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

Phase 2

Completed

• Conditions: Acute Cough
• Interventions: Drug: FP01

• Registration Number: NCT01597349
• Lead Sponsor: Avalo Therapeutics, Inc.

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.

Detailed Description

Not available

Study Timeline

• Study Start: 2012-05
• Study First Submitted: 2012-05-09
• Study First Submitted QC: 2012-05-11
• Study First Posted: 2012-05-14
• Primary Completion: 2012-09
• Study Completion: 2012-09
• Status Verified: 2014-01
• Disposition First Submitted: 2014-01-27
• Disposition First Submitted QC: 2014-01-27
• Last Update Submitted: 2014-01-27
• Disposition First Posted: 2014-02-28
• Last Update Posted: 2014-02-28

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 208

Inclusion Criteria

Not provided

Exclusion Criteria

Not provided

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Arm && Interventions

Group	Intervention	Description
Placebo	FP01	-
FP01 High dose	FP01	-
FP01 Low dose	FP01	-

Primary Outcome Measures

Name	Time	Method
Change in cough count, active vs placebo treatment period	Daily for 48 hours

Secondary Outcome Measures

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

Trial Locations

Locations (5)

Clinica Internacional Sede Lima; 🇵🇪 Lima, Peru

Clinica Las Lilas; 🇨🇱 Santiago, Chile

Biomedical Research Group; 🇨🇱 Santiago, Chile

Clinica Internacional Sede San Borja; 🇵🇪 Lima, Peru

Unidad de Investigación Clinica San Pablo; 🇵🇪 Lima, Peru