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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
Timeline
Screening 3 weeks
Treatment Varies
Follow Up from baseline to day 14
Awards & highlights
Study Summary
This trial will test a new medication to see if it safely and effectively relieves chronic cough in patients.
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.Check my eligibility
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.See study design
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 belowSelect...
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.
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
Treatment Details
Study Objectives
Outcome measures can provide a clearer picture of what you can expect from a treatment.Primary outcome measures
Change in cough frequency per hour, assessed objectively over 24 hours (24-hour OCC) using VitaloJAK cough recorder
Secondary outcome measures
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
+2 moreTrial 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
Mannitol
2019
Completed Phase 4
~2900
Find a Location
Who is running the clinical trial?
Genentech, Inc.Lead Sponsor
1,539 Previous Clinical Trials
567,609 Total Patients Enrolled
Clinical TrialsStudy DirectorGenetech
2,200 Previous Clinical Trials
888,442 Total Patients Enrolled
Media Library
Eligibility Criteria:
This trial includes the following eligibility criteria:- Your lung function test shows that you can breathe out at least 60% of the air you're supposed to.I have had colorectal cancer, asthma, COPD, or upper cervical cancer for over a year.I have never smoked or quit smoking more than 6 months ago, with less than 20 pack-years of history.You have a high number of coughs in response to a mannitol challenge test.I am not pregnant, breastfeeding, nor planning to become pregnant soon.I haven't taken strong CYP3A affecting drugs in the last month.You have a type of asthma that is not caused by allergies, and have tested negative for common allergens.I have not taken cough suppressant medication in the last 2 weeks.I have been diagnosed with asthma for at least a year.I have had issues with food or liquid going into my lungs or repeated lung infections.I have not had a respiratory infection in the last 8 weeks.I've had a chest X-ray or CT scan in the last 6 months showing no serious lung issues other than COPD.I haven't taken opioids or specific medications for cough in the last 2 weeks.I have a history of bleeding or bruising easily.My lung function test shows severe obstruction.My cough is severe, scoring 40 or more on a scale.I have had COVID-19 or symptoms of it within the last 8 weeks.Your test results at screening are not within the normal range for the lab conducting the tests.I haven't had cancer in the last 5 years, except for certain skin or cervical cancers.You have a history of allergic asthma with positive test results for specific allergens like pet dander, dust mites, or mold.I have been taking ACE inhibitor medication for the last 12 weeks.I have been on stable lung medication for at least 12 weeks.I have had serious liver problems.I have been diagnosed with mild to moderate COPD.I smoked the equivalent of 10 packs of cigarettes a year and quit within the last 6 months.I have been on stable asthma treatment for at least 3 months.Your lung function is below a certain level as measured by a breathing test.You have had a chest X-ray or CT scan of your chest within the last 5 years that shows no major problems causing your chronic cough.
Research Study Groups:
This trial has the following groups:- Group 1: Part B: Chronic Refractory Cough with Chronic Obstructive Pulmonary Disease with Chronic Bronchitis
- Group 2: Part A: CRC Asthma atopic
- Group 3: Part A: CRC Asthma non-atopic
- Group 4: Part A: Unexplained Chronic Cough
- Group 5: Part B: Chronic Refractory Cough with Chronic Obstructive Pulmonary Disease
Awards:
This trial has 0 awards, including: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.
Does this clinical trial permit patients who are 18 years or older to participate?
"These medical trials necessitate that patients aged between 18 and 80 submit their applications. Moreover, there are 146 studies for minors and 576 clinical tests open to those over 65 years old."
Answered by AI
What is the total enrollment size of this investigation?
"Affirmative. Records on clinicaltrials.gov signal that this examination is actively recruiting patients, which began in January 13th of 2023 and was recently revised on February 2nd of the same year. 80 study participants are being sought out at 4 testing facilities."
Answered by AI
To what extent is this trial being conducted in various locations?
"Participants for this trial can be recruited from Midwest Clinical Research LLC (St. Louis, Missouri), ADAC Research PA (Greenville, South carolina), Bellingham Asthma, Allergy & Immunology (Bellingham Washington) alongside 4 other authorized clinical sites."
Answered by AI
Is the opportunity to partake in this research currently available?
"Affirmative, according to clinicaltrials.gov the trial is actively searching for test subjects. It was put up on the 13th of January 2023 and most recently updated on February 2nd of this year. 80 participants are being recruited at 4 different locations."
Answered by AI
Can I join this experiment?
"This clinical trial is recruiting 80 individuals with chronic recurrent conjunctivitis and atopic asthma aged 18-80 years. The primary conditions for eligibility include: a pre-existing diagnosis of CRC, chest X-ray or CT scan confirming the absence of any respiratory issues, VAS score≥ 40, FEV1 ≥ 60%, agreement to abstain from sex/use contraception (women) or a condom (men), agree not to donate sperm; in addition those with atopic asthma must have positive IgE test results against one of five perennial allergens while non-atopics will need negative ImmunoCAP tests against relevant local"
Answered by AI
Who else is applying?
What site did they apply to?
Mayo Clinic
What portion of applicants met pre-screening criteria?
Met criteria
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