Inhaled Fluticasone Effects on Upper Airway Patency in Obstructive Lung Disease
Condition: Asthma; Chronic Obstructive Pulmonary Disease; Obstructive Sleep Apnea
MeSH terms: Lung Diseases; Sleep Apnea Syndromes; Lung Diseases, Obstructive; Pulmonary Disease, Chronic Obstructive; Sleep Apnea, Obstructive
Intervention: Inhaled Fluticasone Propionate
Intervention description: Inhaled corticosteroid
Intervention MeSH terms: Fluticasone; Xhance
Phase: Phase 4
Study type: Interventional
Primary purpose: Other
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: None (Open Label)
Enrollment: 25.0
Sex: All
Minimum age: 18 Years
Healthy volunteers: No
Keywords: asthma; COPD; sleep apnea, obstructive

Summary:

      The Chairman of the Veterans' Disability Benefits Commission reported at a recent US Senate
      hearing that asthma, chronic obstructive pulmonary disease (COPD), and sleep apnea are among
      the top 13 most frequent diagnoses leading to disability under the Department of Defense and
      the VA system statutes. Recent research finds that sleep apnea is more common among asthma
      and COPD individuals, and this may be caused by inhaled corticosteroid use. Many Veterans are
      currently using inhaled corticosteroids, and many more will be prescribed such medications,
      given their recent inclusion in international treatment guidelines. As such, this study
      addresses a critical need by researching the role of a potent inhaled corticosteroid in
      promoting sleep apnea, the determinants of this response, and the ways through which it
      occurs. Results from this study will form the foundation for future research aimed at
      expanding understanding of the effects of inhaled corticosteroids on the upper airway, as
      well as developing means to prevent or counteract them.
    

Eligibility criteria:

        Inclusion Criteria:

          -  American Veterans

          -  age 18 and above

          -  diagnosis of asthma and COPD per guidelines

          -  for asthma, persistent symptoms per guidelines

          -  for asthma, a pre-bronchodilator FEV1 55-90% and DLCO 80% predicted

          -  for asthma, physiologic confirmation by bronchodilator or methacholine challenge

          -  for COPD, a post-bronchodilator ratio of FEV1/FVC 70% and FEV1 50%

          -  overall smoking history of <10 pack-years for asthma and 10 pack-years for COPD.

        Exclusion Criteria:

          -  any use of inhaled corticosteroid for >2 weeks at a time during the last 6 months, or
             any use in the last 6 weeks;

          -  as needed use of nasal steroids in the prior 6 months

          -  select medications

          -  recent exacerbation requiring oral or systemic steroids in the past 6 months

          -  diagnosed vocal cords dysfunction

          -  other lung diseases (lung cancer, sarcoidosis, tuberculosis, lung fibrosis) or known
             1-antitrypsin deficiency

          -  significant or actively unstable medical or psychiatric illnesses

          -  diagnosed osteopenia or osteoporosis

          -  established diagnosis of neuromuscular disease

          -  BMI 45 kg/m2 and higher

          -  treated OSA

          -  pregnancy (confirmed on urine test) or desire to get pregnant in the upcoming 6
             months.

          -  smoking in the past 6 months

          -  metallic or electronic implants

          -  claustrophobia