Rehabilitation of Idiopathic Pulmonary Fibrosis (IPF) Patients

Completed · Not applicable

Conditions studied: Idiopathic Pulmonary Fibrosis

In brief

The incidence and prevalence of IPF increase exponentially with age, and IPF occurs more often in older males. Cigarette smoking and environmental dust exposures are known risk factors for developing IPF. For example, the recently deployed military population, as it ages, is at especially increased risk of IPF. No effective therapies exist, although lung transplantation is used to extend survival of selected patients. Defining specific therapy to improve exercise tolerance and dyspnea in IPF patients is thus an urgent priority of veteran-oriented research programs.

Key facts

Study ID

NCT01118221

Run by

US Department of Veterans Affairs

People needed

25

Starts

2010-10-01

Expected to finish

2013-09-01

Last updated by the study team

2015-03-04

Who can join

Age: 40 and older, up to 80. Sex: any. Healthy volunteers: not accepted.

You may qualify if…

• Clinical presentation consistent with IPF with onset between three months and 48 months prior to screening.
• Diagnosis made by high-resolution computed tomographic scan showing highly probable IPF.
• Absence of severe pulmonary hypertension (i.e., PAsys must be less than 55 mm Hg, based on echocardiography) and absence of decompensated right heart failure (NYHA class I or II acceptable).
• Age 40 through 80, inclusive.
• Abnormal pulmonary function tests (FVC 40-90% predicted or DLCO 30-90% predicted or impaired gas exchange with rest or exercise).
• Six-minute walk distance 150 m and 500 m.
• Worsening as demonstrated by any one of the following within the past year: > 10% decrease in percent predicted forced vital capacity or worsening dyspnea at rest or upon exertion, based on history.
• Ability to understand and sign a written informed consent form and comply with the requirements of the study.
• Absence of clinical features suggesting infection, neoplasm, sarcoidosis or collagen-vascular disease.

You may not qualify if…

• Echocardiographic evidence of severe pulmonary hypertension (PAsys>55 mm Hg, based on echocardiography or TR velocity 3.2 m/sec).
• Severe heart failure (NYHA class III or IV or LVEF < 45%).
• Six-minute walk distance < 150 m or > 500 m.
• FEV1/FVC ratio < 0.7 at screening (post-bronchodilator).
• Residual volume > 100% predicted.
• Any condition other than IPF likely to result in the death of the participant within the next two years.
• History of unstable or deteriorating cardiac or neurologic disease.
• Pregnancy or lactation. Patients who are: (a) pregnant or (b) breast feeding are excluded from the study.
• Current treatment with corticosteroids (either oral or inhaled), Cytoxan, azathioprine, colchicine, pirfenidone, anti-tumor necrosis factor therapy or endothelin receptor blockers. Prior treatment is permitted, but at least four weeks of treatment washout prior to inclusion in this study are required.
• Investigational therapy for any indication within 28 days prior to enrollment.
• Degenerative arthritis, cerebrovascular accident or other limitation to mobility preventing completion of the 6-minute walk test.
• Oxygen saturation on room air <80% at rest.

Where it is running

• VA Medical Center, Miami — Miami, Florida, United States

Full record on ClinicalTrials.gov

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