Clinical trial NCT00690885: Interferon-alpha Treatment of Chronic Cough in Chronic Obstructive Pulmonary Disease and Idiopathic Pulmonary Fibrosis
Official title: 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)
Study type: INTERVENTIONAL
Overall status: TERMINATED
Phase: PHASE2
Conditions: Pulmonary Disease, Chronic Obstructive
Pulmonary Fibrosis
Cough
Keywords: chronic cough
COPD
IPF
interferon alpha
Lead sponsor: Ainos, Inc. (f/k/a Amarillo Biosciences Inc.
Sponsor class: INDUSTRY
Collaborators: name: Texas Tech University Health Sciences Center
First posted: 2008-06-05
Enrollment: 1
Sex: ALL
Minimum age (years): 40
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

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.

Eligibility criteria: 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

Primary outcomes:
measure: frequency/severity of cough
timeFrame: weekly
Secondary outcomes:
measure: quality of life
timeFrame: weekly
measure: anti-tussive medication usage
timeFrame: weekly
measure: dyspnea
timeFrame: weekly
Other outcomes:
Locations:
city: Lubbock
country: United States
facility: Texas Tech University Health Sciences Center
state: Texas
Study officials:
affiliation: Texas Tech University Health Sciences Center
name: Lorenz O Lutherer, MD, PhD
role: PRINCIPAL_INVESTIGATOR
References:
citation: Lutherer, LO, et al. Preliminary Results Suggest Prevention of Progression of Idiopathic Pulmonary Fibrosis by Treatment with Low-Dose, Oral Interferon Alpha. Journal of Investigative Medicine 54(1):S278, 2006.