Asthma
Conditions
Keywords
Mild persistent or mild intermittent asthma
Brief 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.
Detailed description
A randomized, cross over study evaluating the effect of Flovent Discus 100 mcg BID vs QVAR 80 mcg BID vs Pulmicort Flexhaler 180 mcg BID on short term growth in pediatric subjects with asthma. Objectives: 1. The primary objective of this study is to compare the effect of Flovent Diskus 100 mcg BID versus Pulmicort Flexhaler 180 mcg BID on short-term lower leg growth velocity as measured by knemometry in pediatric subjects with mild asthma. 2. The secondary objective of this study is to compare the effect of Flovent Diskus 100 mcg BID versus QVAR 80 mcg BID on short-term lower leg growth velocity as measured by knemometry in pediatric subjects with mild asthma. Aims: 1. The primary aim is to show that there is a growth suppressive effect of Pulmicort Flexhaler 180 mcg BID versus Flovent Diskus 100 mcg BID in children with mild asthma. 2. The secondary aim to show that there is a growth suppressive effect of QVAR 80 mcg BID versus Flovent Diskus 100 mcg BID in children with mild asthma. Hypotheses: 1. The primary hypothesis is that treatment with Pulmicort Flexhaler 180mcg BID as compared to Flovent Diskus 100 mcg BID has a growth suppressive effect on lower leg length as assessed by knemometry in pediatric subjects with mild asthma. 2. The secondary hypothesis is that treatment with QVAR 80 mcg BID as compared to Flovent Diskus 100 mcg BID has a growth suppressive effect on lower leg length as assessed by knemometry in pediatric subjects with mild asthma.
Interventions
DRUGFluticasone, Budesonide, Beclomethasone
Fluticasone 100 mcg bid Budesonide 180 mcg bid Beclomethasone 80 mcg bid
DRUGFluticasone, Beclomethasone, Budesonide
Fluticasone 100mcg BID Beclomethasone 80 mcg BID Budesonide 180 mcg BID
DRUGBudesonide, Fluticasone, Beclomethasone
Budesonide180 mcg BID Fluticasone 100 mcg Beclomethasone 80 mcg BID
DRUGBudesonide, Beclomethasone, Fluticasone
Budesonide 180 mcg BID Beclomethasone 80mcg BID Fluticasone 100mcg BID
DRUGBeclomethasone, Fluticasone, Budesonide
Beclomethasone 80 mcg BID Fluticasone 100mcg BID Budesonide 180 mcg BID
DRUGBeclomethasone, Budesonide, Fluticasone
Beclomethasone 80mcg BID Budesonide 180 mcg BID Fluticasone 100mcg BID
Sponsors
West Penn Allegheny Health System
Study design
Allocation
RANDOMIZED
Intervention model
CROSSOVER
Primary purpose
TREATMENT
Masking
NONE
Eligibility
Sex/Gender
ALL
Age
6 Years to 11 Years
Healthy volunteers
Yes
Inclusion criteria
1. Subjects will include females (6 to 9 years of age) and males (6 to 11 years of age). 2. 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. 3. All subjects must have a height within normal limits (5th to 95th percentile) and no history of abnormal growth as assessed by medical history. 4. All subjects must be pre-pubertal (Tanner Stage 1 Sexual Maturity) as assessed by physical examination. 5. 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. 6. Subjects must be willing to comply with study requirements.
Exclusion criteria
1. Subjects will be excluded if they have asthma greater than mild persistent severity as defined by NHLBI guidelines. 2. Subjects will be excluded if they used any systemic or nasal steroids within the past 60 days. 3. Subjects will be excluded if they had more than one burst of systemic steroids within the past year. 4. Subjects will be excluded if their baseline FEV1 is \< 80% predicted. 5. Subjects will be excluded if they have any other serious systemic disease other than asthma. 6. Subjects will be excluded if they have taken any medication known to affect growth i.e. ADHD medications within the past 60 days 7. Subjects will be excluded if they have a history of allergy to any of the study medications, milk protein or lactose. 8. Subjects will be excluded if they have active chickenpox or measles or recent exposure to chickenpox or measles. 9. Subjects will be excluded if they have any history of tuberculosis of the respiratory tract. 10. Subjects will be excluded if they have any active fungal, bacterial, viral or parasitic infections. 11. Subjects will be excluded if they have any history of herpes simplex infection of the eye. 12. Subjects will be excluded if they have taken any immunosuppressive drugs within the past 2 months. 13. Subjects will be excluded if they have any history of Churg-Strauss syndrome or other eosinophilic disorders. 14. Subjects will be excluded if an investigator deems they have any mental or development health issues, such as autism, moderate to severe mental retardation or severe ADHD,that interferes with their ability to complete the knemometry measurements. 15. Subjects will be excluded if an investigator deems they have any physical issues, such as inability to sit independently or amputation of lower leg, that interferes with their ability to complete the knemometry measurements.
