Common Cold Associated With CoughPhase 2NAC cold coughNCT02379637

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

A Phase 2 study testing N-acetylcysteine in people with Common Cold Associated With Cough, run by Novartis at 5 sites in Canada.

Completed

Finished. The study has ended and is not enrolling. Results may be posted on the official record.

Official record

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Trial summary

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

Who is it for?: Ages 18 to 65 years
Conditions the study is for: Common Cold Associated With Cough
What is being tested?: N-acetylcysteine
Could I receive a placebo?: Yes, some participants may receive a placebo
How many people: 70 participants
Where: 5 sitesCanada
Study dates: Jan 2015to Apr 2015
Phase: Phase 2
Are there results?: Yes, posted in the registrySummary in the doctors' view

Key requirements

Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.

Ages 18 to 65 years
All sexes
No healthy volunteers
Adult, Older adult

Who may be able to join

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

Who cannot join

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

Trial locations and contacts

5 sites in 1 country.

City, postcode or hospital

5 sites in 1 country

Canada5 sites

Study site
Chicoutimi, Quebec
Study site
Montreal, Quebec
Study site
Québec, Quebec
Study site
Sherbrook, Quebec
Study site
Victoriaville, Quebec

Other trials in Canada

About this study

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

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

Conditions: Common Cold Associated With Cough
Being tested: N-acetylcysteine, Placebo
Keywords: N-acetylcysteine, adults, cough and cold
Medical subject headings: Cough, Common Cold

What participants receive

What participants receive. In a randomised study each person is assigned to one group by chance.

N-acetylcysteineDrug
PlaceboDrug

Study groups in NCT02379637
Study group	Role	What they receive
A N-acetylcysteine	Experimental	N-acetylcysteine Receives: Drug: N-acetylcysteine
B Placebo	Placebo comparator	Placebo Receives: Drug: Placebo

What is being measured

The primary outcome is the main question the study is designed to answer.

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
Measured: 72 hours

Secondary outcomes (1)

Safety of Daily Dose of NAC (Number of Patients With Adverse Advents)
Number of patients with adverse advents
Measured: 7 Days

Timeline

From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.

Jan 2015Apr 2015

First posted5 Mar 2015 (estimated)
Study startJan 2015
Primary completionApr 2015
Study completionApr 2015

Resources

Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
Posted resultsParticipant flow, outcome measures and adverse events reported by the sponsor.
Other trials for Common Cold Associated With CoughStudies of the same condition, open and under way.
What the trial phases meanHow a treatment moves from first tests in people to approval.

More details

For doctors and researchers: how the study is designed, who runs it, and its registry IDs.

Study design

Study type: Interventional
Phase: Phase 2
Primary purpose: Treatment
Allocation: Randomised
Intervention model: Parallel groups
Masking: Quadruple blind
Who is masked: Participant, Care provider, Investigator, Outcomes assessor
Enrolment: 70 participants (actual)

IDs, dates and publications

ClinicalTrials.gov ID: NCT02379637
Sponsor's protocol ID: 2160-A-201
Acronym: NAC cold cough
Status last verified: May 2016
First submitted: 13 Feb 2015
Last updated: 11 Jul 2016
Results posted: Yes, on ClinicalTrials.gov
Data monitoring committee: No

Study at a glance

From the registry record, last updated by the sponsor on 11 Jul 2016. Recruitment status is as the sponsor reported it: confirm with the study team.

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
ClinicalTrials.gov ID: NCT02379637
Acronym / sponsor ID: NAC cold cough / 2160-A-201
Conditions: Common Cold Associated With Cough
Keywords: N-acetylcysteine, adults, cough and cold
Phase: Phase 2
Study type: Interventional
Recruitment status: Completed
Enrolment: 70 participants (actual)
Lead sponsor: NovartisIndustry (pharma, biotech, devices)
Study start: Jan 2015
Primary completion: Apr 2015 (actual)
Study completion: Apr 2015 (actual)
First posted: 5 Mar 2015 (estimated)
Results: Posted 11 Jul 2016

Clinical summary

The research question as the sponsor registered it. This describes what the study plans to test, not what it found.

