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Completed

NCT Number: NCT02379637

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

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

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Key information

Conditions

Common Cold Associated With Cough Common Cold Cough Infections Pathological Conditions, Signs and Symptoms Picornaviridae Infections RNA Virus Infections Respiration Disorders Respiratory Tract Diseases Respiratory Tract Infections Signs and Symptoms Signs and Symptoms, Respiratory Virus Diseases

Age range

18 year–65 year

Sex eligibility

All sexes

Study type

Interventional

Phase

Phase 2

Primary location

Chicoutimi, Quebec, Canada

Loading trial locations.

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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

Treatment and study plan

N-acetylcysteine

Drug

Placebo

Drug

Primary outcomes

  1. Cough Count (Number of Coughs Will be Measured by a 24-hour Ambulatory Cough Monitoring System for the First 72 Hours)

    Time frame: 72 hours

    Number of coughs will be measured by a 24-hour ambulatory cough monitoring system for the first 72 hours

Secondary outcomes

  1. Safety of Daily Dose of NAC (Number of Patients With Adverse Advents)

    Time frame: 7 Days

    Number of patients with adverse advents

Sponsors and collaborators

Lead sponsor

Novartis

Industry

Registry information

Official study 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

Acronym: NAC cold cough

Important dates

Study start
2015
Primary completion
2015
Study completion
2015
First posted
Mar 5, 2015
Registry last updated
Jul 11, 2016

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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