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

NCT01703923 | Completed Phase 2

• 1 other identifier: Clin01-003
• Study Type: interventional
• Target: 83
• Locations: 1 country
• Sites: 8

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.

Conditions

Chronic Refractory Cough

Outcome Measures

Primary Outcomes (1)

• 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

Secondary Outcomes (3)

• LCQ

  Days 0, 14, 28, & 42

• VAS Score

  Days 1, 14, 28, & 42

• Cough Severity Diary

  Days 0, 14, 28, & 42

Study Arms (2)

FP01 6mg or Placebo

EXPERIMENTAL

FP01 6mg Oral

Drug: FP01; Drug: placebo

FP01 12mg or Placebo

EXPERIMENTAL

FP01 12mg Oral

Drug: FP01; Drug: placebo

Interventions

FP01 DRUG

FP01 12mg or Placebo; FP01 6mg or Placebo

placebo DRUG

FP01 12mg or Placebo; FP01 6mg or Placebo

Eligibility Criteria

• Age: 18 Years - 75 Years
• Sex: all
• Healthy Volunteers: Yes
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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

You may not qualify if:

• 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

Sponsors & Collaborators

• Avalo Therapeutics, Inc.: lead

Study Sites (8)

Allergy & Asthma Associates of Santa Clara Valley

San Jose, California, 95117, United States

Location

Sher Allergy Specialists

Largo, Florida, 33778, United States

Location

South Florida Clinical Research Trials, LLC

Miami, Florida, 33186, United States

Location

American Health Research

Charlotte, North Carolina, 28207, United States

Location

Wake Research, LLC

Raleigh, North Carolina, 27612, United States

Location

Oklahoma Institute of Allergy and Asthma

Oklahoma City, Oklahoma, 73131, United States

Location

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

Tulsa, Oklahoma, 74136, United States

Location

Bellingham Asthma and Allergy Associates

Bellingham, Washington, 98225, United States

Location

Study Officials

• Blake Paterson, MD

  Avalo Therapeutics, Inc.

  STUDY CHAIR

Study Design

• Study Type: interventional
• Phase: phase 2
• Allocation: RANDOMIZED
• Masking: TRIPLE
• Who Masked: PARTICIPANT, INVESTIGATOR, OUTCOMES ASSESSOR
• Purpose: TREATMENT
• Intervention Model: CROSSOVER
• Sponsor Type: INDUSTRY
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: October 8, 2012
• First Posted: October 11, 2012
• Study Start: November 1, 2012
• Primary Completion: September 1, 2013
• Study Completion: September 1, 2013
• Last Updated: November 5, 2014

Record last verified: 2014-10

Locations

US (8)