## Protocol Section
### Identification Module
**NCT ID:** NCT01442779

**Brief Title:** Clinical Trial of Low Dose Oral Interferon Alpha in Idiopathic Pulmonary Fibrosis

**Official Title:** Clinical Trial of Low Dose Oral Interferon Alpha in Idiopathic Pulmonary Fibrosis

#### Organization Study ID Info
**ID:** 00190
#### Organization
**Class:** OTHER
**Full Name:** Texas Tech University Health Sciences Center
### Status Module
#### Completion Date
**Date:** 2007-05

**Type:** ACTUAL

#### Expanded Access Info
#### Last Update Post Date
**Date:** 2012-04-20

**Type:** ESTIMATED

**Last Update Submit Date:** 2012-04-18

**Overall Status:** COMPLETED

#### Primary Completion Date
**Date:** 2007-05

**Type:** ACTUAL

#### Results First Post Date
**Date:** 2011-09-29

**Type:** ESTIMATED

**Results First Submit Date:** 2009-09-23

**Results First Submit QC Date:** 2011-08-23

#### Start Date
**Date:** 2000-09

**Status Verified Date:** 2012-04

#### Study First Post Date
**Date:** 2011-09-29
**Type:** ESTIMATED
**Study First Submit Date:** 2009-09-23
**Study First Submit QC Date:** 2011-08-23
### Sponsor Collaborators Module

#### Collaborators

**Class:** INDUSTRY

**Name:** Ainos, Inc. (f/k/a Amarillo Biosciences Inc.

#### Lead Sponsor

**Class:** OTHER

**Name:** Texas Tech University Health Sciences Center

#### Responsible Party

**Type:** SPONSOR

### Oversight Module

**Oversight Has DMC:** False

### Description Module

**Brief Summary:** The purpose of this study is to determine the possible efficacy of low dose, orally administered interferon alpha in subjects with Idiopathic Pulmonary Fibrosis (IPF).

**Detailed Description:** This is a pilot study to determine if oral administration of low doses of Interferon alpha might be effective in treating Idiopathic Pulmonary Fibrosis (IPF). This is a disease that damages the lungs leading to marked decreases in the quality of life and death within 3-5 years after diagnosis. The cause is unknown. The standard treatment has for some time been steroids such as prednisone or prednisolone because of their anti-inflammatory actions, but there is little evidence that steroids either improve the condition, prevent further deterioration or improve life expectancy. Additionally, they have many side effects.

In this disease, normal cells are damaged for unknown reasons and replaced by a type of scar. This scar tissue prevents the easy movement of oxygen from the lungs into the blood, making it difficult for the patient to perform normal activities. With progression, which usually occurs rapidly, patients require supplemental oxygen to perform even simple tasks.

Interferons are chemicals normally produced in the body and the rate of their production has been shown to be reduced in the lungs of patients with IPF. They are involved in regulating the activity of the immune system which may play a role in initiating the damage to the lungs in IPF and they also can inhibit the activity of the cells that form the scar tissue. Our hypothesis is that treating patients with interferon might prevent damage to additional normal tissue and prevent the formation of additional scar tissue. This would prevent progression, improve the quality of life and extend the expected life span if successful. Another study has been ongoing in which IPF patients have been given injections of large doses of another type of interferon. This treatment regimen is expensive and side effects have been fairly frequent.

In contrast, we are treating IPF patients with low doses of interferon administered orally. The interferon is taken three times per day by letting a lozenge dissolve in the mouth. These low doses have been shown to produce effects in patients with other diseases and they produce very few side effects. If side effects occur, they usually are not severe and go away quickly. Those reported most commonly by other subjects have been headaches, nausea, rashes, respiratory infections, sore throat or diarrhea. No one has had to stop taking the medicine because of the side effects. The medicine is provided free of charge.

This study has been going on for about 5 years. The subjects are given the same tests that they receive as part of their standard of care. These include chest x-rays, High Resolution CT scans, pulmonary function tests and some blood tests. They are done before starting interferon alpha, and, depending on the test, are repeated at 3-, 6-, 9- or 12 month intervals. In addition subjects are asked to complete questionnaires on the quality of life, cough history and a dyspnea index at each visit.

