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

This study has been terminated.
(Insufficient patient accrual)
Sponsor:
Collaborator:
Texas Tech University Health Sciences Center
Information provided by (Responsible Party):
Amarillo Biosciences, Inc.
ClinicalTrials.gov Identifier:
NCT00690885
First received: June 3, 2008
Last updated: April 20, 2012
Last verified: April 2012
  Purpose

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).


Condition Intervention Phase
Pulmonary Disease, Chronic Obstructive
Pulmonary Fibrosis
Cough
Drug: interferon-alpha lozenges
Drug: placebo lozenges
Phase 2

Study Type: Interventional
Study Design: Allocation: Randomized
Endpoint Classification: Efficacy Study
Intervention Model: Parallel Assignment
Masking: Double Blind (Subject, Caregiver, Investigator, Outcomes Assessor)
Primary Purpose: Treatment
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)

Resource links provided by NLM:


Further study details as provided by Amarillo Biosciences, Inc.:

Primary Outcome Measures:
  • frequency/severity of cough [ Time Frame: weekly ] [ Designated as safety issue: No ]

Secondary Outcome Measures:
  • quality of life [ Time Frame: weekly ] [ Designated as safety issue: No ]
  • anti-tussive medication usage [ Time Frame: weekly ] [ Designated as safety issue: No ]
  • dyspnea [ Time Frame: weekly ] [ Designated as safety issue: No ]

Enrollment: 1
Study Start Date: June 2008
Study Completion Date: April 2012
Primary Completion Date: April 2012 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
Experimental: 1
lozenges containing 150 IU of natural human interferon-alpha
Drug: interferon-alpha lozenges
150 IU natural human interferon-alpha lozenges for oral dissolution given 3 times per day for 4 weeks
Other Names:
  • oral IFN-alpha
  • oral IFN-alpha lozenges
  • Veldona lozenges
Placebo Comparator: 2
matching placebo lozenges
Drug: placebo lozenges
matching placebo lozenges
Other Name: placebo

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

Ages Eligible for Study:   40 Years and older
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   No
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
  Contacts and Locations
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

Please refer to this study by its ClinicalTrials.gov identifier: NCT00690885

Locations
United States, Texas
Texas Tech University Health Sciences Center
Lubbock, Texas, United States, 79430
Sponsors and Collaborators
Amarillo Biosciences, Inc.
Texas Tech University Health Sciences Center
Investigators
Principal Investigator: Lorenz O Lutherer, MD, PhD Texas Tech University Health Sciences Center
  More Information

Additional Information:
Publications:
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.

Responsible Party: Amarillo Biosciences, Inc.
ClinicalTrials.gov Identifier: NCT00690885     History of Changes
Other Study ID Numbers: 07HUCO01
Study First Received: June 3, 2008
Last Updated: April 20, 2012
Health Authority: United States: Food and Drug Administration

Keywords provided by Amarillo Biosciences, Inc.:
chronic cough
COPD
IPF
interferon alpha

Additional relevant MeSH terms:
Chronic Disease
Cough
Fibrosis
Idiopathic Pulmonary Fibrosis
Lung Diseases
Lung Diseases, Obstructive
Pulmonary Disease, Chronic Obstructive
Pulmonary Fibrosis
Disease Attributes
Idiopathic Interstitial Pneumonias
Lung Diseases, Interstitial
Pathologic Processes
Respiration Disorders
Respiratory Tract Diseases
Signs and Symptoms
Signs and Symptoms, Respiratory
Interferon-alpha
Interferons
Anti-Infective Agents
Antineoplastic Agents
Antiviral Agents
Immunologic Factors
Pharmacologic Actions
Physiological Effects of Drugs
Therapeutic Uses

ClinicalTrials.gov processed this record on October 23, 2014