Inhaled Fluticasone Effects on Upper Airway Patency in Obstructive Lung Disease

• Status: Terminated
• Trial end date: 2016-04-07
• Target enrollment: 0
• Participant gender: All

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.

• Phase: Phase 4
• Accepts Healthy Volunteers?: No

Details

• Lead Sponsor: VA Office of Research and Development
• Treatments: Fluticasone; Xhance

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