### Conditions Module

**Conditions:**

- Respiratory Tract Diseases

- Lung Diseases

- Lung Diseases, Interstitial

- Pulmonary Fibrosis

**Keywords:**

- Idiopathic Pulmonary Fibrosis

- Interferon alpha

### Design Module

#### Design Info

**Allocation:** NON_RANDOMIZED

**Intervention Model:** SINGLE_GROUP

##### Masking Info

**Masking:** NONE

**Primary Purpose:** TREATMENT

#### Enrollment Info

**Count:** 18

**Type:** ACTUAL

**Phases:**

- PHASE2

**Study Type:** INTERVENTIONAL

### Arms Interventions Module

### Interventions

#### Intervention 1

**Description:** dose form - oral lozenge dose - 150 International Units (IU) frequency - 3 times a day duration - at least 1 year

**Name:** Interferon alpha oral lozenge

**Type:** DRUG

### Outcomes Module

#### Primary Outcomes

**Description:** 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.

**Measure:** Minimal/no Progression (1 yr) by High Resolution Computed Tomography (HRCT) & Pulmonary Function

**Time Frame:** 1 yr

**Measure:** Minimal/no Change in Quality of Life

**Time Frame:** 12 months

#### Secondary Outcomes

**Description:** changes in cough status after treatment for 1 month.

**Measure:** Participants With Change in Cough

**Time Frame:** 1 month

### Eligibility Module

**Eligibility Criteria:** Inclusion Criteria:

* The only subjects to be included in this study are those diagnosed with Idiopathic Pulmonary Fibrosis with diagnosis based on the criteria published by the American Thoracic Society in the International Consensus Statement.

  1. Exclusion of other known causes of interstitial lung disease.
  2. Abnormal pulmonary function studies.
  3. Bibasilar reticular abnormalities with minimal ground glass opacities on HRCT scan.
  4. Biopsy or lavage showing no features supporting alternative diagnosis.
  5. Patient older than 50 years of age.
  6. Insidious onset of otherwise unexplained dyspnea on exertion.
  7. Duration greater than 3 months.
  8. Bibasilar, inspiratory crackles.

Exclusion Criteria:

* under the age of 50
* history of hypersensitivity to interferons
* history of hypersensitivity to biological products such as vaccines
* pregnant or lactating women
* women of child bearing age not pregnancy protected during the study
* unresolved serious cardiovascular disease

