AzTrials
AzTrials

Chronic Respiratory FailurePhase 3NCT00230984

IRAD2 : Patients With Respiratory Failure at Home

A Phase 3 study testing education, Oral dietary supplements (563 kcal/d), RESPIFOR and exercises on an ergometric bicycle 3 to 5 times a week in people with Chronic Respiratory Failure and Nutritional Depletion, run by University Hospital, Grenoble at 8 sites in 2 countries.

Completed

Finished. The study has ended and is not enrolling. Results may be posted on the official record.

Official record
Search all trials

Trial summary

Title : Effects of home pulmonary rehabilitation in patients with chronic respiratory failure and nutritional depletion. This is a randomized controlled, open clinical trial with two groups. Read more about this study

Who is it for?
Ages 18 years and older
What is being tested?
education, Oral dietary supplements (563 kcal/d), RESPIFOR and exercises on an ergometric bicycle 3 to 5 times a week
How many people
200 participants
Where
8 sitesin 2 countries
Study dates
Apr 2003to Jun 2008
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 18 years and older
  • All sexes
  • No healthy volunteers
  • Adult, Older adult

Who may be able to join

  • well informed and consenting person
  • woman is old enough to procreate
  • Assisted respiratory treatment at home for 3 months : oxygenotherapy > 8 hours per day and/or assisted ventilation > 6 hours per day.
  • PaO2 without oxygenotherapy ≤ 8 kPa or 60 mmHg on ambient air at the beginning of assisted respiratory treatment.
  • Affection : chronic obstructive bronchopneumopathy, diffuse bronchial dilatation, non neuromuscular restrictive syndrome (pulmonary diffuse infiltration, parietal lesion) obstructive and restrictive syndrome.
  • malnourished person, one of following criteria :Body Mass Index ≤ 21kg/m2 or weight loss (10% of the previous weight) or non-fatty mass measured by 50 Hz impedancemetry ≤25th percentiles or ≤ 63% of ideal weight for women, ≤ 67% of ideal weight for men.

Who cannot join

  • Sleep apnea with daytime drowsiness (drowsiness scale of Epworth > 9/24)
  • Known pathology that reduce the vital prognosis at 6 months (AIDS, cancer...).
  • History of hormone dependent cancer ( breast cancer, prostate cancer), pathologic Prostate Specific Antigen.
  • Inability to follow a rehabilitation program

Trial locations and contacts

8 sites in 2 countries.

8 sites in 2 countries

France7 sites

  • University Hospital Dominique Larrey

    Limoges, 87042

  • Rehabilitation Department of Cyr Voisin

    Loos, 59374

  • University Hospital Arnaud de Villeneuve

    Montpellier, 34295

  • Hospital la Pitiè-Salpétrière

    Paris, 75000

  • University Hospital of Poitiers

    Poitiers, 86021

  • University Hospital Bois Guillaume

    Rouen, 76230

  • North University Hospital of St Etienne

    Saint-Etienne, 42055

Other trials in France

Switzerland1 site

  • Departement of Medicine, University Hospital of Genève

    Geneva, 1211

Other trials in Switzerland

About this study

Official title: Effects of Home Pulmonary Rehabilitation in Patients With Chronic Respiratory Failure and Nutritional Depletion.

Title : Effects of home pulmonary rehabilitation in patients with chronic respiratory failure and nutritional depletion.

This is a randomized controlled, open clinical trial with two groups.

  • first group, 100 patients : control group, patients followed with no add-on intervention
  • Second group, 100 patients : rehabilitation group with education, oral supplements, exercise and androgenic steroids.
Read the detailed description

Title : Effects of home pulmonary rehabilitation in patients with chronic respiratory failure and nutritional depletion

State of the art :

The IRAD2 trial is evaluating a 3-month home intervention which includes education, oral supplements, exercise and androgenic steroids in undernourished patients with chronic respiratory failure. The main objective is to increase the six-minute walking distance by more than 50 m with an improvement in health-related quality-of-life. Secondary end-points include a reduction in exacerbation rates by 25%, a reduction in health-related costs and an increase in survival during the year following intervention.

Material and methods :

This interventional, multi-centre, prospective, two-armed parallel, controlled trial is being conducted in 200 patients. In both groups, "Control" and "Rehabilitation", 7 home visits are scheduled during the 3-month intervention for education purpose. In the "Rehabilitation" group, patients will receive 160 mg/d of oral testosterone undecanoate in men, 80 mg/d in women, oral dietary supplements (563 kcal/d) and exercises on an ergometric bicycle 3 to 5 times a week.

Expected results :

In the event of significant responses to intervention, this trial would validate a comprehensive and global home-care for undernourished patients with chronic respiratory failure combining therapeutic education, oral supplements, androgenic substitution and physical activity.

Being tested
education, Oral dietary supplements (563 kcal/d), RESPIFOR, exercises on an ergometric bicycle 3 to 5 times a week, 160 mg/d of oral testosterone undecanoate in men, 80 mg/d in women
Keywords
Chronic Respiratory Failure, Pulmonary Rehabilitation, Nutritional Depletion, Home, COPD, Oral Dietary Supplements, Therapeutic Education, Androgens, Exacerbation, Survival
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.

  • educationBehavioural

  • Oral dietary supplements (563 kcal/d), RESPIFORDrug

  • exercises on an ergometric bicycle 3 to 5 times a weekBehavioural

  • 160 mg/d of oral testosterone undecanoate in men, 80 mg/d in womenDrug

What is being measured

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

  1. An increase of the six-minute walking distance by more than 50 m with an improvement in health-related quality-of-life.

