IRAD2 : Patients With Respiratory Failure at Home

Chronic Respiratory Failure Clinical Trial

Official title:

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

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT00230984
• Other study ID #: DCIC 01 05
• Status: Completed
• Phase: Phase 3
• First received: September 30, 2005
• Last updated: July 7, 2009
• Start date: April 2003
• Est. completion date: June 2008

Study information

• Verified date: July 2006
• Source: University Hospital, Grenoble
• Contact: n/a
• Is FDA regulated: No
• Health authority: France: Afssaps - Agence française de sécurité sanitaire des produits de santé (Saint-Denis)
• Study type: Interventional

Clinical 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.

• 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.

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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 200
• Est. completion date: June 2008
• Est. primary completion date: June 2008
• Accepts healthy volunteers: No
• Gender: Both
• Age group: 18 Years and older

Eligibility

Inclusion Criteria:

• 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.

Exclusion Criteria:

• 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

Study Design

Allocation: Randomized, Endpoint Classification: Efficacy Study, Intervention Model: Parallel Assignment, Masking: Open Label, Primary Purpose: Treatment

Related Conditions & MeSH terms

• Chronic Respiratory Failure
• Nutritional Depletion
• Respiratory Insufficiency

Intervention

Behavioral:
• education

Drug:
• Oral dietary supplements (563 kcal/d), RESPIFOR

Behavioral:
• exercises on an ergometric bicycle 3 to 5 times a week

Drug:
• 160 mg/d of oral testosterone undecanoate in men, 80 mg/d in women

Locations

Country	Name	City	State
France	University Hospital Dominique Larrey	Limoges
France	Rehabilitation Department of Cyr Voisin	Loos
France	University Hospital Arnaud de Villeneuve	Montpellier
France	Hospital la Pitiè-Salpétrière	Paris
France	University Hospital of Poitiers	Poitiers
France	University Hospital Bois Guillaume	Rouen
France	North University Hospital of St Etienne	St Etienne
Switzerland	Departement of Medicine, University Hospital of Genève	Genève

Sponsors (7)

Lead Sponsor	Collaborator
University Hospital, Grenoble	Association AGIR à Dom,, Association ANTADIR ,, Ministry of Health, France, Nutricia France, swizerland),, Organon, Societe Francophone de Nutrition Enterale et Parenterale

Countries where clinical trial is conducted

France,  Switzerland, 

References & Publications (10)

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. Review. — View Citation

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. — View Citation

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. — View Citation

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. — View Citation

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. — View Citation

Rönning 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. — View Citation

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. — View Citation

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. — View Citation

Schols AM. Nutrition in chronic obstructive pulmonary disease. Curr Opin Pulm Med. 2000 Mar;6(2):110-5. Review. — View Citation

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. — View Citation

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	An increase of the six-minute walking distance by more than 50 m with an improvement in health-related quality-of-life.
Secondary	Reduction in exacerbation rates by 25%
Secondary	Quality of life assessed by generic QOL.
Secondary	Reduction in health-related costs
Secondary	Increase in survival during the year following intervention.