**Minimum Age:** 50 Years

**Sex:** ALL

**Standard Ages:**

- ADULT

- OLDER_ADULT

### Contacts Locations Module

#### Locations

**Location 1:**

**City:** Lubbock

**Country:** United States

**Facility:** Texas Tech University Health Sciences Center

**State:** Texas

**Zip:** 79430

#### Overall Officials

**Official 1:**

**Affiliation:** Texas Tech University Health Sciences Center

**Name:** Cynthia Jumper, MD

**Role:** PRINCIPAL_INVESTIGATOR

## Derived Section

### Condition Browse Module - Ancestors

- ID: D000010335

- Term: Pathologic Processes

### Condition Browse Module - Browse Branches

- Abbrev: BC23

- Name: Symptoms and General Pathology

- Abbrev: All

- Name: All Conditions

- Abbrev: BC08

- Name: Respiratory Tract (Lung and Bronchial) Diseases

- Abbrev: Rare

- Name: Rare Diseases

### Condition Browse Module - Browse Leaves

- ID: M8485

- Name: Fibrosis

- Relevance: HIGH

- As Found: Fibrosis

- ID: M11168

- Name: Lung Diseases

- Relevance: HIGH

- As Found: Lung Disease

- ID: M14512

- Name: Pulmonary Fibrosis

- Relevance: HIGH

- As Found: Pulmonary Fibrosis

- ID: M27989

- Name: Idiopathic Pulmonary Fibrosis

- Relevance: HIGH

- As Found: Idiopathic Pulmonary Fibrosis

- ID: M19813

- Name: Lung Diseases, Interstitial

- Relevance: HIGH

- As Found: Lung Diseases, Interstitial

- ID: M14977

- Name: Respiratory Tract Diseases

- Relevance: HIGH

- As Found: Respiratory Tract Diseases

- ID: T3003

- Name: Idiopathic Pulmonary Fibrosis

- Relevance: HIGH

- As Found: Idiopathic Pulmonary Fibrosis

### Condition Browse Module - Meshes

- ID: D000008171

- Term: Lung Diseases

- ID: D000011658

- Term: Pulmonary Fibrosis

- ID: D000054990

- Term: Idiopathic Pulmonary Fibrosis

- ID: D000012140

- Term: Respiratory Tract Diseases

- ID: D000017563

- Term: Lung Diseases, Interstitial

- ID: D000005355

- Term: Fibrosis

### Intervention Browse Module - Ancestors

- ID: D000000970

- Term: Antineoplastic Agents

- ID: D000000998

- Term: Antiviral Agents

- ID: D000000890

- Term: Anti-Infective Agents

- ID: D000007155

- Term: Immunologic Factors

- ID: D000045505

- Term: Physiological Effects of Drugs

### Intervention Browse Module - Browse Branches

- Abbrev: Infe

- Name: Anti-Infective Agents

- Abbrev: ANeo

- Name: Antineoplastic Agents

- Abbrev: All

- Name: All Drugs and Chemicals

### Intervention Browse Module - Browse Leaves

- ID: M10407

- Name: Interferons

- Relevance: HIGH

- As Found: Recurrent

- ID: M19243

- Name: Interferon-alpha

- Relevance: HIGH

- As Found: Status

- ID: M4314

- Name: Antiviral Agents

- Relevance: LOW

- As Found: Unknown

- ID: M4214

- Name: Anti-Infective Agents

- Relevance: LOW

- As Found: Unknown

- ID: M10201

- Name: Immunologic Factors

- Relevance: LOW

- As Found: Unknown

### Intervention Browse Module - Meshes

- ID: D000007372

- Term: Interferons

- ID: D000016898

- Term: Interferon-alpha

### Misc Info Module

- Version Holder: 2024-05-24

## Results Section

### Adverse Events Module

#### Event Groups

**Group ID:** EG000

**Title:** Interferon Alpha

**Description:** 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.

**ID:** EG000

**Other Num at Risk:** 18

**Serious Number Affected:** 4

**Serious Number At Risk:** 18

**Title:** Interferon Alpha

**Frequency Threshold:** 0

#### Serious Events

**Term:** Death

**Assessment Type:** NON_SYSTEMATIC_ASSESSMENT

**Notes:** The deaths that occurred were complications of the disease (IPF), not related to the study drug

**Organ System:** Respiratory, thoracic and mediastinal disorders

##### Stats

**Group ID:** EG000

**Num Affected:** 4

**Num At Risk:** 18

**Num Events:** 4

## Results Section - Baseline Characteristics Module

### Denomination Counts

**Group ID:** BG000

**Value:** 18

**Units:** Participants

### Group

**ID:** BG000

**Title:** Interferon Alpha

**Description:** 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.

