Chronic Refractory CoughPhase 2NCT01703923
An Exploratory Study of FP01 Lozenges in Subjects With Chronic Refractory Cough
A Phase 2 study testing FP01 in people with Chronic Refractory Cough, run by Avalo Therapeutics, Inc. at 8 sites in United States.
Trial summary
The purpose of this study is to determine the antitussive effect size and dose response of FP01 lozenges in subjects with chronic cough and to demonstrate the safety and tolerability of FP01 lozenges in subjects with chronic cough. Read more about this study
- Who is it for?
- Ages 18 to 75 yearsHealthy volunteers can take part
- Conditions the study is for
- Chronic Refractory Cough
- What is being tested?
- FP01
- Type of treatment
- Pill or oral medicine
- Could I receive a placebo?
- Yes, some participants may receive a placebo
- How many people
- 83 participants
- Where
- 8 sitesUnited States
- Study dates
- Nov 2012to Sep 2013
- 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 18 to 75 years
- All sexes
- Healthy volunteers accepted
- Adult, Older adult
Who may be able to join
- Subject must sign an Institutional Review Board approved informed consent and agree to complete required clinic visits
- Subjects must be able to read and write English
- Subject must exceed a cough severity threshold (VAS) during screening visit (Cough Severity VAS Score ≥ 35 mm)
- Mean CSD frequency domain (Only Questions 1-3 at time of screening) score > 3.0
- Stable chest X-ray
- Forced expiratory volume 1 (FEV1) and forced vital capacity (FVC) >70% predicted measured using spirometry
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- Body mass index (BMI) 18.5 - 38
- Subjects must be non-smokers or have refrained from using nicotine or nicotine containing products for at least 6 months
- Female subjects should be either post-menopausal (amenorrhea for at least 12 consecutive months), surgically sterile, or women of child-bearing potential with a negative serum beta human chorionic gonadotropin pregnancy test prior to entering the study and who are using or agree to use an acceptable method of contraception as determined by the Investigator
Who cannot join
- Recent significant change in pulmonary status or upper respiratory tract infection (<4 weeks of randomization)
- Female subjects who are pregnant, breast feeding or sexually active without contraception.
- History of chronic obstructive pulmonary disease (COPD)
- History of asthma that required any significant change in treatment within 2 weeks of randomization. Subjects with asthma are eligible as long as the subject is not being treated with oral steroids but may enroll as long as no new medication to control their asthma has been prescribed within two weeks of study enrollment.
- History of inhalational exposure (chemical, smoke, water, etc.) within 6 months of randomization
- Chest X-ray suggestive of granulomatous disease, malignancy, pneumonia, other acute pulmonary or pleural processes
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- Current treatment with angiotensin converting enzyme (ACE) inhibitors
- Recent myocardial infarction, or history of congestive cardiac failure
- Active, concomitant disease which might limit the ability of the subject to participate in the study as determined by the Investigator (i.e., diabetes mellitus, congestive heart failure, unstable angina, etc.)
- Prior or current renal disease; calculated creatinine clearance < 30 mL/min (calculated CrCl < 30)
- History of Human Immunodeficiency Virus (HIV) or current clinically significant liver disease
- Use of opioids, neuromodulators (eg., gabapentin, pregabalin) first generation antihistamines (eg., diphenhydramine, chlorpheniramine) or antidepressants for the treatment of cough, during the study. Subjects taking drugs in these classes for chronic cough at time of screening may have them discontinued at least 2 days prior to randomization.
- Use of other NMDA-receptor antagonists (e.g. dextromethorphan, ketamine, amantadine) within 2 days of randomization
- Use of any of the following medications which may interact with memantine: quinidine, nicotine, neuroleptics such as chlorpromazine and promethazine, amitriptyline, baclofen, warfarin and hydrochlorothiazide
- Known hypersensitivity to memantine hydrochloride
- Observation of oral lesion(s) or abnormal finding(s) on oral cavity examination done at study screening or Day 0
- History of oropharyngeal leukoplakia, carcinoma or parotid dysfunction
- Subject has clinically significant abnormal laboratory test results at the screening visit (Subject may be enrolled by exception, as determined by the Principal Investigator and consented by Cerecor's Medical Monitor.)
- Subject has had clinically significant bleeding or donated blood or plasma within 30 days of randomization
- Subject has history of alcohol or drug abuse in past 2 years
- Subject has a positive drug and alcohol screen. Subjects receiving benzodiazepines by prescription, who test positive for benzodiazepines at the screening visit will be allowed.
- Subjects who have any disease or condition (medical or surgical) that might compromise hematologic, cardiovascular, pulmonary, renal, gastrointestinal, or central nervous system function; or any other conditions that might interfere with the absorption, distribution, metabolism, or excretion of the study drug, or that would place the subject at increased risk, as determined by the Investigator.
Trial locations and contacts
8 sites in 1 country.
8 sites in 1 country
United States8 sites
Bellingham Asthma and Allergy Associates
Bellingham, Washington, 98225
American Health Research
Charlotte, North Carolina, 28207
Sher Allergy Specialists
Largo, Florida, 33778
South Florida Clinical Research Trials, LLC
Miami, Florida, 33186
Oklahoma Institute of Allergy and Asthma
Oklahoma City, Oklahoma, 73131
Wake Research, LLC
Raleigh, North Carolina, 27612
Allergy & Asthma Associates of Santa Clara Valley
San Jose, California, 95117
Allergy, Asthma and Immunology Center, P.C./ Vital Prospects Clinical Research Institute, P.C.
