NCT01722773

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.

Trial Health

87
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
40

participants targeted

Target at P25-P50 for not_applicable

Timeline
Completed

Started Apr 2001

Typical duration for not_applicable

Geographic Reach
1 country

1 active site

Status
completed

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

Study Start

First participant enrolled

April 1, 2001

Completed
3 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

April 1, 2004

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

April 1, 2004

Completed
8.6 years until next milestone

First Submitted

Initial submission to the registry

November 1, 2012

Completed
6 days until next milestone

First Posted

Study publicly available on registry

November 7, 2012

Completed
Last Updated

November 7, 2012

Status Verified

November 1, 2012

Enrollment Period

3 years

First QC Date

November 1, 2012

Last Update Submit

November 5, 2012

Conditions

COPD

Keywords

COPD

Outcome Measures

Primary Outcomes (1)

  • CRDQ

    Chronic Respiratory Disease Questionnaire

    6 months

Secondary Outcomes (4)

  • 6-minutes walk test

    6 months

  • TDI

    6 months

  • PO2

    6 months

  • NIF

    6 months

Other Outcomes (1)

  • Side effect questionnaire

    6 months

Study Arms (2)

Bipap

ACTIVE COMPARATOR

Bipap

Device: Bipap (Respironics, Inc)

Standard of care

NO INTERVENTION

No intervention

Interventions

Bipap (Respironics, Inc)DEVICE

Bipap every night pressure at 15/5 with heated humidifier

Also known as: Non-invasive Positive pressure ventilation
Bipap

Eligibility Criteria

Age35 Years+
Sexall
Healthy VolunteersNo
Age GroupsAdult (18-64), Older Adult (65+)

You may qualify if:

  • 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

You may not qualify if:

  • 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

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Univeristy of IOwa

Iowa City, Iowa, 52241, United States

Location

MeSH Terms

Conditions

Pulmonary Disease, Chronic Obstructive

Interventions

Continuous Positive Airway Pressure

Condition Hierarchy (Ancestors)

Lung Diseases, ObstructiveLung DiseasesRespiratory Tract DiseasesChronic DiseaseDisease AttributesPathologic ProcessesPathological Conditions, Signs and Symptoms

Intervention Hierarchy (Ancestors)

Positive-Pressure RespirationRespiration, ArtificialAirway ManagementTherapeuticsRespiratory Therapy

Study Design

Study Type
interventional
Phase
not applicable
Allocation
RANDOMIZED
Masking
NONE
Purpose
TREATMENT
Intervention Model
SINGLE GROUP
Sponsor Type
OTHER
Responsible Party
PRINCIPAL INVESTIGATOR
PI Title
Staff Physician

Study Record Dates

First Submitted

November 1, 2012

First Posted

November 7, 2012

Study Start

April 1, 2001

Primary Completion

April 1, 2004

Study Completion

April 1, 2004

Last Updated

November 7, 2012

Record last verified: 2012-11

Locations

US(1)