### Measure

#### Measurement

**Group ID:** BG000

**Value:** 0

**Category Title:** <=18 years

#### Measurement

**Group ID:** BG000

**Value:** 7

**Category Title:** Between 18 and 65 years

#### Measurement

**Group ID:** BG000

**Value:** 11

**Category Title:** >=65 years

**Class Title:** 

### Measure

#### Measurement

**Group ID:** BG000

**Spread:** 8.8

**Value:** 67

**Class Title:** 

### Measure

#### Measurement

**Group ID:** BG000

**Value:** 9

**Category Title:** Female

#### Measurement

**Group ID:** BG000

**Value:** 9

**Category Title:** Male

**Class Title:** 

### Measure

#### Measurement

**Group ID:** BG000

**Value:** 18

**Class Title:** United States

**Denomination Units Selected:** 

## Results Section - Baseline Characteristics Module

### Measure 1
**Parameter Type:** COUNT_OF_PARTICIPANTS
**Title:** Age, Categorical
**Unit of Measure:** Participants
### Measure 2
**Dispersion Type:** STANDARD_DEVIATION
**Parameter Type:** MEAN
**Title:** Age Continuous
**Unit of Measure:** years
### Measure 3
**Parameter Type:** COUNT_OF_PARTICIPANTS
**Title:** Sex: Female, Male
**Unit of Measure:** Participants
### Measure 4
**Parameter Type:** NUMBER
**Title:** Region of Enrollment
**Unit of Measure:** participants
## Results Section - More Information Module
### Certain Agreement
**PI Sponsor Employee:** True
### Point of Contact
**Email:** Lorenz.Lutherer@ttuhsc.edu
**Organization:** Texas Tech University Health Sciences Center
**Phone:** 806-743-2532
**Title:** Lorenz Lutherer, MD, PhD
## Results Section - Outcome Measures Module
### Outcome Measure 1
### Outcome Measure 2
### Outcome Measure 3
## Results Section
### Outcome Measures Module
#### Outcome Measure 1
**Class:**
##### Category
**Measurements:**
- **Comment:** 
- **Group ID:** OG000
- **Lower Limit:** 
- **Spread:** 
- **Upper Limit:** 
- **Value:** 12
**Title:** 
#### Outcome Measure 2
**Class:**
##### Category
**Measurements:**
- **Comment:** 
- **Group ID:** OG000
- **Lower Limit:** 
- **Spread:** 
- **Upper Limit:** 
- **Value:** 12
**Title:** 
#### Outcome Measure 3
**Class:**
##### Category
**Measurements:**
- **Comment:** 
- **Group ID:** OG000
- **Lower Limit:** 
- **Spread:** 
- **Upper Limit:** 
- **Value:** 5
**Title:** 
## Results Section
### Outcome Measures Module
#### Outcome Measure 1
**Description:** 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.
**Parameter Type:** NUMBER
**Reporting Status:** POSTED
**Time Frame:** 1 yr
**Title:** Minimal/no Progression (1 yr) by High Resolution Computed Tomography (HRCT) & Pulmonary Function
**Type:** PRIMARY
**Unit of Measure:** Participants
##### Group
**Description:** 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.
**ID:** OG000
**Title:** Interferon Alpha
#### Outcome Measure 2
**Parameter Type:** NUMBER
**Population Description:** Analysis was performed only on those subject who continue on medication for at least one year.
**Reporting Status:** POSTED
**Time Frame:** 12 months
**Title:** Minimal/no Change in Quality of Life
**Type:** PRIMARY
**Unit of Measure:** Participants
##### Group
**Description:** 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.
**ID:** OG000
**Title:** Interferon Alpha
#### Outcome Measure 3
**Description:** changes in cough status after treatment for 1 month.
**Parameter Type:** NUMBER
**Population Description:** 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.
**Reporting Status:** POSTED
**Time Frame:** 1 month
**Title:** Participants With Change in Cough
**Type:** SECONDARY
**Unit of Measure:** Participants
##### Group
**Description:** 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.
**ID:** OG000
**Title:** Interferon Alpha
### Participant Flow Module
#### Group
**Description:** 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.
**ID:** FG000
**Title:** Interferon Alpha
#### Period
**Title:** Overall Study
##### Withdraw
**Type:** Withdrawal by Subject
###### Reason
**Group ID:** FG000
**Number of Subjects:** 3
##### Withdraw
**Type:** Death
###### Reason
**Group ID:** FG000
**Number of Subjects:** 3
##### Withdraw
**Type:** Non-compliance
###### Reason
**Group ID:** FG000
**Number of Subjects:** 1
##### Milestone
**Type:** STARTED
###### Achievement
**Group ID:** FG000
**Number of Subjects:** 18
##### Milestone
**Type:** COMPLETED
###### Achievement
**Group ID:** FG000
**Number of Subjects:** 11
##### Milestone
**Type:** NOT COMPLETED
###### Achievement
**Group ID:** FG000
**Number of Subjects:** 7
**Recruitment Details:** Medical clinic
**Has Results:** True