What side effects are associated with this type of intervention?

Common treatments for COPD include bronchodilators, inhaled corticosteroids, and mucolytics. Short-acting bronchodilators, such as albuterol, can cause side effects like tremors, nervousness, and increased heart rate. Long-acting bronchodilators, including tiotropium and salmeterol, may lead to dry mouth, constipation, and potential cardiovascular effects. Inhaled corticosteroids, such as fluticasone, can increase the risk of oral thrush and pneumonia. Mucolytics like N-acetylcysteine (NAC) are generally well-tolerated but can cause gastrointestinal discomfort and, when nebulized, may induce cough or bronchospasm. Combination therapies often share the side effects of their individual components.

What prior FDA approvals exist?

The FDA has approved several classes of drugs for the treatment of Chronic Obstructive Pulmonary Disease (COPD). These include long-acting beta agonists (LABAs) such as olodaterol and vilanterol, long-acting muscarinic antagonists (LAMAs) like tiotropium and glycopyrrolate, and inhaled corticosteroids (ICS) such as fluticasone. Combination therapies, which include LABA/LAMA combinations (e.g., umeclidinium/vilanterol) and LABA/ICS combinations (e.g., fluticasone/vilanterol), have also been approved. These treatments aim to improve lung function, reduce symptoms, and prevent exacerbations in COPD patients.

What other types of research exist?

Promising novel alternatives to GDC-6599 for COPD patients include: 1) Umeclidinium, a long-acting muscarinic antagonist (LAMA) shown to improve lung function. 2) CHF6001, an inhaled phosphodiesterase-4 inhibitor that reduces inflammation. 3) Glycopyrronium, another LAMA available in various forms. These treatments have demonstrated efficacy and safety in recent studies.

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Unknown

GDC-6599 for Chronic Cough

Q: What is the mechanism of action of this treatment?

Common treatments for Chronic Obstructive Pulmonary Disease (COPD) include bronchodilators, inhaled corticosteroids, and mucolytics. Bronchodilators, such as beta agonists and muscarinic antagonists, relax the muscles around the airways, improving airflow. Inhaled corticosteroids reduce airway inflammation, decreasing swelling and mucus production. Mucolytics thin and loosen mucus, aiding in its clearance from the airways. These mechanisms are vital for COPD patients as they alleviate symptoms, enhance breathing, and reduce the frequency of exacerbations, thereby improving overall quality of life.

Phase 2

Waitlist Available

Research Sponsored by Genentech, Inc.

Eligibility Criteria Checklist

Specific guidelines that determine who can or cannot participate in a clinical trial

Must have

Never or former smoker (≥ 6 months prior to screening) with < 20 pack-years or equivalent history

Physician diagnosis of asthma for ≥ 12 months based upon GINA STEP 2-5

Must not have

Pregnant or breastfeeding, or intention of becoming pregnant during the study or within 28 days after the final dose of GDC-6599

Treatment with any strong inhibitor or inducer of CYP3A within 28 days or 5 drug-elimination half-lives, whichever is longer, prior to initiation of study drug

Timeline

Screening 3 weeks

Treatment Varies

Follow Up from baseline to day 14

Summary

This trial is testing a new drug called GDC-6599 to see if it can help people with chronic coughs that haven't been cured by other treatments. The study will look at how well the drug works, its safety, and how it behaves in the body.

Who is the study for?

Adults with chronic cough and a physician's diagnosis of asthma or COPD, who are not current smokers and have used bronchodilator medication for at least 12 weeks. They must not be pregnant, breastfeeding, or planning to become pregnant soon. Participants should not have had respiratory infections recently or been treated with certain medications like opioids for cough within the last two weeks.

What is being tested?

The trial is testing GDC-6599 against a placebo to see if it helps people with chronic cough. It's a Phase IIa study where patients will randomly receive either the drug or placebo in different periods without knowing which one they're taking (double-blind). The effects on coughing, safety, how the body processes the drug (pharmacokinetics), and its biological actions (pharmacodynamics) are being studied.

What are the potential side effects?

While specific side effects of GDC-6599 aren't listed here, common ones in trials may include nausea, headache, dizziness, fatigue or allergic reactions. Safety monitoring will identify any potential adverse effects during this study.

Eligibility Criteria

Inclusion Criteria

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

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I have never smoked or quit smoking more than 6 months ago, with less than 20 pack-years of history.

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I have been diagnosed with asthma for at least a year.

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I've had a chest X-ray or CT scan in the last 6 months showing no serious lung issues other than COPD.

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My cough is severe, scoring 40 or more on a scale.

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I have been on stable lung medication for at least 12 weeks.

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I have been diagnosed with mild to moderate COPD.

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I have been on stable asthma treatment for at least 3 months.

Exclusion Criteria

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

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I am not pregnant, breastfeeding, nor planning to become pregnant soon.

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I haven't taken strong CYP3A affecting drugs in the last month.

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I have not taken cough suppressant medication in the last 2 weeks.

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I have had issues with food or liquid going into my lungs or repeated lung infections.

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I have not had a respiratory infection in the last 8 weeks.

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I haven't taken opioids or specific medications for cough in the last 2 weeks.

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I have a history of bleeding or bruising easily.

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I haven't had cancer in the last 5 years, except for certain skin or cervical cancers.

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I have had serious liver problems.

