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

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)

Status

Terminated

Phases

Phase 2

Study type

Interventional

Source

ClinicalTrials.gov

Registry ID

NCT00690885

Enrollment

Registered

2008-06-05

Start date

2008-06-30

Completion date

2012-04-30

Last updated

2012-04-24

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Cough, Pulmonary Disease, Chronic Obstructive, Pulmonary Fibrosis

Keywords

chronic cough, COPD, IPF, interferon alpha

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.

Interventions

DRUGinterferon-alpha lozenges

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

DRUGplacebo lozenges

matching placebo lozenges

Study design

Allocation

RANDOMIZED

Intervention model

PARALLEL

Primary purpose

TREATMENT

Masking

QUADRUPLE (Subject, Caregiver, Investigator, Outcomes Assessor)

Eligibility

Sex/Gender

ALL

Age

40 Years to No maximum

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

Design outcomes

Primary

Measure	Time frame
frequency/severity of cough	weekly

Secondary

Measure	Time frame
quality of life	weekly
anti-tussive medication usage	weekly
dyspnea	weekly

Countries

United States

Outcome results

None listed

Source: ClinicalTrials.gov · Data processed: Feb 4, 2026