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Study to Evaluate the Efficacy of N-acetylcysteine (NAC) in the Treatment of the Common Cold and Cough (NAC cold cough)

Primary Purpose

Common Cold Associated With Cough

Status
Completed
Phase
Phase 2
Locations
Canada
Study Type
Interventional
Intervention
N-acetylcysteine
Placebo
Sponsored by
Novartis
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional treatment trial for Common Cold Associated With Cough focused on measuring N-acetylcysteine, adults, cough and cold

Eligibility Criteria

18 Years - 65 Years (Adult, Older Adult)All SexesDoes not accept healthy volunteers

Inclusion Criteria:

  • Cold/URTI symptoms occurring no more than 4 days
  • cough due to a cold or acute viral (URTI) with an onset of no more than 3 days
  • cough frequency with specified cut-off

Exclusion Criteria:

  • A subchronic, or chronic cough (cough duration > 2 months) due to any condition other than a cold/URTI
  • Diagnosed as suffering from any pulmonary conditions associated with cough, e.g., chronic obstructive pulmonary disease (COPD), acute or chronic bronchitis, asthma, cystic fibrosis
  • Taking any medications known to induce cough
  • Fever of greater than 39°C (102°F) orally
  • Complication of the common cold like otitis media, severe sinusitis, or pneumonia
  • Other protocol-defined inclusion/exclusion criteria may apply

Sites / Locations

Arms of the Study

Arm 1

Arm 2

Arm Type

Experimental

Placebo Comparator

Arm Label

A N-acetylcysteine

B Placebo

Arm Description

N-acetylcysteine

Placebo

Outcomes

Primary Outcome Measures

Cough Count (Number of Coughs Will be Measured by a 24-hour Ambulatory Cough Monitoring System for the First 72 Hours)
Number of coughs will be measured by a 24-hour ambulatory cough monitoring system for the first 72 hours

Secondary Outcome Measures

Safety of Daily Dose of NAC (Number of Patients With Adverse Advents)
Number of patients with adverse advents

Full Information

First Posted
February 13, 2015
Last Updated
May 31, 2016
Sponsor
Novartis
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1. Study Identification

Unique Protocol Identification Number
NCT02379637
Brief Title
Study to Evaluate the Efficacy of N-acetylcysteine (NAC) in the Treatment of the Common Cold and Cough
Acronym
NAC cold cough
Official Title
A Randomized, Parallel-Group, Double-Blind, Placebo-Controlled, Multiple-Dose, Proof-of-Concept Study to Evaluate the Efficacy of N-acetylcysteine Capsules in the Treatment of the Common Cold (Viral URTI) Associated With Cough in an Adult Population
Study Type
Interventional

2. Study Status

Record Verification Date
May 2016
Overall Recruitment Status
Completed
Study Start Date
January 2015 (undefined)
Primary Completion Date
April 2015 (Actual)
Study Completion Date
April 2015 (Actual)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Sponsor
Name of the Sponsor
Novartis

4. Oversight

Data Monitoring Committee
No

5. Study Description

Brief Summary
This study is designed to improve knowledge regarding the initial effectiveness of N-acetylcysteine (NAC) on cold and cough symptoms.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Common Cold Associated With Cough
Keywords
N-acetylcysteine, adults, cough and cold

7. Study Design

Primary Purpose
Treatment
Study Phase
Phase 2
Interventional Study Model
Parallel Assignment
Masking
ParticipantCare ProviderInvestigatorOutcomes Assessor
Allocation
Randomized
Enrollment
70 (Actual)

8. Arms, Groups, and Interventions

Arm Title
A N-acetylcysteine
Arm Type
Experimental
Arm Description
N-acetylcysteine
Arm Title
B Placebo
Arm Type
Placebo Comparator
Arm Description
Placebo
Intervention Type
Drug
Intervention Name(s)
N-acetylcysteine
Intervention Type
Drug
Intervention Name(s)
Placebo
Primary Outcome Measure Information:
Title
Cough Count (Number of Coughs Will be Measured by a 24-hour Ambulatory Cough Monitoring System for the First 72 Hours)
Description
Number of coughs will be measured by a 24-hour ambulatory cough monitoring system for the first 72 hours
Time Frame
72 hours
Secondary Outcome Measure Information:
Title
Safety of Daily Dose of NAC (Number of Patients With Adverse Advents)
Description
Number of patients with adverse advents
Time Frame
7 Days

10. Eligibility

Sex
All
Minimum Age & Unit of Time
18 Years
Maximum Age & Unit of Time
65 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
Inclusion Criteria: Cold/URTI symptoms occurring no more than 4 days cough due to a cold or acute viral (URTI) with an onset of no more than 3 days cough frequency with specified cut-off Exclusion Criteria: A subchronic, or chronic cough (cough duration > 2 months) due to any condition other than a cold/URTI Diagnosed as suffering from any pulmonary conditions associated with cough, e.g., chronic obstructive pulmonary disease (COPD), acute or chronic bronchitis, asthma, cystic fibrosis Taking any medications known to induce cough Fever of greater than 39°C (102°F) orally Complication of the common cold like otitis media, severe sinusitis, or pneumonia Other protocol-defined inclusion/exclusion criteria may apply
Facility Information:
City
Chicoutimi
State/Province
Quebec
Country
Canada
City
Montreal
State/Province
Quebec
Country
Canada
City
Sherbrook
State/Province
Quebec
Country
Canada
City
Victoriaville
State/Province
Quebec
Country
Canada
City
Quebec
Country
Canada

12. IPD Sharing Statement

Learn more about this trial

Study to Evaluate the Efficacy of N-acetylcysteine (NAC) in the Treatment of the Common Cold and Cough

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