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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.
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:
Aims:
Hypotheses:
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| 1 Treatment Sequence, FPQ | Experimental | Period 2 Flovent Diskus Period 4 Pulmicort Flexhaler Period 6 QVAR |
|
| 2 Treatment Sequence, FQP | Experimental | Period 2 Flovent Diskus Period 4 QVAR Period 6 Pulmicort |
|
| 3 Treatment Sequence, PFQ | Experimental | Period 2 Pulmicort Period 4 Flovent Period 6 QVAR |
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| 4-Treatment Sequence, PQF | Experimental | Period 2 Pulmicort Period 4 QVAR Period 6 Flovent |
|
| 5 Treatment Sequence, QFP | Experimental | Period 2 QVAR Period 4 Flovent Period 6 Pulmicort |
|
| 6 Treatment Sequence, QPF | Experimental |
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Fluticasone, Budesonide, Beclomethasone | Drug | Fluticasone 100 mcg bid Budesonide 180 mcg bid Beclomethasone 80 mcg bid |
|
| Measure | Description | Time Frame |
|---|---|---|
| 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. | 1 yr |
| Measure | Description | Time Frame |
|---|---|---|
| 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. | 1 yr |
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Inclusion Criteria:
Exclusion Criteria:
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| Name | Affiliation | Role |
|---|---|---|
| Deborah A Gentile, MD | Allegheny Singer Research Institute/Allegheny General Hospital | Principal Investigator |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Pediatric Alliance-Greentree Division | Green Tree | Pennsylvania | 15220 | United States | ||
| Allegheny General Hospital |
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| ID | Title | Description |
|---|---|---|
| FG000 | 1 Treatment Sequence, FPQ | Period 2 Flovent Diskus Period 4 Pulmicort Flexhaler Period 6 QVAR Fluticasone, Budesonide, Beclomethasone: Fluticasone 100 mcg bid Budesonide 180 mcg bid Beclomethasone 80 mcg bid |
| FG001 | 2 Treatment Sequence, FQP |
| Title | Milestones | Reasons Not Completed | |||||
|---|---|---|---|---|---|---|---|
| Overall Study |
|
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Period 2 QVAR Period 4 Pulmicort Period 6 Flovent
|
| Fluticasone, Beclomethasone, Budesonide | Drug | Fluticasone 100mcg BID Beclomethasone 80 mcg BID Budesonide 180 mcg BID |
|
|
| Budesonide, Fluticasone, Beclomethasone | Drug | Budesonide180 mcg BID Fluticasone 100 mcg Beclomethasone 80 mcg BID |
|
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| Budesonide, Beclomethasone, Fluticasone | Drug | Budesonide 180 mcg BID Beclomethasone 80mcg BID Fluticasone 100mcg BID |
|
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| Beclomethasone, Fluticasone, Budesonide | Drug | Beclomethasone 80 mcg BID Fluticasone 100mcg BID Budesonide 180 mcg BID |
|
|
| Beclomethasone, Budesonide, Fluticasone | Drug | Beclomethasone 80mcg BID Budesonide 180 mcg BID Fluticasone 100mcg BID |
|
|
| Pittsburgh |
| Pennsylvania |
| 15212 |
| United States |
Period 2 Flovent Diskus Period 4 QVAR Period 6 Pulmicort Fluticasone, Beclomethasone, Budesonide: Fluticasone 100mcg BID Beclomethasone 80 mcg BID Budesonide 180 mcg BID |
| FG002 | 3 Treatment Sequence, PFQ | Period 2 Pulmicort Period 4 Flovent Period 6 QVAR Budesonide, Fluticasone, Beclomethasone: Budesonide180 mcg BID Fluticasone 100 mcg Beclomethasone 80 mcg BID |
| FG003 | 4-Treatment Sequence, PQF | Period 2 Pulmicort Period 4 QVAR Period 6 Flovent Budesonide, Beclomethasone, Fluticasone: Budesonide 180 mcg BID Beclomethasone 80mcg BID Fluticasone 100mcg BID |
| FG004 | 5 Treatment Sequence, QFP | Period 2 QVAR Period 4 Flovent Period 6 Pulmicort Beclomethasone, Fluticasone, Budesonide: Beclomethasone 80 mcg BID Fluticasone 100mcg BID Budesonide 180 mcg BID |
| FG005 | 6 Treatment Sequence, QPF | Period 2 QVAR Period 4 Pulmicort Period 6 Flovent Beclomethasone, Budesonide, Fluticasone: Beclomethasone 80mcg BID Budesonide 180 mcg BID Fluticasone 100mcg BID |
| FG006 | Enrolled But Not Randomized. | These subjects were consented but not randomized. |
