Healthy Subjects
Conditions
Brief summary
This was an open label, multicentric, non-comparative, single arm prospective post marketing surveillance (PMS) study to evaluate the safety and tolerability of Mucinex™ (GGE, 600 mg ER bi-layer tablets, taken as 1200 mg BID dose) in the treatment of otherwise healthy patients with symptoms of cough, thickened mucus and chest congestion due to URTI. Symptomatic patients who visited the outpatient department of hospitals and clinics or general physicians and had agreed to participate in this study were screened and enrolled into the study.
Interventions
DRUGMucinex™ extended-release (SE)
2 tablets of Mucinex™ (GGE, 600 mg extended-release bi-layer tablets)
Sponsors
Reckitt Benckiser LLC
Study design
Allocation
NA
Intervention model
SINGLE_GROUP
Primary purpose
BASIC_SCIENCE
Masking
NONE
Eligibility
Sex/Gender
ALL
Age
18 Years to 82 Years
Healthy volunteers
Yes
Inclusion criteria
Patients were eligible for enrolment in the study if they fulfilled the following criteria: 1. Males and females (non-pregnant) patients of ≥ 18 years of age. 2. Otherwise healthy patients suffering from cough with symptoms of thickened mucus and chest congestion and a diagnosis of any one of the following: * Acute Bronchitis * Upper Respiratory Tract Infections (URTI) such as naso-pharyngitis * Sinusitis 3. Females of child bearing potential: 1. Must have used efficacious and reliable method of contraception during the entire duration of the study {e.g. double barrier methods (e.g., condom and spermicidal); intrauterine device (IUD) } or remained sexually inactive throughout the study\*. 2. Must have had a negative urine pregnancy test (UPT) at Screening/Baseline (test must have a sensitivity of at least 25 mIU/mL for HCG). 3. Must have been non-lactating. 4. Patients must have demonstrated their willingness to participate in the study and comply with the study procedures and required visits. 5. Patients must have been willing to authorize use and disclosure of protected health information collected for the study. 6. Patients must have had the ability to understand and sign a written consent, which had to be signed prior to study specific procedures being performed. * \*Abstinence (sexually inactive) was not an acceptable form of contraception; however, abstinent female patients could have been admitted to the study if they agreed, and signed a statement to the effect, that upon becoming sexually active, they would use a condom with spermicide from that time through 30 days beyond completion of the study (Visit 2).
Exclusion criteria
Patients were excluded from the study if they fulfilled any of the following: 1. Females who were pregnant or lactating or planning to become pregnant during the study period. 2. Patients with a history of chronic cough of \> 3 weeks duration. 3. Patients with any of the following conditions: * Asthma * Chronic bronchitis * Emphysema * Other chronic pulmonary conditions such as Chronic Obstructive Pulmonary Disease (COPD) or cystic fibrosis (CF), etc. 4. Patients with known hypersensitivity to GGE. 5. Patients with temperature greater than 101°F (38.3°C) at Screening/Baseline. 6. Patients with a serious and/or uncontrolled medical condition (chronic or active liver disease, renal impairment, heart disease, diabetes, severe respiratory disease, rheumatoid arthritis, current malignancies, immunocompromised conditions or any other disease) that in the opinion of the investigator would interfere with the study or place the patient at unacceptable risk. 7. Patients with a history or examination findings of alcohol dependence, alcohol or drug abuse or suspected abuse within the past 2 years. 8. Patients who had participated in a study of an investigational drug within 30 days prior to the Screening/Baseline visit. 9. Patients who in the opinion of the investigator were unable to comply fully with the study requirements. 10. Related to persons involved directly or indirectly with the conduct of this study \[i.e., investigator, sub-investigators, study coordinators, other study personnel, employees of Reckitt Benckiser or Ecron AcuNova Ltd. (EAL), formerly known as Manipal Acunova Limited (MAL) and the families of each\].
