Back to resultsSham CPAP vs. Straight CPAP for Chronic Cough
Primary Purpose
Chronic Cough, OSA
Status
Completed
Phase
Not Applicable
Locations
United States
Study Type
Interventional
Intervention
Straight CPAP
Sham CPAP
Sponsored by
About this trial
This is an interventional treatment trial for Chronic Cough focused on measuring Obstructive Sleep Apnea, CPAP
Eligibility Criteria
Inclusion Criteria:
- Cough of more than 2 month duration
- Not active smoker with history of stoppage of smoking for more than 6 months
- Evaluation and treatment by other providers for suspected gastroesophageal reflux disease (GERD), upper airway cough syndrome (UACS), or cough-variant asthma (CVA) for at least 1 month
- Normal chest radiography or computed tomography (CT) scans (patients with up to 2 lung nodules less than 3 mm will be allowed if there is no history of malignancy elsewhere)
- Normal spirometry with predicted diffusing capacity of the lung for carbon dioxide (DLCO) more than 50% predicted. Pulmonary Function Test criteria: no evidence of airflow limitation (FEV1/FVC > 0.7) or significant chest restriction (FVC > 70% predicted) with predicted DLCO more than 50% predicted
Exclusion Criteria:
- Pregnancy
- Recent pneumonia (less than 6 months)
- Congestive heart failure, acute or chronic renal disease, jaundice or chronic liver disease, pulmonary embolism, stroke or neurodegenerative disease, malignancy
- Use of supplemental oxygen or positive airway pressure therapy (if patients have been diagnosed with obstructive sleep apnea in the past but were non-compliant with positive airway pressure therapy, they will not be excluded)
- Use of opiates for cough suppression (opiate use for pain suppression can be included)
- Alcoholism, drug dependence (including chewing tobacco) or illicit drug use
- Esophageal cancer or laryngeal surgery
- Craniofacial abnormalities that preclude CPAP placement
Sites / Locations
- University of Utah
Arms of the Study
Arm 1
Arm 2
Arm Type
Experimental
Sham Comparator
Arm Label
Straight CPAP
Sham CPAP
Arm Description
Patients randomized to straight CPAP will receive 10 cm of air pressure, or as determined by the results of polysomnography, for 6 weeks. Following the 6-week visit, patients will be placed on straight CPAP with equipment approved by insurance for an additional 6 weeks.
Patients randomized to sham CPAP will receive 1-2 cm of air pressure for 6 weeks. Following the 6-week visit, patients will be placed on straight CPAP with equipment approved by insurance for an additional 6 weeks.
Outcomes
Primary Outcome Measures
Change in Leicester Cough Questionnaire Score
Subjects will complete the Leicester Cough Questionnaire at the baseline and 6-week visits. The Leicester Cough Questionnaire comprises 19 items, which assess symptoms, or the impact of symptoms, over the last 2 weeks on a seven-point Likert scale. Scores in three domains (physical, psychological and social) are calculated as a mean for each domain (range 1 to 7). A total score (range 3 to 21) is also calculated by adding the domain scores together. Higher scores indicate better quality of life. The change in Leicester Cough Questionnaire score will be compared between the Straight CPAP and Sham CPAP groups
Secondary Outcome Measures
Change in Cough Frequency
Subjects will wear a Leicester cough monitor for 24 hours at the baseline and 6-week visits, which will record cough frequency during that period. The change in cough frequency from baseline to 6 weeks will be compared between the Straight CPAP and SHAM CPAP groups
8 Isoprostane Level in Exhaled Breath Condensate
Samples of breath condensate will be collected from study subjects at the baseline and 6-week visits. The 8 isoprostane level from baseline to 6-weeks will be compared between the Straight CPAP and Sham CPAP groups
Interleukin-8 (IL-8) Level in Exhaled Breath Condensate
Samples of breath condensate will be collected from study subjects at the baseline and 6-week visits. IL-6 level from baseline to 6-weeks will be compared between the Straight CPAP and Sham CPAP groups
Nitrite/Nitrate (NOX) Level in Exhaled Breath Condensate
Samples of breath condensate will be collected from study subjects at the baseline and 6-week visits. NOX level from baseline to 6-weeks will be compared between the Straight CPAP and Sham CPAP groups.