Tulsa, Oklahoma, 74136
About this study
Official title: An Exploratory, Randomized, Placebo-Controlled, Double-Blind, Crossover Study of FP01 Lozenges in Subjects With Chronic Refractory Cough
The purpose of this study is to determine the antitussive effect size and dose response of FP01 lozenges in subjects with chronic cough and to demonstrate the safety and tolerability of FP01 lozenges in subjects with chronic cough.
- Conditions
- Chronic Refractory Cough
- Being tested
- FP01, placebo
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
FP01Drug
placeboDrug
| Study group | Role | What they receive |
|---|---|---|
| FP01 6mg or Placebo | Experimental | FP01 6mg Oral Receives: Drug: FP01; Drug: placebo |
| FP01 12mg or Placebo | Experimental | FP01 12mg Oral Receives: Drug: FP01; Drug: placebo |
What is being measured
The primary outcome is the main question the study is designed to answer.
Cough Count/Frequency
Change in start-to-end difference in cough count, active vs. placebo treatment periods
Measured: Day 0-1, Day 14-15; Day 28-29, Day 42-43
Secondary outcomes (3)
LCQ
Start-to-end difference in Leicester Cough Questionnaire (LCQ) score, active vs. placebo treatment periods
Measured: Days 0, 14, 28, & 42
VAS Score
Start-to-end difference in Visual analogue scale (VAS) score, active vs. placebo treatment periods
Measured: Days 1, 14, 28, & 42
Cough Severity Diary
Start-to-end difference in CSD score, active vs. placebo treatment periods
Measured: Days 0, 14, 28, & 42
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted11 Oct 2012 (estimated)
- Study startNov 2012
- Primary completionSep 2013
- Study completionSep 2013
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Chronic Refractory CoughStudies 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
- Crossover
- Masking
- Triple blind
- Who is masked
- Participant, Investigator, Outcomes assessor
- Enrolment
- 83 participants (actual)
Sponsor and investigators
- Lead sponsor
- Avalo Therapeutics, Inc.
- Sponsor type
- Industry (pharma, biotech, devices)
- Responsible party
- Sponsor
- Investigators
- Blake Paterson, MD, Study chair, Avalo Therapeutics, Inc.
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT01703923
- Sponsor's protocol ID
- Clin01-003
- Status last verified
- Oct 2014
- First submitted
- 8 Oct 2012
- Last updated
- 5 Nov 2014
- Results posted
- No
- Data monitoring committee
- No
Study at a glance
From the registry record, last updated by the sponsor on 5 Nov 2014. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- An Exploratory, Randomized, Placebo-Controlled, Double-Blind, Crossover Study of FP01 Lozenges in Subjects With Chronic Refractory Cough
- ClinicalTrials.gov ID
- NCT01703923
- Acronym / sponsor ID
- Clin01-003
- Conditions
- Chronic Refractory Cough
- Phase
- Phase 2
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 83 participants (actual)
- Lead sponsor
- Avalo Therapeutics, Inc.Industry (pharma, biotech, devices)
- Study start
- Nov 2012
- Primary completion
- Sep 2013 (actual)
- Study completion
- Sep 2013 (actual)
- First posted
- 11 Oct 2012 (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 the antitussive effect size and dose response of FP01 lozenges in subjects with chronic cough and to demonstrate the safety and tolerability of FP01 lozenges in subjects with chronic cough.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Crossover
- Masking
- Triple blind (participant, investigator, outcomes assessor)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| FP01 6mg or Placebo | Experimental | Drug: FP01, Drug: placeboFP01 6mg Oral |
| FP01 12mg or Placebo | Experimental | Drug: FP01, Drug: placeboFP01 12mg Oral |
Who may qualify
- Ages
- 18 to 75 years
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (9 listed)
- Subject must sign an Institutional Review Board approved informed consent and agree to complete required clinic visits
- Subjects must be able to read and write English
- Subject must exceed a cough severity threshold (VAS) during screening visit (Cough Severity VAS Score ≥ 35 mm)
- Mean CSD frequency domain (Only Questions 1-3 at time of screening) score > 3.0
- Stable chest X-ray
Key exclusion criteria (22 listed)
- Recent significant change in pulmonary status or upper respiratory tract infection (<4 weeks of randomization)
- Female subjects who are pregnant, breast feeding or sexually active without contraception.
- History of chronic obstructive pulmonary disease (COPD)
- History of asthma that required any significant change in treatment within 2 weeks of randomization. Subjects with asthma are eligible as long as the subject is not being treated with oral steroids but may enroll as long as no new medication to control their asthma has been prescribed within two weeks of study enrollment.
- History of inhalational exposure (chemical, smoke, water, etc.) within 6 months of randomization
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 |
|---|---|---|
| FP01 | Drug | FP01 12mg or Placebo, FP01 6mg or Placebo |
| placebo | Drug | FP01 12mg or Placebo, FP01 6mg or Placebo |
Primary outcome
Cough Count/Frequency
Time frame: Day 0-1, Day 14-15; Day 28-29, Day 42-43
Change in start-to-end difference in cough count, active vs. placebo treatment periods
3 secondary outcomes
LCQ
Time frame: Days 0, 14, 28, & 42
VAS Score
Time frame: Days 1, 14, 28, & 42
Cough Severity Diary
Time frame: Days 0, 14, 28, & 42
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 5 Nov 2014.
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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.
Blake Paterson, MD study chair
Avalo Therapeutics, Inc.
8 sites in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 2 study testing FP01 in people with Chronic Refractory Cough, run by Avalo Therapeutics, Inc. at 8 sites 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 9 inclusion and 22 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: finished, as of the sponsor's last update on 5 Nov 2014. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 8 sites 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. 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 is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
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?
Cough Count/Frequency (time frame: Day 0-1, Day 14-15; Day 28-29, Day 42-43). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
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 5 Nov 2014.