Clinical trial NCT01722773: Trial of Non-invasive Ventilation for Stable COPD
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: COPD
Keywords: COPD
Lead sponsor: University of Iowa
Sponsor class: OTHER
First posted: 2012-11-07
Enrollment: 40
Sex: ALL
Minimum age (years): 35
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: SINGLE_GROUP
Primary purpose: TREATMENT

Brief summary: 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.

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.

Eligibility criteria: 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

Primary outcomes:
measure: CRDQ
timeFrame: 6 months
Secondary outcomes:
measure: 6-minutes walk test
timeFrame: 6 months
measure: TDI
timeFrame: 6 months
measure: PO2
timeFrame: 6 months
measure: NIF
timeFrame: 6 months
Other outcomes:
measure: Side effect questionnaire
timeFrame: 6 months
Locations:
city: Iowa City
country: United States
facility: Univeristy of IOwa
state: Iowa
Study officials:
References: