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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)

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ClinicalTrials.gov Identifier: NCT02379637
Recruitment Status : Completed
First Posted : March 5, 2015
Results First Posted : July 11, 2016
Last Update Posted : July 11, 2016
Sponsor:
Information provided by (Responsible Party):
Novartis

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

Condition or disease Intervention/treatment Phase
Common Cold Associated With Cough Drug: N-acetylcysteine Drug: Placebo Phase 2

Study Type : Interventional  (Clinical Trial)
Actual Enrollment : 70 participants
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)
Primary Purpose: Treatment
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 Start Date : January 2015
Actual Primary Completion Date : April 2015
Actual Study Completion Date : April 2015

Resource links provided by the National Library of Medicine

MedlinePlus related topics: Common Cold Cough

Arm Intervention/treatment
Experimental: A N-acetylcysteine
N-acetylcysteine
Drug: N-acetylcysteine
Placebo Comparator: B Placebo
Placebo
Drug: Placebo



Primary Outcome Measures :
  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 Outcome Measures :
  1. Safety of Daily Dose of NAC (Number of Patients With Adverse Advents) [ Time Frame: 7 Days ]
    Number of patients with adverse advents



Information from the National Library of Medicine

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Ages Eligible for Study:   18 Years to 65 Years   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
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

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT02379637


Locations
Canada, Quebec
Chicoutimi, Quebec, Canada
Montreal, Quebec, Canada
Sherbrook, Quebec, Canada
Victoriaville, Quebec, Canada
Canada
Quebec, Canada
Sponsors and Collaborators
Novartis

Responsible Party: Novartis
ClinicalTrials.gov Identifier: NCT02379637     History of Changes
Other Study ID Numbers: 2160-A-201
First Posted: March 5, 2015    Key Record Dates
Results First Posted: July 11, 2016
Last Update Posted: July 11, 2016
Last Verified: May 2016

Keywords provided by Novartis:
N-acetylcysteine
adults
cough and cold

Additional relevant MeSH terms:
Cough
Common Cold
Respiration Disorders
Respiratory Tract Diseases
Signs and Symptoms, Respiratory
Signs and Symptoms
Picornaviridae Infections
RNA Virus Infections
Virus Diseases
Respiratory Tract Infections
Acetylcysteine
N-monoacetylcystine
Antiviral Agents
Anti-Infective Agents
Expectorants
Respiratory System Agents
Free Radical Scavengers
Antioxidants
Molecular Mechanisms of Pharmacological Action
Protective Agents
Physiological Effects of Drugs
Antidotes