N/A
N=22
Sham CPAP vs. Straight CPAP for Chronic Cough
Chronic Cough · OSA
Bottom Line
View on ClinicalTrials.gov: NCT03172130 ↗Enrolled (actual)
22
Serious AEs
0.0%
Results posted
Jun 2020
Primary outcome: Primary: Change in Leicester Cough Questionnaire Score — 6.61; 2.07 score on a scale
Study Design & Population
- Study type
- Interventional
- Phase
- N/A
- Interventions
- Straight CPAP (Device); Sham CPAP (Device)
- Age
- Adult, Older Adult · 18+ yrs
- Sex
- All
- Sponsor
- Krishna M. Sundar
- Primary completion
- Nov 2019
Outcome Measures
| Outcome | Result | p-value |
|---|---|---|
| PRIMARY Change in Leicester Cough Questionnaire Score |
6.61; 2.07 | — |
| SECONDARY Change in Cough Frequency |
— | — |
| SECONDARY 8 Isoprostane Level in Exhaled Breath Condensate |
4.92; 3.99; 7.35; 5.04 | — |
| SECONDARY Interleukin-8 (IL-8) Level in Exhaled Breath Condensate |
1.52; 1.02; 1.00; 1.04 | — |
| SECONDARY Nitrite/Nitrate (NOX) Level in Exhaled Breath Condensate |
3.34; 3.35; 2.91; 5.26 | — |
| SECONDARY Hydrogen Peroxide (H2O2) Level in Exhaled Breath Condensate |
2458.02; 1714.42; 1654.07; 1468.04 | — |
| SECONDARY Change in Leukotriene B4 (LTB4) Level in Exhaled Breath Condensate |
— | — |
| SECONDARY Change in Gastroesophageal Reflux Disease Quality of Life (GERD-QoL) Questionnaire Score |
9.4; 6.3 | — |
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.
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
Data sourced from ClinicalTrials.gov (NCT03172130). Outcome figures and adverse-event rates are extracted automatically from the registry's posted results and are provided for clinician reference, not as a substitute for the primary publication.