This is an open-label, multicenter, single-group study designed to determine the effectiveness of Mucinex® when used by patients to treat SCB over a 12-week period, following a 2-week run-in period of no treatment (to establish a baseline).
Data will be collected via the Vitaccess Real\[TM\] platform from adult patients with SCB and HCPs based in the US. During the 12-week period of receiving treatment, patient participants will take Mucinex® 12h, 2 x 600 mg (1200 mg total) twice daily and complete weekly bespoke surveys and the CASA-Q instrument. Patient-reported data will include prior usage of Mucinex®, treatment compliance, treatment satisfaction, and symptoms. During this same period of time, HCPs will report treatment satisfaction via electronic case report forms (eCRFs), and will also have the ability to spontaneously report any treatment-emergent adverse events.
Study Type
INTERVENTIONAL
Allocation
NA
Purpose
TREATMENT
Masking
NONE
Enrollment
82
During the 12-week period of receiving treatment, patient participants will take Mucinex® 12h, 2 x 600 mg (1200 mg total) twice daily.
American Health Research
Charlotte, North Carolina, United States
Clinical Research of Rock Hill
Rock Hill, South Carolina, United States
Describe patient-reported real-world clinical use of Mucinex® (i.e., prior to study start) in patients with SCB.
Patient-reported quantitative data via "Prior usage of Mucinex®" bespoke survey. This comprises three questions regarding patients' previous use of Mucinex, the approximate timing of use, and the frequency of use.
Time frame: At baseline (week 0).
Describe change in patient-reported real-world clinical use of Mucinex® (i.e., treatment compliance) in patients with SCB.
Patient-reported quantitative data via "Treatment compliance" bespoke survey.
Time frame: Every 1 week during 12 week period of receiving Mucinex® (week 2 to 14).
Describe change in patient-reported real-world clinical use of Mucinex® (i.e., treatment satisfaction) in patients with SCB.
Patient-reported quantitative data via "Treatment satisfaction" bespoke survey.
Time frame: Every 2 weeks during 12 week period of receiving Mucinex® (week 2 to 14).
Describe change in patient-reported real-world clinical use of Mucinex® (i.e., symptoms) in patients with SCB.
Patient-reported quantitative data via "Symptoms" bespoke survey.
Time frame: Every 1 week during 12 week period of receiving Mucinex® (week 2 to 14).
Describe change in patient-reported real-world clinical use of Mucinex® (i.e., cough and sputum production and its impact) in patients with SCB.
Patient-reported quantitative data via the Cough and Sputum Assessment Questionnaire, CASA-Q (web- and app-based). This is a validated instrument to measure cough and sputum production, and their impact in patients with chronic obstructive pulmonary disease (COPD) and/or chronic bronchitis
Time frame: Every 1 week during 12 week period of receiving Mucinex® (week 2 to 14).
Describe change in HCP-reported real-world clinical use of Mucinex® (i.e., treatment-emergent adverse events) in patients with SCB.
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HCP-reported quantitative data via electronic case report forms ("Treatment-emergent adverse events" survey).
Time frame: As many times as needed during 12 week period of receiving Mucinex® (week 2 to 14).
Describe change in HCP-reported real-world clinical use of Mucinex® (i.e., treatment satisfaction) in patients with SCB.
HCP-reported quantitative data via electronic case report forms ("Treatment satisfaction" survey).
Time frame: At final visit (week 14).
Describe change in HCP-reported real-world clinical use of Mucinex® (i.e., energy levels) in patients with SCB.
HCP-reported quantitative data via electronic case report forms ("Energy levels" survey).
Time frame: At week 8, and at final visit (week 14).
Describe change in HCP-reported real-world clinical use of Mucinex® (i.e., healthcare resource use) in patients with SCB.
HCP-reported quantitative data via electronic case report forms ("Healthcare resource use" survey).
Time frame: At baseline visit (week 0), at week 8, and at final visit (week 14).
Describe the rate of patient-reported chronic bronchitis ePRO improvements while on treatment with Mucinex® compared to patient history or baseline.
Patient-reported quantitative data via the Cough and Sputum Assessment Questionnaire, CASA-Q (web- and app-based).
Time frame: At baseline (week 0), and every 1 week during 14 week study period.
Describe the rate of concomitant rescue and/or maintenance inhaler use while on treatment with Mucinex® compared to patient history/baseline established as part of Medication Record Log completed by HCP in the eCRF at baseline visit.
HCP-reported quantitative data via electronic case report forms ("Treatment-emergent adverse events" survey).
Time frame: As many times as needed during 12 week period of receiving Mucinex® (week 2 to 14).
Describe the HCP-reported rate of healthcare resource utilization while on treatment with Mucinex® compared to patient history or baseline.
HCP-reported quantitative data via electronic case report forms ("Healthcare resource use" survey).
Time frame: At baseline visit (week 0), at week 8, and at final visit (week 14).
Assess HCP-reported treatment satisfaction of patients while on treatment with Mucinex®.
HCP-reported quantitative data via electronic case report forms ("Treatment satisfaction" survey).
Time frame: At final visit (week 14).
Assess patient-reported treatment satisfaction while on treatment with Mucinex®.
Patient-reported quantitative data via "Treatment satisfaction" bespoke survey.
Time frame: Every 2 weeks during 12 week period of receiving Mucinex® (week 2 to 14).