Trial Outcomes & Findings for Supplemental Oxygen in Pulmonary Fibrosis (NCT NCT01961362)

NCT ID: NCT01961362

Last Updated: 2020-02-25

Results Overview

The University of California San Diego Shortness of Breath Questionnaire (or UCSD SOB) is a tool that measures shortness of breath using 24 items, each with response options ranging from 0 to 5, corresponding to "None at all" and "Maximally or unable to do because of breathlessness." Thus, scores for the UCSD SOB range from 0 to 120, with higher scores indicating greater shortness of breath.

• Recruitment status: COMPLETED
• Target enrollment: 19 participants
• Primary outcome timeframe: UCSD SOB score at one month after being prescribed supplemental O2
• Results posted on: 2020-02-25

Participant Flow

We enrolled patients with PF not using supplemental O2 and then followed them forward until they were prescribed supplemental O2 by their treating practitioner, and then we followed them for an additional 12 months after being prescribed O2.

We enrolled 19 subjects.

Participant milestones

Measure	Pulmonary Fibrosis Patients Patients with pulmonary fibrosis of any cause (idiopathic, connective tissue disease, chronic hypersensitivity pneumonitis)
Overall Study STARTED	19
Overall Study COMPLETED	19
Overall Study NOT COMPLETED	0

Reasons for withdrawal

Withdrawal data not reported

Baseline Characteristics

Supplemental Oxygen in Pulmonary Fibrosis

Baseline characteristics by cohort

Measure	Pulmonary Fibrosis Patients n=19 Participants Patients with pulmonary fibrosis of any cause (idiopathic, connective tissue disease, chronic hypersensitivity pneumonitis). We enrolled patients with PF not using supplemental O2 and then followed them forward until they were prescribed supplemental O2 by their treating practitioner, and then we followed them for an additional 12 months after being prescribed O2.
Age, Categorical <=18 years	0 Participants n=5 Participants
Age, Categorical Between 18 and 65 years	7 Participants n=5 Participants
Age, Categorical >=65 years	12 Participants n=5 Participants
Age, Continuous	67.5 years STANDARD_DEVIATION 10.1 • n=5 Participants
Sex: Female, Male Female	6 Participants n=5 Participants
Sex: Female, Male Male	13 Participants n=5 Participants
Race (NIH/OMB) American Indian or Alaska Native	0 Participants n=5 Participants
Race (NIH/OMB) Asian	1 Participants n=5 Participants
Race (NIH/OMB) Native Hawaiian or Other Pacific Islander	0 Participants n=5 Participants
Race (NIH/OMB) Black or African American	0 Participants n=5 Participants
Race (NIH/OMB) White	18 Participants n=5 Participants
Race (NIH/OMB) More than one race	0 Participants n=5 Participants
Race (NIH/OMB) Unknown or Not Reported	0 Participants n=5 Participants
Region of Enrollment United States	19 participants n=5 Participants
Percentage of Predicted Forced Vital Capacity	64.9 Percentage of predicted FVC STANDARD_DEVIATION 16.1 • n=5 Participants
University of California San Diego Shortness of Breath Questionnaire	32.9 units on a scale STANDARD_DEVIATION 14.0 • n=5 Participants

PRIMARY outcome

Timeframe: UCSD SOB score at one month after being prescribed supplemental O2

The University of California San Diego Shortness of Breath Questionnaire (or UCSD SOB) is a tool that measures shortness of breath using 24 items, each with response options ranging from 0 to 5, corresponding to "None at all" and "Maximally or unable to do because of breathlessness." Thus, scores for the UCSD SOB range from 0 to 120, with higher scores indicating greater shortness of breath.

Outcome measures

Measure	Pulmonary Fibrosis Patients n=19 Participants Patients with pulmonary fibrosis of any cause (idiopathic, connective tissue disease, chronic hypersensitivity pneumonitis)
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 Standard Deviation 8.7

SECONDARY outcome

Timeframe: One month after daily-use supplemental oxygen implementation

The PCS of the SF-36 assesses a domain of quality of life. Its scores range from 0-100, with higher scores indicating better quality of life on this domain.

Outcome measures

Measure	Pulmonary Fibrosis Patients n=19 Participants Patients with pulmonary fibrosis of any cause (idiopathic, connective tissue disease, chronic hypersensitivity pneumonitis)
Change in Physical Component Summary (PCS) Score From the Medical Outcomes Study Short-Form, 36-item Questionnaire (SF-36).	-0.07 units on a scale Standard Error 1.2

SECONDARY outcome

Timeframe: One month after daily-use supplemental oxygen implementation

The Fatigue Severity Scale is a 9-item questionnaire, scored from 9-63, with higher scores indicating more severe fatigue.

Outcome measures

Measure	Pulmonary Fibrosis Patients n=19 Participants Patients with pulmonary fibrosis of any cause (idiopathic, connective tissue disease, chronic hypersensitivity pneumonitis)
Fatigue Severity Scale	5.2 units on a scale Standard Error 2.4

Adverse Events

Pulmonary Fibrosis Patients

Serious events: 0 serious events

Other events: 0 other events

Deaths: 0 deaths

Serious adverse events

Adverse event data not reported

Other adverse events

Adverse event data not reported

Additional Information

Dr. Jeffrey J. Swigris

National Jewish Health

Phone: 303-398-1621

Email: swigrisj@njhealth.org

Results disclosure agreements

• Principal investigator is a sponsor employee
• Publication restrictions are in place