Continuous Positive Airway Pressure Versus Noninvasive Ventilation in Patients With Overlap Syndrome

NCT01427673 | Unknown Phase 3

• 1 other identifier: USAF
• Study Type: interventional
• Target: 150
• Locations: 1 country
• Sites: 1

Brief Summary

The purpose of this study is to determine if Bipap should assume a standard-of-care role in the management of overlap syndrome.

Conditions

Chronic Obstructive Pulmonary Disease; Obstructive Sleep Apnea; Overlap Syndrome

Keywords

Chronic Obstructive Pulmonary Disease; Obstructive Sleep Apnea; Overlap Syndrome; COPD; OSA

Outcome Measures

Primary Outcomes (1)

• The co-primary AECOPD and heart failure (AHF) outcome will be subdivided (see below).

  Number of patients with events: Occurrence of at least 1 COPD exacerbation; Occurrence of at least 1 COPD exacerbation leading to hospitalization; Occurrence of premature discontinuation of CPAP or Bipap; Occurrence of at least one clinician-diagnosed acute or acute-on-chronic heart failure event; Occurrence of arrythmogenic events requiring either the outpatient initiation of a new non-B blocker antiarrythmic agent or hospitalization to treat an arrythmia; Number of events (stratified by number of events over the 12 month period)will also be measured.

  12 month intervention period

Secondary Outcomes (2)

• Difference in exertional and questionnaire-based quality-of-life indicators

  12 month intervention period

• Safety outcome measures

  12 month intervention period

Study Arms (2)

CPAP Procedure control group

ACTIVE COMPARATOR

Overlap patients randomly assigned to the CPAP titrated per AASM guidelines.

Procedure: Bipap procedure

Bipap procedure group

EXPERIMENTAL

Overlap patients randomized to Bipap titrated per AASM guidleines with an IPAP to EPAP diffrence of at least 8 cm H2O.

Procedure: Bipap procedure

Interventions

Bipap procedure PROCEDURE

Overlap patients randomized to Bipap titrated per AASM guidleines with an IPAP to EPAP diffrence of at least 8 cm H2O.

Bipap procedure group; CPAP Procedure control group

Eligibility Criteria

• Age: 35 Years - 80 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• Patients aged \> 35 years, the diagnosis of both OSA and COPD. OSA must have been diagnosed using an American Academy of Sleep Medicine (AASM)-protocol overnight Type I polysomnogram assessment with a resultant RDI of \>5 events/hour in association with OSA-attributable diurnal symptoms.
• COPD must be diagnosed using American Thoracic Society (ATS)-protocol pulmonary function testing.
• Patients must have Global Obstructive Lung Disease (GOLD) stage II COPD FEV1/FVC \< 70% predicted in conjunction with an FEV1 \<80% predicted.
• The patient must have a \> 10 pack years smoking history and a documented history of at least one exacerbation leading to treatment with systemic glucocorticoids or antibiotics or hospitalization within the previous year.

You may not qualify if:

• Significant diseases other than COPD, i.e. disease or condition which, in the opinion of the investigator, may have put the patient at risk because of participation in the study or may have influenced either the results of the study or the patients' ability to participate in the study
• Patients with a diagnosis of asthma
• Patients with a life-threatening pulmonary obstruction, or a history of cystic fibrosis
• Patients with known active tuberculosis
• Patients with brittle/unstable diabetes mellitus
• Patients with a history of myocardial infarction within the year prior to Visit 1
• Patients with cardiac arrhythmia that required medical or surgical treatment in the 3 months prior to enrollment
• Patients who had taken an investigational drug within 30 days or 6 half-lives (whichever is greater) prior to Visit 1
• Use of systemic corticosteroid medication at unstable doses (i.e., less than 6 weeks on stable dose) or at doses in excess of the equivalent of 10 mg prednisolone per day or 20 mg every other day
• Pregnant or nursing women or women of childbearing potential not using a medically approved means of contraception (i.e., oral contraceptives).
• Patients with any respiratory infection or COPD exacerbation in the 4 weeks prior to Visit 1 or during the run-in period should have been postponed. In the case of a respiratory infection or COPD exacerbation during the run-in period, the run-in period could have been extended up to 4 weeks
• Patients who, during their CPAP titration study are found to require such excessive CPAP pressures as to mandate a Bipap titration
• Patients with either Cheyne-stokes respiration noted on PSG assessment or a central sleep apnea with an associated central event index \> 5 events/hour (using AASM central apnea/hypopnea scoring criteria)

Sponsors & Collaborators

• United States Air Force: lead
• Landstuhl Regional Medical Center: collaborator
• Good Samaritan Hospital: collaborator
• Dayton Respiratory Center: collaborator
• Tripler Army Medical Center: collaborator

Study Sites (1)

Wright-Patterson Medical Center

Wpafb, Ohio, 45433, United States

Location

Related Publications (1)

• Lee R. McNicholas WT. Obstructive sleep apnea in chronic obstructive pulmonary disease patients. Current Opinion in Pulmonary Medicine. 17(2):79-83, 2011. Hiestand D. Phillips B. The overlap syndrome: chronic obstructive pulmonary disease and obstructive sleep apnea. Critical Care Clinics. 24(3):551-63, vii, 2008. Owens RL. Malhotra A. Sleep-disordered breathing and COPD: the overlap syndrome. Respiratory Care. 55(10):1333-44; discussion 1344-6, 2010. Marin JM. Soriano JB. Carrizo SJ. Boldova A. Celli BR. Outcomes in Patients with Chronic Obstructive Pulmonary Disease and Obstructive Sleep Apnea The Overlap Syndrome. Am J Respir Crit Care Med Vol 182. pp 325-331, 2010.

  RESULT

MeSH Terms

Conditions

Pulmonary Disease, Chronic Obstructive; Sleep Apnea, Obstructive

Condition Hierarchy (Ancestors)

Lung Diseases, Obstructive; Lung Diseases; Respiratory Tract 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

Central Study Contacts

Patrick F Allan, MD

CONTACT

937-608-7958; sallanrj@yahoo.com

Dara Regn, MD

CONTACT

937-672-4447; dara.regn@wpafb.af.mil

Study Design

• Study Type: interventional
• Phase: phase 3
• Allocation: RANDOMIZED
• Masking: SINGLE
• Who Masked: INVESTIGATOR
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: FED
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Chief, Pulmonary, Critical Care and Sleep Medicine

Study Record Dates

• First Submitted: August 29, 2011
• First Posted: September 1, 2011
• Study Start: December 1, 2011
• Primary Completion: December 1, 2013
• Study Completion: February 1, 2014
• Last Updated: September 1, 2011

Record last verified: 2011-08

Locations

US (1)