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Number of Adverse Events (AEs), Type of AE(s) and Frequency of AE(s) | Up to Day 9 | Treatment Emergent Adverse Event (TEAE) are events occurring after the first dose of study medication. Frequency of AE(s) - the total Number of Events Type of AE(s) - Serious TEAE and Non serious TEAE |
| Number of Subjects Affected With Adverse Events | Up to Day 9 | Proportion of patients with AE(s) - Number of Subjects affected with Events |
| Number of Adverse Events by Severity, Seriousness and the Relationship of AE(s) to Treatment | Up to Day 9 | Intensity determined. Mild = AE did not limit usual activities; subject may have experienced slight discomfort. Moderate = AE resulted in some limitation of usual activities; subject may have experienced significant discomfort. Severe = AE resulted in an inability to carry out usual activities; subject may have experienced intolerable discomfort/pain. Relationship to Investigational Medicinal Products (IMP) Unassessable/Unclassified = Insufficient information to be able to make an assessment Conditional/ Unclassified = Insufficient information to make an assessment at present Unrelated = No possibility that the AE was caused by the IMP Unlikely = Slight, but remote, chance that the AE was caused by the IMP, but the balance of judgment was that it was most likely not due to the IMP. Possible = Reasonable suspicion that the AE was caused by the IMP Probable = Most likely that the AE was caused by the IMP Certain = AE was definitely caused by the IMP |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| Overall Assessment of the Study Medication by End of Study Patient Questionnaire | Up to Day 9 | End of Study Patient Questionnaire is a questionnaire provided to the patients for overall assessment of the study medication at the end of study visit. Satisfied(stfd) Dissatisfied(Dstfd) |
| Overall Assessment of the Study Medication by End of Study Investigator Questionnaire | Up to Day 9 | End of Study Investigator Questionnaire is a questionnaire provided at the end of study visit to the investigator (or sub-investigator as applicable) for overall assessment of the study medication across all patients treated by them. End of study investigator questionnaire was collected from 9 investigators. Mostly Satisfied(MS) Satisfied(Stfd) Very Satisfied(VS) Chest Congestion(CC) Chesty Cough(CCO) Difference(Diff) Between(b/w) Somewhat Agree(SA) Strongly Agree(StA) Upper respiratory tract infection(URTI) Optimal dosage(Opt dos) Cough preparations Available(CPA) |
Participant flow
Recruitment details
This is a multicentric study conducted in 9 study centres across 7 cities in India.
Pre-assignment details
A total of 554 subjects were screened, 552 subjects enrolled and 550 of them completed the study.
Participants by arm
| Arm | Count |
|---|---|
| Mucinex™ Subjects received a twice daily dose of Mucinex™ 600 mg Guaifenesin extended-release bi-layer tablets every 12hours | 552 |
| Total | 552 |
Withdrawals & dropouts
| Period | Reason | FG000 |
|---|---|---|
| Overall Study | Lost to Follow-up | 2 |
Baseline characteristics
| Characteristic | Mucinex™ |
|---|---|
| Age, Continuous | 42.3 Years STANDARD_DEVIATION 15.46 |
| Height | 160.8 cms STANDARD_DEVIATION 8.25 |
| Race Asian | 552 Participants |
| Race others | 0 Participants |
| Sex: Female, Male Female | 203 Participants |
| Sex: Female, Male Male | 349 Participants |
| Weight | 62.5 Kgs STANDARD_DEVIATION 11.08 |
Adverse events
| Event type | EG000 affected / at risk |
|---|---|
| deaths Total, all-cause mortality | 0 / 552 |
| other Total, other adverse events | 28 / 552 |
| serious Total, serious adverse events | 0 / 552 |
Outcome results
Primary
Number of Adverse Events (AEs), Type of AE(s) and Frequency of AE(s)
Treatment Emergent Adverse Event (TEAE) are events occurring after the first dose of study medication. Frequency of AE(s) - the total Number of Events Type of AE(s) - Serious TEAE and Non serious TEAE
Time frame: Up to Day 9
Population: Safety Population: All patients enrolled in the study were included for safety analyses.
| Arm | Measure | Group | Value (NUMBER) |
|---|---|---|---|
| Mucinex™ | Number of Adverse Events (AEs), Type of AE(s) and Frequency of AE(s) | Treatment Emergent Adverse Event (TEAE) | 29 Number of Events |
| Mucinex™ | Number of Adverse Events (AEs), Type of AE(s) and Frequency of AE(s) | Serious TEAE | 0 Number of Events |
| Mucinex™ | Number of Adverse Events (AEs), Type of AE(s) and Frequency of AE(s) | Non serious TEAE | 29 Number of Events |
| Mucinex™ | Number of Adverse Events (AEs), Type of AE(s) and Frequency of AE(s) | Number of Events | 29 Number of Events |
Primary
Number of Adverse Events by Severity, Seriousness and the Relationship of AE(s) to Treatment
Intensity determined. Mild = AE did not limit usual activities; subject may have experienced slight discomfort. Moderate = AE resulted in some limitation of usual activities; subject may have experienced significant discomfort. Severe = AE resulted in an inability to carry out usual activities; subject may have experienced intolerable discomfort/pain. Relationship to Investigational Medicinal Products (IMP) Unassessable/Unclassified = Insufficient information to be able to make an assessment Conditional/ Unclassified = Insufficient information to make an assessment at present Unrelated = No possibility that the AE was caused by the IMP Unlikely = Slight, but remote, chance that the AE was caused by the IMP, but the balance of judgment was that it was most likely not due to the IMP. Possible = Reasonable suspicion that the AE was caused by the IMP Probable = Most likely that the AE was caused by the IMP Certain = AE was definitely caused by the IMP
Time frame: Up to Day 9
Population: Safety Population: All patients enrolled in the study were included for safety analyses.