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Short-term Lower Leg Growth During Treatment With Flovent Diskus 100 mcg BID or Pulmicort Flexhaler 180 mcg BID. | 1 yr | Short-term lower leg growth as assessed by knemometry in pediatric subjects with mild asthma treated with Flovent Discus 100 mcg BID or Pulmicort Flexhaler 180 mcg BID. |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| Short-term Lower Leg Growth During Treatment With Flovent Discus 100 mcg BID or QVAR 80 mcg BID. | 1 yr | Short-term lower leg growth as assessed by knemometry in pediatric subjects with mild asthma during treatment with Flovent Discus 100 mcg BID or QVAR 80 mcg BID. |
Countries
United States
Participant flow
Participants by arm
| Arm | Count |
|---|---|
| All Study Participants | 27 |
| Total | 27 |
Baseline characteristics
| Characteristic | All Study Participants |
|---|---|
| Age, Continuous | 8.4 years STANDARD_DEVIATION 1.57 |
| Race (NIH/OMB) American Indian or Alaska Native | 0 Participants |
| Race (NIH/OMB) Asian | 0 Participants |
| Race (NIH/OMB) Black or African American | 2 Participants |
| Race (NIH/OMB) More than one race | 0 Participants |
| Race (NIH/OMB) Native Hawaiian or Other Pacific Islander | 0 Participants |
| Race (NIH/OMB) Unknown or Not Reported | 0 Participants |
| Race (NIH/OMB) White | 25 Participants |
| Region of Enrollment United States | 27 Participants |
| Sex: Female, Male Female | 5 Participants |
| Sex: Female, Male Male | 22 Participants |
Adverse events
| Event type | EG000 affected / at risk | EG001 affected / at risk | EG002 affected / at risk |
|---|---|---|---|
| deaths Total, all-cause mortality | 0 / 27 | 0 / 27 | 0 / 27 |
| other Total, other adverse events | 7 / 27 | 6 / 27 | 7 / 27 |
| serious Total, serious adverse events | 0 / 27 | 0 / 27 | 0 / 27 |
Outcome results
Primary
Short-term Lower Leg Growth During Treatment With Flovent Diskus 100 mcg BID or Pulmicort Flexhaler 180 mcg BID.
Short-term lower leg growth as assessed by knemometry in pediatric subjects with mild asthma treated with Flovent Discus 100 mcg BID or Pulmicort Flexhaler 180 mcg BID.
Time frame: 1 yr
| Arm | Measure | Value (MEAN) |
|---|---|---|
| Flovent Discus 100 mcg BID | Short-term Lower Leg Growth During Treatment With Flovent Diskus 100 mcg BID or Pulmicort Flexhaler 180 mcg BID. | 0.37 mm/wk |
| Pulmicort Flexhaler 180 mcg BID | Short-term Lower Leg Growth During Treatment With Flovent Diskus 100 mcg BID or Pulmicort Flexhaler 180 mcg BID. | 0.21 mm/wk |
Secondary
Short-term Lower Leg Growth During Treatment With Flovent Discus 100 mcg BID or QVAR 80 mcg BID.
Short-term lower leg growth as assessed by knemometry in pediatric subjects with mild asthma during treatment with Flovent Discus 100 mcg BID or QVAR 80 mcg BID.
Time frame: 1 yr
| Arm | Measure | Value (MEAN) |
|---|---|---|
| Flovent Discus 100 mcg BID | Short-term Lower Leg Growth During Treatment With Flovent Discus 100 mcg BID or QVAR 80 mcg BID. | 0.37 mm/wk |
| Pulmicort Flexhaler 180 mcg BID | Short-term Lower Leg Growth During Treatment With Flovent Discus 100 mcg BID or QVAR 80 mcg BID. | 0.38 mm/wk |