Interferon-alpha Treatment of Chronic Cough in Chronic Obstructive Pulmonary Disease and Idiopathic Pulmonary Fibrosis
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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) |
- frequency/severity of cough [ Time Frame: weekly ] [ Designated as safety issue: No ]
- 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:
|
|
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 |
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| United States, Texas | |
| Texas Tech University Health Sciences Center | |
| Lubbock, Texas, United States, 79430 | |
| Principal Investigator: | Lorenz O Lutherer, MD, PhD | Texas Tech University Health Sciences Center |
More Information
Additional Information:
Publications:
| 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 Lung Diseases Respiration Disorders Pulmonary Disease, Chronic Obstructive Pulmonary Fibrosis Lung Diseases, Obstructive Idiopathic Pulmonary Fibrosis Disease Attributes Pathologic Processes Respiratory Tract Diseases Signs and Symptoms, Respiratory Signs and Symptoms Idiopathic Interstitial Pneumonias |
Lung Diseases, Interstitial Interferon-alpha Interferon Alfa-2a Interferons Antiviral Agents Anti-Infective Agents Therapeutic Uses Pharmacologic Actions Immunologic Factors Physiological Effects of Drugs Angiogenesis Inhibitors Angiogenesis Modulating Agents Growth Substances Growth Inhibitors Antineoplastic Agents |
ClinicalTrials.gov processed this record on May 21, 2013