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| Name | Class |
|---|---|
| Cystic Fibrosis Foundation | OTHER |
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This is a pilot study investigating the effectiveness and clinical efficacy of airway clearance therapy (ACT) in cystic fibrosis (CF). Enrolled subjects will undergo measurements of mucociliary clearance (MCC) and exhaled biomarkers at baseline and after 3 different forms of ACT: high frequency chest wall oscillatory vest, oscillatory positive expiratory pressure device, and whole-body vibration.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Sequence A | Active Comparator | In this arm, the interventions were performed in the following order: Baseline (prior to randomization), Whole body vibration, High Frequency Chest Wall Oscillation (HFCWO, aka "Vest" or TheVest®), Oscillatory Positive Expiratory Pressure (OPEP) (note this is different than the sequence shown in the example latin square shown in the included protocol, as that was meant to serve as an example -- actual randomization and formulation of the employed latin square / sequence generator was performed following completion of the protocol) |
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| Sequence B | Active Comparator | In this arm, the interventions were performed in the following order: Baseline (prior to randomization), HFCWO, OPEP, Whole body vibration (note this is different than the sequence shown in the example latin square shown in the included protocol, as that was meant to serve as an example -- actual randomization and formulation of the employed latin square / sequence generator was performed following completion of the protocol) |
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| Sequence C | Active Comparator | In this arm, the interventions were performed in the following order: Baseline (prior to randomization), OPEP, Whole body vibration, HFCWO (note this is different than the sequence shown in the example latin square shown in the included protocol, as that was meant to serve as an example -- actual randomization and formulation of the employed latin square / sequence generator was performed following completion of the protocol) |
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Baseline (Huff-Cough alone) | Other | Subjects will provide two "huffs" (forced expiratory maneuver with open glottis) followed by a cough every six minutes for a total of six Huff-Coughs. |
| Measure | Description | Time Frame |
|---|---|---|
| Mucociliary Clearance-274 | As described in the protocol, gamma scintigraphy was used to measure clearance of particles from the whole right lung region of interest over 274 minutes. The primary outcome for this study was the area under the particle clearance curve from time 0 to 274 minutes post-inhalation (normalized to time by dividing by 274) and expressed as a percent, representing total average rate of mucociliary clearance (MCC). | 274 minutes |
| Measure | Description | Time Frame |
|---|---|---|
| Mucociliary Clearance-90 | As described in the protocol, gamma scintigraphy was used to measure clearance of particles from the whole right lung region of interest over 274 minutes. This outcome for this study was the area under the particle clearance curve from time 0 to 90 minutes post-inhalation (normalized to time by dividing by 90) and expressed as a percent, representing average rate of mucociliary clearance (MCC) over 90 minutes. |
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Inclusion Criteria:
Exclusion Criteria:
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| Name | Affiliation | Role |
|---|---|---|
| Aaron T Trimble, MD | Fellow | Principal Investigator |
| Scott Donaldson, MD | Associate Professor of Medicine | Principal Investigator |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Marsico Clinical Research Center | Chapel Hill | North Carolina | 27517 | United States |
There are no plans at this time to share individual participant data.
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Following screening, patients performed a baseline study visit prior to randomization into the study arms which determined which order to complete the other three interventions would be performed. Baseline (or "huff-cough") was completed prior to randomization to ensure comparator data if a patient was unable to complete the study.
Patients were screened and recruited from the adult CF clinic at UNC from January 2017 to December 2017.
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| ID | Title | Description |
|---|---|---|
| FG000 | Sequence A | In this arm, the interventions were performed in the following order: Baseline (prior to randomization), Whole body vibration, Vest, Oscillatory Positive Expiratory Pressure (OPEP). (note this is different than the sequence shown in the example latin square shown in the included protocol, as that was meant to serve as an example -- actual randomization and formulation of the employed latin square / sequence generator was performed following completion of the protocol) |
| Title | Milestones | Reasons Not Completed | |||||
|---|---|---|---|---|---|---|---|
| First Intervention |
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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 | Jun 15, 2017 |
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All subjects will undergo baseline testing, followed by study procedures for three separate interventions, with subjects randomized into three arms in which a different sequence in which to complete the studies.
