EUCTR2011-001643-79-LV
Active, not recruiting
Phase 1
A 6-month safety and benefit study of inhaled fluticasone propionate/ salmeterol combination versus inhaled fluticasone propionate in the treatment of 6,200 pediatric subjects 4-11 years old with persistent asthma - VESTRI
GlaxoSmithKline Research & Development Limited0 sites6,250 target enrollmentStarted: December 13, 2011Last updated:
Overview
- Phase
- Phase 1
- Status
- Active, not recruiting
- Enrollment
- 6,250
Overview
Brief Summary
No summary available.
Study Design
- Study Type
- Interventional clinical trial of medicinal product
Eligibility Criteria
- Sex
- All
Inclusion Criteria
- •French subjects: In France, a subject will be eligible for inclusion in this study only if either affiliated to or a beneficiary of a social security category.
- •1\. Informed consent
- •Subject’s legal guardian must be able and willing to give written informed consent to take part in the study.
- •If applicable, subject must be able and willing to give assent to take part in the study according to the local requirement.
- •Subject and their legal guardian understand that the study requires them to be treated on an outpatient basis.
- •Subject and their legal guardian understand that they must comply with study medication and study assessments including recording of symptom scores and rescue albuterol/salbutamol use, attending scheduled study visits, and being accessible by a telephone call.
- •2\. Age: 4\-11 years of age at Visit 1
- •3\. Gender: Male or eligible female. Female subjects should not be enrolled if they are pregnant, lactating or plan to become pregnant during the time of study participation. All females of childbearing potential must have a negative urine pregnancy test result prior to randomization to continue in the study. Females who become pregnant during the course of the study will be discontinued and the pregnancy outcome followed
- •4\. Asthma diagnosis: Asthma, defined by the regional asthma guidelines (i.e., NIH, GINA, etc.), for at least 6 months prior to Visit 1\.
- •Asthma is defined as a chronic inflammatory disorder associated with airway hyperresponsiveness and reversible airways obstruction that leads to recurrent episodes of wheezing, breathlessness, chest tightness, and coughing.
Exclusion Criteria
- •1\. History of life\-threatening asthma: Defined for this protocol as an asthma episode that required intubation, hypercapnea requiring non\-invasive ventilatory support, respiratory arrest, hypoxic seizures or asthma\-related syncopal episode(s).
- •2\. Unstable asthma at Visit 1\.
- •3\. Subjects who are currently receiving high\-dose ICS or ICS/LABA therapy to treat asthma symptoms.
- •4\. Concurrent respiratory disease: Current evidence of pneumonia, pneumothorax, atelectasis, pulmonary fibrotic disease, allergic bronchopulmonary aspergillosis, cystic fibrosis, bronchopulmonary dysplasia, or other severe respiratory abnormalities other than asthma.
- •5\. Respiratory infection: Bacterial or viral infection of the upper or lower respiratory tract, sinus or middle ear (either culture\-documented or suspected) that is not resolved at Visit 1 and that in the opinion of the investigator is expected to affect the subject’s asthma status or the subject’s ability to participate in the study.
- •6\. Subjects with only exercise\-induced asthma are excluded from participation in this study.
- •7\. Asthma exacerbation: An asthma exacerbation requiring systemic (tablets, suspension or injection) corticosteroids within 4 weeks of Visit 1 or more than 4 separate exacerbations in the last 12 months from Visit 1\.
- •These include asthma exacerbations resulting from poor compliance with asthma medications.
- •Each asthma exacerbation must be separated by \>7 days from the discontinuation of OCS to be considered an individual event.
- •8\. Asthma hospitalization: Hospitalization for asthma within 4 weeks of Visit 1 or more than 2 hospitalizations (defined as overnight admission) for asthma in the last 12 months from Visit 1\. Each hospitalization must be separated by \>7 days to be considered an individual event (ED visits \< 24 hours in duration are not considered hospitalizations).
Investigators
Similar Trials
Active, not recruiting
Not Applicable
A 6-month study to assess the safety and benefit of inhaled fluticasone propionate/salmeterol combination compared with inhaled fluticasone propionate in the treatment of children aged 4 to 11 years with asthma.AsthmaMedDRA version: 16.1Level: PTClassification code 10003553Term: AsthmaSystem Organ Class: 10038738 - Respiratory, thoracic and mediastinal disordersTherapeutic area: Diseases [C] - Respiratory Tract Diseases [C08]EUCTR2011-001643-79-ATGlaxoSmithKline Research & Development Limited6,200
Active, not recruiting
Not Applicable
A 6-month study to assess the safety and benefit of inhaled fluticasone propionate/salmeterol combination compared with inhaled fluticasone propionate in the treatment of children aged 4 to 11 years with asthma.AsthmaMedDRA version: 17.0Level: PTClassification code 10003553Term: AsthmaSystem Organ Class: 10038738 - Respiratory, thoracic and mediastinal disordersTherapeutic area: Diseases [C] - Respiratory Tract Diseases [C08]EUCTR2011-001643-79-DEGlaxoSmithKline Research & Development Limited6,200
Active, not recruiting
Not Applicable
A 6-month study to assess the safety and benefit of inhaled fluticasone propionate/salmeterol combination compared with inhaled fluticasone propionate in the treatment of children aged 4 to 11 years with asthma.EUCTR2011-001643-79-HUGlaxoSmithKline Research & Development Limited6,200
Active, not recruiting
Not Applicable
A 6-month study to assess the safety and benefit of inhaled fluticasone propionate/salmeterol combination compared with inhaled fluticasone propionate in the treatment of children aged 4 to 11 years with asthma.EUCTR2011-001643-79-SKGlaxoSmithKline Research & Development Limited6,200
Active, not recruiting
Not Applicable
A 6-month study to assess the safety and benefit of inhaled fluticasone propionate/salmeterol combination compared with inhaled fluticasone propionate in the treatment of children aged 4 to 11 years with asthma.AsthmaMedDRA version: 17.0Level: PTClassification code 10003553Term: AsthmaSystem Organ Class: 10038738 - Respiratory, thoracic and mediastinal disordersTherapeutic area: Diseases [C] - Respiratory Tract Diseases [C08]EUCTR2011-001643-79-LTGlaxoSmithKline Research & Development Limited6,200