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| Name | Class |
|---|---|
| Vitaccess Ltd | INDUSTRY |
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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.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| N/A. Only one arm. | Experimental | Single arm. 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. |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Guafenesin tablets | Drug | During the 12-week period of receiving treatment, patient participants will take Mucinex® 12h, 2 x 600 mg (1200 mg total) twice daily. |
|
| Measure | Description | Time Frame |
|---|---|---|
| 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. | 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. | 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. | 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. | 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 | Every 1 week during 12 week period of receiving Mucinex® (week 2 to 14). |
| Measure | Description | Time Frame |
|---|---|---|
| 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). | At baseline (week 0), and every 1 week during 14 week study period. |
| Measure | Description | Time Frame |
|---|---|---|
| Rate of chronic bronchitis exacerbations in patients who use Mucinex® to manage symptoms of SCB. | HCP-reported quantitative data via electronic case report forms ("Treatment-emergent adverse events" survey). | As many times as needed during 12 week period of receiving Mucinex® (week 2 to 14). |
| Change in patient-reported health-related quality of life in patients who use Mucinex® to manage symptoms of SCB |
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:
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| Name | Affiliation | Role |
|---|---|---|
| Selwyn Spangenthal, MD | American Health Research; Clinical Research of Rock Hill | Principal Investigator |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| American Health Research | Charlotte | North Carolina | 28277 | United States | ||
| Clinical Research of Rock Hill |
| PubMed Identifier | Type | Citation | Retractions |
|---|---|---|---|
| Background | Spangenthal S, Divel C, Borecka O, Fellows A, Llewellyn S. The interplay between CASA-Q domains: insights from a real-world study investigating the effects of extended-release guaifenesin in stable chronic bronchitis. Presented at the 10th American Cough Conference (ACC) 2025; Jun 2025; Dulles, VA, US. https://www.researchgate.net/publication/391522663 | ||
| Background | Divel C, Spangenthal S, Shea T, Borecka O, Llewellyn S, Adeleke M, Patel P. Adjunctive long-term Mucinex® use leading to improvement in stable chronic bronchitis and decreased health care resource utilization - a case report. Am J Respir Crit Care Med 2025;211:A6293. https://doi.org/10.1164/ajrccm.2025.211.Abstracts.A6293 | ||
| Background | Spangenthal S, Llewellyn S, Borecka O, Pollack C, Adeleke M, Kulasekaran A, Birring S, Mazzone S, Shea T. Real world effectiveness of guaifenesin ER in tackling mucus hypersecretion in stable chronic bronchitis. Presented at The Thirteenth London International Cough Symposium; Jul 18-19; London, UK https://www.researchgate.net/publication/382744095 | ||
| Background | Divel C, Borecka O, Llewellyn S, Spangenthal S. Assessment of stable chronic bronchitis improvement with adjunctive long-term Mucinex® use via the cough and sputum assessment questionnaire (CASA-Q). Presented at The Annual Meeting of the American College of Chest Physicians (CHEST) 2025; Oct 19-22; Chicago, IL, US. https://journal.chestnet.org/article/S0012-3692(25)04707-5/fulltext | ||
| Background | Spangenthal S, Divel C, Borecka O, Llewellyn S. Real-world use of Vitaccess Real™ platform to assess quality of life impact with long-term use of Mucinex® in stable chronic bronchitis. Presented at the 32nd International Society of Quality of Life Research (ISOQOL) Annual Conference 2025; Oct 22-25; Milwaukee, WI, US. https://www.researchgate.net/publication/394966835 |
| Label | URL |
|---|---|
| The Thirteenth London International Cough Symposium research poster | View source |
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There is not a plan to make IPD available.
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| ID | Term |
|---|---|
| D029481 | Bronchitis, Chronic |
| ID | Term |
|---|---|
| D001991 | Bronchitis |
| D012141 | Respiratory Tract Infections |
| D007239 | Infections |
| D001982 | Bronchial Diseases |
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Not provided
| ID | Term |
|---|---|
| D000111 | Acetylcysteine |
| ID | Term |
|---|---|
| D003545 | Cysteine |
| D000603 | Amino Acids, Sulfur |
| D013457 | Sulfur Compounds |
| D009930 | Organic Chemicals |
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Phase 4 real-world study
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|
| Describe change in HCP-reported real-world clinical use of Mucinex® (i.e., treatment-emergent adverse events) in patients with SCB. | HCP-reported quantitative data via electronic case report forms ("Treatment-emergent adverse events" survey). | 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). | 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). | 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). | At baseline visit (week 0), at week 8, and at final visit (week 14). |
| 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). |
| 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). | 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). | At final visit (week 14). |
| Assess patient-reported treatment satisfaction while on treatment with Mucinex®. | Patient-reported quantitative data via "Treatment satisfaction" bespoke survey. | Every 2 weeks 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 |
| At baseline (week 0), and every 1 week during 14 week study period. |
| Change in HCP-reported health-related quality of life in patients who use Mucinex® to manage symptoms of SCB. | HCP-reported quantitative data via electronic case report forms ("Energy levels" survey). | At week 8, and at final visit (week 14). |
| Rock Hill |
| South Carolina |
| 29732 |
| United States |
| Background | Spangenthal S, Divel C, Borecka O, Llewellyn S. Adjunctive long-term use of Mucinex® leading to improvement in stable chronic bronchitis and patient's quality of life: A case report. Medical Reports 2025;14:100384. https://www.sciencedirect.com/science/article/pii/S2949918625002293 |
| D012140 |
| Respiratory Tract Diseases |
| D008173 | Lung Diseases, Obstructive |
| D008171 | Lung Diseases |
| D029424 | Pulmonary Disease, Chronic Obstructive |
| D002908 | Chronic Disease |
| D020969 | Disease Attributes |
| D010335 | Pathologic Processes |
| D013568 | Pathological Conditions, Signs and Symptoms |
| D000596 |
| Amino Acids |
| D000602 | Amino Acids, Peptides, and Proteins |