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

• ClinicalTrials.gov Identifier: NCT01703923
• Recruitment Status: Completed
• First Posted: October 11, 2012
• Last Update Posted: November 5, 2014
• Sponsor: Cerecor Inc
• Information provided by (Responsible Party): Cerecor Inc

Study Description

Brief 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.

Condition or disease	Intervention/treatment	Phase
Chronic Refractory Cough	Drug: FP01; Drug: placebo	Phase 2

Study Design

• Study Type: Interventional (Clinical Trial)
• Actual Enrollment: 83 participants
• Allocation: Randomized
• Intervention Model: Crossover Assignment
• Masking: Triple (Participant, Investigator, Outcomes Assessor)
• Primary Purpose: Treatment
• Official Title: An Exploratory, Randomized, Placebo-Controlled, Double-Blind, Crossover Study of FP01 Lozenges in Subjects With Chronic Refractory Cough
• Study Start Date: November 2012
• Actual Primary Completion Date: September 2013
• Actual Study Completion Date: September 2013

Arms and Interventions

Arm	Intervention/treatment
Experimental: FP01 6mg or Placebo; FP01 6mg Oral	Drug: FP01; Drug: placebo
Experimental: FP01 12mg or Placebo; FP01 12mg Oral	Drug: FP01; Drug: placebo

Outcome Measures

Primary Outcome Measures :

1. 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

Secondary Outcome Measures :

1. LCQ [ Time Frame: Days 0, 14, 28, & 42 ]
   Start-to-end difference in Leicester Cough Questionnaire (LCQ) score, active vs. placebo treatment periods
2. VAS Score [ Time Frame: Days 1, 14, 28, & 42 ]
   Start-to-end difference in Visual analogue scale (VAS) score, active vs. placebo treatment periods
3. Cough Severity Diary [ Time Frame: Days 0, 14, 28, & 42 ]
   Start-to-end difference in CSD score, active vs. placebo treatment periods

Eligibility Criteria

• Ages Eligible for Study: 18 Years to 75 Years (Adult, Older Adult)
• Sexes Eligible for Study: All
• Accepts Healthy Volunteers: Yes

Criteria

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.

Contacts and Locations

Locations

United States, California

Allergy & Asthma Associates of Santa Clara Valley

San Jose, California, United States, 95117

United States, Florida

Sher Allergy Specialists

Largo, Florida, United States, 33778

South Florida Clinical Research Trials, LLC

Miami, Florida, United States, 33186

United States, North Carolina

American Health Research

Charlotte, North Carolina, United States, 28207

Wake Research, LLC

Raleigh, North Carolina, United States, 27612

United States, Oklahoma

Oklahoma Institute of Allergy and Asthma

Oklahoma City, Oklahoma, United States, 73131

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

Tulsa, Oklahoma, United States, 74136

United States, Washington

Bellingham Asthma and Allergy Associates

Bellingham, Washington, United States, 98225

Sponsors and Collaborators

Cerecor Inc

Investigators

• Study Chair: Blake Paterson, MD; Cerecor Inc

More Information

• Responsible Party: Cerecor Inc
• ClinicalTrials.gov Identifier: NCT01703923 History of Changes
• Other Study ID Numbers: Clin01-003
• First Posted: October 11, 2012
• Last Update Posted: November 5, 2014
• Last Verified: October 2014

Additional relevant MeSH terms:

Cough; Respiration Disorders; Respiratory Tract Diseases; Signs and Symptoms, Respiratory; Signs and Symptoms