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Expectorant
Mucinex for Chronic Bronchitis (AHR CB Trial)
Phase 4
Recruiting
Led By Selwyn Spangenthal, MD
Research Sponsored by American Health Research
Eligibility Criteria Checklist
Specific guidelines that determine who can or cannot participate in a clinical trial Must have
Adult patients with a diagnosis of SCB at recruitment, male and female, over 40 years of age
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
Timeline
Screening 3 weeks
Treatment Varies
Follow Up every 2 weeks during 12 week period of receiving mucinex® (week 2 to 14).
Awards & highlights
AHR CB Trial Summary
This trial tests if Mucinex® can help treat SCB over 12 weeks, following a 2-week period of not taking any medicine.
Who is the study for?
This trial is for adults over 40 with stable chronic bronchitis, who have a history of smoking or persistent cough with sputum. They must not have used guaifenesin recently and should be able to complete weekly health questionnaires. Pregnant women, those on certain medications, or with other lung conditions are excluded.Check my eligibility
What is being tested?
The study tests the effectiveness of Mucinex® tablets in managing symptoms of stable chronic bronchitis over a period of 12 weeks. Participants will use the medication after a baseline period without treatment to see if there's an improvement in their condition.See study design
What are the potential side effects?
Possible side effects from taking Mucinex® may include nausea, vomiting, dizziness, headache, rash or hypersensitivity reactions. However, individual experiences can vary.
AHR CB Trial Eligibility Criteria
Inclusion Criteria
You may be eligible if you check “Yes” for the criteria belowSelect...
I am over 40 and have been diagnosed with SCB.
Select...
I have had a productive cough and sputum for 3 months each year for the last 2 years.
AHR CB Trial Timeline
Screening ~ 3 weeks3 visits
Treatment ~ Varies
Follow Up ~ every 2 weeks during 12 week period of receiving mucinex® (week 2 to 14).
Screening ~ 3 weeks
Treatment ~ Varies
Follow Up ~every 2 weeks during 12 week period of receiving mucinex® (week 2 to 14).
Treatment Details
Study Objectives
Outcome measures can provide a clearer picture of what you can expect from a treatment.Primary outcome measures
Describe change in HCP-reported real-world clinical use of Mucinex® (i.e., energy levels) in patients with SCB.
Describe change in HCP-reported real-world clinical use of Mucinex® (i.e., healthcare resource use) in patients with SCB.
Describe change in HCP-reported real-world clinical use of Mucinex® (i.e., treatment satisfaction) in patients with SCB.
+6 moreSecondary outcome measures
Assess HCP-reported treatment satisfaction of patients while on treatment with Mucinex®.
Assess patient-reported treatment satisfaction while on treatment with Mucinex®.
Describe the HCP-reported rate of healthcare resource utilization while on treatment with Mucinex® compared to patient history or baseline.
+2 moreOther outcome measures
Change in HCP-reported health-related quality of life in patients who use Mucinex® to manage symptoms of SCB.
Change in patient-reported health-related quality of life in patients who use Mucinex® to manage symptoms of SCB
Rate of chronic bronchitis exacerbations in patients who use Mucinex® to manage symptoms of SCB.
AHR CB Trial Design
1Treatment groups
Experimental Treatment
Group I: N/A. Only one arm.Experimental Treatment1 Intervention
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.
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Who is running the clinical trial?
Vitaccess LtdIndustry Sponsor
5 Previous Clinical Trials
5,940 Total Patients Enrolled
American Health ResearchLead Sponsor
Selwyn Spangenthal, MDPrincipal InvestigatorAmerican Health Research; Clinical Research of Rock Hill
1 Previous Clinical Trials
40 Total Patients Enrolled
Media Library
Eligibility Criteria:
This trial includes the following eligibility criteria:- I have lung cancer or had it, and it's been less than 2 years since my last treatment.I am over 40 and have been diagnosed with SCB.I understand no rescue medicine will be provided during the trial.You have had problems with drinking alcohol or using drugs in the past year.I have a lung condition that is not chronic bronchitis.Your lung function test shows a certain level of restriction, or you have a long history of smoking.I have had a productive cough and sputum for 3 months each year for the last 2 years.I had a severe bronchitis flare-up needing steroids or antibiotics within the last month.You have a mental health condition that makes it difficult for you to take part in the study.You are allergic to guaifenesin or any other ingredients in the product.I haven't used any products containing guaifenesin in the last month.I am on antibiotics or taking steroids like prednisone above 10 mg/day.I am on a stable dose of macrolide antibiotics as decided by my doctor.
Research Study Groups:
This trial has the following groups:- Group 1: N/A. Only one arm.
Awards:
This trial has 3 awards, including:- No Placebo-Only Group - All patients enrolled in this study will receive some form of active treatment.
- Drug Has Already Been Approved - The FDA has already approved this drug, and is just seeking more data.
- Pivotal Trial - The final step before approval, pivotal trials feature drugs that have already shown basic safety & efficacy.
Timeline:
This trial has the following timeline:- Screening: It may take up to 3 Weeks to process to see if you qualify in this trial.
- Treatment: The duration you will receive the treatment varies.
- Follow Ups: You may be asked to continue sharing information regarding the trial for 6 Months after you stop receiving the treatment.
Frequently Asked Questions
These questions and answers are submitted by anonymous patients, and have not been verified by our internal team.
Are there any open slots available for this clinical trial?
"The data hosted on clinicaltrials.gov states that this particular trial is not presently accepting patients, although it was initially posted in May of 2023 and recently updated at the end of April. However, there are 85 other studies actively recruiting participants across the country."
Answered by AI
Can those aged 25 or above join the ongoing trial?
"The age bracket of 40 to 90 years old has been established as the inclusion criteria for this medical trial. Moreover, there are 35 trials specifically targeting minors and 63 dedicated to adults over 65."
Answered by AI
What has been revealed about the safety profile of N/A. Only one arm.?
"As this is a Phase 4 trial, which indicates that the treatment has been approved by government regulators, it receives an overall safety rating of 3."
Answered by AI
What are the intended goals of this clinical experiment?
"The primary intent of this trial is to gauge the degree of patient compliance while taking Mucinex®. Secondary objectives involve determining any rescue and/or maintenance inhaler use, rate of healthcare resource utilization in relation to treatment with Mucinex®, and assessing HCP-reported satisfaction levels when administered medication. All data will be collected via electronic case report forms at baseline (week 0)."
Answered by AI
Is it possible to join this clinical trial?
"In order to be eligible for this clinical trial, individuals must possess a diagnosis of chronic bronchitis and should fall into the 40-90 year old age bracket. This study is hoping to enroll 150 participants in total."
Answered by AI
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