Completed
An Exploratory, Randomized, Placebo-Controlled, Double-Blind, Crossover Study of FP01 Lozenges in Subjects With Chronic Refractory Cough
What is being tested
FP01
+ placebo
+ FP01
Drug
Who is being recruted
From 18 to 75 Years
+31 Eligibility Criteria
How is the trial designed
Treatment Study
Phase 2
Interventional
Study Start: November 2012
Summary
Principal SponsorAvalo Therapeutics, Inc.
Last updated: November 5, 2014
Sourced from a government-validated database.Claim as a partner
Study start date: November 1, 2012
Actual date on which the first participant was enrolled.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.
Principal SponsorAvalo Therapeutics, Inc.
Last updated: November 5, 2014
Sourced from a government-validated database.Claim as a partner
Protocol
This section provides details of the study plan, including how the study is designed and what the study is measuring.Design Details
83 patients to be enrolled
Total number of participants that the clinical trial aims to recruit.Treatment Study
These studies test new ways to treat a disease, condition, or health issue. The goal is to see if a new drug, therapy, or approach works better or has fewer side effects than existing options.
Eligibility
Researchers look for people who fit a certain description, called eligibility criteria: person's general health condition or prior treatments.Criteria
Any sex
Biological sex of participants that are eligible to enroll.From 18 to 75 Years
Range of ages for which participants are eligible to join.Healthy volunteers allowed
If individuals who are healthy and do not have the condition being studied can participate.Criteria
9 inclusion criteria required to participate
Body mass index (BMI) 18.5 - 38
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
Forced expiratory volume 1 (FEV1) and forced vital capacity (FVC) > 70% predicted measured using spirometry
Mean CSD frequency domain (Only Questions 1-3 at time of screening) score > 3.0
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22 exclusion criteria prevent from participating
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.)
Chest X-ray suggestive of granulomatous disease, malignancy, pneumonia, other acute pulmonary or pleural processes
Current treatment with angiotensin converting enzyme (ACE) inhibitors
Female subjects who are pregnant, breast feeding or sexually active without contraception
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Study Plan
Find out more about all the medication administered in this study, their detailed description and what they involve.Treatment Groups
Study Objectives
2 intervention groups are designated in this study
This study does not include a placebo group
Treatment Groups
Group I
ExperimentalFP01 6mg Oral
Group II
ExperimentalFP01 12mg Oral
Study Objectives
Primary Objectives
Secondary Objectives
Study Centers
These are the hospitals, clinics, or research facilities where the trial is being conducted. You can find the location closest to you and its status.This study has 8 locations
Allergy & Asthma Associates of Santa Clara Valley
San Jose, United StatesOpen Allergy & Asthma Associates of Santa Clara Valley in Google MapsSher Allergy Specialists
Largo, United StatesSouth Florida Clinical Research Trials, LLC
Miami, United StatesAmerican Health Research
Charlotte, United StatesCompleted8 Study Centers