What side effects are associated with this type of intervention?

Guaifenesin, an expectorant used to treat chronic bronchitis, is generally well-tolerated but can cause side effects such as nausea, vomiting, dizziness, headache, rash, and diarrhea. Other common treatments for chronic bronchitis include antibiotics, which can lead to gastrointestinal disturbances, allergic reactions, and antibiotic resistance, and inhaled corticosteroids, which may cause oral thrush, hoarseness, and increased risk of pneumonia. It is important to discuss potential side effects with a healthcare provider to manage and mitigate risks effectively.

What prior FDA approvals exist?

Guaifenesin, the active ingredient in Mucinex®, is an FDA-approved expectorant commonly used to treat symptoms of chronic bronchitis by loosening and thinning mucus in the airways. Other related treatments include ambroxol, which is part of the Farcosolvin syrup (a combination of ambroxol, theophylline, and guaifenesin) used for acute exacerbations of chronic bronchitis. These medications aim to improve mucus clearance and alleviate symptoms such as cough and breathlessness.

What other types of research exist?

Promising novel alternatives to Mucinex® for Chronic Bronchitis patients include Erdosteine and N-Acetylcysteine (NAC). Erdosteine has shown efficacy in reducing exacerbations, hospital days, and improving health status in COPD patients, which may translate to benefits for chronic bronchitis. NAC is another option with mucolytic and antioxidant properties that can help manage mucus production and improve respiratory function.

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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

Must not have

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

Pulmonary diagnosis other than CB, (such as cystic fibrosis, alpha-1 antitrypsin deficiency, bronchiectasis, or pulmonary fibrosis)

Timeline

Screening 3 weeks

Treatment Varies

Follow Up every 2 weeks during 12 week period of receiving mucinex® (week 2 to 14).

Awards & highlights

Drug Has Already Been Approved

No Placebo-Only Group

Pivotal Trial

Summary

This trial tests Mucinex® for adults with a persistent cough. Patients will take Mucinex® twice daily for several months. The medication helps by thinning mucus, making it easier to clear from the lungs. Mucinex® contains guaifenesin, which has been observed to thin lower respiratory tract secretions and improve mucus clearance.

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.

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.

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.

Eligibility Criteria

Inclusion Criteria

You may be eligible if you check “Yes” for the criteria below

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I am over 40 and have been diagnosed with SCB.

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I have had a productive cough and sputum for 3 months each year for the last 2 years.

Exclusion Criteria

You may be eligible for the trial if you check “No” for criteria below:

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I have lung cancer or had it, and it's been less than 2 years since my last treatment.

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I have a lung condition that is not chronic bronchitis.

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I am on antibiotics or taking steroids like prednisone above 10 mg/day.

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).

This trial's timeline: 3 weeks for screening, Varies for treatment, and every 2 weeks during 12 week period of receiving mucinex® (week 2 to 14). for reporting.

Treatment Details

Study Objectives

Study objectives can provide a clearer picture of what you can expect from a treatment.

Primary study objectives

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 more

Secondary study objectives

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 more

Other study objectives

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.

Awards & Highlights

Drug Has Already Been Approved

The FDA has already approved this drug, and is just seeking more data.

No Placebo-Only Group

All patients enrolled in this study will receive some form of active treatment.

Pivotal Trial

The final step before approval, pivotal trials feature drugs that have already shown basic safety & efficacy.

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.

0 / 5Eligibility criteria met

Research Highlights

Information in this section is not a recommendation. We encourage patients to speak with their healthcare team when evaluating any treatment decision.

Mechanism Of Action

Side Effect Profile

Prior Approvals

Other Research

The most common treatments for Chronic Bronchitis include expectorants like Mucinex® (Guaifenesin), bronchodilators, and mucolytics. Guaifenesin works by loosening and thinning mucus in the airways, making it easier to cough up and clear from the respiratory tract. This is crucial for Chronic Bronchitis patients as it helps alleviate congestion and improve breathing. Bronchodilators, such as beta agonists and muscarinic antagonists, relax the muscles around the airways, widening them and making it easier to breathe. Mucolytics, like N-acetylcysteine, break down the structure of mucus, reducing its viscosity and aiding in its clearance. These treatments collectively help manage symptoms, improve airflow, and enhance the quality of life for patients with Chronic Bronchitis.