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Clinical Trial Details — Status: Completed

Administrative data

NCT number NCT03172130
Other study ID # IRB #62049
Secondary ID
Status Completed
Phase N/A
First received
Last updated
Start date October 13, 2014
Est. completion date November 25, 2019

Study information

Verified date June 2020
Source University of Utah
Contact n/a
Is FDA regulated No
Health authority
Study type Interventional

Clinical Trial 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.


Recruitment information / eligibility

Status Completed
Enrollment 22
Est. completion date November 25, 2019
Est. primary completion date November 25, 2019
Accepts healthy volunteers No
Gender All
Age group 18 Years to 80 Years
Eligibility 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

Study Design


Related Conditions & MeSH terms


Intervention

Device:
Straight CPAP

Sham CPAP


Locations

Country Name City State
United States University of Utah Salt Lake City Utah

Sponsors (1)

Lead Sponsor Collaborator
Krishna M. Sundar

Country where clinical trial is conducted

United States, 

Outcome

Type Measure Description Time frame Safety issue
Primary 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 Baseline and 6 weeks
Secondary 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 Baseline and 6 weeks
Secondary 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 Baseline and 6 weeks
Secondary 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 Baseline and 6 weeks
Secondary 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. Baseline and 6 weeks
Secondary 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 Baseline and 6 weeks
Secondary 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 Baseline and 6 weeks
Secondary 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 Baseline and 6 weeks
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