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

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details. Identifier: NCT00690885
Recruitment Status : Terminated (Insufficient patient accrual)
First Posted : June 5, 2008
Last Update Posted : April 24, 2012
Texas Tech University Health Sciences Center
Information provided by (Responsible Party):
Amarillo Biosciences, Inc.

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).

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

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.

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Study Type : Interventional  (Clinical Trial)
Actual Enrollment : 1 participants
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Quadruple (Participant, Care Provider, 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)
Study Start Date : June 2008
Actual Primary Completion Date : April 2012
Actual Study Completion Date : April 2012

Arm Intervention/treatment
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

Primary Outcome Measures :
  1. frequency/severity of cough [ Time Frame: weekly ]

Secondary Outcome Measures :
  1. quality of life [ Time Frame: weekly ]
  2. anti-tussive medication usage [ Time Frame: weekly ]
  3. dyspnea [ Time Frame: weekly ]

Information from the National Library of Medicine

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, Learn About Clinical Studies.

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Ages Eligible for Study:   40 Years and older   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No

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

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its identifier (NCT number): NCT00690885

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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
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Principal Investigator: Lorenz O Lutherer, MD, PhD Texas Tech University Health Sciences Center
Additional Information:
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.

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Responsible Party: Amarillo Biosciences, Inc. Identifier: NCT00690885    
Other Study ID Numbers: 07HUCO01
First Posted: June 5, 2008    Key Record Dates
Last Update Posted: April 24, 2012
Last Verified: April 2012
Keywords provided by Amarillo Biosciences, Inc.:
chronic cough
interferon alpha
Additional relevant MeSH terms:
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Lung Diseases
Lung Diseases, Obstructive
Pulmonary Disease, Chronic Obstructive
Pulmonary Fibrosis
Idiopathic Pulmonary Fibrosis
Pathologic Processes
Respiratory Tract Diseases
Respiration Disorders
Signs and Symptoms, Respiratory
Idiopathic Interstitial Pneumonias
Lung Diseases, Interstitial
Interferon alpha-2
Antineoplastic Agents
Antiviral Agents
Anti-Infective Agents
Immunologic Factors
Physiological Effects of Drugs