Timeline

Screening ~ 3 weeks3 visits

Treatment ~ Varies

Follow Up ~ from baseline to day 14

Screening ~ 3 weeks

Treatment ~ Varies

Follow Up ~from baseline to day 14

This trial's timeline: 3 weeks for screening, Varies for treatment, and from baseline to day 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

Change in cough frequency per hour, assessed objectively over 24 hours (24-hour OCC) using VitaloJAK cough recorder

Secondary study objectives

Change in cough hypersensitivity to mannitol, measured as the CDR to mannitol

Change in mannitol-induced AHR

Change in the severity of cough, as assessed through the use of the patient-reported cough severity NRS score

+1 more

Trial Design

5Treatment groups

Experimental Treatment

Group I: Part B: Chronic Refractory Cough with Chronic Obstructive Pulmonary Disease with Chronic BronchitisExperimental Treatment3 Interventions

Patients with Chronic Obstructive Pulmonary Disease with Chronic Bronchitis will be randomized in a 1:1 ratio to receive GDC-6599 or placebo for 14 days during the first study period (Treatment Period 1, Study Visits 2-4). Following a 14-day washout period, patients will cross over to the second study period (Treatment Period 2, Study Visits 5-7) and will receive the alternate treatment (GDC-6599 or placebo) for 14 days starting at Study Visit 5.

Group II: Part B: Chronic Refractory Cough with Chronic Obstructive Pulmonary DiseaseExperimental Treatment3 Interventions

Patients with Chronic Obstructive Pulmonary Disease will be randomized in a 1:1 ratio to receive GDC-6599 or placebo for 14 days during the first study period (Treatment Period 1, Study Visits 2-4). Following a 14-day washout period, patients will cross over to the second study period (Treatment Period 2, Study Visits 5-7) and will receive the alternate treatment (GDC-6599 or placebo) for 14 days starting at Study Visit 5.

Group III: Part A: Unexplained Chronic CoughExperimental Treatment3 Interventions

Patients with Unexplained Chronic Cough will be randomized in a 1:1 ratio to receive GDC-6599 or placebo for 14 days during the first study period (Treatment Period 1, Study Visits 2-4). Following a 14-day washout period, patients will cross over to the second study period (Treatment Period 2, Study Visits 5-7) and will receive the alternate treatment (GDC-6599 or placebo) for 14 days starting at Study Visit 5

Group IV: Part A: CRC Asthma non-atopicExperimental Treatment3 Interventions

Patients with CRC non-atopic asthma will be randomized in a 1:1 ratio to receive GDC-6599 or placebo for 14 days during the first study period (Treatment Period 1, Study Visits 2-4). Following a 14-day washout period, patients will cross over to the second study period (Treatment Period 2, Study Visits 5-7) and will receive the alternate treatment (GDC-6599 or placebo) for 14 days starting at Study Visit 5

Group V: Part A: CRC Asthma atopicExperimental Treatment3 Interventions

Patients with CRC atopic asthma will be randomized in a 1:1 ratio to receive GDC-6599 or placebo for 14 days during the first study period (Treatment Period 1, Study Visits 2-4). Following a 14-day washout period, patients will cross over to the second study period (Treatment Period 2, Study Visits 5-7) and will receive the alternate treatment (GDC-6599 or placebo) for 14 days starting at Study Visit 5

Treatment

First Studied

Drug Approval Stage

How many patients have taken this drug

GDC-6599

2023

Completed Phase 2

~80

Mannitol

2019

Completed Phase 4

~2900

0 / 16Eligibility 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

Common treatments for Chronic Obstructive Pulmonary Disease (COPD) include bronchodilators, inhaled corticosteroids, and mucolytics. Bronchodilators, such as beta agonists and muscarinic antagonists, relax the muscles around the airways, improving airflow. Inhaled corticosteroids reduce airway inflammation, decreasing swelling and mucus production. Mucolytics thin and loosen mucus, aiding in its clearance from the airways. These mechanisms are vital for COPD patients as they alleviate symptoms, enhance breathing, and reduce the frequency of exacerbations, thereby improving overall quality of life.

Long-Acting Bronchodilator Use in the Management of Stable COPD.Should mild COPD be treated? Evidence for early pharmacological intervention.A self-management approach using self-initiated action plans for symptoms with ongoing nurse support in patients with Chronic Obstructive Pulmonary Disease (COPD) and comorbidities: the COPE-III study protocol.

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Who is running the clinical trial?

Genentech, Inc.Lead Sponsor

1,565 Previous Clinical Trials

569,976 Total Patients Enrolled

50 Trials studying Asthma

21,432 Patients Enrolled for Asthma

Clinical TrialsStudy DirectorGenetech

2,233 Previous Clinical Trials

902,213 Total Patients Enrolled

20 Trials studying Asthma

6,277 Patients Enrolled for Asthma

Media Library

GDC-6599 (Unknown) Clinical Trial Eligibility Overview. Trial Name: NCT05660850 — Phase 2

$Asthma Research Study Groups: Part B: Chronic Refractory Cough with Chronic Obstructive Pulmonary Disease with Chronic Bronchitis, Part A: CRC Asthma atopic, Part A: CRC Asthma non-atopic, Part A: Unexplained Chronic Cough, Part B: Chronic Refractory Cough with Chronic Obstructive Pulmonary Disease$