Hydrogen Peroxide (H2O2) Level in Exhaled Breath Condensate
Samples of breath condensate will be collected from study subjects at the baseline and 6-week visits. H2O2 level from baseline to 6-weeks will be compared between the Straight CPAP and Sham CPAP groups
Change in Leukotriene B4 (LTB4) Level in Exhaled Breath Condensate
Samples of breath condensate will be collected from study subjects at the baseline and 6-week visits. The change in LTB4 level from baseline to 6-weeks will be compared between the Straight CPAP and Sham CPAP groups
Change in Gastroesophageal Reflux Disease Quality of Life (GERD-QoL) Questionnaire Score
Subjects will complete the GERD-QoL questionnaire at the baseline and 6-week visits. The GERD-QoL comprises 15 items on a five-point Likert scale; lowest possible score (0) = no symptoms, greatest possible score (75) = worst symptoms. The change in GERD-QoL score will be compared between the Straight CPAP and Sham CPAP groups
Full Information
1. Study Identification
Unique Protocol Identification Number
NCT03172130
Brief Title
Sham CPAP vs. Straight CPAP for Chronic Cough
Official Title
Prospective Study of Efficacy of Sham CPAP vs. Straight CPAP on Cough Intensity in Patients With Chronic Cough
Study Type
Interventional
2. Study Status
Record Verification Date
June 2020
Overall Recruitment Status
Completed
Study Start Date
October 13, 2014 (Actual)
Primary Completion Date
November 25, 2019 (Actual)
Study Completion Date
November 25, 2019 (Actual)
3. Sponsor/Collaborators
Responsible Party, by Official Title
Sponsor-Investigator
Name of the Sponsor
Krishna M. Sundar
4. Oversight
Studies a U.S. FDA-regulated Drug Product
No
Studies a U.S. FDA-regulated Device Product
Yes
Data Monitoring Committee
No
5. Study Description
Brief Summary
Chronic cough is an important clinical problem in primary care and sub-specialty practice. Besides the distress experienced by patients with chronic cough, significant healthcare resources are expended to understand the role of gastroesophageal reflux, asthma and post-nasal drip in understanding their contribution to cough.
Obstructive sleep apnea (OSA) is common in patients with chronic cough. More importantly, treatment of OSA with continuous positive airway pressure (CPAP) has led to improvement in cough for chronic cough patients. Mechanisms by which OSA therapy with CPAP can improve cough includes beneficial effects on reflux and airway inflammation.
The aim of this study is to definitively establish that CPAP therapy for treatment of OSA in chronic cough patients improves cough. While these patients with chronic cough are not routinely screened and treated for OSA, this study aims to evaluate these chronic cough patients with screening questionnaires for OSA and if necessary with polysomnography and randomize them to either CPAP or sham CPAP for 6 weeks.
6. Conditions and Keywords
Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Chronic Cough, OSA
Keywords
Obstructive Sleep Apnea, CPAP
7. Study Design
Primary Purpose
Treatment
Study Phase
Not Applicable
Interventional Study Model
Parallel Assignment
Masking
ParticipantInvestigator
Allocation
Randomized
Enrollment
22 (Actual)
8. Arms, Groups, and Interventions
Arm Title
Straight CPAP
Arm Type
Experimental
Arm Description
Patients randomized to straight CPAP will receive 10 cm of air pressure, or as determined by the results of polysomnography, for 6 weeks. Following the 6-week visit, patients will be placed on straight CPAP with equipment approved by insurance for an additional 6 weeks.
Arm Title
Sham CPAP
Arm Type
Sham Comparator
Arm Description
Patients randomized to sham CPAP will receive 1-2 cm of air pressure for 6 weeks. Following the 6-week visit, patients will be placed on straight CPAP with equipment approved by insurance for an additional 6 weeks.
Intervention Type
Device
Intervention Name(s)
Straight CPAP
Intervention Type
Device
Intervention Name(s)
Sham CPAP
Primary Outcome Measure Information:
Title
Change in Leicester Cough Questionnaire Score
Description
Subjects will complete the Leicester Cough Questionnaire at the baseline and 6-week visits. The Leicester Cough Questionnaire comprises 19 items, which assess symptoms, or the impact of symptoms, over the last 2 weeks on a seven-point Likert scale. Scores in three domains (physical, psychological and social) are calculated as a mean for each domain (range 1 to 7). A total score (range 3 to 21) is also calculated by adding the domain scores together. Higher scores indicate better quality of life. The change in Leicester Cough Questionnaire score will be compared between the Straight CPAP and Sham CPAP groups
Time Frame
Baseline and 6 weeks
Secondary Outcome Measure Information:
Title
Change in Cough Frequency
Description
Subjects will wear a Leicester cough monitor for 24 hours at the baseline and 6-week visits, which will record cough frequency during that period. The change in cough frequency from baseline to 6 weeks will be compared between the Straight CPAP and SHAM CPAP groups
Time Frame
Baseline and 6 weeks
Title
8 Isoprostane Level in Exhaled Breath Condensate
Description
Samples of breath condensate will be collected from study subjects at the baseline and 6-week visits. The 8 isoprostane level from baseline to 6-weeks will be compared between the Straight CPAP and Sham CPAP groups
Time Frame
Baseline and 6 weeks
Title
Interleukin-8 (IL-8) Level in Exhaled Breath Condensate
Description
Samples of breath condensate will be collected from study subjects at the baseline and 6-week visits. IL-6 level from baseline to 6-weeks will be compared between the Straight CPAP and Sham CPAP groups
Time Frame
Baseline and 6 weeks
Title
Nitrite/Nitrate (NOX) Level in Exhaled Breath Condensate
Description
Samples of breath condensate will be collected from study subjects at the baseline and 6-week visits. NOX level from baseline to 6-weeks will be compared between the Straight CPAP and Sham CPAP groups.