| Arm | Measure | Group | Value (NUMBER) |
|---|---|---|---|
| Mucinex™ | Number of Adverse Events by Severity, Seriousness and the Relationship of AE(s) to Treatment | Relationship to IMP - Conditional/Unclassified | 0 Number of Events |
| Mucinex™ | Number of Adverse Events by Severity, Seriousness and the Relationship of AE(s) to Treatment | Treatment Emergent Adverse Event (TEAE) | 29 Number of Events |
| Mucinex™ | Number of Adverse Events by Severity, Seriousness and the Relationship of AE(s) to Treatment | Serious TEAE | 0 Number of Events |
| Mucinex™ | Number of Adverse Events by Severity, Seriousness and the Relationship of AE(s) to Treatment | TEAE Leading to Withdrawal | 0 Number of Events |
| Mucinex™ | Number of Adverse Events by Severity, Seriousness and the Relationship of AE(s) to Treatment | TEAE by severity: Mild | 29 Number of Events |
| Mucinex™ | Number of Adverse Events by Severity, Seriousness and the Relationship of AE(s) to Treatment | TEAE by severity: Moderate | 0 Number of Events |
| Mucinex™ | Number of Adverse Events by Severity, Seriousness and the Relationship of AE(s) to Treatment | TEAE by severity: Severe | 0 Number of Events |
| Mucinex™ | Number of Adverse Events by Severity, Seriousness and the Relationship of AE(s) to Treatment | Relationship to IMP - Certain | 0 Number of Events |
| Mucinex™ | Number of Adverse Events by Severity, Seriousness and the Relationship of AE(s) to Treatment | Relationship to IMP - Probable | 5 Number of Events |
| Mucinex™ | Number of Adverse Events by Severity, Seriousness and the Relationship of AE(s) to Treatment | Relationship to IMP - Possible | 13 Number of Events |
| Mucinex™ | Number of Adverse Events by Severity, Seriousness and the Relationship of AE(s) to Treatment | Relationship to IMP - Unlikely | 3 Number of Events |
| Mucinex™ | Number of Adverse Events by Severity, Seriousness and the Relationship of AE(s) to Treatment | Relationship to IMP - Unrelated | 8 Number of Events |
| Mucinex™ | Number of Adverse Events by Severity, Seriousness and the Relationship of AE(s) to Treatment | Relationship to IMP - Unassessable/Unclassifiable | 0 Number of Events |
Primary
Number of Subjects Affected With Adverse Events
Proportion of patients with AE(s) - Number of Subjects affected with Events
Time frame: Up to Day 9
Population: Safety Population: All patients enrolled in the study were included for safety analyses.
| Arm | Measure | Value (NUMBER) |
|---|---|---|
| Mucinex™ | Number of Subjects Affected With Adverse Events | 28 Number of Subjects affected with Events |
Secondary
Overall Assessment of the Study Medication by End of Study Investigator Questionnaire
End of Study Investigator Questionnaire is a questionnaire provided at the end of study visit to the investigator (or sub-investigator as applicable) for overall assessment of the study medication across all patients treated by them. End of study investigator questionnaire was collected from 9 investigators. Mostly Satisfied(MS) Satisfied(Stfd) Very Satisfied(VS) Chest Congestion(CC) Chesty Cough(CCO) Difference(Diff) Between(b/w) Somewhat Agree(SA) Strongly Agree(StA) Upper respiratory tract infection(URTI) Optimal dosage(Opt dos) Cough preparations Available(CPA)
Time frame: Up to Day 9
Population: Safety Population: All patients enrolled in the study were included for safety analyses.
