Study Stopped
Insufficient patient accrual
Interferon-alpha Treatment of Chronic Cough in Chronic Obstructive Pulmonary Disease and Idiopathic Pulmonary Fibrosis
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)
1 other identifier
interventional
1
1 country
1
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).
Trial Health
Trial Health Score
Automated assessment based on enrollment pace, timeline, and geographic reach
participants targeted
Target at below P25 for phase_2
Started Jun 2008
Typical duration for phase_2
1 active site
Health score is calculated from publicly available data and should be used for screening purposes only.
Trial Relationships
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Study Timeline
Key milestones and dates
Study Start
First participant enrolled
June 1, 2008
CompletedFirst Submitted
Initial submission to the registry
June 3, 2008
CompletedFirst Posted
Study publicly available on registry
June 5, 2008
CompletedPrimary Completion
Last participant's last visit for primary outcome
April 1, 2012
CompletedStudy Completion
Last participant's last visit for all outcomes
April 1, 2012
CompletedApril 24, 2012
April 1, 2012
3.8 years
June 3, 2008
April 20, 2012
Conditions
Keywords
Outcome Measures
Primary Outcomes (1)
frequency/severity of cough
weekly
Secondary Outcomes (3)
quality of life
weekly
anti-tussive medication usage
weekly
dyspnea
weekly
Study Arms (2)
1
EXPERIMENTALlozenges containing 150 IU of natural human interferon-alpha
2
PLACEBO COMPARATORmatching placebo lozenges
Interventions
150 IU natural human interferon-alpha lozenges for oral dissolution given 3 times per day for 4 weeks
Eligibility Criteria
You may qualify if:
- For all patients
- history of clinically significant chronic cough for \> 3 months
- For COPD patients
- \>40 years of age
- 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
You may not qualify if:
- ACE inhibitor use
- GERD
- current cancer or history of lung cancer
- non-ambulatory
- hospitalized in the previous 12 months for heart failure
Contact the study team to confirm eligibility.
Sponsors & Collaborators
Study Sites (1)
Texas Tech University Health Sciences Center
Lubbock, Texas, 79430, United States
Related 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.
BACKGROUND
Related Links
MeSH Terms
Conditions
Interventions
Condition Hierarchy (Ancestors)
Intervention Hierarchy (Ancestors)
Study Officials
- PRINCIPAL INVESTIGATOR
Lorenz O Lutherer, MD, PhD
Texas Tech University Health Sciences Center
Study Design
- Study Type
- interventional
- Phase
- phase 2
- Allocation
- RANDOMIZED
- Masking
- QUADRUPLE
- Who Masked
- PARTICIPANT, CARE PROVIDER, INVESTIGATOR, OUTCOMES ASSESSOR
- Purpose
- TREATMENT
- Intervention Model
- PARALLEL
- Sponsor Type
- INDUSTRY
- Responsible Party
- SPONSOR
Study Record Dates
First Submitted
June 3, 2008
First Posted
June 5, 2008
Study Start
June 1, 2008
Primary Completion
April 1, 2012
Study Completion
April 1, 2012
Last Updated
April 24, 2012
Record last verified: 2012-04