Guafenesin tablets
DrugDuring the 12-week period of receiving treatment, patient participants will take Mucinex® 12h, 2 x 600 mg (1200 mg total) twice daily.
Other names: Mucinex®
NCT Number: NCT05843669
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).
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Notify Me40 year–90 year
All sexes
Interventional
Phase 4
American Health Research, Charlotte, North Carolina, United States
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.
Healthy volunteers accepted: No
Only the study team can determine whether someone qualifies for participation.
Inclusion criteria
Rescue medicine:
Exclusion criteria
During the 12-week period of receiving treatment, patient participants will take Mucinex® 12h, 2 x 600 mg (1200 mg total) twice daily.
Other names: Mucinex®
Time frame: At baseline (week 0).
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: Every 1 week during 12 week period of receiving Mucinex® (week 2 to 14).
Patient-reported quantitative data via "Treatment compliance" bespoke survey.
Time frame: Every 2 weeks during 12 week period of receiving Mucinex® (week 2 to 14).
Patient-reported quantitative data via "Treatment satisfaction" bespoke survey.
Time frame: Every 1 week during 12 week period of receiving Mucinex® (week 2 to 14).
Patient-reported quantitative data via "Symptoms" bespoke survey.
Time frame: Every 1 week during 12 week period of receiving Mucinex® (week 2 to 14).
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: As many times as needed during 12 week period of receiving Mucinex® (week 2 to 14).
HCP-reported quantitative data via electronic case report forms ("Treatment-emergent adverse events" survey).
Time frame: At final visit (week 14).
HCP-reported quantitative data via electronic case report forms ("Treatment satisfaction" survey).
Time frame: At week 8, and at final visit (week 14).
HCP-reported quantitative data via electronic case report forms ("Energy levels" survey).
Time frame: At baseline visit (week 0), at week 8, and at final visit (week 14).
HCP-reported quantitative data via electronic case report forms ("Healthcare resource use" survey).
Time frame: At baseline (week 0), and every 1 week during 14 week study period.
Patient-reported quantitative data via the Cough and Sputum Assessment Questionnaire, CASA-Q (web- and app-based).
Time frame: As many times as needed during 12 week period of receiving Mucinex® (week 2 to 14).
HCP-reported quantitative data via electronic case report forms ("Treatment-emergent adverse events" survey).
Time frame: At baseline visit (week 0), at week 8, and at final visit (week 14).
HCP-reported quantitative data via electronic case report forms ("Healthcare resource use" survey).
Time frame: At final visit (week 14).
HCP-reported quantitative data via electronic case report forms ("Treatment satisfaction" survey).
Time frame: Every 2 weeks during 12 week period of receiving Mucinex® (week 2 to 14).
Patient-reported quantitative data via "Treatment satisfaction" bespoke survey.
Time frame: As many times as needed during 12 week period of receiving Mucinex® (week 2 to 14).
HCP-reported quantitative data via electronic case report forms ("Treatment-emergent adverse events" survey).
Time frame: At baseline (week 0), and every 1 week during 14 week study period.
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: At week 8, and at final visit (week 14).
HCP-reported quantitative data via electronic case report forms ("Energy levels" survey).
American Health Research
Other
An Open-label, Multicenter, Single-group Study to Evaluate the Effects of Long-term Use of Mucinex® in Patients With Stable Chronic Bronchitis.
Acronym: AHR CB
OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.
View the official ClinicalTrials.gov record (opens in a new tab)This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.
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