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Therapeutic Areas: Pediatrics/Neonatology | Pulmonary/Respiratory Diseases | Family Medicine
Disease Category: Asthma (Pediatric)
Location: United States, GA
Does your child have Asthma? This study will compare two different medications and your child's asthma will continue to be treated.
The VESTRI study is being conducted worldwide. The study is comparing a medication which is a combination of two different drugs (fluticasone proprionate/salmeterol) to a medication that has only one drug (fluticasone propionate alone). Both the combination drug and fluticasone propionate alone are available by prescription outside of this clinical research study. It is important to note that this study will compare two different medications and your child's asthma will continue to be treated.
Patient Inclusion Criteria:
- Consent to participate in the study
- Age 4-11 years old
- 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
- Asthma diagnosis for at least 6 months
- Ability to answer questions regarding asthma control and use a metered dose inhaler and DISKUS
- A history of clinical varicella infection or recipient of a varicella vaccine in countries where the product label includes a warning regarding more serious chickenpox infections in patients using corticosteroids.
- History of at least once occurrence of asthma exacerbation within the prior 12 months
- Currently being treated for asthma and no change in asthma therapy for the last 4 weeks (Eligible subjects include: subjects with use of short-acting beta-agonist, leukotriene receptor antagonist, theophylline, or cromolyn whose asthma is not well-controlled; subjects on low-dose ICS monotherapy whose asthma is not well-controlled; subjects on low-dose ICS and one or more adjunctive therapy whose asthma is either controlled or not well-controlled asthma; subjects on medium-dose ICS monotherapy whose asthma is either controlled or not well-controlled; and subjects on medium-dose ICS and one or more adjunctive therapy whose asthma is well-controlled)
Patient Exclusion Criteria:
- History of life-threatening asthma
- Unstable asthma
- Current use of high-dose ICS or ICS/LABA therapy to treat asthma symptoms
- 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.
- Respiratory infection
- Subjects with only exercise-induced asthma
- An asthma exacerbation within the last 4 weeks or more than 4 separate exacerbations in the last 12 months
Clinical Research Atlanta
175 Country Club Drive
Stockbridge, GA 30281
Research Center Information: Clinical Research Atlanta
If you would like to learn more about participating in this study, please send an email message using the form below.
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