| Arm | Measure | Group | Value (NUMBER) |
|---|---|---|---|
| Mucinex™ | Overall Assessment of the Study Medication by End of Study Investigator Questionnaire | Patient satisfaction with the treatment of CC: NS | 1 Number of investigator |
| Mucinex™ | Overall Assessment of the Study Medication by End of Study Investigator Questionnaire | Patient satisfaction with the treatment of CC: VS | 3 Number of investigator |
| Mucinex™ | Overall Assessment of the Study Medication by End of Study Investigator Questionnaire | Patient satisfaction with treatment of CCO:Stfd | 5 Number of investigator |
| Mucinex™ | Overall Assessment of the Study Medication by End of Study Investigator Questionnaire | Treatment Diff b/w CC & CCO congestion: CC first | 7 Number of investigator |
| Mucinex™ | Overall Assessment of the Study Medication by End of Study Investigator Questionnaire | Treatment recommend for CC with URTI Patient:Agree | 5 Number of investigator |
| Mucinex™ | Overall Assessment of the Study Medication by End of Study Investigator Questionnaire | Treatment recommend for CC with URTI Patient: SA | 1 Number of investigator |
| Mucinex™ | Overall Assessment of the Study Medication by End of Study Investigator Questionnaire | Treatment recommend for CC with URTI Patient: StA | 3 Number of investigator |
| Mucinex™ | Overall Assessment of the Study Medication by End of Study Investigator Questionnaire | Opt dos for treating CC compare to other CPA: Yes | 8 Number of investigator |
| Mucinex™ | Overall Assessment of the Study Medication by End of Study Investigator Questionnaire | Treatment outcome with URTIs taking Mucinex: MS | 2 Number of investigator |
| Mucinex™ | Overall Assessment of the Study Medication by End of Study Investigator Questionnaire | Treatment outcome with URTIs taking Mucinex: Stfd | 5 Number of investigator |
| Mucinex™ | Overall Assessment of the Study Medication by End of Study Investigator Questionnaire | Treatment outcome with URTIs taking Mucinex: VS | 2 Number of investigator |
| Mucinex™ | Overall Assessment of the Study Medication by End of Study Investigator Questionnaire | Patient satisfaction with the treatment of CC:Stfd | 5 Number of investigator |
| Mucinex™ | Overall Assessment of the Study Medication by End of Study Investigator Questionnaire | Patient satisfaction with the treatment of CCO: MS | 1 Number of investigator |
| Mucinex™ | Overall Assessment of the Study Medication by End of Study Investigator Questionnaire | Patient satisfaction with the treatment of CCO: VS | 3 Number of investigator |
| Mucinex™ | Overall Assessment of the Study Medication by End of Study Investigator Questionnaire | Reported Improvements: At 2 Days Of Treatment | 5 Number of investigator |
| Mucinex™ | Overall Assessment of the Study Medication by End of Study Investigator Questionnaire | Reported Improvements:Within 3 Days of Treatment | 4 Number of investigator |
| Mucinex™ | Overall Assessment of the Study Medication by End of Study Investigator Questionnaire | Treatment Diff b/w CC & CCO congestion:Cough first | 2 Number of investigator |
| Mucinex™ | Overall Assessment of the Study Medication by End of Study Investigator Questionnaire | Opt dos for treating CC compare to other CPA: No | 1 Number of investigator |
Secondary
Overall Assessment of the Study Medication by End of Study Patient Questionnaire
End of Study Patient Questionnaire is a questionnaire provided to the patients for overall assessment of the study medication at the end of study visit. Satisfied(stfd) Dissatisfied(Dstfd)
Time frame: Up to Day 9
Population: Safety Population: All patients enrolled in the study were included for safety analyses.
