Study of Humidified Air to Improve Mucociliary Clearance (MCC) in COPD

NCT03935932 | Completed Results FDA Device

• 1 other identifier: STUDY19110243
• Study Type: interventional
• Target: 12
• Locations: 1 country
• Sites: 1

Brief 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.

Conditions

COPD

Keywords

COPD; Chronic bronchitis

Outcome Measures

Primary Outcomes (1)

• Mucociliary Clearance Rate - 4 Hours

  Percentage of radioactivity cleared from the right lung

  0-4 hours

Secondary Outcomes (2)

• Mucociliary Clearance Rate - 90 Min

  0-90 minutes

• Area Above Retention Curve - 90 Min

  0-90 minutes

Study Arms (2)

baseline followed by intervention

EXPERIMENTAL

Subjects randomized to perform baseline measurement of clearance on study day 2 and measurement of clearance with nasal delivery of heated and humidified air on day 3

Device: nasal delivery of heated and humidified air

intervention followed by baseline

EXPERIMENTAL

Subjects randomized to perform measurement of clearance with nasal delivery of heated and humidified air on day 2 and baseline measurement of clearance on study day 3

Device: nasal delivery of heated and humidified air

Interventions

nasal delivery of heated and humidified air DEVICE

Subjects will receive nasal delivery of heated and humidified air (plus oxygen if needed) at 30 liters/minute from the Fisher and Paykel myAirvo2 heater/humidifier using an Optiflow nasal cannula.

Also known as: Fisher and Paykel myAirvo2 heater/humidifier, Optiflow nasal cannula.

baseline followed by intervention; intervention followed by baseline

Eligibility Criteria

• Age: 40 Years - 85 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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\<0.70 and a post-bronchodilator FEV1\>20% and ≤70% of predicted normal value at enrollment.
• CAT score ≥ 10, with questions 1 and 2 responses ≥ 5

You may not qualify if:

• 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

Sponsors & Collaborators

• Frank C Sciurba: lead
• Fisher and Paykel Healthcare: collaborator

Study Sites (1)

University of Pittsburgh Medical Center

Pittsburgh, Pennsylvania, 15213, United States

Location

MeSH Terms

Conditions

Pulmonary Disease, Chronic Obstructive; Bronchitis, Chronic

Interventions

Humidifiers

Condition Hierarchy (Ancestors)

Lung Diseases, Obstructive; Lung Diseases; Respiratory Tract Diseases; Chronic Disease; Disease Attributes; Pathologic Processes; Pathological Conditions, Signs and Symptoms; Bronchitis; Respiratory Tract Infections; Infections; Bronchial Diseases

Intervention Hierarchy (Ancestors)

Equipment and Supplies; Household Articles; Technology, Industry, and Agriculture

Results Point of Contact

• Title: Tim Corcoran, Associate Professor
• Organization: University of Pittsburgh

corcorante@upmc.edu

4126922210

Study Officials

• Frank C Sciurba, MD

  University of Pittsburgh

  PRINCIPAL INVESTIGATOR

Publication Agreements

• PI is Sponsor Employee: Yes

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: NONE
• Masking Details: Open label
• Purpose: TREATMENT
• Intervention Model: CROSSOVER
• Sponsor Type: OTHER
• Responsible Party: SPONSOR INVESTIGATOR
• PI Title: Professor of Medicine and Education

Model Details: Open label, single treatment administration, crossover

Study Record Dates

• First Submitted: April 30, 2019
• First Posted: May 2, 2019
• Study Start: July 15, 2019
• Primary Completion: February 15, 2021
• Study Completion: February 15, 2021
• Last Updated: June 8, 2023
• Results First Posted: June 8, 2023

Record last verified: 2023-06

Data Sharing

• IPD Sharing: Will not share

Locations

US (1)