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| Name | Class |
|---|---|
| Meda Pharmaceuticals | INDUSTRY |
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The purpose of this study is to see how two doses of Flunisolide HFA (an FDA approved inhaled medication to treat asthma) affect the small airways in children with asthma.
This is a prospective, randomized, parallel, open label study. The primary aim is to compare the average change in spirometric values (Forced expiratory volume 1 (FEV1) and Forced Expiratory Flow 25-75% (FEF 25-75%) and Impulse Oscillometry System (IOS) values (Resistance at 5 Hz (R5), Resistance at 20 Hz (R20), Area of reactance (AX), Resonant frequency (Fres)) from baseline to week 6 from participants randomized flunisolide hydrofluoroalkane (HFA) 1 inhalation BID and to flunisolide HFA 2 inhalations BID. The change in scores from baseline to six week follow up will initially be compared using paired t-tests and Chi-squared tests for trend. Repeated measurements will be analyzed using generalized linear mixed-effects regression modeling (GLMM) techniques. For continuous outcomes (e.g. FEV1, FEF 25-75%, Fres, reactance at 5 Hz (X5), AX, R5-R20). The identity link function and normal distribution will be used. For count data (e.g., use of Beta-agonists, episodes of coughing, episodes of wheezing, etc.) the log link function and the Poisson distribution will be used. If we dichotomize outcomes (e.g., a Beta-agonist was used, coughing occurred, etc.) the logit link function and Bernoulli distribution will be used.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Flunisolide 160 mcg per day | Active Comparator | Patients will receive inhaled Flunisolide HFA 80 mcg twice per day for a total of 160 mcg per day over the 6 week study period |
|
| Flunisolide 320 mcg per day | Active Comparator | Patients will receive inhaled Flunisolide HFA 160 mcg twice per day for a total of 320 mcg per day over the 6 week study period |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Flunisolide HFA | Drug |
|
| Measure | Description | Time Frame |
|---|---|---|
| Spirometry Forced Expiratory Volume 1 (FEV1) After Flunisolide | the most used outcome in respiratory studies | Before and after treatment at baseline and six week followup |
| Impulse Oscillometry (IOS) Area of Reactance (AX) After Flunisolide Treatment | A composite measure of small airway dysfunction. A reduction in IOS scores indicate an improvement. | Baseline and six week followup |
| Spirometry Forced Expiratory Flow 25-75% (FEF 25-75%) | Indirectly assess small airway function. | baseline and six week followup |
| Impulse Oscillometry (IOS) Resistance 5 (R5) | Resistance of the respiratory system at 5 Hz is a measure of total airway resistance. Elevated value is indicative of respiratory dysfunction. | initial visit and six week followup |
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Inclusion Criteria:
Exclusion Criteria:
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| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| University of Louisville Pediatric Pulmonology | Louisville | Kentucky | 40202 | United States |
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| ID | Title | Description |
|---|---|---|
| FG000 | Flunisolide 160 mcg Per Day | Patients will receive inhaled Flunisolide HFA 80 mcg twice per day for a total of 160 mcg per day over the 6 week study period Flunisolide HFA |
| FG001 | Flunisolide 320 mcg Per Day | Patients will receive inhaled Flunisolide HFA 160 mcg twice per day for a total of 320 mcg per day over the 6 week study period Flunisolide HFA |
| Title | Milestones | Reasons Not Completed | |||||||||||||||||||||
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| Overall Study |
|
|
Those subjects that completed the study protocol.
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| ID | Title | Description |
|---|---|---|
| BG000 | Flunisolide 160 mcg Per Day | Patients will receive inhaled Flunisolide HFA 80 mcg twice per day for a total of 160 mcg per day over the 6 week study period Flunisolide HFA |
| BG001 | Flunisolide 320 mcg Per Day |
| Units | Counts |
|---|---|
| Participants |
|
| Title | Description | Population Description | Parameter Type | Dispersion Type | Unit of Measure | Calculate Percentage | Denominator Units Selected | Denominators | Classes |
|---|---|---|---|---|---|---|---|---|---|
| Age, Continuous | Mean |
| 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 | Spirometry Forced Expiratory Volume 1 (FEV1) After Flunisolide | the most used outcome in respiratory studies | Those subjects that completed the study protocol. | Posted | Mean | Standard Deviation | % of predicted | Before and after treatment at baseline and six week followup |
|
up to 6 weeks
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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 | Flunisolide 160 mcg Per Day | Patients will receive inhaled Flunisolide HFA 80 mcg twice per day for a total of 160 mcg per day over the 6 week study period Flunisolide HFA |
| Term | Organ System | Source Vocabulary | Assessment Type | Notes | Statistical Information |
|---|---|---|---|---|---|
| Urinary tract infection | Renal and urinary disorders | Systematic Assessment |
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The small numbers of subjects who qualified and completed the study.
