Trial Outcomes & Findings for Clinical Trial of Low Dose Oral Interferon Alpha in Idiopathic Pulmonary Fibrosis (NCT NCT01442779)

NCT ID: NCT01442779

Last Updated: 2012-04-20

Results Overview

Disease progression was determined by comparing results of the High Resolution Computed Tomography(HRCT) and pulmonary function at one year to the baseline HRCT \& pulmonary function. The same radiologist did the comparsion for all subjects.

• Recruitment status: COMPLETED
• Study phase: PHASE2
• Target enrollment: 18 participants
• Primary outcome timeframe: 1 yr
• Results posted on: 2012-04-20

Participant Flow

Medical clinic

Participant milestones

Measure	Interferon Alpha Treatment with low dose oral interferon alpha lozenges taken 3 times daily (approximately 6 hours apart). Lozenge is to be dissolved under tongue or by moving around in mouth.
Overall Study STARTED	18
Overall Study COMPLETED	11
Overall Study NOT COMPLETED	7

Reasons for withdrawal

Measure	Interferon Alpha Treatment with low dose oral interferon alpha lozenges taken 3 times daily (approximately 6 hours apart). Lozenge is to be dissolved under tongue or by moving around in mouth.
Overall Study Withdrawal by Subject	3
Overall Study Death	3
Overall Study Non-compliance	1

Baseline Characteristics

Clinical Trial of Low Dose Oral Interferon Alpha in Idiopathic Pulmonary Fibrosis

Baseline characteristics by cohort

Measure	Interferon Alpha n=18 Participants Treatment with low dose oral interferon alpha lozenges taken 3 times daily (approximately 6 hours apart). Lozenge is to be dissolved under tongue or by moving around in mouth.
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	11 Participants n=5 Participants
Age Continuous	67 years STANDARD_DEVIATION 8.8 • n=5 Participants
Sex: Female, Male Female	9 Participants n=5 Participants
Sex: Female, Male Male	9 Participants n=5 Participants
Region of Enrollment United States	18 participants n=5 Participants

PRIMARY outcome

Timeframe: 1 yr

Disease progression was determined by comparing results of the High Resolution Computed Tomography(HRCT) and pulmonary function at one year to the baseline HRCT & pulmonary function. The same radiologist did the comparsion for all subjects.

Outcome measures

Measure	Interferon Alpha n=18 Participants Treatment with low dose oral interferon alpha lozenges taken 3 times daily (approximately 6 hours apart). Lozenge is to be dissolved under tongue or by moving around in mouth.
Minimal/no Progression (1 yr) by High Resolution Computed Tomography (HRCT) & Pulmonary Function	12 Participants

PRIMARY outcome

Timeframe: 12 months

Population: Analysis was performed only on those subject who continue on medication for at least one year.

Outcome measures

Measure	Interferon Alpha n=18 Participants Treatment with low dose oral interferon alpha lozenges taken 3 times daily (approximately 6 hours apart). Lozenge is to be dissolved under tongue or by moving around in mouth.
Minimal/no Change in Quality of Life	12 Participants

SECONDARY outcome

Timeframe: 1 month

Population: During the course of the study it was noted that subjects experienced a change in the cough that is sometimes associated with IPF. The 6 subjects still enrolled in the study were asked to complete a questionnare regarding the status of the cough.

changes in cough status after treatment for 1 month.

Outcome measures

Measure	Interferon Alpha n=6 Participants Treatment with low dose oral interferon alpha lozenges taken 3 times daily (approximately 6 hours apart). Lozenge is to be dissolved under tongue or by moving around in mouth.
Participants With Change in Cough	5 Participants

Adverse Events

Interferon Alpha

Serious events: 4 serious events

Other events: 0 other events

Deaths: 0 deaths

Serious adverse events

Measure	Interferon Alpha n=18 participants at risk Treatment with low dose oral interferon alpha lozenges taken 3 times daily (approximately 6 hours apart). Lozenge is to be dissolved under tongue or by moving around in mouth.
Respiratory, thoracic and mediastinal disorders Death	22.2% 4/18 • Number of events 4

Other adverse events

Adverse event data not reported

Additional Information

Lorenz Lutherer, MD, PhD

Texas Tech University Health Sciences Center

Phone: 806-743-2532

Email: Lorenz.Lutherer@ttuhsc.edu

Results disclosure agreements

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