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| Oscillatory Positive Expiatory Pressure Device | Device | Subjects will use an Areobika® branded OPEP device (10 breaths through highest tolerated resistance) prior to undergoing a Huff-Cough. Subjects will use the device six times every six minutes. |
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| Whole-Body Vibration Platform | Device | Subjects will be seated on a PowerPlate® whole-body vibration platform for 90 seconds prior to Huff-Cough. Six intervals on the platform will be completed six minutes apart. |
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| High Frequency Chest Wall Oscillatory Vest | Device | Subjects will use TheVest® using a standardized "Minnesota Protocol" divided into six, four-minute segments, each followed by a Huff-Cough. |
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| 90 minutes |
| Change in Rate of MCC | Change in slope of particle clearance curve between pre intervention and ACT period. | pre-ACT (0-16 mins) and during ACT (16-50 mins) |
| Change in Fraction of Exhaled Nitric Oxide (FENO) | FENO measurements were obtained pre- and post- intervention. The difference of post- vs pre- ACT FENO was reported. | pre and immediately post intervention (50 mins post inhalation) |
| Purine Analysis (AMP) in Exhaled Breath Condensate | Exhaled breath condensate was collected using a commercial device for this purpose. Concentrations of the purine adenosine monophosphate (AMP) and urea in this liquid were determined using mass spectrometry. This outcome was the difference in concentrations of AMP normalized to urea in this exhaled breath condensate between post-ACT and pre-ACT intervention. | pre and immediately post intervention (50 mins post inhalation) |
| Purine Analysis (Adenosine) in Exhaled Breath Condensate (EBC) | Difference of concentration of adenosine (a purine) in EBC between post-ACT and pre-ACT intervention. | pre and immediately post intervention (50 mins post inhalation) |
| Purine Analysis (Hypoxanthine) in Exhaled Breath Condensate | Difference of concentration of hypoxanthine (a purine) in Exhaled Breath Condensate between post-ACT and pre-ACT intervention. | pre and immediately post intervention (50 mins post inhalation) |
| FG001 | Sequence B | In this arm, the interventions were performed in the following order: Baseline (prior to randomization), Vest, OPEP, Whole body vibration (note this is different than the sequence shown in the example latin square shown in the included protocol, as that was meant to serve as an example -- actual randomization and formulation of the employed latin square / sequence generator was performed following completion of the protocol) |
| FG002 | Sequence C | In this arm, the interventions were performed in the following order: Baseline (prior to randomization), OPEP, Whole body vibration, Vest (note this is different than the sequence shown in the example latin square shown in the included protocol, as that was meant to serve as an example -- actual randomization and formulation of the employed latin square / sequence generator was performed following completion of the protocol) |
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| NOT COMPLETED |
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| Washout (3-21 Days) |
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| Second Intervention |
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| Washout (3-21 Days) |
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| Third Intervention |
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Adults with CF from the UNC adult CF center.
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| ID | Title | Description |
|---|---|---|
| BG000 | Sequence A | In this arm, the interventions were performed in the following order: Baseline (prior to randomization), Whole body vibration, Vest, OPEP (note this is different than the sequence shown in the example latin square shown in the included protocol, as that was meant to serve as an example -- actual randomization and formulation of the employed latin square / sequence generator was performed following completion of the protocol) |
| BG001 | Sequence B | In this arm, the interventions were performed in the following order: Baseline (prior to randomization), Vest, OPEP, Whole body vibration (note this is different than the sequence shown in the example latin square shown in the included protocol, as that was meant to serve as an example -- actual randomization and formulation of the employed latin square / sequence generator was performed following completion of the protocol) |
| BG002 | Sequence C | In this arm, the interventions were performed in the following order: Baseline (prior to randomization), OPEP, Whole body vibration, Vest (note this is different than the sequence shown in the example latin square shown in the included protocol, as that was meant to serve as an example -- actual randomization and formulation of the employed latin square / sequence generator was performed following completion of the protocol) |
| BG003 | Total | Total of all reporting groups |
| Units | Counts |
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| Participants |
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| Title | Description | Population Description | Parameter Type | Dispersion Type | Unit of Measure | Calculate Percentage | Denominator Units Selected | Denominators | Classes | ||||||||||
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| Age, Categorical | Count of Participants | Participants |
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| Age, Continuous | Mean | Full Range | years |
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| Sex: Female, Male | Count of Participants | Participants |
