Acute CoughPhase 2NCT01597349
Antitussive Effects of FP01 Lozenges in Subjects With Cough Due to Upper Respiratory Tract Infection
A Phase 2 study testing FP01 in people with Acute Cough, run by Avalo Therapeutics, Inc. at 5 sites in 2 countries.
Trial summary
The purpose of this research study is to learn how effective and safe FP01 lozenges are when given to subjects with a cough due to an upper respiratory tract infection. The study will include subjects who have an upper respiratory tract infection, with a cough of less than six weeks duration. Read more about this study
- Who is it for?
- Ages 18 to 65 years
- Conditions the study is for
- Acute Cough
- What is being tested?
- FP01
- Could I receive a placebo?
- Yes, some participants may receive a placebo
- How many people
- 208 participants
- Where
- 5 sitesin 2 countries
- Study dates
- May 2012to Sep 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 18 to 65 years
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
None listed.
Who cannot join
- Subject who are using antibiotics at study screening or for whom antibiotics are currently indicated as determined by the Investigator.
- History of cough of greater than 6 weeks in duration.
- History of any chronic pulmonary disease including tuberculosis, lung cancer, chronic bronchitis or emphysema
- History of pneumonia, influenza or whooping cough within the past 30 days.
- History of asthma that required any treatment within 2 weeks of study
- T > 38.5oC with no history of anti-pyretic medication for > 24 hours from screening visit
Show all 22Show fewer
- History of inhalational exposure (chemical, smoke, water, etc.) within the past 6 months
- Chest X-ray suggestive of granulomatous disease, malignancy, COPD, bronchiectasis, pneumonia, pleural processes or other underlying pulmonary disease
- Active, concurrent 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 ClCr < 30)
- Known immune deficiency condition
- Use of opioids or anticonvulsants within 3 days of study screening.
- Known hypersensitivity to memantine or lozenge excipients.
- Current oral lesions or abnormal findings on buccal examination done at study screening.
- History of oropharyngeal or gastroesophageal carcinoma, or gastro/esophageal/duodenal resection.
- 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.)
- Any clinically significant finding on the ECG done at the screening visit, as determined by the investigator. (Subject may be enrolled by exception, as determined by the Principal Investigator and consented by Cerecor's Medical Monitor).
- Female subjects who are pregnant, breast feeding or sexually active without contraception.
- Subject has donated blood or plasma within the last 45 days.
- Subject has history of alcohol or drug abuse in past 2 years.
- Subject has a positive drug screen.
- Subject has a positive HIV, Hepatitis B or Hepatitis C test.
Trial locations and contacts
5 sites in 2 countries.
5 sites in 2 countries
Peru3 sites
Clinica Internacional Sede Lima
Lima
Clinica Internacional Sede San Borja
Lima
Unidad de Investigación Clinica San Pablo
Lima
Chile2 sites
Clinica Las Lilas
Santiago, 7510524
Biomedical Research Group
Santiago
About this study
Official title: An Exploratory, Randomized, Placebo Controlled, Double Blind, Parallel Arm Dose Ranging Study to Determine the Antitussive Effects of FP01 Lozenges in Subjects With Cough Due to Upper Respiratory Tract Infection
The purpose of this research study is to learn how effective and safe FP01 lozenges are when given to subjects with a cough due to an upper respiratory tract infection. The study will include subjects who have an upper respiratory tract infection, with a cough of less than six weeks duration.
- Conditions
- Acute Cough
- Being tested
- FP01
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
FP01Drug
Lozenge 3 times per day, low dose, high dose, or placebo for 48 hours.
| Study group | Role | What they receive |
|---|---|---|
| FP01 High dose | Experimental | Not described Receives: Drug: FP01 |
| FP01 Low dose | Experimental | Not described Receives: Drug: FP01 |
| Placebo | Placebo comparator | Not described Receives: Drug: FP01 |
What is being measured
The primary outcome is the main question the study is designed to answer.
Change in cough count, active vs placebo treatment period
Measured: Daily for 48 hours
Secondary outcomes (1)
Safety
The evaluation of treatment safety will take into account the recorded adverse events, vital signs, clinical and laboratory assessments and the buccal cavity examination
Measured: Daily over 3 days
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted14 May 2012 (estimated)
- Study startMay 2012
- Primary completionSep 2012
- Study completionSep 2012
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Acute 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
- Parallel groups
- Masking
- Double blind
- Who is masked
- Participant, Investigator
- Enrolment
- 208 participants (actual)
Sponsor and investigators
- Lead sponsor
- Avalo Therapeutics, Inc.
- Sponsor type
- Industry (pharma, biotech, devices)
- Responsible party
- Sponsor
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT01597349
- Sponsor's protocol ID
- CLIN01-002-A
- Status last verified
- Jan 2014
- First submitted
- 9 May 2012
- Last updated
- 28 Feb 2014
- Results posted
- No
- Data monitoring committee
- No
Study at a glance
From the registry record, last updated by the sponsor on 28 Feb 2014. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- An Exploratory, Randomized, Placebo Controlled, Double Blind, Parallel Arm Dose Ranging Study to Determine the Antitussive Effects of FP01 Lozenges in Subjects With Cough Due to Upper Respiratory Tract Infection
- ClinicalTrials.gov ID
- NCT01597349
- Acronym / sponsor ID
- CLIN01-002-A
- Conditions
- Acute Cough
- Phase
- Phase 2
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 208 participants (actual)
- Lead sponsor
- Avalo Therapeutics, Inc.Industry (pharma, biotech, devices)
- Study start
- May 2012
- Primary completion
- Sep 2012 (actual)
- Study completion
- Sep 2012 (actual)
- First posted
- 14 May 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 research study is to learn how effective and safe FP01 lozenges are when given to subjects with a cough due to an upper respiratory tract infection. The study will include subjects who have an upper respiratory tract infection, with a cough of less than six weeks duration.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Double blind (participant, investigator)
- Number of arms
- 3
| Arm | Type | Receives |
|---|---|---|
| FP01 High dose | Experimental | Drug: FP01 |
| FP01 Low dose | Experimental | Drug: FP01 |
| Placebo | Placebo comparator | Drug: FP01 |
Who may qualify
- Ages
- 18 to 65 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (0 listed)
Key exclusion criteria (22 listed)
- Subject who are using antibiotics at study screening or for whom antibiotics are currently indicated as determined by the Investigator.
- History of cough of greater than 6 weeks in duration.
- History of any chronic pulmonary disease including tuberculosis, lung cancer, chronic bronchitis or emphysema
- History of pneumonia, influenza or whooping cough within the past 30 days.
- History of asthma that required any treatment within 2 weeks of study
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 |
|---|---|---|
| FP01Lozenge 3 times per day, low dose, high dose, or placebo for 48 hours. | Drug | FP01 High dose, FP01 Low dose, Placebo |
Primary outcome
Change in cough count, active vs placebo treatment period
Time frame: Daily for 48 hours
1 secondary outcome
Safety
Time frame: Daily over 3 days
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 28 Feb 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.
The record lists no contact. Use the official record to reach the sponsor.
5 sites in 2 countries: 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 Acute Cough, run by Avalo Therapeutics, Inc. at 5 sites in 2 countries.
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 0 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 28 Feb 2014. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 5 sites in Peru, Chile. 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 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?
Change in cough count, active vs placebo treatment period (time frame: Daily for 48 hours). 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 28 Feb 2014.