American Health Research | Clinical Research of Charlotte
Status and phase
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About
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).
Full description
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.
Enrollment
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Inclusion criteria
Rescue medicine:
• No rescue medicine will be provided. Information regarding concurrent rescue medications, either OTC or via prescription, will be collected.
Exclusion criteria
Primary purpose
Allocation
Interventional model
Masking
150 participants in 1 patient group
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Central trial contact
Selwyn Spangenthal, MD; Connie Divel, BSc
Data sourced from clinicaltrials.gov
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