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| Race (NIH/OMB) | Count of Participants | Participants |
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| 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 | Mucociliary Clearance-274 | As described in the protocol, gamma scintigraphy was used to measure clearance of particles from the whole right lung region of interest over 274 minutes. The primary outcome for this study was the area under the particle clearance curve from time 0 to 274 minutes post-inhalation (normalized to time by dividing by 274) and expressed as a percent, representing total average rate of mucociliary clearance (MCC). | Posted | Mean | Standard Error | percent clearance | 274 minutes |
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| Secondary | Mucociliary Clearance-90 | As described in the protocol, gamma scintigraphy was used to measure clearance of particles from the whole right lung region of interest over 274 minutes. This outcome for this study was the area under the particle clearance curve from time 0 to 90 minutes post-inhalation (normalized to time by dividing by 90) and expressed as a percent, representing average rate of mucociliary clearance (MCC) over 90 minutes. | All subjects were included for analysis | Posted | Mean | Standard Deviation | percent clearance | 90 minutes |
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| Secondary | Change in Rate of MCC | Change in slope of particle clearance curve between pre intervention and ACT period. | Only 4 subjects were included due to poor quality data obtained for slope measurement due to subject movement during the study (other MCC data used area under the curve data from key frames in which there was no subject movement, which proved to be more reliable). This data was not analyzed statistically. | Posted | Mean | Full Range | %clearance / minute | pre-ACT (0-16 mins) and during ACT (16-50 mins) |
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| Secondary | Change in Fraction of Exhaled Nitric Oxide (FENO) | FENO measurements were obtained pre- and post- intervention. The difference of post- vs pre- ACT FENO was reported. | Only subjects who had measurable FENO above detection limits of the device (i.e. <5 ppm) for both before and after ACT were included in analysis. Data from subjects during interventions who did not have a detectable FENO for both pre- and post- ACT were excluded for analysis. | Posted | Mean | Standard Deviation | ppm of NO | pre and immediately post intervention (50 mins post inhalation) |
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| Secondary | Purine Analysis (AMP) in Exhaled Breath Condensate | Exhaled breath condensate was collected using a commercial device for this purpose. Concentrations of the purine adenosine monophosphate (AMP) and urea in this liquid were determined using mass spectrometry. This outcome was the difference in concentrations of AMP normalized to urea in this exhaled breath condensate between post-ACT and pre-ACT intervention. | Posted | Mean | Standard Deviation | unitless ratio (AMP/Urea conc.) | pre and immediately post intervention (50 mins post inhalation) |
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| Secondary | Purine Analysis (Adenosine) in Exhaled Breath Condensate (EBC) | Difference of concentration of adenosine (a purine) in EBC between post-ACT and pre-ACT intervention. | Posted | Mean | Standard Deviation | unitless ratio (adenosine/Urea conc.) | pre and immediately post intervention (50 mins post inhalation) |
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| Secondary | Purine Analysis (Hypoxanthine) in Exhaled Breath Condensate | Difference of concentration of hypoxanthine (a purine) in Exhaled Breath Condensate between post-ACT and pre-ACT intervention. | Posted | Mean | Standard Deviation | unitless ratio (adenosine/Urea conc.) | pre and immediately post intervention (50 mins post inhalation) |
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Screening for adverse event occurred from time of subject enrollment through completion and follow-up of all study procedures, up to a total of approximately 1 year.
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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) |
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| EG000 | Huff-Cough Alone | Subjects will provide two "huffs" (forced expiratory maneuver with open glottis) followed by a cough every six minutes for a total of six Huff-Coughs. Huff-Cough alone: Subjects will provide two "huffs" (forced expiratory maneuver with open glottis) followed by a cough every six minutes for a total of six Huff-Coughs. | 0 | 10 | 0 | 10 | 0 | 10 |
| EG001 | Oscillatory Positive Expiatory Pressure Device (OPEP) | Subjects will use an Areobika® branded OPEP device (10 breaths through highest tolerated resistance) prior to undergoing a Huff-Cough. Subjects will use the device six times every six minutes. Oscillatory Positive Expiatory Pressure Device: Subjects will use an Areobika® branded OPEP device (10 breaths through highest tolerated resistance) prior to undergoing a Huff-Cough. Subjects will use the device six times every six minutes. | 0 | 10 | 0 | 10 | 0 | 10 |
| EG002 | Whole Body Vibration | Subjects will be seated on a PowerPlate® whole-body vibration platform for 90 seconds prior to Huff-Cough. Six intervals on the platform will be completed six minutes apart. Whole-Body Vibration Platform: Subjects will be seated on a PowerPlate® whole-body vibration platform for 90 seconds prior to Huff-Cough. Six intervals on the platform will be completed six minutes apart. | 0 | 10 | 0 | 10 | 0 | 10 |
