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

NCT01597349 | Completed Phase 2

• 1 other identifier: CLIN01-002-A
• Study Type: interventional
• Target: 208
• Locations: 2 countries
• Sites: 5

Brief Summary

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.

Conditions

Acute Cough

Outcome Measures

Primary Outcomes (1)

• Change in cough count, active vs placebo treatment period

  Daily for 48 hours

Secondary Outcomes (1)

• Safety

  Daily over 3 days

Study Arms (3)

FP01 High dose

EXPERIMENTAL

Drug: FP01

FP01 Low dose

EXPERIMENTAL

Drug: FP01

Placebo

PLACEBO COMPARATOR

Drug: FP01

Interventions

FP01 DRUG

Lozenge 3 times per day, low dose, high dose, or placebo for 48 hours.

FP01 High dose; FP01 Low dose; Placebo

Eligibility Criteria

• Age: 18 Years - 65 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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.)
• Subject must exceed a cough severity threshold (VAS) during screening visit (Cough Severity VAS score ≥ 40 mm).
• Subjects who recall that their average number of days with cough during their usual cold history is 3 or greater (URTI cough history \> 3).
• 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.
• 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.
• Subject must sign an Institutional Review Board approved informed consent and agree to complete required clinic visits.

You may not qualify if:

• Subject who are using antibiotics at study screening or for whom antibiotics are currently indicated as determined by the Investigator.
• History of cough of greater than 6 weeks in duration.
• History of any chronic pulmonary disease including tuberculosis, lung cancer, chronic bronchitis or emphysema
• History of pneumonia, influenza or whooping cough within the past 30 days.
• History of asthma that required any treatment within 2 weeks of study
• T \> 38.5oC with no history of anti-pyretic medication for \> 24 hours from screening visit
• History of inhalational exposure (chemical, smoke, water, etc.) within the past 6 months
• Chest X-ray suggestive of granulomatous disease, malignancy, COPD, bronchiectasis, pneumonia, pleural processes or other underlying pulmonary disease
• 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.)
• Prior or current renal disease; calculated creatinine clearance \< 30 ml/min (calculated ClCr \< 30)
• Known immune deficiency condition
• Use of opioids or anticonvulsants within 3 days of study screening.
• Known hypersensitivity to memantine or lozenge excipients.
• Current oral lesions or abnormal findings on buccal examination done at study screening.
• History of oropharyngeal or gastroesophageal carcinoma, or gastro/esophageal/duodenal resection.

Sponsors & Collaborators

• Avalo Therapeutics, Inc.: lead

Study Sites (5)

Clinica Las Lilas

Santiago, 7510524, Chile

Location

Biomedical Research Group

Santiago, Chile

Location

Clinica Internacional Sede Lima

Lima, Peru

Location

Clinica Internacional Sede San Borja

Lima, Peru

Location

Unidad de Investigación Clinica San Pablo

Lima, Peru

Location

Study Design

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

Study Record Dates

• First Submitted: May 9, 2012
• First Posted: May 14, 2012
• Study Start: May 1, 2012
• Primary Completion: September 1, 2012
• Study Completion: September 1, 2012
• Last Updated: February 28, 2014

Record last verified: 2014-01

Locations

CL (2); PE (3)