Pulmonary Disease, Chronic ObstructivePhase 2NCT00690885
Interferon-alpha Treatment of Chronic Cough in Chronic Obstructive Pulmonary Disease and Idiopathic Pulmonary Fibrosis
A Phase 2 study testing interferon-alpha lozenges in people with Pulmonary Disease, Chronic Obstructive and Pulmonary Fibrosis, run by Ainos, Inc. (f/k/a Amarillo Biosciences Inc. at 1 site in United States.
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). Read more about this study
- Who is it for?
- Ages 40 years and older
- Conditions the study is for
- Pulmonary Disease, Chronic Obstructive, Pulmonary Fibrosis, Cough
- What is being tested?
- interferon-alpha lozenges
- Type of treatment
- Pill or oral medicine
- Could I receive a placebo?
- Yes, some participants may receive a placebo
- How many people
- 1 participants
- Where
- 1 siteUnited States
- Study dates
- Jun 2008to Apr 2012
- Phase
- Phase 2
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 40 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- 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
Show all 12Show fewer
- 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
Who cannot join
- ACE inhibitor use
- GERD
- current cancer or history of lung cancer
- non-ambulatory
- hospitalized in the previous 12 months for heart failure
Trial locations and contacts
1 site in 1 country.
United States1 site
Texas Tech University Health Sciences Center
Lubbock, Texas, 79430
About this study
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)
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).
Read the 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.
- Being tested
- interferon-alpha lozenges, placebo lozenges
- Keywords
- chronic cough, COPD, IPF, interferon alpha
- Medical subject headings
- Pulmonary Disease, Chronic Obstructive, Pulmonary Fibrosis, Cough, Chronic Cough
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
interferon-alpha lozengesDrug
Also called oral IFN-alpha, oral IFN-alpha lozenges, Veldona lozenges
150 IU natural human interferon-alpha lozenges for oral dissolution given 3 times per day for 4 weeks
placebo lozengesDrug
Also called placebo
matching placebo lozenges
| Study group | Role | What they receive |
|---|---|---|
| 1 | Experimental | lozenges containing 150 IU of natural human interferon-alpha Receives: Drug: interferon-alpha lozenges |
| 2 | Placebo comparator | matching placebo lozenges Receives: Drug: placebo lozenges |
What is being measured
The primary outcome is the main question the study is designed to answer.
frequency/severity of cough
Measured: weekly
Secondary outcomes (3)
quality of life
Measured: weekly
anti-tussive medication usage
Measured: weekly
dyspnea
Measured: weekly
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted5 Jun 2008 (estimated)
- Study startJun 2008
- Primary completionApr 2012
- Study completionApr 2012
Why it stopped: Insufficient patient accrual
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (1)Papers the sponsor has linked to this study.
- Other trials for Pulmonary Disease, Chronic ObstructiveStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase 2
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Quadruple blind
- Who is masked
- Participant, Care provider, Investigator, Outcomes assessor
- Enrolment
- 1 participants (actual)
Sponsor and investigators
- Lead sponsor
- Ainos, Inc. (f/k/a Amarillo Biosciences Inc.
- Sponsor type
- Industry (pharma, biotech, devices)
- Collaborators
- Texas Tech University Health Sciences Center
- Responsible party
- Sponsor
- Investigators
- Lorenz O Lutherer, MD, PhD, Principal investigator, Texas Tech University Health Sciences Center
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT00690885
- Sponsor's protocol ID
- 07HUCO01
- Status last verified
- Apr 2012
- First submitted
- 3 Jun 2008
- Last updated
- 24 Apr 2012
- Results posted
- No
- Data monitoring committee
- No
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.
Study at a glance
From the registry record, last updated by the sponsor on 24 Apr 2012. Recruitment status is as the sponsor reported it: confirm with the study team.
- 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)
- ClinicalTrials.gov ID
- NCT00690885
- Acronym / sponsor ID
- 07HUCO01
- Keywords
- chronic cough, COPD, IPF, interferon alpha
- Phase
- Phase 2
- Study type
- Interventional
- Recruitment status
- TerminatedReason stopped: Insufficient patient accrual
- Enrolment
- 1 participants (actual)
- Lead sponsor
- Ainos, Inc. (f/k/a Amarillo Biosciences Inc.Industry (pharma, biotech, devices)
- Collaborators
- Texas Tech University Health Sciences Center
- Study start
- Jun 2008
- Primary completion
- Apr 2012 (actual)
- Study completion
- Apr 2012 (actual)
- First posted
- 5 Jun 2008 (estimated)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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).
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.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Quadruple blind (participant, care provider, investigator, outcomes assessor)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| 1 | Experimental | Drug: interferon-alpha lozengeslozenges containing 150 IU of natural human interferon-alpha |
| 2 | Placebo comparator | Drug: placebo lozengesmatching placebo lozenges |
Who may qualify
- Ages
- 40 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (12 listed)
- 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
Key exclusion criteria (5 listed)
- ACE inhibitor use
- GERD
- current cancer or history of lung cancer
- non-ambulatory
- hospitalized in the previous 12 months for heart failure
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| interferon-alpha lozengesAlso: oral IFN-alpha, oral IFN-alpha lozenges, Veldona lozenges150 IU natural human interferon-alpha lozenges for oral dissolution given 3 times per day for 4 weeks | Drug | 1 |
| placebo lozengesAlso: placebomatching placebo lozenges | Drug | 2 |
Primary outcome
frequency/severity of cough
Time frame: weekly
3 secondary outcomes
quality of life
Time frame: weekly
anti-tussive medication usage
Time frame: weekly
dyspnea
Time frame: weekly
Results and safety
The study was stopped early (reason given: Insufficient patient accrual). Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 24 Apr 2012.
- BackgroundLutherer, 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.
- American Lung Association - COPD fact sheetLink provided by the sponsor.
- American Lung Association - Interstitial Lung Diseases and Pulmonary FibrosisLink provided by the sponsor.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Lorenz O Lutherer, MD, PhD principal investigator
Texas Tech University Health Sciences Center
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 2 study testing interferon-alpha lozenges in people with Pulmonary Disease, Chronic Obstructive and Pulmonary Fibrosis, run by Ainos, Inc. (f/k/a Amarillo Biosciences Inc. at 1 site in United States.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 12 inclusion and 5 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: stopped early, as of the sponsor's last update on 24 Apr 2012. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in United States. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. Some participants in this study may receive a placebo. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
What does this phase mean?
Phase 2 studies give the treatment to a larger group to see whether it has the intended effect and to keep checking safety.
Not every study follows the same path, and some studies (observational studies, device studies) have no phase.
Are results available for this study?
The study was stopped early (reason given: Insufficient patient accrual). Results are not available in the source record.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
frequency/severity of cough (time frame: weekly). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT00690885, which also lists 1 linked publication.
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 24 Apr 2012.