Treatment Of Symptomatic Asthma In Children
This study has been completed.
Sponsor:
GlaxoSmithKline
Information provided by (Responsible Party):
GlaxoSmithKline
ClinicalTrials.gov Identifier:
NCT00197106
First received: September 9, 2005
Last updated: May 31, 2012
Last verified: April 2012
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Purpose
This study is being conducted to investigate whether in childhood salmeterol/ fluticasone propionate 50/100 bd delivered via the Diskus® inhaler and fluticasone propionate 200 mcg bd delivered via the Diskus® inhaler are non- inferior in terms of symptom control. Additionally we aim to show that salmeterol/ fluticasone propionate 50/100 bd is at least as good in terms of lung function improvement and bronchial hyperreactivity and enables a steroid-sparing management of asthma in children.
| Condition | Intervention | Phase |
|---|---|---|
|
Asthma |
Drug: Salmeterol/ fluticasone propionate Diskus® inhaler 50/100 mcg Drug: fluticasone propionate 2 x 100 mcg |
Phase 4 |
| Study Type: | Interventional |
| Study Design: | Allocation: Randomized Endpoint Classification: Efficacy Study Intervention Model: Parallel Assignment Masking: Double Blind (Subject, Investigator) Primary Purpose: Treatment |
| Official Title: | See Detailed Description |
Resource links provided by NLM:
Further study details as provided by GlaxoSmithKline:
Primary Outcome Measures:
- Percentage of Symptom-free Days During the Last 10 Weeks of the Treatment Period [ Time Frame: Last 10 weeks of the treatment period (Weeks 16-26) ] [ Designated as safety issue: No ]Asthma symptom-free days are defined as days (24 hour period) with no symptoms, as recorded in the participant's diary.
Secondary Outcome Measures:
- Percentage of Symptom-free Days During the Entire Treatment Period [ Time Frame: Baseline to Week 26 ] [ Designated as safety issue: No ]Asthma symptom-free days are defined as days (24 hour period) with no symptoms, as recorded in the participant's diary
- Mean Change From Baseline in Percentage Predicted Forced Expiratory Volume in One Second (FEV1) at Week 26 [ Time Frame: Baseline and Week 26 ] [ Designated as safety issue: No ]Change from Baseline was calculated as the Week 26 value minus the Baseline value. The percentage predicted FEV1 is defined as the volume of air that can be forced out in one second after taking a deep breath and is corrected for the FEV1 value corresponding with the same age.
- Mean Change From Baseline in Forced Vital Capacity (FVC) at Week 26 [ Time Frame: Baseline and Week 26 ] [ Designated as safety issue: No ]Change from Baseline was calculated as the Week 26 value minus the Baseline value. Forced vital capacity is defined as the maximum volume of air that can be forcibly expired from the lungs and is calculated by use of spirometry. The spirometry test is performed by using a device called a spirometer, which measures the amount of air one can blow out maximally. Generally, the participant is asked to take the deepest breath they can, and then exhale into the sensor as hard as possible, for as long as possible. The test is normally repeated three times to ensure reproducibility.
- Mean Change From Baseline in Midexpiratory Flow (MEF 50) at Week 26 [ Time Frame: Baseline and Week 26 ] [ Designated as safety issue: No ]Change from Baseline was calculated as the Week 26 value minus the Baseline value. MEF 50 is defined as maximum expiratory flow rate at 50% of vital capacity. Vital capacity is the maximum amount of air that a person can expel from the lungs after first filling the lungs to their maximum extent. Midexpiratory flow was calculated by use of spirometry. The test is normally repeated at least three times in order to ensure reproducibility.
- Geometric Means of Nitric Oxide (NO) at Week 26 [ Time Frame: Baseline and Week 26 ] [ Designated as safety issue: No ]Geometric mean values of NO at week 26 were compared using ANCOVA with adjustment for baseline value of NO, age, gender and center. Analysis of covariance (ANCOVA) is a general linear model with one continuous outcome variable (quantitative) and one or more factor variables.
- Percent Change From Baseline in RINT Measurements at Week 26 [ Time Frame: Baseline and Week 26 ] [ Designated as safety issue: No ]Change from Baseline was calculated as the Week 26 value minus the Baseline value. Interrupter respiratory resistance (RINT) measurements were calculated by a combined analysis for relation between change from baseline and occurrence of the endpoint. RINT is a technique that is used for evaluating lung function in poorly collaborating patients (e.g., small children). The measurement is performed during tidal breathing (normal breathing) instead of during maximal expiration, as is done by a spirometry test.
