drugset / Trial / NCT00230984
IRAD2 : Patients With Respiratory Failure at Home
Phase 3
Completed
200 enrolled
University Hospital, Grenoble
Association AGIR à Dom, · collabAssociation ANTADIR , · collabMinistry of Health, France · collabNutricia France, swizerland), · collabOrganon · collabSociete Francophone de Nutrition Enterale et Parenterale · collab
RandomizedParallel-groupOpen-labelTreatment
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.
Timeline
- Start
- 2003-04
- Primary completion
- 2008-06
- Completion
- 2008-06
Publications
- Background 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.
- 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.
- 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.
- 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.
- 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.
- 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.
- 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.
- 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.
- 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.
- 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.
- 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.
Drugs
| Evaluation | Drug | Modality | Dose | Route |
|---|---|---|---|---|
| Subject | RESPIFOR | Unknown | 563 unknown | Oral |
| Subject | Testosterone Undecanoate | Small molecule | 80 mg | Oral |
| Subject | Testosterone Undecanoate | Small molecule | 160 mg | Oral |