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

Ainos

Status and phase: Terminated; Phase 2

Conditions: Pulmonary Fibrosis; Pulmonary Disease, Chronic Obstructive; Cough

Treatments: Drug: placebo lozenges; Drug: interferon-alpha lozenges

Study type: Interventional

Funder types: Other; Industry

Identifiers

NCT00690885

07HUCO01

Details and patient eligibility

About

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).

Full 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.

Enrollment: 1 patient

Sex: All

Ages: 40+ years old

Volunteers: No Healthy Volunteers

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

Trial design

Primary purpose: Treatment

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: Quadruple Blind

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1 participants in 2 patient groups, including a placebo group

1

Experimental group

Description:

lozenges containing 150 IU of natural human interferon-alpha

Treatment:

Drug: interferon-alpha lozenges

2

Placebo Comparator group

Description:

matching placebo lozenges

Treatment:

Drug: placebo lozenges