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

Chronic Refractory Cough Clinical Trial

Official title:

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

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT01703923
• Other study ID #: Clin01-003
• Status: Completed
• Phase: Phase 2
• First received: October 8, 2012
• Last updated: October 30, 2014
• Start date: November 2012
• Est. completion date: September 2013

Study information

• Verified date: October 2014
• Source: Cerecor Inc
• Contact: n/a
• Is FDA regulated: No
• Health authority: United States: Food and Drug Administration
• Study type: Interventional

Clinical 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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 83
• Est. completion date: September 2013
• Est. primary completion date: September 2013
• Accepts healthy volunteers: Accepts Healthy Volunteers
• Gender: Both
• Age group: 18 Years to 75 Years

Eligibility

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)

• 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.

Study Design

Allocation: Randomized, Intervention Model: Crossover Assignment, Masking: Double Blind (Subject, Investigator, Outcomes Assessor), Primary Purpose: Treatment

Related Conditions & MeSH terms

• Chronic Refractory Cough
• Cough

Intervention

Drug:
• FP01

• placebo

Locations

Country	Name	City	State
United States	Bellingham Asthma and Allergy Associates	Bellingham	Washington
United States	American Health Research	Charlotte	North Carolina
United States	Sher Allergy Specialists	Largo	Florida
United States	South Florida Clinical Research Trials, LLC	Miami	Florida
United States	Oklahoma Institute of Allergy and Asthma	Oklahoma City	Oklahoma
United States	Wake Research, LLC	Raleigh	North Carolina
United States	Allergy & Asthma Associates of Santa Clara Valley	San Jose	California
United States	Allergy, Asthma and Immunology Center, P.C./ Vital Prospects Clinical Research Institute, P.C.	Tulsa	Oklahoma

Sponsors (1)

Lead Sponsor	Collaborator
Cerecor Inc

Country where clinical trial is conducted

United States, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Cough Count/Frequency	Change in start-to-end difference in cough count, active vs. placebo treatment periods	Day 0-1, Day 14-15; Day 28-29, Day 42-43	No
Secondary	LCQ	Start-to-end difference in Leicester Cough Questionnaire (LCQ) score, active vs. placebo treatment periods	Days 0, 14, 28, & 42	No
Secondary	VAS Score	Start-to-end difference in Visual analogue scale (VAS) score, active vs. placebo treatment periods	Days 1, 14, 28, & 42	No
Secondary	Cough Severity Diary	Start-to-end difference in CSD score, active vs. placebo treatment periods	Days 0, 14, 28, & 42	No