- Number of Asthma Exacerbations Per Treatment Group at Week 26 [ Time Frame: Week 26 ] [ Designated as safety issue: No ]An exacerbation is defined as a worsening of the asthma complaints (commonly referred to as an asthma attack) and is reported by the participant experiencing the event. An exacerbation was verified by the use of asthma rescue medication.
- Mean Change From Baseline in Provocation Dose (PD20) Causing a 20% Fall in FEV1 at Week 26 [ Time Frame: Baseline and Week 26 ] [ Designated as safety issue: No ]PD20 was calculated by using increasing dosages of methacholine. The dosage that caused a 20% fall in FEV1 was used for analysis. The presented data are ratios (month 6/Baseline) of geometric mean PD20 values.
- Bronchial Hyperresponsiveness With PD20 AMP in Selected Centres [ Time Frame: 26 weeks ] [ Designated as safety issue: No ]Bronchial hyperresponsiveness with PD20 AMP in selected centres was not analyzed, as this outcome measure was removed in a protocol amendment.
- Daily FEV1 and PEF Via the Electronic Peak Flow/FEV1 Meter (PIKO-1) [ Time Frame: 26 weeks ] [ Designated as safety issue: No ]Daily FEV1 and PEF via the electronic pea kflow/FEV1 meter (PIKO-1) was not assessed because data from the peak flow meters could not be used for analysis.
- Frequency of Asthma Exacerbations (Discriminated on Severity) [ Time Frame: 26 weeks ] [ Designated as safety issue: No ]The frequency of asthma exacerbations (discriminated on severity) was not analyzed because of the low overall frequency.
- Cumulative Number of Symptom-free Weeks Until the End of Treatment [ Time Frame: 26 weeks ] [ Designated as safety issue: No ]This outcome measure was not analyzed due to different insights after protocol finalization; it has become clear that the definition of good and maximal controlled weeks is not very distinctive and can therefore actually not be used.
- Weekly Percentage of Participants With 'Good Controlled Weeks' and 'Maximal Controlled Weeks' [ Time Frame: 26 weeks ] [ Designated as safety issue: No ]This outcome measure was not analyzed due to different insights after protocol finalization; it has become clear that the definition of good and maximal controlled weeks is not very distinctive and can therefore actually not be used.
- Time to Asthma Control, Defined as the Time to First 'Good Controlled Week' or 'Maximum Controlled Week' [ Time Frame: 26 weeks ] [ Designated as safety issue: No ]This outcome measure was not analyzed due to different insights after protocol finalization; it has become clear that the definition of good and maximal controlled weeks is not very distinctive and can therefore actually not be used.
| Enrollment: | 176 |
| Study Start Date: | June 2005 |
| Study Completion Date: | October 2008 |
| Primary Completion Date: | October 2008 (Final data collection date for primary outcome measure) |
| Arms | Assigned Interventions |
|---|---|
|
Active Comparator: arm 1
Active Comparator single arm study
|
Drug: Salmeterol/ fluticasone propionate Diskus® inhaler 50/100 mcg
comparator
Drug: fluticasone propionate 2 x 100 mcg
comparator
Other Names:
|
Detailed Description:
A multicentre, randomised, double blind, parallel group study to compare the efficacy and safety of Salmeterol/Fluticasone propionate combination product (Seretide®) 50/100mcg with Fluticasone propionate (Flixotide®) 200mcg, both delivered twice daily via the DISKUS inhaler, in the treatment of children aged 6-12 years with symptomatic asthma.
Eligibility| Ages Eligible for Study: | 6 Years to 12 Years |
| Genders Eligible for Study: | Both |
| Accepts Healthy Volunteers: | No |
Criteria
Inclusion criteria:
- Male or female subjects aged 6-12 years (inclusive)
- A female is eligible to enter and participate in the study if she is:
of non-child-bearing potential; OR of child-bearing potential, but not lactating and pregnant. She declares that it is not probable that she will become pregnant during the study (a pregnancy test can be performed at the investigators discretion)
- Subjects with a documented history of asthma for at least 6 months
- Subjects with a documented history of BHR within 12 months prior to inclusion or BHR on visit 1 (PD20 methacholine < 150 mcg or an equivalence for histamine)
- Subjects who have received BDP, budesonide up to 100-200 mcg bd or fluticasone propionate at a dose of up to 125 mcg bd for at least 4 weeks before the start of the run-in period.
