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

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

Get a concise snapshot of the trial, including recruitment status, study phase, enrollment targets, and key timeline milestones.

Recruitment Status

TERMINATED

Clinical Phase

PHASE2

Total Enrollment

1 participants

Study Classification

INTERVENTIONAL

Study Start Date

2008-06-30

Study Completion Date

2012-04-30

Brief Summary

Review the sponsor-provided synopsis that highlights what the study is about and why it is being conducted.

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).

Related Clinical Trials

Explore similar clinical trials based on study characteristics and research focus.

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

NCT01442779

Respiratory Tract Diseases Lung Diseases Lung Diseases, Interstitial +1 more

COMPLETED PHASE2

A Study to Test Whether BI 1839100 Improves Cough in People With Idiopathic Pulmonary Fibrosis or Progressive Pulmonary Fibrosis

NCT06360094

Idiopathic Pulmonary Fibrosis Progressive Pulmonary Fibrosis

TERMINATED PHASE2

Study Evaluating INS018_055 Administered Orally to Subjects With Idiopathic Pulmonary Fibrosis

NCT05975983

Idiopathic Pulmonary Fibrosis (IPF)

RECRUITING PHASE2

A Study of the Safety and Clinical Effects of Interferon Gamma-1b in Patients With Idiopathic Pulmonary Fibrosis (IPF)

NCT00047658

Idiopathic Pulmonary Fibrosis

COMPLETED PHASE2

A Pilot Study of Aerosol Interferon-gamma for Treatment of Idiopathic Pulmonary Fibrosis

NCT00563212

Pulmonary Fibrosis

COMPLETED PHASE1

Detailed Description

Dive into the extended narrative that explains the scientific background, objectives, and procedures in greater depth.

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.

Conditions

See the medical conditions and disease areas that this research is targeting or investigating.

Pulmonary Disease, Chronic Obstructive Pulmonary Fibrosis Cough

Study Design

Understand how the trial is structured, including allocation methods, masking strategies, primary purpose, and other design elements.

Allocation Method

RANDOMIZED

Intervention Model

PARALLEL

Primary Study Purpose

TREATMENT

Blinding Strategy

QUADRUPLE

Participants Caregivers Investigators Outcome Assessors

Study Groups

Review each arm or cohort in the study, along with the interventions and objectives associated with them.

1

lozenges containing 150 IU of natural human interferon-alpha

Group Type EXPERIMENTAL

interferon-alpha lozenges

Intervention Type DRUG

150 IU natural human interferon-alpha lozenges for oral dissolution given 3 times per day for 4 weeks

2

matching placebo lozenges

Group Type PLACEBO_COMPARATOR

placebo lozenges

Intervention Type DRUG

matching placebo lozenges

Interventions

Learn about the drugs, procedures, or behavioral strategies being tested and how they are applied within this trial.

interferon-alpha lozenges

150 IU natural human interferon-alpha lozenges for oral dissolution given 3 times per day for 4 weeks

Intervention Type DRUG

placebo lozenges

matching placebo lozenges

Intervention Type DRUG

Other Intervention Names

Discover alternative or legacy names that may be used to describe the listed interventions across different sources.

oral IFN-alpha oral IFN-alpha lozenges Veldona lozenges placebo

Eligibility Criteria

Check the participation requirements, including inclusion and exclusion rules, age limits, and whether healthy volunteers are accepted.

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