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This study is a single center, randomized pilot study to evaluate the clinical effectiveness of nasal high flow 20LPM humidification therapy in subjects with Cystic Fibrosis.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Experimental Therapy | Experimental | High-Flow, 20 LPM (via Optiflow cannula) Heated (34C) Humidified Air |
|
| Control Therapy (Low Flow) | Placebo Comparator | Low FLow, 5 LPM (via Optiflow cannula) Room Temperature (23-26C) Ambient Air |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| High-Flow, 20 LPM (via Optiflow cannula) | Device | Nasal high flow humidification (20LPM) therapy will be administered using Optiflow with Airvo 2. |
|
| Measure | Description | Time Frame |
|---|---|---|
| Change in Cystic Fibrosis Questionnaire-Revised (CFQ-R) | The Cystic Fibrosis Questionnaire-Revised (CFQ-R) is a validated health-related quality of life measure for CF that meets US Food and Drug Administration psychometric requirements for patient reported outcomes. It contains both generic and CF-specific scales and has demonstrated responsiveness in previous clinical studies. Scores range from 0 to 100 with higher scores indicating better health. | Day 0 to Day 6 or upon discharge from the hospital, whichever comes first |
| Measure | Description | Time Frame |
|---|---|---|
| Sputum Collection | Sputum is collected during pulmonary function test (PFT) to later measure the biophysical properties of cystic fibrosis sputum. | 10 minutes |
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Inclusion Criteria:
Exclusion Criteria:
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| Name | Affiliation | Role |
|---|---|---|
| Bruce K Rubin, MD | Virginia Commonwealth University | Principal Investigator |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Children's Hospital of Richmond at VCU | Richmond | Virginia | 23298 | United States |
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| ID | Title | Description |
|---|---|---|
| FG000 | Experimental Therapy | High-Flow, 20 LPM (via Optiflow cannula) Heated (34C) Humidified Air High-Flow, 20 LPM (via Optiflow cannula): Nasal high flow humidification (20LPM) therapy will be administered using Optiflow with Airvo 2. |
| FG001 | Control Therapy (Low Flow) | Low FLow, 5 LPM (via Optiflow cannula) Room Temperature (23-26C) Ambient Air Low FLow, 5 LPM (via Optiflow cannula): standard humidified wall medical air. |
| Title | Milestones | Reasons Not Completed | |||||||||||||||||||||
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| Overall Study |
|
|
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| ID | Title | Description |
|---|---|---|
| BG000 | Experimental Therapy | High-Flow, 20 LPM (via Optiflow cannula) Heated (34C) Humidified Air High-Flow, 20 LPM (via Optiflow cannula): Nasal high flow humidification (20LPM) therapy will be administered using Optiflow with Airvo 2. |
| BG001 | Control Therapy (Low Flow) |
| 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 | Change in Cystic Fibrosis Questionnaire-Revised (CFQ-R) | The Cystic Fibrosis Questionnaire-Revised (CFQ-R) is a validated health-related quality of life measure for CF that meets US Food and Drug Administration psychometric requirements for patient reported outcomes. It contains both generic and CF-specific scales and has demonstrated responsiveness in previous clinical studies. Scores range from 0 to 100 with higher scores indicating better health. | Results could not be reported for 4 participants due to missing baseline data in one case, missing followup data in one case, and no CFQ-R data in two cases. | Posted | Mean | Standard Deviation | change in score on a scale | Day 0 to Day 6 or upon discharge from the hospital, whichever comes first |
|
Length of hospital stay - up to 3 months
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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 | Experimental Therapy | High-Flow, 20 LPM (via Optiflow cannula) Heated (34C) Humidified Air High-Flow, 20 LPM (via Optiflow cannula): Nasal high flow humidification (20LPM) therapy will be administered using Optiflow with Airvo 2. |
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| Term | Organ System | Source Vocabulary | Assessment Type | Notes | Statistical Information |
|---|---|---|---|---|---|
| Nasal discomfort | Product Issues | Non-systematic Assessment |
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| Title | Organization | Phone | Extension | |
|---|---|---|---|---|
| Bruce K. Rubin MEngr, MD, MBA, FRCPC | Virginia Commonwealth University | 804 828 9604 | bruce.rubin@vcuhealth.org |
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| Type | Includes Protocol | Includes SAP | Includes ICF | Document Label | Document Date | Document Uploaded Date | Document File Name |
|---|---|---|---|---|---|---|---|
| Prot_SAP | Yes | Yes | No | Study Protocol and Statistical Analysis Plan | May 25, 2016 | Nov 20, 2020 | Prot_SAP_000.pdf |
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| ID | Term |
|---|---|
| D003550 | Cystic Fibrosis |
| ID | Term |
|---|---|
| D010182 | Pancreatic Diseases |
| D004066 | Digestive System Diseases |
| D008171 | Lung Diseases |
| D012140 | Respiratory Tract Diseases |
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| Low FLow, 5 LPM (via Optiflow cannula) | Device | standard humidified wall medical air. |
|
| Difficulty sleeping |
|
| Morning headache |
|
| Withdrawal by Subject |
|
Low FLow, 5 LPM (via Optiflow cannula) Room Temperature (23-26C) Ambient Air Low FLow, 5 LPM (via Optiflow cannula): standard humidified wall medical air. |
| BG002 | Total | Total of all reporting groups |
| years |
|
| Sex: Female, Male | Count of Participants | Participants |
|
| Ethnicity (NIH/OMB) | Count of Participants | Participants |
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| Race (NIH/OMB) | Count of Participants | Participants |
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| Region of Enrollment | Number | participants |
|
| OG001 | Control Therapy (Low Flow) | Low FLow, 5 LPM (via Optiflow cannula) Room Temperature (23-26C) Ambient Air Low FLow, 5 LPM (via Optiflow cannula): standard humidified wall medical air. |
|
|
| Secondary | Sputum Collection | Sputum is collected during pulmonary function test (PFT) to later measure the biophysical properties of cystic fibrosis sputum. | We were unable to collect sputum samples from the participants | Posted | 10 minutes |
|
|
| 0 |
| 6 |
| 0 |
| 6 |
| 2 |
| 6 |
| EG001 | Control Therapy (Low Flow) | Low FLow, 5 LPM (via Optiflow cannula) Room Temperature (23-26C) Ambient Air Low FLow, 5 LPM (via Optiflow cannula): standard humidified wall medical air. | 0 | 9 | 0 | 9 | 1 | 9 |
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| D030342 |
| Genetic Diseases, Inborn |
| D009358 | Congenital, Hereditary, and Neonatal Diseases and Abnormalities |
| D007232 | Infant, Newborn, Diseases |