Sham CPAP vs. Straight CPAP for Chronic Cough

NCT03172130 | Completed Results FDA Device

• 1 other identifier: IRB #62049
• Study Type: interventional
• Target: 22
• Locations: 1 country
• Sites: 1

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.

Conditions

Chronic Cough; OSA

Keywords

Obstructive Sleep Apnea; CPAP

Outcome Measures

Primary Outcomes (1)

• 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 Outcomes (7)

• Change in Cough Frequency

  Baseline and 6 weeks

• 8 Isoprostane Level in Exhaled Breath Condensate

  Baseline and 6 weeks

• Interleukin-8 (IL-8) Level in Exhaled Breath Condensate

  Baseline and 6 weeks

• Nitrite/Nitrate (NOX) Level in Exhaled Breath Condensate

  Baseline and 6 weeks

• Hydrogen Peroxide (H2O2) Level in Exhaled Breath Condensate

  Baseline and 6 weeks

Study Arms (2)

Straight CPAP

EXPERIMENTAL

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.

Device: Straight CPAP

Sham CPAP

SHAM COMPARATOR

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.

Device: Sham CPAP

Interventions

Straight CPAP DEVICE

Straight CPAP

Sham CPAP DEVICE

Sham CPAP

Eligibility Criteria

• Age: 18 Years - 80 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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

You may not qualify if:

• 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

Sponsors & Collaborators

• Krishna M. Sundar: lead

Study Sites (1)

University of Utah

Salt Lake City, Utah, 84132, United States

Location

Related Publications (1)

• 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.

  PMID: 32356074 DERIVED

MeSH Terms

Conditions

Chronic Cough; Sleep Apnea, Obstructive

Condition Hierarchy (Ancestors)

Cough; Respiration Disorders; Respiratory Tract Diseases; Signs and Symptoms, Respiratory; Signs and Symptoms; Pathological Conditions, Signs and Symptoms; Sleep Apnea Syndromes; Apnea; Sleep Disorders, Intrinsic; Dyssomnias; Sleep Wake Disorders; Nervous System Diseases

Results Point of Contact

• Title: Krishna Sundar
• Organization: University of Utah

krishna.sundar@hsc.utah.edu

801-581-7806

Study Officials

• Krishna Sundar, MD

  University of Utah

  PRINCIPAL INVESTIGATOR

Publication Agreements

• PI is Sponsor Employee: No
• Restrictive Agreement: No

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: DOUBLE
• Who Masked: PARTICIPANT, INVESTIGATOR
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: SPONSOR INVESTIGATOR
• PI Title: Principal Investigator

Study Record Dates

• First Submitted: May 27, 2017
• First Posted: June 1, 2017
• Study Start: October 13, 2014
• Primary Completion: November 25, 2019
• Study Completion: November 25, 2019
• Last Updated: June 18, 2020
• Results First Posted: June 4, 2020

Record last verified: 2020-06

Data Sharing

• IPD Sharing: Will not share

Locations

US (1)