Last updated: 11/07/2018 07:30:07
Nebulized fluticasone propionate VS oral prednisone in Chinese pediatric and adolescent subjects with an acute exacerbation of asthma
EudraCT ID
Not applicable
EU CT Number
Not applicable
Trial status
Completed
Completed
Trial overview
Official title: A multicentre, randomized, double-blind, double-dummy, active-controlled, parallel-group study to determine the efficacy and safety of nebulized fluticasone propionate 1mg twice daily compared with oral prednisone administered for 7 days to Chinese pediatric and adolescent subjects (aged 4 to 16 years) with an acute exacerbation of asthma
Trial description: This is a multicentre, randomized, double-blind, double-dummy, active-controlled, parallel-group study to determine the efficacy and safety of nebulized fluticasone propionate 1mg twice daily compared with oral prednisone administered for 7 days to Chinese pediatric and adolescent subjects (aged 4 to 16 years) with an acute exacerbation of asthma
Primary purpose:
Treatment
Trial design:
Parallel Assignment
Masking:
Triple (Participant, Care Provider, Investigator)
Allocation:
Randomized
Primary outcomes:
Mean morning peak expiratory flow (AM PEF) on diary card over the treatment assessment period in Intent-to-Treat (ITT) Population
Timeframe: Days 2 to 8
Mean morning PEF on diary card over the treatment assessment period in Per Protocol (PP) Population
Timeframe: Days 2 to 8
Secondary outcomes:
Mean evening PEF on diary card over the treatment assessment period
Timeframe: Days 1/2 to 8
Median day-time and night-time symptom scores over the treatment assessment period
Timeframe: Days 2 to 8
Median number of use of rescue medications during day and night over the treatment assessment period
Timeframe: Days 2 to 8
Clinical assessment of lung function of forced expiratory volume in 1 second (FEV1) and forced vital capacity (FVC) during the treatment period
Timeframe: During the treatment period at Day 5, Day 8
Mean change from Baseline in clinical scoring index at Day 5 and Day 8
Timeframe: Baseline, Day 5 and Day 8
Mean global evaluation for efficacy by participant/parent and investigator
Timeframe: Day 8
Interventions:
Drug: fluticasone propionate inhalation solution
Drug: oral prednisone
Drug: placebo inhalation solution
Drug: placebo tablet
Drug: salbutamol
Enrollment:
261
Observational study model:
Not applicable
Primary completion date:
2013-21-06
Time perspective:
Not applicable
Clinical publications:
Zhang H, Shang Y, Xie J, Liu E, Cheng H, Zhou W, Li C, Jin Z, Zhong L, Bao Y, Cao L, Shen K, Liu C, luo L, Peng J, Du X. A randomized, double-blind, non-inferiority study to investigate the efficacy and safety of nebulized fluticasone propionate inhalation solution compared with oral prednisone in pediatric and adolescent subjects with acute exacerbation of asthma. 2017;32(9):708-712.
Medical condition
Asthma
Product
fluticasone propionate
Collaborators
Not applicable
Study date(s)
November 2012 to June 2013
Type
Interventional
Phase
3
Participation criteria
Sex
Female & Male
Age
4 - 16 years
Accepts healthy volunteers
No
- Chinese male and female pediatric or adolescent subjects aged 4 to 16 years, inclusive
- Subjects have an established diagnosis of asthma
- Severe respiratory dysfunction.
- History of mechanical ventilation due to respiratory failure.
Inclusion and exclusion criteria
Inclusion criteria:
- Chinese male and female pediatric or adolescent subjects aged 4 to 16 years, inclusive
- Subjects have an established diagnosis of asthma
- The definition of asthma. According to Chinese Guideline for the diagnosis and optimal management of asthma in children [Respiratory branch of pediatric society,Chinese Medical. Association. 2008, revised version], the subjects can be diagnosed when meeting the criteria. The diagnosis criteria is listed in the protocol.
- The severity of an acute exacerbation of asthma is defined as PEF of 50% to 75% predicted via a peak flow meter, with a clinical scoring index of ≥2. The clinical scoring index represents the sum of the score for each of four signs: respiratory rate (0=low to 3=high, dependent on age), wheezing (0=none to 3=severe), inspiration/expiration ratio (0=2:1 to 3=1:3), and accessory muscle (0=none to 3=marked use).
- Subjects can properly use a mini-wright peak flow meter, nebulizer and MDI with/without a spacer, and accurately complete a diary card with parental assistance, if required.
- Subjects’ parents/guardians are willing to give written informed consent.
Exclusion criteria:
- Severe respiratory dysfunction.
- History of mechanical ventilation due to respiratory failure.
- Admission to hospital due to respiratory disease within the previous 2 weeks, including asthmatic exacerbations.
- Clinical or lab evidence of a serious, uncontrolled systemic disease or presence of any disease likely to interfere with the objectives of this study, such as pulmonary cystic fibrosis and bronchopulmonary dysplasia.
- Known or suspected hypersensitivity to glucocorticosteroids or β2 agonists.
- Clinical visual evidence of oral candidiasis at Visit1.
- Use of the medications below in Table 1 according to the following defined time intervals prior to presentation. The list is provided in the protocol.
Trial location(s)
Study documents
Scientific result summary
Available language(s): English
Protocol
Available language(s): English
If you wish to request for full study report, please contact - [email protected]
Results overview
Results posted on ClinicalTrials.gov
Recruitment status
Completed
Actual primary completion date
2013-21-06
Actual study completion date
2013-21-06
Plain language summaries
Plain language summaries of clinical trial results for Phase 2-4 clinical trials that were initiated on or after January 2022 will be posted by GSK within one year following study completion.
Additional information about the trial
Additional information
Not applicable
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