| Arm | Measure | Group | Value (COUNT_OF_PARTICIPANTS) |
|---|---|---|---|
| Mucinex™ | Overall Assessment of the Study Medication by End of Study Patient Questionnaire | Improvement of Chest Congestion: Very Satisfied | 95 Participants |
| Mucinex™ | Overall Assessment of the Study Medication by End of Study Patient Questionnaire | Improvement of Chest Congestion: Satisfied | 379 Participants |
| Mucinex™ | Overall Assessment of the Study Medication by End of Study Patient Questionnaire | Improvement of Chest Congestion: Mostly Satisfied | 67 Participants |
| Mucinex™ | Overall Assessment of the Study Medication by End of Study Patient Questionnaire | Improvement of Chest Congestion: Not Satisfied | 9 Participants |
| Mucinex™ | Overall Assessment of the Study Medication by End of Study Patient Questionnaire | Improvement of Chest Congestion: Missing | 2 Participants |
| Mucinex™ | Overall Assessment of the Study Medication by End of Study Patient Questionnaire | Improvement of Chesty Cough: Very Satisfied | 97 Participants |
| Mucinex™ | Overall Assessment of the Study Medication by End of Study Patient Questionnaire | Improvement of Chesty Cough: Satisfied | 372 Participants |
| Mucinex™ | Overall Assessment of the Study Medication by End of Study Patient Questionnaire | Improvement of Chesty Cough: Mostly Satisfied | 73 Participants |
| Mucinex™ | Overall Assessment of the Study Medication by End of Study Patient Questionnaire | Improvement of Chesty Cough: Not Satisfied | 8 Participants |
| Mucinex™ | Overall Assessment of the Study Medication by End of Study Patient Questionnaire | Improvement of Chesty Cough: Missing | 2 Participants |
| Mucinex™ | Overall Assessment of the Study Medication by End of Study Patient Questionnaire | First Improvement: During 1st Day of Treatment | 75 Participants |
| Mucinex™ | Overall Assessment of the Study Medication by End of Study Patient Questionnaire | First Improvement: At 2 Days Of Treatment | 360 Participants |
| Mucinex™ | Overall Assessment of the Study Medication by End of Study Patient Questionnaire | First Improvement: Within 3 Days of Treatment | 95 Participants |
| Mucinex™ | Overall Assessment of the Study Medication by End of Study Patient Questionnaire | First Improvement: More than 3 Days of Treatment | 20 Participants |
| Mucinex™ | Overall Assessment of the Study Medication by End of Study Patient Questionnaire | First Improvement: Missing | 2 Participants |
| Mucinex™ | Overall Assessment of the Study Medication by End of Study Patient Questionnaire | Dosing easy to take / convenient: Yes | 445 Participants |
| Mucinex™ | Overall Assessment of the Study Medication by End of Study Patient Questionnaire | Dosing easy to take / convenient: No | 105 Participants |
| Mucinex™ | Overall Assessment of the Study Medication by End of Study Patient Questionnaire | Dosing easy to take / convenient: Missing | 2 Participants |
| Mucinex™ | Overall Assessment of the Study Medication by End of Study Patient Questionnaire | Effective to Treat Chest congestion:Very Satisfied | 108 Participants |
| Mucinex™ | Overall Assessment of the Study Medication by End of Study Patient Questionnaire | Effective to Treat Chest congestion:Somewhat Stfd | 386 Participants |
| Mucinex™ | Overall Assessment of the Study Medication by End of Study Patient Questionnaire | Effective to Treat Chest congestion:Somewhat Dstfd | 51 Participants |
| Mucinex™ | Overall Assessment of the Study Medication by End of Study Patient Questionnaire | Effective to Treat Chest congestion: Dissatisfied | 5 Participants |
| Mucinex™ | Overall Assessment of the Study Medication by End of Study Patient Questionnaire | Effective to Treat Chest congestion: Missing | 2 Participants |
| Mucinex™ | Overall Assessment of the Study Medication by End of Study Patient Questionnaire | Effective to Treat Chesty cough: Very Satisfied | 149 Participants |
| Mucinex™ | Overall Assessment of the Study Medication by End of Study Patient Questionnaire | Effective to Treat Chesty cough:Somewhat Satisfied | 361 Participants |
| Mucinex™ | Overall Assessment of the Study Medication by End of Study Patient Questionnaire | Effective to Treat Chesty cough: Somewhat Dstfd | 34 Participants |
| Mucinex™ | Overall Assessment of the Study Medication by End of Study Patient Questionnaire | Effective to Treat Chesty cough: Dissatisfied | 6 Participants |
| Mucinex™ | Overall Assessment of the Study Medication by End of Study Patient Questionnaire | Effective to Treat Chesty cough: Missing | 2 Participants |
| Mucinex™ | Overall Assessment of the Study Medication by End of Study Patient Questionnaire | Recommend to Family and friends: Yes | 305 Participants |
| Mucinex™ | Overall Assessment of the Study Medication by End of Study Patient Questionnaire | Recommend to Family and friends: Maybe | 216 Participants |
| Mucinex™ | Overall Assessment of the Study Medication by End of Study Patient Questionnaire | Recommend to Family and friends: No | 10 Participants |
| Mucinex™ | Overall Assessment of the Study Medication by End of Study Patient Questionnaire | Recommend to Family and friends: Missing | 21 Participants |
| Mucinex™ | Overall Assessment of the Study Medication by End of Study Patient Questionnaire | Mucinex as first choice | 171 Participants |
| Mucinex™ | Overall Assessment of the Study Medication by End of Study Patient Questionnaire | Mucinex as top two options | 133 Participants |
| Mucinex™ | Overall Assessment of the Study Medication by End of Study Patient Questionnaire | Mucinex as alternative, But not primary | 1 Participants |