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).
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 Type
INTERVENTIONAL
Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
QUADRUPLE
Enrollment
1
150 IU natural human interferon-alpha lozenges for oral dissolution given 3 times per day for 4 weeks
matching placebo lozenges
Texas Tech University Health Sciences Center
Lubbock, Texas, United States
frequency/severity of cough
Time frame: weekly
quality of life
Time frame: weekly
anti-tussive medication usage
Time frame: weekly
dyspnea
Time frame: weekly
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