Antitussive Effects of FP01 Lozenges in Subjects With Cough Due to Upper Respiratory Tract Infection

An Exploratory, Randomized, Placebo Controlled, Double Blind, Parallel Arm Dose Ranging Study to Determine the Antitussive Effects of FP01 Lozenges in Subjects With Cough Due to Upper Respiratory Tract Infection

The purpose of this research study is to learn how effective and safe FP01 lozenges are when given to subjects with a cough due to an upper respiratory tract infection. The study will include subjects who have an upper respiratory tract infection, with a cough of less than six weeks duration.

Study Overview

• Status: Completed
• Conditions: Acute Cough
• Intervention / Treatment: Drug: FP01

• Study Type: Interventional
• Enrollment (Actual): 208
• Phase: Phase 2

Contacts and Locations

Study Locations

• Chile
  • Santiago, Chile, 7510524
    • Clinica Las Lilas
  • Santiago, Chile
    • Biomedical Research Group
• Peru
  • Lima, Peru
    • Clinica Internacional Sede Lima
  • Lima, Peru
    • Clinica Internacional Sede San Borja
  • Lima, Peru
    • Unidad de Investigación Clinica San Pablo

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 18 years to 65 years (Adult, Older Adult)
• Accepts Healthy Volunteers: No
• Genders Eligible for Study: All

Description

gastroesophageal INCLUSION CRITERIA

1. Subject must state that they have had a "cold" for < 14 days. A "cold" is defined as:

   • Moderate or severe rhinorrhea (i.e., using 2 or more tissues per hour for any 1 hour within 12 hours preceding study screening AND
   • At least one other respiratory symptom (cough, pharyngeal symptoms [sore throat], nasal congestion of moderate or severe intensity, headache, etc.)
2. Subject must exceed a cough severity threshold (VAS) during screening visit (Cough Severity VAS score ≥ 40 mm).
3. Subjects who recall that their average number of days with cough during their usual cold history is 3 or greater (URTI cough history > 3).
4. Subjects who do not smoke or use nicotine or nicotine containing products. Ex-smokers/ex-tobacco users must have stopped using tobacco products for at least 6 months prior to study screening.
5. Female subjects should be either post-menopausal (amenorrhea for at least 12 consecutive months), surgically sterile, or women of child-bearing potential (WOCP) with a negative serum beta human chorionic gonadotropin (HCG) 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. Acceptable contraceptives include abstinence OR intrauterine devices (IUDs), hormonal contraceptives (oral, depot, patch or injectable) for ≥ three months prior to screening OR use of double barrier methods such as condoms or diaphragms with spermicidal gel or foam.
6. Subject must sign an Institutional Review Board approved informed consent and agree to complete required clinic visits.

EXCLUSION CRITERIA

1. Subject who are using antibiotics at study screening or for whom antibiotics are currently indicated as determined by the Investigator.
2. History of cough of greater than 6 weeks in duration.
3. History of any chronic pulmonary disease including tuberculosis, lung cancer, chronic bronchitis or emphysema
4. History of pneumonia, influenza or whooping cough within the past 30 days.
5. History of asthma that required any treatment within 2 weeks of study
6. T > 38.5oC with no history of anti-pyretic medication for > 24 hours from screening visit
7. History of inhalational exposure (chemical, smoke, water, etc.) within the past 6 months
8. Chest X-ray suggestive of granulomatous disease, malignancy, COPD, bronchiectasis, pneumonia, pleural processes or other underlying pulmonary disease
9. Active, concurrent 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.)
10. Prior or current renal disease; calculated creatinine clearance < 30 ml/min (calculated ClCr < 30)
11. Known immune deficiency condition
12. Use of opioids or anticonvulsants within 3 days of study screening.
13. Known hypersensitivity to memantine or lozenge excipients.
14. Current oral lesions or abnormal findings on buccal examination done at study screening.
15. History of oropharyngeal or gastroesophageal carcinoma, or gastro/esophageal/duodenal resection.
16. 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.)
17. Any clinically significant finding on the ECG done at the screening visit, as determined by the investigator. (Subject may be enrolled by exception, as determined by the Principal Investigator and consented by Cerecor's Medical Monitor).
18. Female subjects who are pregnant, breast feeding or sexually active without contraception.
19. Subject has donated blood or plasma within the last 45 days.
20. Subject has history of alcohol or drug abuse in past 2 years.
21. Subject has a positive drug screen.
22. Subject has a positive HIV, Hepatitis B or Hepatitis C test.

Study Plan

How is the study designed?

Design Details

• Primary Purpose: Treatment
• Allocation: Randomized
• Interventional Model: Parallel Assignment
• Masking: Double

Number of Arms

3

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
Placebo Comparator: Placebo	Drug: FP01; Lozenge 3 times per day, low dose, high dose, or placebo for 48 hours.
Experimental: FP01 High dose	Drug: FP01; Lozenge 3 times per day, low dose, high dose, or placebo for 48 hours.
Experimental: FP01 Low dose	Drug: FP01; Lozenge 3 times per day, low dose, high dose, or placebo for 48 hours.

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Time Frame
Change in cough count, active vs placebo treatment period	Daily for 48 hours

Secondary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Safety	The evaluation of treatment safety will take into account the recorded adverse events, vital signs, clinical and laboratory assessments and the buccal cavity examination	Daily over 3 days

Collaborators and Investigators

• Sponsor: Avalo Therapeutics, Inc.

Study record dates

Study Major Dates

• Study Start: May 1, 2012
• Primary Completion (Actual): September 1, 2012
• Study Completion (Actual): September 1, 2012

Study Registration Dates

• First Submitted: May 9, 2012
• First Submitted That Met QC Criteria: May 11, 2012
• First Posted (Estimate): May 14, 2012

Study Record Updates

• Last Update Posted (Estimate): February 28, 2014
• Last Update Submitted That Met QC Criteria: January 27, 2014
• Last Verified: January 1, 2014

More Information

Terms related to this study

• Additional Relevant MeSH Terms: Infections; Respiratory Tract Diseases; Respiration Disorders; Signs and Symptoms, Respiratory; Respiratory Tract Infections; Cough
• Other Study ID Numbers: CLIN01-002-A