials.gov
Papers2
The papers the trial lists on ClinicalTrials.gov.
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 comparisons7
Comparisons of the trial's two groups, calculated by ConductScience from the counts it posted.
| Comparison | Source |
|---|---|
| FSC DPI vs FP DPI: Number of Participants With at Least One Asthma Exacerbation Over the 6-month Study Treatment Period | Trial comparisons |
FSC DPI vs FP DPI: Number of Participants Experiencing an Event in the Composite Safety Endpoint of Serious Asthma Outcomes ( Asthma-related Hospitalization, Asthma-related Endotracheal Intubation, or Asthma-related Death) | Trial comparisons |
| FSC DPI vs FP DPI: Number of Participants Experiencing Asthma-related Endotracheal Intubations Over the 6-month Study Treatment Period | Trial comparisons |
| FSC DPI vs FP DPI: Number of Participants Withdrawn From Study Treatment Due to Asthma Exacerbation Over the 6-month Study Treatment Period | Trial comparisons |
| FSC DPI vs FP DPI: Number of Participants Experiencing Asthma-related Deaths Over the 6-month Study Treatment Period. | Trial comparisons |
| FSC DPI vs FP DPI: Number of Participants Experiencing Asthma-related Hospitalizations Over the 6-month Study Treatment Period | Trial comparisons |
| FSC DPI vs FP DPI: 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/NCT01462344
GET https://conductscience.org/api/trials/v1/NCT01462344/events?page=2