Effect of Ambulatory Oxygen on the Walking Test in Patients With Pulmonary Fibrosis
Condition: Pulmonary Fibrosis
MeSH terms: Pulmonary Fibrosis; Fibrosis
Study type: Interventional
Phase: Phase 2

Summary: 
      Patients with pulmonary fibrosis often desaturate on exercise. There are no data showing
      whether ambulatory oxygen can be useful to improve exercise capacity in this condition.
      Ambulatory ambulatory oxygen is often denied to these patients based on studies conducted on
      patients with chronic obstructive pulmonary disease, a completely different condition for
      physiopathology, prognosis, and response to therapy. We therefore planned a controlled study
      to verify the usefulness of ambulatory oxygen in patients with pulmonary fibrosis
    

Detailed description: 
      Criteria for inclusion: Patients with a diagnosis of pulmonary fibrosis of any kind, with
      oxygen saturation >90% in ambient air at rest, showing a desaturation <88% during a
      preliminary 6 minutes walking test Criteria for exclusion: Inability to give consent, age <18
      or >85 years, walking problems from causes different from pulmonary disease

      Procedure:

      In a preliminary session, the flow of oxygen needed to prevent desaturation during walking is
      established according to a validated protocol Guyatt et al, Am J Respir Crit Care Med
      2001,163:,942-946.) Two 6 minutes walking tests are then performed in a corridor, at least
      30' apart, during administration of oxygen or medical air, in random order and double blind,
      at the same pre-determined flow, administered through a nasal cannula connected to a wall
      outlet (concealed from sight, being in a side rum at about mid distance in the corridor)
      through a 10 mt plastic tubing. Oxygen saturation and pulse rate are monitored through a
      dedicated recording oximeter (Minoxy, Cosmed) , whose display is concealed to both the
      patient and the operator, with an alarm set for oxygen saturation <70%, to stop the test in
      case severe desaturation would occur Data are then transferred to computer for analysis only
      after both test are performed. Walked distance is recorded by the operator unaware of
      treatment.

      At the end of each test, a short questionnaire is administered with 10 cm Visual Analogue
      Scales (VAS) for dyspnoea, fatigue, and preference compared to performing the test without
      any treatment. At the end of the second test a further scale is submitted, asking about the
      preference between the two treatments.

      Primary outcomes are the distance walked and the difference in preference of the two
      treatments compared o no treatment. Secondary outcomes are differences in minimal saturation
      level and maximal pulse rate during the test and in the report of dyspnea and fatigue at the
      end of the test, and the reported preference between the two treatments.

      Statistical analysis to evaluate the effect of the treatment on walking distance, heart
      frequency and oxygen saturation is performed using generalized linear model with a gaussian
      family and identity link and including order of treatment as a fixed effect. Parameters
      evaluated using VAS are analyzed using Koch adaptation of Wilkoxon rank test (Senn SS.
      Cross-over Trials in Clinical Research, 2nd Edition. Wiley 2002)
    

Intervention name(s): oxygen; medical air
Intervention type(s): Drug; Drug
Intervention description(s): information already included in arm/group descriptions.; Placebo
Other intervention name(s): ambulatory oxygen; Placebo
Allocation: Randomized
Intervention model: Crossover Assignment
Masking: Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)
Primary purpose: Supportive Care
Keywords: Oxygen therapy