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An Exploratory Study of FP01 Lozenges in Subjects With Chronic Refractory Cough | Clinical Trials | Clareo Health

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An Exploratory Study of FP01 Lozenges in Subjects With Chronic Refractory Cough

An Exploratory, Randomized, Placebo-Controlled, Double-Blind, Crossover Study of FP01 Lozenges in Subjects With Chronic Refractory Cough

NCT01703923•Avalo Therapeutics, Inc.

View on ClinicalTrials.gov

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.

Eligibility

Age

18 - 75 years

Sex

ALL

Healthy Volunteers

Yes

Inclusion Criteria

•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
•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

Exclusion Criteria

•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
•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)
+12 more criteria

Locations (8)

Allergy & Asthma Associates of Santa Clara Valley

San Jose, California, United States

Sher Allergy Specialists

Largo, Florida, United States

South Florida Clinical Research Trials, LLC

Miami, Florida, United States

American Health Research

Charlotte, North Carolina, United States

Wake Research, LLC

Raleigh, North Carolina, United States

Oklahoma Institute of Allergy and Asthma

Oklahoma City, Oklahoma, United States

Allergy, Asthma and Immunology Center, P.C./ Vital Prospects Clinical Research Institute, P.C.

Tulsa, Oklahoma, United States

Bellingham Asthma and Allergy Associates

Bellingham, Washington, United States

Key Dates

Start Date

November 1, 2012

Primary Completion Date

September 1, 2013

Completion Date

September 1, 2013

Last Updated

November 5, 2014

Enrollment

ACTUAL participants

Conditions

Chronic Refractory Cough

Interventions

FP01

DRUG

placebo

DRUG

A Study To Evaluate The Efficacy, Safety, Pharmacokinetics, And Pharmacodynamic Effects Of GDC-6599 In Patients With Chronic Cough

NCT05660850

Chronic Refractory Cough (CRC) With Non-atopic AsthmaCRC With Atopic Asthma+3 more

View study

Data Source & Attribution

This clinical trial information is sourced from ClinicalTrials.gov, a service of the U.S. National Institutes of Health.

ClinicalTrials.gov last update: November 5, 2014Data synced to Clareo: March 29, 2026

Modifications: This data has been reformatted for display purposes. Eligibility criteria have been parsed into inclusion/exclusion sections. Location data has been geocoded to enable distance-based search. For the authoritative and most current information, please visit ClinicalTrials.gov.

Neither the United States Government nor Clareo Health make any warranties regarding the data. Check ClinicalTrials.gov frequently for updates.

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