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

NCT ID: NCT02379637

Last Updated: 2016-07-11

Study Results

Results available

Outcome measurements, participant flow, baseline characteristics, and adverse events have been published for this study.

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Basic Information

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Recruitment Status

COMPLETED

Clinical Phase

PHASE2

Total Enrollment

70 participants

Study Classification

INTERVENTIONAL

Study Start Date

2015-01-31

Study Completion Date

2015-04-30

Brief Summary

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

Detailed Description

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Conditions

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Common Cold Associated With Cough

Study Design

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Allocation Method

RANDOMIZED

Intervention Model

PARALLEL

Primary Study Purpose

TREATMENT

Blinding Strategy

QUADRUPLE

Participants Caregivers Investigators Outcome Assessors

Study Groups

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A N-acetylcysteine

N-acetylcysteine

Group Type EXPERIMENTAL

N-acetylcysteine

Intervention Type DRUG

B Placebo

Placebo

Group Type PLACEBO_COMPARATOR

Placebo

Intervention Type DRUG

Interventions

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N-acetylcysteine

Intervention Type DRUG

Placebo

Intervention Type DRUG

Eligibility Criteria

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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
Minimum Eligible Age

18 Years

Maximum Eligible Age

65 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No

Sponsors

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Novartis

INDUSTRY

Sponsor Role lead

Responsible Party

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Responsibility Role SPONSOR

Locations

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Chicoutimi, Quebec, Canada

Site Status

Montreal, Quebec, Canada

Site Status

Québec, Quebec, Canada

Site Status

Sherbrook, Quebec, Canada

Site Status

Victoriaville, Quebec, Canada

Site Status

Countries

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Canada

Other Identifiers

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2160-A-201

Identifier Type: -

Identifier Source: org_study_id

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