Study of Humidified Air to Improve Mucociliary Clearance (MCC) in COPD
Condition: COPD
Study type: Interventional

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.
    

Detailed description: 
      Chronic bronchitis is a component of Chronic Obstructive Pulmonary Disease (COPD), along with
      emphysema. COPD is associated with smoking, exposure to environmental pollutants, or
      occupational exposures. In the airways mucus acts to trap inhaled toxins or pathogens. In a
      healthy lung mucus is cleared by mucociliary and cough clearance. Mucociliary clearance
      involves the synchronous motion of cilia underneath the mucus sheet that lines the airways.
      This drives the mucus sheet out of the airways (like a conveyer belt) continually clearing
      particulate and pathogens. In chronic bronchitis, mucus is overproduced due to toxic stimuli.
      Mucus clearance may also be defective due to airway obstruction and insufficient cough. This
      results in the accumulation of mucus that contributes to airway obstruction.

      Therapies for improving mucus clearance may decrease the degree of airway obstruction
      experienced by COPD patients. Heated, high-flow, humidified air or oxygen may improve mucus
      clearance by hydrating the mucus in the airways and may also help to increase airway patency.
      A similar intervention was shown to improve mucus clearance in subjects with bronchiectasis.

      The investigators have developed nuclear imaging-based methods for measuring mucus clearance
      from the lungs. These techniques have been applied to evaluate novel therapies for the
      treatment of cystic fibrosis lung disease. Here the investigators will apply these techniques
      to determine whether treatment with heated-humidified air will improve mucus clearance in
      subjects with COPD.

      Study participation involves 3 visits.

      Study day 1 includes:

        1. A conversation with a physician and completion of informed consent

        2. Pulmonary function testing (including albuterol administration)

        3. The completion of a series of questionnaires

      Study days 2 and 3 include:

        1. A urine pregnancy test (if applicable)

        2. Performance of a Co57 transmission scan

        3. The inhalation of a radiopharmaceutical (Technetium-99m sulfur colloid) from a nebulizer

        4. Lying flat in a nuclear medicine camera for 90 minutes while scans are collected.

        5. Remaining at the test center for a follow up scan approximately 2.5 hours later. This
           scan will take 10 minutes.

        6. Nasal delivery of heated humidified air (with supplemental oxygen if needed) at a rate
           of 30 liters per minute through a nasal cannula, on one study day. This will be started
           during the first 10 minutes of the 90 minute scanning period and continued for 4 hours.
           One the other study day there will be no treatment so that a baseline measurement of
           mucociliary clearance can be made. The order of the study days will be randomized.

      Participants will be asked to refrain from using short-acting beta agonist (SABA) medications
      for 6 hours prior to study days 2 and 3, and long-acting beta agonists (LABA) or long-acting
      muscarinic antagonists (LAMA) for 24 hours prior to study days 2 and 3.
    

Intervention name(s): nasal delivery of heated and humidified air
Intervention type(s): Device
Intervention description(s): 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.
Other intervention name(s): Fisher and Paykel myAirvo2 heater/humidifier; Optiflow nasal cannula.
Allocation: Randomized
Intervention model: Crossover Assignment
Intervention model description: Open label, single treatment administration, crossover
Masking: None (Open Label)
Primary purpose: Treatment
Keywords: COPD; Chronic bronchitis