An Open-label, Multicenter, Single-group Study to Evaluate the Effects of Long-term Use of Mucinex® in Patients With Stable Chronic Bronchitis.
试验速览
- 阶段
- 4 期
- 状态
- 已完成
- 发起方
- 入组人数
- 82
- 试验地点
- 2
- 主要终点
- Describe change in patient-reported real-world clinical use of Mucinex® (i.e., cough and sputum production and its impact) in patients with SCB.
研究概览
简要总结
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).
详细描述
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.
研究设计
- 研究类型
- Interventional
- 分配方式
- Na
- 干预模型
- Single Group
- 主要目的
- Treatment
- 盲法
- None
入排标准
- 年龄范围
- 40 Years 至 90 Years（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •Adult patients with a diagnosis of SCB at recruitment, male and female, over 40 years of age
- •A Pulmonary Function Test with FEV1/FVC less than 0.7 (70%) at the time of enrollment or at least a 10 year history of cigarette abuse.
- •Patients who have chronic sputum production 3 months out of the year for 2 consecutive years and a productive cough as part of their symptoms.
- •Patients who understand and are able to fill out a questionnaire and ePRO weekly
- •Patients who have not used guaifenesin containing products within one month of the time of study enrollment
- •Patients with 6 to 12 (ideally 12)-month historical data - retrieved from either electronic medical records (EMR), electronic health records (EHRs), or provided by the patient via interview.
- •Rescue medicine:
- •No rescue medicine will be provided. Information regarding concurrent rescue medications, either OTC or via prescription, will be collected.
排除标准
- •Patients who are pregnant or breastfeeding
- •Participation in another study involving an investigational product within 30 days of the baseline visit
- •Pulmonary diagnosis other than CB, (such as cystic fibrosis, alpha-1 antitrypsin deficiency, bronchiectasis, or pulmonary fibrosis)
- •Active lung cancer or history of lung cancer if it has been less than 2 years since lung resection or other treatment including chemotherapy or radiation. If the patient has a history of lung cancer, they must be in remission
- •Psychiatric disorder that precludes participation in the study
- •History of alcohol and/or drug abuse within one year of study start
- •Patients taking intermittent antibiotics and patients taking oral and systemic corticosteroids (e.g., prednisone at a dose of > 10 mg/day).
- •Patients on a chronic stable dose of macrolide antibiotics at the start of the study may be included at the discretion of the Principal Investigator.
- •Patients who had an acute exacerbation of chronic bronchitis within a period of one month of starting the study that required systematic steroids or antibiotics
- •Hypersensitivity to guaifenesin, or any other excipient listed in the product.
研究组 & 干预措施
N/A. Only one arm.
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.
干预措施: Guafenesin tablets (Drug)
结局指标
主要结局
Describe change in patient-reported real-world clinical use of Mucinex® (i.e., cough and sputum production and its impact) in patients with SCB.
时间窗: 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
Describe change in HCP-reported real-world clinical use of Mucinex® (i.e., treatment satisfaction) in patients with SCB.
时间窗: At final visit (week 14).
HCP-reported quantitative data via electronic case report forms ("Treatment satisfaction" survey).
Describe patient-reported real-world clinical use of Mucinex® (i.e., prior to study start) in patients with SCB.
时间窗: 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.
Describe change in patient-reported real-world clinical use of Mucinex® (i.e., treatment satisfaction) in patients with SCB.
时间窗: Every 2 weeks during 12 week period of receiving Mucinex® (week 2 to 14).
Patient-reported quantitative data via "Treatment satisfaction" bespoke survey.
Describe change in HCP-reported real-world clinical use of Mucinex® (i.e., energy levels) in patients with SCB.
时间窗: At week 8, and at final visit (week 14).
HCP-reported quantitative data via electronic case report forms ("Energy levels" survey).
Describe change in HCP-reported real-world clinical use of Mucinex® (i.e., healthcare resource use) in patients with SCB.
时间窗: 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).
Describe change in patient-reported real-world clinical use of Mucinex® (i.e., treatment compliance) in patients with SCB.
时间窗: Every 1 week during 12 week period of receiving Mucinex® (week 2 to 14).
Patient-reported quantitative data via "Treatment compliance" bespoke survey.
Describe change in patient-reported real-world clinical use of Mucinex® (i.e., symptoms) in patients with SCB.
时间窗: Every 1 week during 12 week period of receiving Mucinex® (week 2 to 14).
Patient-reported quantitative data via "Symptoms" bespoke survey.
Describe change in HCP-reported real-world clinical use of Mucinex® (i.e., treatment-emergent adverse events) in patients with SCB.
时间窗: 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).
次要结局
- Describe the rate of patient-reported chronic bronchitis ePRO improvements while on treatment with Mucinex® compared to patient history or baseline.(At baseline (week 0), and every 1 week during 14 week study period.)
- Assess patient-reported treatment satisfaction while on treatment with Mucinex®.(Every 2 weeks during 12 week period of receiving Mucinex® (week 2 to 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.(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.(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®.(At final visit (week 14).)