| COMPLETED |
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| NOT COMPLETED |
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| ID | Title | Description |
|---|---|---|
| BG000 | All Study Participants |
| Units | Counts |
|---|---|
| Participants |
|
| Title | Description | Population Description | Parameter Type | Dispersion Type | Unit of Measure | Calculate Percentage | Denominator Units Selected | Denominators | Classes | ||||||||||||
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| Age, Continuous | Mean | Standard Deviation | years |
| |||||||||||||||||
| Sex: Female, Male | Count of Participants | Participants |
| ||||||||||||||||||
| Race (NIH/OMB) | Count of Participants | Participants |
| ||||||||||||||||||
| Region of Enrollment | Count of Participants | Participants |
|
| Type | Title | Description | Population Description | Reporting Status | Anticipated Posting Date | Parameter Type | Dispersion Type | Unit of Measure | Calculate Percentage | Time Frame | Units Analyzed | Denominator Units Selected | Arm/Group Information | Denominators | Classes | Analyses | |||||||||||||||||||||||
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| 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. | Posted | Mean | 95% Confidence Interval | mm/wk | 1 yr |
|
|
| |||||||||||||||||||||||||||||
| 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. | Posted | Mean | 95% Confidence Interval | mm/wk | 1 yr |
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| ID | Title | Description | Deaths (Affected) | Deaths (At Risk) | Serious Events (Affected) | Serious Events (At Risk) | Other Events (Affected) | Other Events (At Risk) |
|---|---|---|---|---|---|---|---|---|
| EG000 | Flovent Discus 100 mcg BID | 0 | 27 | 0 | 27 | 7 | 27 | |
| EG001 | Pulmicort Flexhaler 180 mcg BID | 0 | 27 | 0 | 27 | 6 | 27 | |
| EG002 | QVAR 80 mcg BID | 0 | 27 | 0 | 27 | 7 | 27 |
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| Term | Organ System | Source Vocabulary | Assessment Type | Notes | Statistical Information |
|---|---|---|---|---|---|
| Colds/viral illnesses | General disorders |
| |||
| Headaches | General disorders |
| |||
| Respiratory infections | Respiratory, thoracic and mediastinal disorders |
| |||
| Worsening allergies | Immune system disorders |
| |||
| Bodily injuries | General disorders |
| |||
| Asthma exacerbation | Immune system disorders |
| |||
| Ear infection | Ear and labyrinth disorders |
| |||
| Sinus infection | General disorders |
| |||
| Pneumonia | Respiratory, thoracic and mediastinal disorders |
|
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| Title | Organization | Phone | Extension | |
|---|---|---|---|---|
| Deborah Gentile, MD | Allegheny Health Network | 412-359-4099 | dgentile@ahn.org |
| ID | Term |
|---|---|
| D001249 | Asthma |
| ID | Term |
|---|---|
| D001982 | Bronchial Diseases |
| D012140 | Respiratory Tract Diseases |
| D008173 | Lung Diseases, Obstructive |
| D008171 | Lung Diseases |
| D012130 | Respiratory Hypersensitivity |
| D006969 | Hypersensitivity, Immediate |
| D006967 | Hypersensitivity |
| D007154 | Immune System Diseases |
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| ID | Term |
|---|---|
| D000068298 | Fluticasone |
| D019819 | Budesonide |
| D001507 | Beclomethasone |
| ID | Term |
|---|---|
| D000730 | Androstadienes |
| D000736 | Androstenes |
| D000731 | Androstanes |
| D013256 | Steroids |
| D000072473 | Fused-Ring Compounds |
| D011083 | Polycyclic Compounds |
| D011282 | Pregnenediones |
| D011283 | Pregnenes |
| D011278 | Pregnanes |
| D011246 | Pregnadienetriols |
| D011245 | Pregnadienes |
| D013258 | Steroids, Chlorinated |
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| Native Hawaiian or Other Pacific Islander |
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| Black or African American |
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| White |
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| More than one race |
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| Unknown or Not Reported |
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