NCT00135538

Brief Summary

The purpose of this study is to investigate whether noninvasive ventilation by nose mask during the night has additional benefits next to pulmonary rehabilitation in patients with severe hypercapnic COPD.

Trial Health

43
At Risk

Trial Health Score

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

Trial has exceeded expected completion date
Enrollment
100

participants targeted

Target at P25-P50 for phase_3

Timeline
Completed

Started Nov 2004

Typical duration for phase_3

Geographic Reach
1 country

1 active site

Status
unknown

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

November 1, 2004

Completed
10 months until next milestone

First Submitted

Initial submission to the registry

August 25, 2005

Completed
1 day until next milestone

First Posted

Study publicly available on registry

August 26, 2005

Completed
3.6 years until next milestone

Study Completion

Last participant's last visit for all outcomes

April 1, 2009

Completed
Last Updated

April 5, 2007

Status Verified

April 1, 2007

First QC Date

August 25, 2005

Last Update Submit

April 4, 2007

Conditions

Pulmonary Disease, Chronic Obstructive

Keywords

Pulmonary Disease, Chronic ObstructiveIntermittent Positive-Pressure VentilationRehabilitation

Outcome Measures

Primary Outcomes (1)

  • Health related quality of life measured by the Chronic Respiratory Questionnaire

Secondary Outcomes (7)

  • Activities of daily Living

  • Dyspnea (Medical Research Council Scale [MRC], baseline dyspnea index [BDI], Borg)

  • Exercise tolerance (Cycle ergometer test, 6-minute walk distance [6-MWD], incremental shuttle walking test [ISWT], endurance shuttle walking test [ESWT])

  • Pulmonary function testing

  • Sleep quality (polysomnography)

  • +2 more secondary outcomes

Interventions

Noninvasive positive pressure ventilationDEVICE

Eligibility Criteria

Age40 Years - 75 Years
Sexall
Healthy VolunteersNo
Age GroupsAdult (18-64), Older Adult (65+)

You may qualify if:

  • COPD (FEV1\< 50%, Tiffeneau \< 70%)
  • Dyspnoea on exertion and a reduced exercise capacity
  • Age 75 years or less
  • PaCO2 \> 6.0 kPa at rest without oxygen

You may not qualify if:

  • Cardial/neuromuscular diseases limiting a successful rehabilitation
  • Obstructive sleep apnoea syndrome: apnea/hypopnea index (AHI) \> 10
  • Previous exposure to chronic NIPPV
  • Participation in a pulmonary rehabilitation program less than 18 months ago

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

University medical Hospital Groningen

Groningen, Provincie Groningen, 9700 RB, Netherlands

Location

Related Publications (4)

  • Altenburg WA, Duiverman ML, Ten Hacken NH, Kerstjens HA, de Greef MH, Wijkstra PJ, Wempe JB. Changes in the endurance shuttle walk test in COPD patients with chronic respiratory failure after pulmonary rehabilitation: the minimal important difference obtained with anchor- and distribution-based method. Respir Res. 2015 Feb 19;16(1):27. doi: 10.1186/s12931-015-0182-x.

    PMID: 25849109DERIVED

  • Duiverman ML, Wempe JB, Bladder G, Vonk JM, Zijlstra JG, Kerstjens HA, Wijkstra PJ. Two-year home-based nocturnal noninvasive ventilation added to rehabilitation in chronic obstructive pulmonary disease patients: a randomized controlled trial. Respir Res. 2011 Aug 23;12(1):112. doi: 10.1186/1465-9921-12-112.

    PMID: 21861914DERIVED

  • Duiverman ML, Wempe JB, Bladder G, Jansen DF, Kerstjens HA, Zijlstra JG, Wijkstra PJ. Nocturnal non-invasive ventilation in addition to rehabilitation in hypercapnic patients with COPD. Thorax. 2008 Dec;63(12):1052-7. doi: 10.1136/thx.2008.099044. Epub 2008 Aug 18.

    PMID: 18710905DERIVED

  • Duiverman ML, Wempe JB, Bladder G, Kerstjens HA, Wijkstra PJ. Health-related quality of life in COPD patients with chronic respiratory failure. Eur Respir J. 2008 Aug;32(2):379-86. doi: 10.1183/09031936.00163607. Epub 2008 Apr 2.

    PMID: 18385168DERIVED

MeSH Terms

Conditions

Pulmonary Disease, Chronic Obstructive

Condition Hierarchy (Ancestors)

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

Study Officials

  • Marieke L Duiverman

    University Medical Center Groningen

    PRINCIPAL INVESTIGATOR

Study Design

Study Type
interventional
Phase
phase 3
Allocation
RANDOMIZED
Masking
NONE
Purpose
TREATMENT
Intervention Model
PARALLEL
Sponsor Type
OTHER

Study Record Dates

First Submitted

August 25, 2005

First Posted

August 26, 2005

Study Start

November 1, 2004

Study Completion

April 1, 2009

Last Updated

April 5, 2007

Record last verified: 2007-04

Locations

NL(1)