Clinical trial NCT02551068: High Oxygen Delivery to Preserve Exercise Capacity in Idiopathic Pulmonary Fibrosis Patients Treated With Nintedanib
Official title: High Oxygen Delivery to Preserve Exercise Capacity in IPF Patients Treated With Nintedanib: The HOPE-IPF Study
Study type: INTERVENTIONAL
Overall status: RECRUITING
Phase: NA
Conditions: Idiopathic Pulmonary Fibrosis
Lead sponsor: University of British Columbia
Sponsor class: OTHER
Collaborators: name: Boehringer Ingelheim
First posted: 2015-09-16
Enrollment: 88
Sex: ALL
Minimum age (years): 19
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

Brief summary: The purpose is to determine if patients with idiopathic pulmonary fibrosis (IPF) taking nintedanib will have improved exercise endurance, breathlessness and quality of life if breathing 60% oxygen compared to standard of care during an 8 week exercise training program.

Detailed description: Pulmonary rehabilitation is a structured evidence-based exercise and education intervention that is recommended for most patients with IPF. Pulmonary rehabilitation improves functional capacity (6-minute walk distance \[6MWD\]), breathlessness and quality of life in patients, however these benefits are often modest and only temporary. Nintedanib is an antifibrotic medication that has been shown to slow the decline of lung function. Use of antifibrotic medications in the pulmonary rehabilitation setting may therefore allow prolonged benefit of exercise training by preventing IPF progression and the resulting worsening symptoms and functional decline. Unpublished data suggest that breathing 60% oxygen in a pulmonary rehabilitation setting could enable patients to train at higher exercise intensities and thus derive greater physiological adaptations and clinical benefits compared with traditional pulmonary rehabilitation.

This is a randomized, blinded study with two arms (standard of care or 60% oxygen). The decision to start or stop treatment with nintedanib will be made by the participants treating physician based on clinical findings. If the treating physician decides to discontinue nintedanib, the participant will be allowed to continue in the study.

The exercise training program is 8 weeks long, with visits 3 times a week. In addition to the exercise training there are 13 visits occurring before, during and after the 8 week exercise training program. At study visits, participants will be required to conduct a 6 minute walk test and complete a quality of life questionnaire. Select study visits will also require lung function tests and exercise tests to be conducted.

Eligibility criteria: Inclusion Criteria:

* Age 19 years or older
* Idiopathic Pulmonary Fibrosis (IPF) diagnosis according to American Thoracic Society and/or European Respiratory Society consensus criteria
* Appropriate candidate for pulmonary rehabilitation
* prescribed nintedanib by their treating physician or currently on nintedanib
* 6 minute walk distance 50m or more
* Oxygen saturation 92% or more by pulse oximetry at rest while breathing room air
* Clinically stable for the preceding 6 weeks

Exclusion Criteria:

* Contraindication to treatment with nintedanib (based on Canadian labeling)
* Contraindication to exercise testing (e.g. significant cardiovascular, musculoskeletal, neurological disease)
* Other significant extra-pulmonary disease that, based on clinical assessment, could impair exercise capacity and/or oxygenation
* Forced vital capacity (FVC) less than 50% or Diffusion capacity for carbon monoxide (DLCO) less than 25%
* Concurrent or recent participation (less than 6 months) in a pulmonary rehabilitation program
* Use of prednisone greater than 10 mg/day for more than 2 weeks within 3 months of the first study visit
* Use of pirfenidone within 4 weeks of screening
* Significant emphysema (less than 10% volume on high resolution computed tomography (HRCT) or forced expiratory volume at one second (FEV1)/FVC less than 0.70)

Primary outcomes:
measure: Change from baseline in exercise duration during the constant load exercise test at 8 weeks
timeFrame: 8 weeks
Secondary outcomes:
measure: Change in 6 Minute Walk Distance (6MWD) at 8 weeks
timeFrame: 8 weeks
measure: Change in the amount a patient is troubled by their breathlessness at 8 weeks
timeFrame: 8 weeks
measure: Change in the amount a patient is troubled by their breathlessness during the 6 Minute Walk Distance test at 8 weeks
timeFrame: 8 weeks
measure: Change in the amount a patient is troubled by their breathlessness during the cycle exercise test at 8 weeks
timeFrame: 8 weeks
measure: Change in how much shortness of breath the patient experiences while doing normal activities at 8 weeks
timeFrame: 8 weeks
measure: Change in the amount of physical work a patient can do before becoming breathless at 8 weeks
timeFrame: 8 weeks
measure: Patient reported change in amount of physical activity at 8 weeks
timeFrame: 8 weeks
measure: Change in amount of physical activity at 8 weeks
timeFrame: 8 weeks
measure: Change in Quality of Life at 8 weeks
timeFrame: 8 weeks
Other outcomes:
Locations:
city: Calgary
country: Canada
facility: University of Calgary
state: Alberta
city: Edmonton
country: Canada
facility: University of Alberta
state: Alberta
city: Kelowna
country: Canada
facility: UBC Okanagan
state: British Columbia
city: Vancouver
country: Canada
facility: St. Paul's Hospital
state: British Columbia
city: Hamilton
country: Canada
facility: McMaster University
state: Ontario
city: Kingston
country: Canada
facility: Queens University
state: Ontario
city: Montreal
country: Canada
facility: McGill University
state: Quebec
city: Quebec
country: Canada
facility: Laval University
Study officials:
affiliation: St. Paul's Hospital
name: Chris Ryerson, MD
role: PRINCIPAL_INVESTIGATOR
affiliation: St. Paul's Hospital
name: Jordan Guenette, PhD
role: PRINCIPAL_INVESTIGATOR
References:
citation: Ryerson CJ, Camp PG, Eves ND, Schaeffer M, Syed N, Dhillon S, Jensen D, Maltais F, O'Donnell DE, Raghavan N, Roman M, Stickland MK, Assayag D, Bourbeau J, Dion G, Fell CD, Hambly N, Johannson KA, Kalluri M, Khalil N, Kolb M, Manganas H, Moran-Mendoza O, Provencher S, Ramesh W, Rolf JD, Wilcox PG, Guenette JA. High Oxygen Delivery to Preserve Exercise Capacity in Patients with Idiopathic Pulmonary Fibrosis Treated with Nintedanib. Methodology of the HOPE-IPF Study. Ann Am Thorac Soc. 2016 Sep;13(9):1640-7. doi: 10.1513/AnnalsATS.201604-267OC.