| EG003 | High Frequency Chest Wall Oscillatory Vest | Subjects will use TheVest® using a standardized "Minnesota Protocol" divided into six, four-minute segments, each followed by a Huff-Cough. High Frequency Chest Wall Oscillatory Vest: Subjects will use TheVest® using a standardized "Minnesota Protocol" divided into six, four-minute segments, each followed by a Huff-Cough. | 0 | 10 | 0 | 10 | 0 | 10 |
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| Title | Organization | Phone | Extension | |
|---|---|---|---|---|
| Scott Donaldson, MD | University of North Carolina at Chapel Hill | 984-974-9198 | scott_donaldson@med.unc.edu |
| Jan 9, 2019 |
| Prot_SAP_000.pdf |
| ID | Term |
|---|---|
| D003550 | Cystic Fibrosis |
| ID | Term |
|---|---|
| D010182 | Pancreatic Diseases |
| D004066 | Digestive System Diseases |
| D008171 | Lung Diseases |
| D012140 | Respiratory Tract Diseases |
| D030342 | Genetic Diseases, Inborn |
| D009358 | Congenital, Hereditary, and Neonatal Diseases and Abnormalities |
| D007232 | Infant, Newborn, Diseases |
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| ID | Term |
|---|---|
| C074807 | BaseLine dental cement |
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| Between 18 and 65 years |
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| >=65 years |
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| Male |
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| Asian |
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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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| Superiority |
| OG002 | Whole Body Vibration | Subjects will be seated on a PowerPlate® whole-body vibration platform for 90 seconds prior to Huff-Cough. Six intervals on the platform will be completed six minutes apart. Whole-Body Vibration Platform: Subjects will be seated on a PowerPlate® whole-body vibration platform for 90 seconds prior to Huff-Cough. Six intervals on the platform will be completed six minutes apart. |
| OG003 | High Frequency Chest Wall Oscillatory Vest | Subjects will use TheVest® using a standardized "Minnesota Protocol" divided into six, four-minute segments, each followed by a Huff-Cough. High Frequency Chest Wall Oscillatory Vest: Subjects will use TheVest® using a standardized "Minnesota Protocol" divided into six, four-minute segments, each followed by a Huff-Cough. |
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| OG002 |
| Whole Body Vibration |
Subjects will be seated on a PowerPlate® whole-body vibration platform for 90 seconds prior to Huff-Cough. Six intervals on the platform will be completed six minutes apart. Whole-Body Vibration Platform: Subjects will be seated on a PowerPlate® whole-body vibration platform for 90 seconds prior to Huff-Cough. Six intervals on the platform will be completed six minutes apart. |
| OG003 | High Frequency Chest Wall Oscillatory Vest | Subjects will use TheVest® using a standardized "Minnesota Protocol" divided into six, four-minute segments, each followed by a Huff-Cough. High Frequency Chest Wall Oscillatory Vest: Subjects will use TheVest® using a standardized "Minnesota Protocol" divided into six, four-minute segments, each followed by a Huff-Cough. |
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| OG002 | Whole Body Vibration | Subjects will be seated on a PowerPlate® whole-body vibration platform for 90 seconds prior to Huff-Cough. Six intervals on the platform will be completed six minutes apart. Whole-Body Vibration Platform: Subjects will be seated on a PowerPlate® whole-body vibration platform for 90 seconds prior to Huff-Cough. Six intervals on the platform will be completed six minutes apart. |
| OG003 | High Frequency Chest Wall Oscillatory Vest | Subjects will use TheVest® using a standardized "Minnesota Protocol" divided into six, four-minute segments, each followed by a Huff-Cough. High Frequency Chest Wall Oscillatory Vest: Subjects will use TheVest® using a standardized "Minnesota Protocol" divided into six, four-minute segments, each followed by a Huff-Cough. |
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| Whole Body Vibration |
Subjects will be seated on a PowerPlate® whole-body vibration platform for 90 seconds prior to Huff-Cough. Six intervals on the platform will be completed six minutes apart. Whole-Body Vibration Platform: Subjects will be seated on a PowerPlate® whole-body vibration platform for 90 seconds prior to Huff-Cough. Six intervals on the platform will be completed six minutes apart. |
| OG003 | High Frequency Chest Wall Oscillatory Vest | Subjects will use TheVest® using a standardized "Minnesota Protocol" divided into six, four-minute segments, each followed by a Huff-Cough. High Frequency Chest Wall Oscillatory Vest: Subjects will use TheVest® using a standardized "Minnesota Protocol" divided into six, four-minute segments, each followed by a Huff-Cough. |
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| OG003 | High Frequency Chest Wall Oscillatory Vest | Subjects will use TheVest® using a standardized "Minnesota Protocol" divided into six, four-minute segments, each followed by a Huff-Cough. High Frequency Chest Wall Oscillatory Vest: Subjects will use TheVest® using a standardized "Minnesota Protocol" divided into six, four-minute segments, each followed by a Huff-Cough. |
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| OG003 | High Frequency Chest Wall Oscillatory Vest | Subjects will use TheVest® using a standardized "Minnesota Protocol" divided into six, four-minute segments, each followed by a Huff-Cough. High Frequency Chest Wall Oscillatory Vest: Subjects will use TheVest® using a standardized "Minnesota Protocol" divided into six, four-minute segments, each followed by a Huff-Cough. |
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