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

Study Overview
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Brief Summary
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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
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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.

Official Title
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Evaluation of Natural Human Interferon Alpha Lozenges in the Treatment of Chronic Cough in Patients With Chronic Obstructive Pulmonary Disease (COPD) or Idiopathic Pulmonary Fibrosis (IPF)

Conditions
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Pulmonary Disease, Chronic Obstructive, Pulmonary Fibrosis, Cough

Intervention / Treatment
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* Drug: interferon-alpha lozenges
* Drug: placebo lozenges


Participation Criteria
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Eligibility Criteria
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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

Ages Eligible for Study
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Minimum Age: 40 Years

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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No

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Treatment
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Quadruple


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: 1<br>lozenges containing 150 IU of natural human interferon-alpha | Drug: interferon-alpha lozenges<br>* 150 IU natural human interferon-alpha lozenges for oral dissolution given 3 times per day for 4 weeks<br>* Other names: Veldona lozenges;|
| Placebo Comparator: 2<br>matching placebo lozenges | Drug: placebo lozenges<br>* matching placebo lozenges<br>* Other names: placebo;|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| frequency/severity of cough |  | weekly | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| quality of life |  | weekly | 
| anti-tussive medication usage |  | weekly | 
| dyspnea |  | weekly | 

 Terms related to the study
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Keywords Provided by Centre Hospitalier Valida
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chronic cough, COPD, IPF, interferon alpha