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Completed

NCT Number: NCT01722773

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.

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Key information

Age range

35 year and older

Sex eligibility

All sexes

Study type

Interventional

Phase

Not applicable

Primary location

Univeristy of IOwa

Iowa City, Iowa, 52241, United States

About this study

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.

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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

Treatment and study plan

Bipap (Respironics, Inc)

Device

Bipap every night pressure at 15/5 with heated humidifier

Other names: Non-invasive Positive pressure ventilation

Primary outcomes

  1. CRDQ

    Time frame: 6 months

    Chronic Respiratory Disease Questionnaire

Secondary outcomes

  1. 6-minutes walk test

    Time frame: 6 months

    Walking distances in feet

  2. TDI

    Time frame: 6 months

    Transitional Dyspnea Index

  3. PO2

    Time frame: 6 months

    Oxygenation

  4. NIF

    Time frame: 6 months

    Negative Inspiratory force

Other outcomes

  1. Side effect questionnaire

    Time frame: 6 months

    Side effects with mask use

Sponsors and collaborators

Lead sponsor

University of Iowa

Other

Registry information

Important dates

Study start
2001
Primary completion
2004
Study completion
2004
First posted
Nov 7, 2012
Registry last updated
Nov 7, 2012

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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