Trial of Non-invasive Ventilation for Stable COPD

The use of domiciliary non-invasive positive pressure ventilation (NPPV) in stable chronic obstructive pulmonary disease (COPD) with chronic hypercapnic respiratory failure has yielded variable effects on survival, quality of life and dyspnea. The investigators hypothesized that use of NPPV in stable COPD might result in improvement in quality of life and dyspnea.

Study Overview

• Status: Completed
• Conditions: COPD
• Intervention / Treatment: Device: Bipap (Respironics, Inc)

Detailed Description

Chronic obstructive pulmonary disease (COPD) is associated with progressive decline in lung function with resultant chronic respiratory failure. This leads to significant rates of hospitalization, disability, and death. COPD is also associated with sleep disordered breathing and nocturnal hypoventilation, resulting in nocturnal and daytime hypoxemia and hypercapnia. These, in turn, can contribute to fatigue, dyspnea and impaired quality of life. Presence of hypercapnia is associated with a 33% 5-year survival. Nocturnal NPPV can theoretically rest overloaded respiratory muscles, prevent nocturnal hypoventilation, and reset central respiratory drive in patients with hypercapnia. The use of non-invasive positive pressure ventilation (NPPV) in late stage COPD appears logical to change this inexorable course, to alleviate symptoms and to improve quality of life. While NPPV has a definite role in the management of acute hypercapnic respiratory failure, its role in the management of late stage stable COPD is controversial. Multiple studies have shown no survival benefit for nocturnal NPPV in chronic hypercapnic stable COPD patients. The effects on quality of life and dyspnea scores in such patients have been inconsistent. The variable efficacy might have been due to late administration of the intervention in the course of disease, in the presence of advanced hypercapnic respiratory failure. We sought to assess the effect of applying NPPV on indices of health-related quality of life in patients with relative normocapnia. We hypothesized that patients with stable severe COPD have improved quality of life and reduced dyspnea with the use of NPPV.

• Study Type: Interventional
• Enrollment (Anticipated): 40
• Phase: Not Applicable

Contacts and Locations

Study Locations

• United States
  • Iowa
    • Iowa City, Iowa, United States, 52241
      • Univeristy of Iowa

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 35 years and older (Adult, Older Adult)
• Accepts Healthy Volunteers: No
• Genders Eligible for Study: All

Description

Inclusion Criteria:

• stable chronic obstructive pulmonary disease (COPD) defined as forced expiratory volume in the first second (FEV1)/forced vital capacity (FVC) ratio of <0.70, with at least 10 pack-years smoking history

Exclusion Criteria:

• congestive heart failure, obstructive sleep apnea, chronic respiratory conditions other than COPD, age < 35 years, any disease limiting life expectancy to less than two years, active malignancy other than non-melanotic skin cancer in the previous two years, and with any anatomic variation or disease process that precluded wearing a nasal mask

Study Plan

How is the study designed?

Design Details

• Primary Purpose: Treatment
• Allocation: Randomized
• Interventional Model: Single Group Assignment
• Masking: None (Open Label)

Number of Arms

2

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
No Intervention: Standard of care; No intervention
Active Comparator: Bipap	Device: Bipap (Respironics, Inc); Bipap every night pressure at 15/5 with heated humidifier; Other Names: Non-invasive Positive pressure ventilation

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
CRDQ	Chronic Respiratory Disease Questionnaire	6 months

Secondary Outcome Measures

Outcome Measure	Measure Description	Time Frame
6-minutes walk test	Walking distances in feet	6 months
TDI	Transitional Dyspnea Index	6 months
PO2	Oxygenation	6 months
NIF	Negative Inspiratory force	6 months

Other Outcome Measures

Outcome Measure	Measure Description	Time Frame
Side effect questionnaire	Side effects with mask use	6 months

Collaborators and Investigators

• Sponsor: University of Iowa

Study record dates

Study Major Dates

• Study Start: April 1, 2001
• Primary Completion (Actual): April 1, 2004
• Study Completion (Actual): April 1, 2004

Study Registration Dates

• First Submitted: November 1, 2012
• First Submitted That Met QC Criteria: November 5, 2012
• First Posted (Estimate): November 7, 2012

Study Record Updates

• Last Update Posted (Estimate): November 7, 2012
• Last Update Submitted That Met QC Criteria: November 5, 2012
• Last Verified: November 1, 2012

More Information

Terms related to this study

• Keywords: COPD
• Other Study ID Numbers: NPPV