Common Cold Associated With Cough
Conditions
Keywords
N-acetylcysteine, adults, cough and cold
Brief summary
This study is designed to improve knowledge regarding the initial effectiveness of N-acetylcysteine (NAC) on cold and cough symptoms.
Interventions
DRUGN-acetylcysteine
DRUGPlacebo
Sponsors
Novartis
Study design
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
TREATMENT
Masking
QUADRUPLE (Subject, Caregiver, Investigator, Outcomes Assessor)
Eligibility
Sex/Gender
ALL
Age
18 Years to 65 Years
Healthy volunteers
No
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/
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Cough Count (Number of Coughs Will be Measured by a 24-hour Ambulatory Cough Monitoring System for the First 72 Hours) | 72 hours | Number of coughs will be measured by a 24-hour ambulatory cough monitoring system for the first 72 hours |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| Safety of Daily Dose of NAC (Number of Patients With Adverse Advents) | 7 Days | Number of patients with adverse advents |
Countries
Canada
Participant flow
Recruitment details
8 centers in canada Start date 26 Jan 2015 End date 01 Apr 2015
Pre-assignment details
Screening and randomization are on day 1 Duration of the study = 7 days
Participants by arm
| Arm | Count |
|---|---|
| A N-acetylcysteine N-acetylcysteine
N-acetylcysteine | 35 |
| B Placebo Placebo
Placebo | 35 |
| Total | 70 |
Withdrawals & dropouts
| Period | Reason | FG000 | FG001 |
|---|---|---|---|
| Overall Study | Adverse Event | 1 | 0 |
| Overall Study | Protocol Violation | 0 | 1 |
| Overall Study | Withdrawal by Subject | 1 | 0 |
Baseline characteristics
| Characteristic | A N-acetylcysteine | B Placebo | Total |
|---|---|---|---|
| Age, Continuous | 33 years STANDARD_DEVIATION 11.06 | 34 years STANDARD_DEVIATION 12.9 | 33.5 years STANDARD_DEVIATION 11.94 |
| Body mass index | 26.3 kg/m^2 STANDARD_DEVIATION 4.49 | 27.3 kg/m^2 STANDARD_DEVIATION 4.59 | 26.8 kg/m^2 STANDARD_DEVIATION 4.53 |
| Region of Enrollment Canada | 35 participants | 35 participants | 70 participants |
| Sex: Female, Male Female | 23 Participants | 23 Participants | 46 Participants |
| Sex: Female, Male Male | 12 Participants | 12 Participants | 24 Participants |
Adverse events
| Event type | EG000 affected / at risk | EG001 affected / at risk |
|---|---|---|
| deaths Total, all-cause mortality | — / — | — / — |
| other Total, other adverse events | 2 / 35 | 2 / 35 |
| serious Total, serious adverse events | 0 / 35 | 0 / 35 |
Outcome results
Primary
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
Time frame: 72 hours
Population: Full Analysis set
| Arm | Measure | Value (MEAN) | Dispersion |
|---|---|---|---|
| A N-acetylcysteine | Cough Count (Number of Coughs Will be Measured by a 24-hour Ambulatory Cough Monitoring System for the First 72 Hours) | 6.92 log-transformed total cough count | Standard Deviation 0.95 |
| B Placebo | Cough Count (Number of Coughs Will be Measured by a 24-hour Ambulatory Cough Monitoring System for the First 72 Hours) | 6.51 log-transformed total cough count | Standard Deviation 0.83 |
Secondary
Safety of Daily Dose of NAC (Number of Patients With Adverse Advents)
Number of patients with adverse advents
Time frame: 7 Days
| Arm | Measure | Value (NUMBER) |
|---|---|---|
| A N-acetylcysteine | Safety of Daily Dose of NAC (Number of Patients With Adverse Advents) | 4 participants |
| B Placebo | Safety of Daily Dose of NAC (Number of Patients With Adverse Advents) | 4 participants |