Inhaled Fluticasone Effects on Upper Airway Patency in Obstructive Lung Disease

NCT01554488 | Terminated Phase 4 Results DMC FDA Drug

• 1 other identifier: CLIN-20-11S
• Study Type: interventional
• Target: 25
• Locations: 1 country
• Sites: 1

Brief 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.

Conditions

Asthma; Chronic Obstructive Pulmonary Disease; Obstructive Sleep Apnea

Keywords

asthma; COPD; sleep apnea, obstructive

Outcome Measures

Primary Outcomes (1)

• Upper Airway Critical Closing Pressure (Pcrit) at Week 16

  Pressure at which the pharyngeal upper airway closes during stable non-REM sleep, measured as described in the referenced citation.

  16-week randomized controlled phase

Secondary Outcomes (4)

• Tongue Strength at Anterior Location at Week 16

  16-week randomized phase

• Tongue Strength at Posterior Location at Week 16

  16-week randomized phase

• Tongue Fatigability at Anterior Location at Week 16

  16-week randomized treatment phase

• Tongue Fatigability of Posterior Location at Week 16

  16-week randomized treatment phase

Other Outcomes (4)

• Tongue Volume at Week 16

  16-week randomized treatment phase

• Percentage Fat Content (Fat Fraction) of the Tongue at Week 16

  16-week randomized controlled phase

• Volume of Pharyngeal Upper Airway Surrounding Structures at Week 16

  16-week randomized controlled phase

Study Arms (2)

Arm 1

EXPERIMENTAL

High dose inhaled fluticasone (1760mcg/day)

Drug: Inhaled Fluticasone Propionate

Arm 2

ACTIVE COMPARATOR

Low dose inhaled fluticasone (88mcg/day)

Drug: Inhaled Fluticasone Propionate

Interventions

Inhaled Fluticasone Propionate DRUG

Inhaled corticosteroid

Arm 1; Arm 2

Eligibility Criteria

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

You may qualify if:

• 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.

You may not qualify if:

• 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

Sponsors & Collaborators

• VA Office of Research and Development: lead

Study Sites (1)

William S. Middleton Memorial Veterans Hospital, Madison, WI

Madison, Wisconsin, 53705, United States

Location

Related Publications (2)

• Teodorescu M, Xie A, Sorkness CA, Robbins J, Reeder S, Gong Y, Fedie JE, Sexton A, Miller B, Huard T, Hind J, Bioty N, Peterson E, Kunselman SJ, Chinchilli VM, Soler X, Ramsdell J, Loredo J, Israel E, Eckert DJ, Malhotra A. Effects of inhaled fluticasone on upper airway during sleep and wakefulness in asthma: a pilot study. J Clin Sleep Med. 2014 Feb 15;10(2):183-93. doi: 10.5664/jcsm.3450.

  PMID: 24533002 BACKGROUND

• Humbert IA, Reeder SB, Porcaro EJ, Kays SA, Brittain JH, Robbins J. Simultaneous estimation of tongue volume and fat fraction using IDEAL-FSE. J Magn Reson Imaging. 2008 Aug;28(2):504-8. doi: 10.1002/jmri.21431.

  PMID: 18666214 BACKGROUND

MeSH Terms

Conditions

Asthma; Pulmonary Disease, Chronic Obstructive; Sleep Apnea, Obstructive

Condition Hierarchy (Ancestors)

Bronchial Diseases; Respiratory Tract Diseases; Lung Diseases, Obstructive; Lung Diseases; Respiratory Hypersensitivity; Hypersensitivity, Immediate; Hypersensitivity; Immune System Diseases; Chronic Disease; Disease Attributes; Pathologic Processes; Pathological Conditions, Signs and Symptoms; Sleep Apnea Syndromes; Apnea; Respiration Disorders; Sleep Disorders, Intrinsic; Dyssomnias; Sleep Wake Disorders; Nervous System Diseases

Limitations and Caveats

Study was terminated early due to low accrual. The original scientific question remains unanswered. Based on the experience with this study, a multi-center study would be necessary to accrue sufficient participants to answer the question.

Results Point of Contact

• Title: Mihaela Teodorescu, MD-Principle Investigator
• Organization: William S. Middleton Memorial VA Hospital

mt3@medicine.wisc.edu

(608)2561901

Study Officials

• Mihaela Teodorescu, MD

  William S. Middleton Memorial Veterans Hospital, Madison, WI

  PRINCIPAL INVESTIGATOR

Publication Agreements

• PI is Sponsor Employee: Yes

Study Design

• Study Type: interventional
• Phase: phase 4
• Allocation: RANDOMIZED
• Masking: NONE
• Purpose: OTHER
• Intervention Model: PARALLEL
• Sponsor Type: FED
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: February 29, 2012
• First Posted: March 15, 2012
• Study Start: March 12, 2013
• Primary Completion: February 3, 2016
• Study Completion: April 7, 2016
• Last Updated: February 5, 2020
• Results First Posted: February 5, 2020

Record last verified: 2020-01

Locations

US (1)