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NCT00690885 Clinical Trial

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

Pulmonary Disease, Chronic Obstructive Clinical Trial

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)

Clinical Trial Details — Status: Terminated

Administrative data
NCT number NCT00690885
Other study ID # 07HUCO01
Secondary ID
Status Terminated
Phase Phase 2
First received June 3, 2008
Last updated April 20, 2012
Start date June 2008
Est. completion date April 2012

Study information
Verified date April 2012
Source Amarillo Biosciences, Inc.
Contact n/a
Is FDA regulated No
Health authority
Study type Interventional

Clinical Trial 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).

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.

Recruitment information / eligibility
Status Terminated
Enrollment 1
Est. completion date April 2012
Est. primary completion date April 2012
Accepts healthy volunteers No
Gender All
Age group 40 Years and older
Eligibility 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

Study Design

Related Conditions & MeSH terms

Intervention

Drug:
• interferon-alpha lozenges
150 IU natural human interferon-alpha lozenges for oral dissolution given 3 times per day for 4 weeks
• placebo lozenges
matching placebo lozenges

Locations
Country Name City State
United States Texas Tech University Health Sciences Center Lubbock Texas

Sponsors (2)
Lead Sponsor Collaborator
Amarillo Biosciences, Inc. Texas Tech University Health Sciences Center

Country where clinical trial is conducted

United States, 

References & Publications (1)

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.

Outcome
Type Measure Description Time frame Safety issue
Primary frequency/severity of cough weekly
Secondary quality of life weekly
Secondary anti-tussive medication usage weekly
Secondary dyspnea weekly
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