Effect of Flovent Discus vs QVAR vs Pulmicort Flexhaler on Short Term Growth (NCT01520688) | Clinical Trial Compass
CompletedPhase 4
Effect of Flovent Discus vs QVAR vs Pulmicort Flexhaler on Short Term Growth
United States32 participantsStarted 2012-02
Plain-language summary
Children with mild persistent asthma that have asthma symptoms once or twice a week and use a daily controller, while children with mild intermittent asthma rarely have asthma symptoms and do not use a daily controller. Inhaled corticosteroids are the standard treatment for mild peristent asthma. The purpose of this study is to measure children rate of growth while on different inhaled corticosteroids.
Who can participate
Age range6 Years – 11 Years
SexALL
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Inclusion criteria
✓. Subjects will include females (6 to 9 years of age) and males (6 to 11 years of age).
✓. All subjects must have a history of physician diagnosed mild intermittent or mild persistent asthma as documented by PCP medical record or detailed history by study investigator.
✓. All subjects must have a height within normal limits (5th to 95th percentile) and no history of abnormal growth as assessed by medical history.
✓. All subjects must be pre-pubertal (Tanner Stage 1 Sexual Maturity) as assessed by physical examination.
✓. Subjects may be on current treatment with montelukast as this drug does not affect growth. If a subject is on montelukast at screening/baseline, they will remain on a stable dose throughout the study.
✓. Subjects must be willing to comply with study requirements.
Exclusion criteria
✕. Subjects will be excluded if they have asthma greater than mild persistent severity as defined by NHLBI guidelines.
✕. Subjects will be excluded if they used any systemic or nasal steroids within the past 60 days.
✕. Subjects will be excluded if they had more than one burst of systemic steroids within the past year.
✕. Subjects will be excluded if their baseline FEV1 is \< 80% predicted.
✕. Subjects will be excluded if they have any other serious systemic disease other than asthma.
What they're measuring
1
Short-term Lower Leg Growth During Treatment With Flovent Diskus 100 mcg BID or Pulmicort Flexhaler 180 mcg BID.