IRAD2 : Patients With Respiratory Failure at Home

NCT00230984 | Completed Phase 3

• 1 other identifier: DCIC 01 05
• Study Type: interventional
• Target: 200
• Locations: 2 countries
• Sites: 8

Brief 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.

Conditions

Chronic Respiratory Failure; Nutritional Depletion

Keywords

Chronic Respiratory Failure; Pulmonary Rehabilitation; Nutritional Depletion; Home; COPD; Oral Dietary Supplements; Therapeutic Education; Androgens; Exacerbation; Survival

Outcome Measures

Primary Outcomes (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)

• Reduction in exacerbation rates by 25%

• Quality of life assessed by generic QOL.

• Reduction in health-related costs

• Increase in survival during the year following intervention.

Interventions

education BEHAVIORAL

Oral dietary supplements (563 kcal/d), RESPIFOR DRUG

exercises on an ergometric bicycle 3 to 5 times a week BEHAVIORAL

160 mg/d of oral testosterone undecanoate in men, 80 mg/d in women DRUG

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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.

You may not qualify if:

• 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

Sponsors & Collaborators

• University Hospital, Grenoble: lead
• Societe Francophone de Nutrition Enterale et Parenterale: collaborator
• Association ANTADIR ,: collaborator
• Ministry of Health, France: collaborator
• Association AGIR à Dom,: collaborator
• Nutricia France, swizerland),: collaborator
• Organon: collaborator

Study Sites (8)

University Hospital Dominique Larrey

Limoges, 87042, France

Location

Rehabilitation Department of Cyr Voisin

Loos, 59374, France

Location

University Hospital Arnaud de Villeneuve

Montpellier, 34295, France

Location

Hospital la Pitiè-Salpétrière

Paris, 75000, France

Location

University Hospital of Poitiers

Poitiers, 86021, France

Location

University Hospital Bois Guillaume

Rouen, 76230, France

Location

North University Hospital of St Etienne

Saint-Etienne, 42055, France

Location

Departement of Medicine, University Hospital of Genève

Geneva, 1211, Switzerland

Location

Related Publications (11)

• 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.

  PMID: 9817145 BACKGROUND

• 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.

  PMID: 5292850 BACKGROUND

• 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.

  PMID: 8617085 BACKGROUND

• 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.

  PMID: 6110912 BACKGROUND

• 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.

  PMID: 8947081 BACKGROUND

• 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.

  PMID: 10556174 BACKGROUND

• 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.

  PMID: 6794394 BACKGROUND

• 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.

  PMID: 8484624 BACKGROUND

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

  PMID: 10741769 BACKGROUND

• 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.

  PMID: 2595635 BACKGROUND

• 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.

  PMID: 21700760 DERIVED

MeSH Terms

Conditions

Pulmonary Disease, Chronic Obstructive

Interventions

Educational Status; Dietary Supplements; testosterone undecanoate; Menogaril

Condition Hierarchy (Ancestors)

Lung Diseases, Obstructive; Lung Diseases; Respiratory Tract Diseases; Chronic Disease; Disease Attributes; Pathologic Processes; Pathological Conditions, Signs and Symptoms

Intervention Hierarchy (Ancestors)

Socioeconomic Factors; Population Characteristics; Food; Diet, Food, and Nutrition; Physiological Phenomena; Food and Beverages; Nogalamycin; Daunorubicin; Anthracyclines; Naphthacenes; Polycyclic Aromatic Hydrocarbons; Hydrocarbons, Aromatic; Hydrocarbons, Cyclic; Hydrocarbons; Organic Chemicals; Polycyclic Compounds; Aminoglycosides; Glycosides; Carbohydrates

Study Officials

• Christophe PISON, MD

  Pneumology Department, University Hospital of Grenoble

  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: September 30, 2005
• First Posted: October 3, 2005
• Study Start: April 1, 2003
• Primary Completion: June 1, 2008
• Study Completion: June 1, 2008
• Last Updated: July 8, 2009

Record last verified: 2006-07

Locations

FR (7); CH (1)