| Title | Organization | Phone | Extension | |
|---|---|---|---|---|
| Nemr Eid, MD | University Louisville | 502-852-3772 | n.eid@louisville.edu |
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| Type | Includes Protocol | Includes SAP | Includes ICF | Document Label | Document Date | Document Uploaded Date | Document File Name |
|---|---|---|---|---|---|---|---|
| ICF | No | No | Yes | Informed Consent Form | Feb 26, 2017 | Aug 16, 2017 | ICF_000.pdf |
| Prot_SAP | Yes | Yes | No | Study Protocol and Statistical Analysis Plan | Feb 26, 2017 | Nov 13, 2017 | Prot_SAP_003.pdf |
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| ID | Term |
|---|---|
| C007734 | flunisolide |
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Patients will receive inhaled Flunisolide HFA 160 mcg twice per day for a total of 320 mcg per day over the 6 week study period
Flunisolide HFA
| BG002 | Total | Total of all reporting groups |
| years |
|
| Sex: Female, Male | Count of Participants | Participants |
|
| Race (NIH/OMB) | Count of Participants | Participants |
|
| Region of Enrollment | Number | participants |
|
| OG002 | Flunisolide 160 mcg Per Day Posttreatment - 6 Wks | After 6 weeks treatment value for Patients who received inhaled Flunisolide HFA 80 mcg twice per day for a total of 160 mcg per day over the 6 week study period |
| OG003 | Flunisolide 320 mcg Per Day Posttreatment - 6 Weeks | After 6 week valeus for patients who received inhaled Flunisolide HFA 160 mcg twice per day for a total of 320 mcg per day over the 6 week study period Flunisolide HFA |
|
|
|
| Primary | Impulse Oscillometry (IOS) Area of Reactance (AX) After Flunisolide Treatment | A composite measure of small airway dysfunction. A reduction in IOS scores indicate an improvement. | Those subjects that completed the study protocol. | Posted | Mean | Standard Deviation | cmH2O/L | Baseline and six week followup |
|
|
|
|
| Primary | Spirometry Forced Expiratory Flow 25-75% (FEF 25-75%) | Indirectly assess small airway function. | Those subjects that completed the study protocol. | Posted | Mean | Standard Deviation | % of predicted | baseline and six week followup |
|
|
|
|
| Primary | Impulse Oscillometry (IOS) Resistance 5 (R5) | Resistance of the respiratory system at 5 Hz is a measure of total airway resistance. Elevated value is indicative of respiratory dysfunction. | Only data for subjects who completed study are presented. | Posted | Mean | Standard Deviation | cmH2O(L/s) | initial visit and six week followup |
|
|
|
|
| 0 |
| 10 |
| 1 |
| 10 |
| 0 |
| 10 |
| EG001 | Flunisolide 320 mcg Per Day | Patients will receive inhaled Flunisolide HFA 160 mcg twice per day for a total of 320 mcg per day over the 6 week study period Flunisolide HFA | 0 | 9 | 0 | 9 | 0 | 9 |
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| Mixed Models Analysis |
generalized linear mixed-effects models (GLMM) using the identity link function and normal distribution were used |
| 0.820 |
| Equivalence |
secondary goal was to evaluate whether flunisolide HFA 320 mcg when compared to flunisolide 160 mcg lead to significantly better improvement in the same outcome measures over time. |
| Mixed Models Analysis | 0.582 | Equivalence | A goal was to evaluate whether flunisolide HFA 320 mcg when compared to flunisolide 160 mcg lead to significantly better improvement in the same outcome measures over time. |
| Mixed Models Analysis |
generalized linear mixed-effects models (GLMM) using the identity link function and normal distribution were used. |
| .906 |
| Equivalence |
The primary aim is to compare the average change in spirometric values (FEV1 and FEF25-75%) and AX from baseline to Week 6 from participants randomized flunisolide HFA 1 inhalation BID and to flunisolide HFA 2 inhalations BID. |
| Mixed Models Analysis | generalized linear mixed-effects models (GLMM) using the identity link function and normal distribution were used. | .102 | Equivalence | The primary aim is to compare the average change in spirometric values (FEV1 and FEF25-75%) and AX from baseline to Week 6 from participants randomized flunisolide HFA 1 inhalation BID and to flunisolide HFA 2 inhalations BID. |
|
| Mixed Models Analysis |
generalized linear mixed-effects models (GLMM) using the identity link function and normal distribution were used |
| .543 |
| Equivalence |
To assess the impact of flunisolide on small airway parameters using spirometry and impulse oscillometry and determine whether there is a dose-related difference (320 mcg vs 160 mcg) with flunisolide HFA in pediatric patients who have evidence of small airway obstruction. |
| Mixed Models Analysis | generalized linear mixed-effects models (GLMM) using the identity link function and normal distribution were used | .6 | Equivalence | To assess the impact of flunisolide on small airway parameters using spirometry and impulse oscillometry and determine whether there is a dose-related difference (320 mcg vs 160 mcg) with flunisolide HFA in pediatric patients who have evidence of small airway obstruction. |