Time Frame
Baseline and 6 weeks
Title
Hydrogen Peroxide (H2O2) Level in Exhaled Breath Condensate
Description
Samples of breath condensate will be collected from study subjects at the baseline and 6-week visits. H2O2 level from baseline to 6-weeks will be compared between the Straight CPAP and Sham CPAP groups
Time Frame
Baseline and 6 weeks
Title
Change in Leukotriene B4 (LTB4) Level in Exhaled Breath Condensate
Description
Samples of breath condensate will be collected from study subjects at the baseline and 6-week visits. The change in LTB4 level from baseline to 6-weeks will be compared between the Straight CPAP and Sham CPAP groups
Time Frame
Baseline and 6 weeks
Title
Change in Gastroesophageal Reflux Disease Quality of Life (GERD-QoL) Questionnaire Score
Description
Subjects will complete the GERD-QoL questionnaire at the baseline and 6-week visits. The GERD-QoL comprises 15 items on a five-point Likert scale; lowest possible score (0) = no symptoms, greatest possible score (75) = worst symptoms. The change in GERD-QoL score will be compared between the Straight CPAP and Sham CPAP groups
Time Frame
Baseline and 6 weeks
10. Eligibility
Sex
All
Minimum Age & Unit of Time
18 Years
Maximum Age & Unit of Time
80 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
Inclusion Criteria:
Cough of more than 2 month duration
Not active smoker with history of stoppage of smoking for more than 6 months
Evaluation and treatment by other providers for suspected gastroesophageal reflux disease (GERD), upper airway cough syndrome (UACS), or cough-variant asthma (CVA) for at least 1 month
Normal chest radiography or computed tomography (CT) scans (patients with up to 2 lung nodules less than 3 mm will be allowed if there is no history of malignancy elsewhere)
Normal spirometry with predicted diffusing capacity of the lung for carbon dioxide (DLCO) more than 50% predicted. Pulmonary Function Test criteria: no evidence of airflow limitation (FEV1/FVC > 0.7) or significant chest restriction (FVC > 70% predicted) with predicted DLCO more than 50% predicted
Exclusion Criteria:
Pregnancy
Recent pneumonia (less than 6 months)
Congestive heart failure, acute or chronic renal disease, jaundice or chronic liver disease, pulmonary embolism, stroke or neurodegenerative disease, malignancy
Use of supplemental oxygen or positive airway pressure therapy (if patients have been diagnosed with obstructive sleep apnea in the past but were non-compliant with positive airway pressure therapy, they will not be excluded)
Use of opiates for cough suppression (opiate use for pain suppression can be included)
Alcoholism, drug dependence (including chewing tobacco) or illicit drug use
Esophageal cancer or laryngeal surgery
Craniofacial abnormalities that preclude CPAP placement
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Krishna Sundar, MD
Organizational Affiliation
University of Utah
Official's Role
Principal Investigator
Facility Information:
Facility Name
University of Utah
City
Salt Lake City
State/Province
Utah
ZIP/Postal Code
84132
Country
United States
12. IPD Sharing Statement
Plan to Share IPD
No
Citations:
PubMed Identifier
32356074
Citation
Sundar KM, Willis AM, Smith S, Hu N, Kitt JP, Birring SS. A Randomized, Controlled, Pilot Study of CPAP for Patients with Chronic Cough and Obstructive Sleep Apnea. Lung. 2020 Jun;198(3):449-457. doi: 10.1007/s00408-020-00354-1. Epub 2020 Apr 30.
Results Reference
derived
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Sham CPAP vs. Straight CPAP for Chronic Cough
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