Secondary outcomes (4)

  1. Reduction in exacerbation rates by 25%

  2. Quality of life assessed by generic QOL.

  3. Reduction in health-related costs

  4. Increase in survival during the year following intervention.

Timeline

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

  1. First posted3 Oct 2005 (estimated)
  2. Study startApr 2003
  3. Primary completionJun 2008
  4. Study completionJun 2008

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
200 participants
IDs, dates and publications
ClinicalTrials.gov ID
NCT00230984
Sponsor's protocol ID
DCIC 01 05
Status last verified
Jul 2006
First submitted
30 Sep 2005
Last updated
8 Jul 2009
Results posted
No

Publications

  • Veale D, Chailleux E, Taytard A, Cardinaud JP. Characteristics and survival of patients prescribed long-term oxygen therapy outside prescription guidelines. Eur Respir J. 1998 Oct;12(4):780-4. doi: 10.1183/09031936.98.12040780.

    PubMed 9817145

  • Ronning O. Alterations in craniofacial morphogenesis induced by parenterally administered papain. An experimental study on the rat. Suom Hammaslaak Toim. 1971;67:Suppl 3:3-96. No abstract available.

    PubMed 5292850

  • Chailleux E, Fauroux B, Binet F, Dautzenberg B, Polu JM. Predictors of survival in patients receiving domiciliary oxygen therapy or mechanical ventilation. A 10-year analysis of ANTADIR Observatory. Chest. 1996 Mar;109(3):741-9. doi: 10.1378/chest.109.3.741.

    PubMed 8617085

  • Long term domiciliary oxygen therapy in chronic hypoxic cor pulmonale complicating chronic bronchitis and emphysema. Report of the Medical Research Council Working Party. Lancet. 1981 Mar 28;1(8222):681-6.

    PubMed 6110912

  • Okubadejo AA, Paul EA, Jones PW, Wedzicha JA. Does long-term oxygen therapy affect quality of life in patients with chronic obstructive pulmonary disease and severe hypoxaemia? Eur Respir J. 1996 Nov;9(11):2335-9. doi: 10.1183/09031936.96.09112335.

    PubMed 8947081

  • Barnes PJ. Novel approaches and targets for treatment of chronic obstructive pulmonary disease. Am J Respir Crit Care Med. 1999 Nov;160(5 Pt 2):S72-9. doi: 10.1164/ajrccm.160.supplement_1.17.

    PubMed 10556174

  • Hunter AM, Carey MA, Larsh HW. The nutritional status of patients with chronic obstructive pulmonary disease. Am Rev Respir Dis. 1981 Oct;124(4):376-81. doi: 10.1164/arrd.1981.124.4.376.

    PubMed 6794394

  • Schols AM, Soeters PB, Dingemans AM, Mostert R, Frantzen PJ, Wouters EF. Prevalence and characteristics of nutritional depletion in patients with stable COPD eligible for pulmonary rehabilitation. Am Rev Respir Dis. 1993 May;147(5):1151-6. doi: 10.1164/ajrccm/147.5.1151.

    PubMed 8484624

  • Schols AM. Nutrition in chronic obstructive pulmonary disease. Curr Opin Pulm Med. 2000 Mar;6(2):110-5. doi: 10.1097/00063198-200003000-00005.

    PubMed 10741769

  • Schols AM, Mostert R, Soeters PB, Greve LH, Wouters EF. Nutritional state and exercise performance in patients with chronic obstructive lung disease. Thorax. 1989 Nov;44(11):937-41. doi: 10.1136/thx.44.11.937.

    PubMed 2595635

  • Pison CM, Cano NJ, Cherion C, Caron F, Court-Fortune I, Antonini MT, Gonzalez-Bermejo J, Meziane L, Molano LC, Janssens JP, Costes F, Wuyam B, Similowski T, Melloni B, Hayot M, Augustin J, Tardif C, Lejeune H, Roth H, Pichard C; IRAD Investigators. Multimodal nutritional rehabilitation improves clinical outcomes of malnourished patients with chronic respiratory failure: a randomised controlled trial. Thorax. 2011 Nov;66(11):953-60. doi: 10.1136/thx.2010.154922. Epub 2011 Jun 23.

    PubMed 21700760

Questions about this trial

What is this clinical trial studying?

A Phase 3 study testing education, Oral dietary supplements (563 kcal/d), RESPIFOR and exercises on an ergometric bicycle 3 to 5 times a week in people with Chronic Respiratory Failure and Nutritional Depletion, run by University Hospital, Grenoble at 8 sites in 2 countries.

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 6 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: finished, as of the sponsor's last update on 8 Jul 2009. Status can change between updates, so confirm with the study contact before making plans.

Where is the study taking place?

The record lists 8 sites in France, Switzerland. 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?

The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.

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?

An increase of the six-minute walking distance by more than 50 m with an improvement in health-related quality-of-life.. 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 NCT00230984, which also lists 11 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 8 Jul 2009.

AzTrials uses cookies for analytics and advertising. You can accept or reject them; the site works either way. Privacy Policy.

Free account

Log in to keep searching

You’ve used your 3 free searches. AzTrials is free: log in or create a free account to keep searching clinical trials and save the ones you want to follow.

Create a free accountLog in