- Subjects who are able to use a electronic peakflow /FEV1 meter (PIKO-1)
- Subjects who have a normal length SD score between -2SD and +2SD
- Subjects who are able to use a Diskus inhaler
- Subjects who are able to perform reproducible lung function tests at visit 1 (variation FEV1 < 5% between the two best measurements)
- Subjects and their guardians, who have given written informed consent to participate in the study
- Subjects or their parent/ guardian who are able to understand and complete a DRC. The DRC may be completed by a parent/guardian if the subject is unable to do this him/ herself
- Subjects able to use Ventolin on an 'as required for symptoms' basis
Exclusion criteria:
- Subjects who have been hospitalised for their asthma within 4 weeks of visit 1
- Subjects who had an acute upper respiratory tract infection within 2 weeks or a lower respiratory tract infection within 4 weeks prior to visit 1
- Subjects who received oral, parental or depot corticosteroids within 4 weeks prior to visit 1
- Subjects who have a known respiratory disorder other than asthma and/or systemic/thoracic abnormalities which influence normal lung function
- Subjects with a disorder that affects growth (e.g. Turner's syndrome)
- Subjects who have received any investigational drugs within 4 weeks of visit 1
- Subjects with a known or suspected hypersensitivity to inhaled steroids, β2-agonists or lactose
- Subjects who use any medication that significantly inhibit the cytochrome P450 subfamily enzyme CYP3A4, including ritonavir and ketoconazole
- Subjects who concurrently participate in another clinical study
- Subjects who have previously been randomised in this trial
Contacts and Locations
Please refer to this study by its ClinicalTrials.gov identifier: NCT00197106
Locations
| Netherlands | |
| GSK Investigational Site | |
| Almere, Netherlands, 1315 RA | |
| GSK Investigational Site | |
| Amsterdam, Netherlands, 1105 AZ | |
| GSK Investigational Site | |
| Arnhem, Netherlands, 6815 AD | |
| GSK Investigational Site | |
| Breda, Netherlands, 4819 EV | |
| GSK Investigational Site | |
| Den Haag, Netherlands, 2566 MJ | |
| GSK Investigational Site | |
| Eindhoven, Netherlands, 5623 EJ | |
| GSK Investigational Site | |
| Enschede, Netherlands, 7511JX | |
| GSK Investigational Site | |
| Gouda, Netherlands, 2803 HG | |
| GSK Investigational Site | |
| Groningen, Netherlands, 9713 GZ | |
| GSK Investigational Site | |
| Helmond, Netherlands, 5707 HA | |
| GSK Investigational Site | |
| Hoorn, Netherlands, 1624 NP | |
| GSK Investigational Site | |
| Leeuwarden, Netherlands, 8934 AD | |
| GSK Investigational Site | |
| Maastricht, Netherlands, 6229 HX | |
| GSK Investigational Site | |
| Nijmegen, Netherlands, 6532 SZ | |
| GSK Investigational Site | |
| Sittard, Netherlands, 6131 BK | |
| GSK Investigational Site | |
| Utrecht, Netherlands, 3584 CX | |
| GSK Investigational Site | |
| Veldhoven, Netherlands, 5504 DB | |
| GSK Investigational Site | |
| Zwolle, Netherlands, 8025 AB | |
Sponsors and Collaborators
GlaxoSmithKline
Investigators
| Study Director: | GSK Clinical Trials | GlaxoSmithKline |
More Information
No publications provided by GlaxoSmithKline
Additional publications automatically indexed to this study by ClinicalTrials.gov Identifier (NCT Number):
| Responsible Party: | GlaxoSmithKline |
| ClinicalTrials.gov Identifier: | NCT00197106 History of Changes |
| Other Study ID Numbers: | SAM101667 |
| Study First Received: | September 9, 2005 |
| Results First Received: | September 11, 2009 |
| Last Updated: | May 31, 2012 |
| Health Authority: | Netherlands: Medicines Evaluation Board (MEB) |
Keywords provided by GlaxoSmithKline:
|
salmeterol/fluticasone combination Asthma bronchial hyperresponsiveness Children symptom control |
Additional relevant MeSH terms:
|
Asthma Bronchial Diseases Respiratory Tract Diseases Lung Diseases, Obstructive Lung Diseases Respiratory Hypersensitivity Hypersensitivity, Immediate Hypersensitivity Immune System Diseases Salmeterol Fluticasone Adrenergic beta-2 Receptor Agonists Adrenergic beta-Agonists Adrenergic Agonists |
Adrenergic Agents Neurotransmitter Agents Molecular Mechanisms of Pharmacological Action Pharmacologic Actions Physiological Effects of Drugs Bronchodilator Agents Autonomic Agents Peripheral Nervous System Agents Anti-Asthmatic Agents Respiratory System Agents Therapeutic Uses Dermatologic Agents Anti-Allergic Agents Anti-Inflammatory Agents |
ClinicalTrials.gov processed this record on May 23, 2013