Interferon-alpha Treatment of Chronic Cough in Chronic Obstructive Pulmonary Disease and Idiopathic Pulmonary Fibrosis

Phase 2

Terminated

• Conditions: Pulmonary Disease, Chronic Obstructive; Cough; Pulmonary Fibrosis
• Interventions: Drug: placebo lozenges; Drug: interferon-alpha lozenges

• Registration Number: NCT00690885
• Lead Sponsor: Ainos, Inc. (f/k/a Amarillo Biosciences Inc.

Brief Summary

The purpose of this study is to determine whether lozenges containing interferon-alpha can reduce the frequency and severity of coughing in patients with chronic obstructive pulmonary disease (COPD) and idiopathic pulmonary fibrosis (IPF).

Detailed Description

Both chronic obstructive pulmonary disease (COPD) and idiopathic pulmonary fibrosis (IPF) frequently lead to a chronic cough that negatively impacts the quality of life (QOL) for patients and those around them. This is a randomized, double-blind, placebo-controlled trial to determine whether interferon-alpha, delivered in low doses via orally dissolving lozenges given 3 times per day for 4 weeks, can reduce the frequency and severity of chronic cough in patients with COPD or IPF. Cough frequency will be assessed via 24-hour digital audio recordings made prior to entry, and at weeks 2 and 4 of treatment. Cough severity will be assessed via a 100-mm visual analog scale questionnaire completed by the subject prior to entry and then weekly during treatment. Subjects will also complete questionnaires regarding cough frequency, duration and intensity, QOL, dyspnea, and antitussive medication usage weekly during treatment. All questionnaires will be repeated weekly during a 4-week post-treatment observation period to assess durability of response.

Study Timeline

• Study Start: 2008-06
• Study First Submitted: 2008-06-03
• Study First Submitted QC: 2008-06-04
• Study First Posted: 2008-06-05
• Status Verified: 2012-04
• Primary Completion: 2012-04
• Study Completion: 2012-04
• Last Update Submitted: 2012-04-20
• Last Update Posted: 2012-04-24

Recruitment & Eligibility

• Status: TERMINATED
• Sex: All
• Target Recruitment: 1

Inclusion Criteria

For all patients

• history of clinically significant chronic cough for > 3 months
• For COPD patients
• >40 years of age
• 20-pack-year history of smoking
• GOLD classification of Stage 1 or higher
• For IPF patients
• > 50 years of age
• history of unexplained dyspnea on exertion of > 3 months
• exhibits coughing and bilateral, basilar, inspiratory crackles on physical exam
• presents as being in a stable phase of IPF
• lung biopsy or HRCT indicative of IPF

Exclusion Criteria

• ACE inhibitor use
• GERD
• current cancer or history of lung cancer
• non-ambulatory
• hospitalized in the previous 12 months for heart failure

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Arm && Interventions

Group	Intervention	Description
2	placebo lozenges	matching placebo lozenges
1	interferon-alpha lozenges	lozenges containing 150 IU of natural human interferon-alpha

Primary Outcome Measures

Name	Time	Method
frequency/severity of cough	weekly

Secondary Outcome Measures

Name	Time	Method
quality of life	weekly
anti-tussive medication usage	weekly
dyspnea	weekly

Trial Locations

Locations (1)

Texas Tech University Health Sciences Center; 🇺🇸 Lubbock, Texas, United States