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Pulmonary Disease, Chronic ObstructivePhase 3NCT00135538

The Additional Value of Noninvasive Ventilation Next to Rehabilitation in Hypercapnic COPD Patients

A Phase 3 study testing Noninvasive positive pressure ventilation in people with Pulmonary Disease, Chronic Obstructive, run by Groningen Research Institute for Asthma and COPD at 1 site in Netherlands.

Unknown status

Status not confirmed. The sponsor has not verified this record for over two years, so it may be out of date.

Official record
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Trial 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. Read more about this study

Who is it for?
Ages 40 to 75 years
Conditions the study is for
Pulmonary Disease, Chronic Obstructive
What is being tested?
Noninvasive positive pressure ventilation
Type of treatment
Medical device
How many people
100 participants
Where
1 siteNetherlands
Study dates
Nov 2004to Apr 2009
Phase
Phase 3
Are there results?
None posted in the registry

Key requirements

Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.

  • Ages 40 to 75 years
  • All sexes
  • No healthy volunteers
  • Adult, Older adult

Who may be able to join

  • 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

Who cannot join

  • 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

Trial locations and contacts

1 site in 1 country.

Netherlands1 site

  • University medical Hospital Groningen

    Groningen, Provincie Groningen, 9700 RB

Other trials in Netherlands

About this study

Official title: Does Chronic Ventilatory Support Improve the Outcomes of Rehabilitation in Hypercapnic COPD Patients?

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.

Read the detailed description

Several randomised controlled trials in patients with stable Chronic Obstructive Pulmonary Disease (COPD) have demonstrated that pulmonary rehabilitation (PR) improves dyspnoea, exercise tolerance, and health-related quality of life. Research in this field has been important in our department for several years. The first study in this respect was started in 1986 comparing outpatient rehabilitation with rehabilitation in the community in patients with severe COPD. This study showed that rehabilitation supervised by a physical therapist in the community is effective for a long period in contrast to outpatient rehabilitation. In 1990 the second study started showing that positive initial benefits of home based rehabilitation on quality of life can be maintained for 18 months if the patients visit the local physical therapist once a month.

However, less positive effects of rehabilitation have been reported in the more severe patients. Because of dyspnoea due to inspiratory muscle fatigue patients may not receive an adequate training stimulus, and therefore rehabilitation might be less effective. In these more severe patients alternative therapies are needed. These non-pharmacological treatments include nutritional supplementation, oxygen therapy, lung transplantation, lung volume reduction surgery and ventilatory support.

The last few years a discussion within the 4 home mechanical ventilation centres (HMV) in the Netherlands has been started about the role of chronic ventilatory support in end-stage COPD. Theoretically, it might be effective because:

  1. a resetting of the respiratory centre may reduce daytime PaCO2;
  2. a better internal milieu (pH, PaO2, PaCO2) may improve peripheral muscle function;
  3. resting the respiratory muscles during the night may increase their daytime strength and endurance;
  4. a reduction in the number of nocturnal arousals may improve the quality of sleep. Nevertheless, none of these mechanisms has been proven and currently there is no evidence that noninvasive positive pressure ventilation (NIPPV) should be given to stable patients with COPD. While several randomised controlled trials (RCT's) on NIPPV have been published with different outcomes, a recent meta-analysis did not show beneficial effects on blood gasses, lung function, respiratory muscle function and walking distance.

In contrast several uncontrolled studies did show clear benefits from NIPPV on gas-exchange, dyspnoea and quality of life. Possible reasons for these conflicting outcomes are differences in:

  1. selection of patients,
  2. adequacy of ventilatory support,
  3. length of ventilatory support. Interestingly, it seems that studies with a positive outcome included mainly patients with hypercapnia, suggesting this as an important selection criterion.

The hypothesis is that long term NIPPV in hypercapnic patients with COPD may improve the effects of rehabilitation at home regarding health status, ADL function, dyspnoea and exercise tolerance. Secondly, we like to elucidate the exact mechanisms why NIPPV might be effective in this group of patients.

Comparison: patients who receive noninvasive ventilation during the night while following a pulmonary rehabilitation program with patients who only follow a rehabilitation program without receiving the noninvasive ventilation.

Being tested
Noninvasive positive pressure ventilation
Keywords
Pulmonary Disease, Chronic Obstructive, Intermittent Positive-Pressure Ventilation, Rehabilitation
Medical subject headings
Pulmonary Disease, Chronic Obstructive

What participants receive

What participants receive. In a randomised study each person is assigned to one group by chance.

  • Noninvasive positive pressure ventilationDevice

What is being measured

The primary outcome is the main question the study is designed to answer.

  1. Health related quality of life measured by the Chronic Respiratory Questionnaire

Secondary outcomes (7)

  1. Activities of daily Living

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

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

  4. Pulmonary function testing

  5. Sleep quality (polysomnography)

  6. Respiratory muscle activity (endurance shuttle walking test [EMG])

  7. Respiratory muscle strength (PImax, PEmax)

Timeline

From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.

  1. First posted26 Aug 2005 (estimated)
  2. Study startNov 2004
  3. Study completionApr 2009 (estimated)

Resources

More details

For doctors and researchers: how the study is designed, who runs it, and its registry IDs.

Study design
Study type
Interventional
Phase
Phase 3
Primary purpose
Treatment
Allocation
Randomised
Intervention model
Parallel groups
Masking
None (open label)
Enrolment
100 participants
IDs, dates and publications
ClinicalTrials.gov ID
NCT00135538
Sponsor's protocol ID
RECOVER1
Status last verified
Apr 2007
First submitted
25 Aug 2005
Last updated
5 Apr 2007
Results posted
No
Data monitoring committee
No

Publications

  • 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.

    PubMed 25849109

  • 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.

    PubMed 21861914

  • 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.

    PubMed 18710905

  • 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.

    PubMed 18385168

Questions about this trial

What is this clinical trial studying?

A Phase 3 study testing Noninvasive positive pressure ventilation in people with Pulmonary Disease, Chronic Obstructive, run by Groningen Research Institute for Asthma and COPD at 1 site in Netherlands.

The full registered description is in the About this study section and the official record.

Who may be eligible to take part?

The sponsor lists 4 inclusion and 4 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.

Is this clinical trial currently recruiting?

The record says: status not confirmed, as of the sponsor's last update on 5 Apr 2007. Status can change between updates, so confirm with the study contact before making plans.

Where is the study taking place?

The record lists 1 site in Netherlands. Whether a site is taking part right now should be confirmed with that site. See every site.

What are the possible benefits and risks?

They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.

What does this phase mean?

Phase 3 studies compare the treatment with the current standard treatment or a placebo in a large group, to confirm how well it works and watch for side effects.

Not every study follows the same path, and some studies (observational studies, device studies) have no phase.

Are results available for this study?

Results are not available in the source record.

How can a doctor refer a patient or contact the research team?

The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.

What does the primary outcome measure?

Health related quality of life measured by the Chronic Respiratory Questionnaire. It is what the study was designed to measure, not a finding.

Where can I read the original study information?

On the ClinicalTrials.gov record for NCT00135538, which also lists 4 linked publications.

Does a listing mean the treatment is approved or proven to work?

No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.

How often is this information updated?

AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 5 Apr 2007.

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