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Nebulized Fluticasone Propionate VS Oral Prednisone in Chinese Pediatric and Adolescent Subjects With an Acute Exacerbation of Asthma

Information source: GlaxoSmithKline
ClinicalTrials.gov processed this data on August 20, 2015
Link to the current ClinicalTrials.gov record.

Condition(s) targeted: Asthma

Intervention: fluticasone propionate inhalation solution (Drug); oral prednisone (Drug); placebo inhalation solution (Drug); placebo tablet (Drug); salbutamol (Drug)

Phase: Phase 3

Status: Completed

Sponsored by: GlaxoSmithKline

Official(s) and/or principal investigator(s):
GSK Clinical Trials, Study Director, Affiliation: GlaxoSmithKline

Summary

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

Clinical Details

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

Study design: Allocation: Randomized, Endpoint Classification: Safety/Efficacy Study, Intervention Model: Parallel Assignment, Masking: Double Blind (Subject, Caregiver, Investigator), Primary Purpose: Treatment

Primary outcome: morning PEF (peak expiratory flow)

Secondary outcome:

evening PEF

Day-time and night-time symptom scores

Rescue medications

Clinic assessments of lung function

Clinical scoring index

Patient/parent and investigator global evaluation

Detailed 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 (FP) 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. This study is for supporting registration of FP Nebules treating Chinese pediatric and adolescent subjects (aged 4 to 16 years) with an acute exacerbation of asthma in China. At least 250 subjects, aged 4-16 years old, diagnosed an acute exacerbation of asthma at presentation, are eligible to take part in the study if they meet the inclusion criteria. They are randomly assigned at the ratio 1: 1 to one of the following treatment groups for 7 days: FP Nebules 2×0. 5mg/2ml twice daily/Placebo tablets once daily; Or, Oral prednisone tablets once daily (2mg/kg. day, up to 40mg/day for 4 days, then 1mg/kg. day or half of the original dose, up to 20mg/day for 3 days) / Placebo Nebules 2×2ml 0. 9% saline twice daily. While all subjects are given Salbutamol Nebules / MDI for relief of symptoms. After randomization (visit 1), the following visits are on Day5 (visit 2) and Day8 (visit 3), and a follow-up phone call (visit4) will happen two weeks post treatment on Day 21 for collection of adverse events. The primary endpoint is mean morning PEF on diary card over the treatment assessment period. The secondary endpoints include subject derived data (symptom scores ), evening PEF on diary card, use of rescue medications, clinic assessments of pulmonary function ( FEV1, and FVC) , clinical scoring index , patient/parent and investigator global evaluation, and use of rescue medications during the trial. Safety endpoints include AEs, vital signs, and oropharyngeal examinations, and laboratory tests (haematology, urinalysis, chemistry). The subjects are assessed for compliance on completion of diary card.

Eligibility

Minimum age: 4 Years. Maximum age: 16 Years. Gender(s): Both.

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.

Locations and Contacts

GSK Investigational Site, Beijing 100191, China

GSK Investigational Site, Beijing, China

GSK Investigational Site, Changchun, China

GSK Investigational Site, Chongqing 400014, China

GSK Investigational Site, Shanghai 200040, China

GSK Investigational Site, Shanghai 200092, China

GSK Investigational Site, Wuxi 214023, China

GSK Investigational Site, Changsha, Hunan 410005, China

GSK Investigational Site, Yanji, Jilin 133000, China

GSK Investigational Site, Shenyang, Liaoning 110004, China

GSK Investigational Site, Wenzhou, Zhejiang 323027, China

Additional Information

Starting date: November 2012
Last updated: November 21, 2013

Page last updated: August 20, 2015

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