N/A
Completed N=19
Supplemental Oxygen in Pulmonary Fibrosis
Source: ClinicalTrials.gov NCT01961362 ↗Enrolled (actual)
19
Serious AEs
0.0%
Results posted
Feb 2020
Primary outcomePrimary: Change in University of California San Diego Shortness of Breath Questionnaire From Immediately Prior to One Month After Starting Daily-use Supplemental Oxygen — 0.9 points — p=0.6
Summary
To enhance understanding of supplemental oxygen-its utility in and adoption by patients with pulmonary fibrosis-by examining how patients perceive it and by determining how perceptions and patient-centered outcome measures change from before to after supplemental oxygen is prescribed.
Outcome Measures
| Outcome | Result | p-value |
|---|---|---|
| PRIMARY Change in University of California San Diego Shortness of Breath Questionnaire From Immediately Prior to One Month After Starting Daily-use Supplemental Oxygen |
0.9 | 0.6 |
| SECONDARY Change in Physical Component Summary (PCS) Score From the Medical Outcomes Study Short-Form, 36-item Questionnaire (SF-36). |
-0.07 | <0.05 sig |
| SECONDARY Fatigue Severity Scale |
5.2 | — |
Eligibility Criteria
Inclusion Criteria
Patient-Participants
(Using daily 02 therapy at time of enrollment)
- Diagnosis of PF
- Able to read and speak English
- Has been on daily-use supplemental oxygen for more than one year
(Not using daily 02 therapy at time of enrollment)
- Diagnosis of PF
- Able to read, speak and write in English
- Has not been prescribed daily-use supplemental oxygen
- Forced vital capacity <75% and diffusing capacity <65% of predicted values
- Subject's physician allows the subject to abstain from daily-use supplemental oxygen for 7-10 days after prescription to allow data for collection
Primary Supporters
- Self-report status of providing care or support to a person living with pulmonary fibrosis who has used supplemental oxygen for more than one year
- Able to speak English
O2 Prescribers
- Self-report status of being a prescriber of daily-use supplemental oxygen to PF patients
- Able to speak English
Exclusion Criteria
Patient-Participants (Using daily 02 therapy at time of enrollment)
- No diagnosis of PF
- Unable to read and speak English
- Has been on daily-use supplemental oxygen for less than one year
(Not using daily 02 therapy at time of enrollment)
- No diagnosis of PF
- Unable to read, speak and write in English
- Using supplemental oxygen during the day
- Subject's physician does not allow the subject to abstain from daily-use supplemental oxygen for 7-10 days after prescription to allow data for collection
Primary Supporters • Not meeting inclusion criteria
O2 Prescribers
- Not meeting inclusion criteria
Data sourced from ClinicalTrials.gov (NCT01961362). 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. Informational only — not medical advice.