N/A
N=25
Rehabilitation of Idiopathic Pulmonary Fibrosis (IPF) Patients
Idiopathic Pulmonary Fibrosis
Bottom Line
View on ClinicalTrials.gov: NCT01118221 ↗Enrolled (actual)
25
Serious AEs
0.0%
Results posted
Jan 2015
Primary outcome: Primary: 6 Minute Walk Distance — -6.2; -15.3 meters
Study Design & Population
- Study type
- Interventional
- Phase
- N/A
- Interventions
- pulmonary rehabilitation (Behavioral)
- Age
- Adult, Older Adult · 40+ yrs
- Sex
- All
- Sponsor
- US Department of Veterans Affairs
- Primary completion
- Sep 2013
Outcome Measures
| Outcome | Result | p-value |
|---|---|---|
| PRIMARY 6 Minute Walk Distance |
-6.2; -15.3 | — |
| SECONDARY Systemic Markers of Oxidant Stress |
16.48; 17.96 | — |
| SECONDARY Maximum Oxygen Uptake |
-35; -119 | — |
Summary
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.
Eligibility Criteria
Inclusion Criteria
- 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.
Exclusion Criteria
- 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 500 m.
- FEV1/FVC ratio 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.
Data sourced from ClinicalTrials.gov (NCT01118221). Outcome figures and adverse-event rates are extracted automatically from the registry's posted results and are provided for clinician reference, not as a substitute for the primary publication.