N/A
N=12
Study of Humidified Air to Improve Mucociliary Clearance (MCC) in COPD
COPD
Bottom Line
View on ClinicalTrials.gov: NCT03935932 ↗Enrolled (actual)
12
Serious AEs
0.0%
Results posted
Jun 2023
Primary outcome: Primary: Mucociliary Clearance Rate - 4 Hours — 47; 56 percent clearance — p=0.11
Study Design & Population
- Study type
- Interventional
- Phase
- N/A
- Interventions
- nasal delivery of heated and humidified air (Device)
- Age
- Adult, Older Adult · 40+ yrs
- Sex
- All
- Sponsor
- Frank C Sciurba
- Primary completion
- Feb 2021
Outcome Measures
| Outcome | Result | p-value |
|---|---|---|
| PRIMARY Mucociliary Clearance Rate - 4 Hours |
47; 56 | 0.11 |
| SECONDARY Mucociliary Clearance Rate - 90 Min |
22; 34 | 0.11 |
| SECONDARY Area Above Retention Curve - 90 Min |
6.2; 8.0 | 0.35 |
Summary
This purpose of this study is to determine whether nasal delivery of heated and humidified air for a period of 4 hours will improve the clearance of mucus from the lungs of patients with chronic obstructive pulmonary disease (COPD). Mucus clearance will be measured using a nuclear medicine imaging procedure called a mucociliary clearance scan. Humidified air (with added oxygen if needed) will be delivered from the Fisher and Paykel myAirvo2 heater/humidifier through an Optiflow nasal cannula.
Eligibility Criteria
Inclusion Criteria
- Male or Female 40 to 85 years old
- Diagnosis of chronic bronchitis
- Able to regularly produce sputum
- Clinically stable
- Current smoker or ex-smoker with a tobacco history of ≥10 pack-years (1 pack year = 20 cigarettes smoked per day for 1 year)
- History of moderate to very severe COPD with a post-bronchodilator FEV1/FVC 20% and ≤70% of predicted normal value at enrollment.
- CAT score ≥ 10, with questions 1 and 2 responses ≥ 5
Exclusion Criteria
- Pregnant or nursing or unwilling to perform pregnancy testing
- Unwilling or unable to refrain for SABA/LABA use ahead of the study
- Unable to lie recumbent for 90 min,
- Clinically important pulmonary disease other than COPD (e.g. active lung infection, clinically significant bronchiectasis, pulmonary fibrosis, cystic fibrosis, hypoventilation syndrome associated with obesity, lung cancer, alpha 1 anti-trypsin deficiency and primary ciliary dyskinesia) or another diagnosed pulmonary or systemic disease that is associated with elevated peripheral eosinophil counts (e.g. allergic bronchopulmonary aspergillosis/mycosis, Churg-Strauss syndrome, hyper-eosinophilic syndrome) and/ or radiological findings suggestive of a respiratory disease other than COPD that is contributing to the subject's respiratory symptoms.
- Any disorder, including, but not limited to, cardiovascular, gastrointestinal, hepatic, renal, neurological, musculoskeletal, infectious, endocrine, metabolic, hematological, psychiatric, or major physical impairment that is not stable in the opinion of the Investigator and/or could:
- Affect the safety of the subject throughout the study
- Influence the findings of the study or their interpretation
- Impede the subject's ability to complete the entire duration of study
- Treatment with systemic corticosteroids and/or antibiotics, and/or hospitalization for a COPD exacerbation within 2 weeks prior to enrollment, based on last dose of steroids or last date of hospitalization whatever occurred later
- Acute upper or lower respiratory infection within 2 weeks prior to enrollment
- Supplemental oxygen use at greater than 3 liters/min
Data sourced from ClinicalTrials.gov (NCT03935932). 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.