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

Study design

Primary purpose: Treatment
Allocation: Randomised
Intervention model: Parallel groups
Masking: Quadruple blind (participant, care provider, investigator, outcomes assessor)
Number of arms: 2

Arm	Type	Receives
A N-acetylcysteine	Experimental	Drug: N-acetylcysteineN-acetylcysteine
B Placebo	Placebo comparator	Drug: PlaceboPlacebo

Who may qualify

Ages: 18 to 65 years
Sex: All
Healthy volunteers: Not accepted
Age groups: Adult, Older adult

Key inclusion criteria (3 listed)

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

Key exclusion criteria (6 listed)

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

Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.

Interventions

Intervention	Type	Arms
N-acetylcysteine	Drug	A N-acetylcysteine
Placebo	Drug	B Placebo

Primary outcome

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

1 secondary outcome

Safety of Daily Dose of NAC (Number of Patients With Adverse Advents)
Time frame: 7 Days

Results and safety

Results posted to the registry on 11 Jul 2016, as reported by the sponsor. Figures are copied from the record, not re-analysed. Full results on ClinicalTrials.gov.

Participant flow

Group	Started	Completed
A N-acetylcysteine	35	33
B Placebo	35	34

Primary outcome: 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. Mean (Standard Deviation). Unit: log-transformed total cough count

Measure	A N-acetylcysteine n = 35	B Placebo n = 35
Value	6.92 (0.95)	6.51 (0.83)

Population analysed: Full Analysis set

1 secondary outcome is reported in the full results.

Adverse events

Other adverse events reported at 3% frequency or more

Group	Serious adverse events	Other adverse events	Deaths
A N-acetylcysteine	0 of 35 (0%)	2 of 35 (5.7%)	Not reported
B Placebo	0 of 35 (0%)	2 of 35 (5.7%)	Not reported

Loading the posted results from ClinicalTrials.gov…

Research links

Official record on ClinicalTrials.govLast updated by the sponsor 11 Jul 2016.
Posted resultsParticipant flow, baseline, all outcome measures and adverse events.

Referral and contact

AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.

The record lists no contact. Use the official record to reach the sponsor.

5 sites in 1 country: see every site and its status.

Questions about this trial

What is this clinical trial studying?

A Phase 2 study testing N-acetylcysteine in people with Common Cold Associated With Cough, run by Novartis at 5 sites in Canada.

The full registered description is in the About this study section and the official record.

Who may be eligible to take part?

The sponsor lists 3 inclusion and 6 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.

Is this clinical trial currently recruiting?

The record says: finished, as of the sponsor's last update on 11 Jul 2016. Status can change between updates, so confirm with the study contact before making plans.

Where is the study taking place?

The record lists 5 sites in Canada. Whether a site is taking part right now should be confirmed with that site. See every site.

What are the possible benefits and risks?

They depend on the study and the treatment, and no study can promise a benefit. Some participants in this study may receive a placebo. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.

What does this phase mean?

Phase 2 studies give the treatment to a larger group to see whether it has the intended effect and to keep checking safety.

Not every study follows the same path, and some studies (observational studies, device studies) have no phase.

Are results available for this study?

Yes. Results are posted in the registry (first posted 11 Jul 2016). A summary is in the For doctors view, and the full results are on ClinicalTrials.gov.

How can a doctor refer a patient or contact the research team?

The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.

What does the primary outcome measure?

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). It is what the study was designed to measure, not a finding.

Where can I read the original study information?

On the ClinicalTrials.gov record for NCT02379637.

Does a listing mean the treatment is approved or proven to work?

No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.

How often is this information updated?

AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 11 Jul 2016.