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The primary objective of the study is to show that ventilation heterogeneity identified by hyperpolarized helium-3 lung MRI is prevalent children with poorly controlled asthma despite guidelines-based treatment with ICS. The secondary objective is to demonstrate whether or not eight weeks of treatment with extra-fine particle ICS (HFA-BDP) improves ventilation heterogeneity compared to treatment with a coarse particle ICS (fluticasone HFA or dry powder).
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Beclomethasone | Experimental | Subjects are being randomized to 8 weeks of beclomethasone or fluticasone treatment followed by a 4 week study drug washout with resumption of standard asthma medication regimen for 4 weeks, followed by 8 weeks of beclomethasone or fluticasone (whichever drug was not taken the first 8 weeks) |
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| fluticasone | Experimental | Subjects are being randomized to 8 weeks of beclomethasone or fluticasone treatment followed by a 4 week study drug washout with resumption of standard asthma medication regimen for 4 weeks, followed by 8 weeks of beclomethasone or fluticasone (whichever drug was not taken the first 8 weeks) |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| beclomethasone | Drug |
| ||
| fluticasone |
| Measure | Description | Time Frame |
|---|---|---|
| Ventilation Heterogeneity Index (VHI) | VHI = lung defect volume divided by total lung volume. It is a ratio scale. | Baseline |
| Measure | Description | Time Frame |
|---|---|---|
| Change in Ventilation Heterogenity Index (VHI) | VHI = lung defect volume divided by total lung volume. This is a ratio scale that will be measured at four timepoints: enrollment (week 0), end of treatment 1(week 12), start of treatment 2 (week 16), and end of treatment 2 (week 24). The VHI will be compared at the beginning and end of phase 1 and at the beginning and end of phase two using ANOVA based on a mixed-effects model, with fixed effects of sequence, period, and treatment of a random effect of subject within sequence, and baseline covariate. |
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Inclusion Criteria:
an ACT ≤ 19 and/or ACQ ≥ 1.5 units at the screening and/or randomization visits despite continuous or intermittent treatment with ICS and/or an anti-leukotriene within six months before enrollment.
Exclusion Criteria:
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| Name | Affiliation | Role |
|---|---|---|
| W. Gerald Teague, MD | University of Virginia | Principal Investigator |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| University of Virginia - Fontaine Research Park | Charlottesville | Virginia | 22908 | United States |
| PubMed Identifier | Type | Citation | Retractions |
|---|---|---|---|
| 33621442 | Derived | Gerald Teague W, Mata J, Qing K, Tustison NJ, Mugler JP, Meyer CH, de Lange EE, Shim YM, Wavell K, Altes TA. Measures of ventilation heterogeneity mapped with hyperpolarized helium-3 MRI demonstrate a T2-high phenotype in asthma. Pediatr Pulmonol. 2021 Jun;56(6):1440-1448. doi: 10.1002/ppul.25303. Epub 2021 Feb 23. |
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| Type | Date | Date Unknown |
|---|---|---|
| Release | Feb 7, 2022 | |
| Reset | Mar 2, 2022 | |
| Release | Apr 13, 2022 |
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|
| Baseline (week 0), week 12, week 16, and week 24 |
| Reset | May 10, 2022 |
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| Release Date | Unrelease Date | Unrelease Date Unknown | Reset Date | MCP Release Number |
|---|---|---|---|---|
| Feb 7, 2022 | Mar 2, 2022 | |||
| Apr 13, 2022 | May 10, 2022 |
| 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 |
|---|---|
| D001507 | Beclomethasone |
| D000068298 | Fluticasone |
| ID | Term |
|---|---|
| D011246 | Pregnadienetriols |
| D011245 | Pregnadienes |
| D011278 | Pregnanes |
| D013256 | Steroids |
| D000072473 | Fused-Ring Compounds |
| D011083 | Polycyclic Compounds |
| D013258 | Steroids, Chlorinated |
| D000730 | Androstadienes |
| D000736 | Androstenes |
| D000731 | Androstanes |
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