Inhaled GDC-6988 for Obstructive Lung Disease
Recruiting in Palo Alto (17 mi)
+1 other location
Age: 18+
Sex: Any
Travel: May Be Covered
Time Reimbursement: Varies
Trial Phase: Phase 1 & 2
Recruiting
Sponsor: Genentech, Inc.
Disqualifiers: Pregnancy, Acute respiratory infection, Immunodeficiency, others
No Placebo Group
Trial Summary
What is the purpose of this trial?
This study evaluates the safety, tolerability, and activity of inhaled GDC-6988 in patients with muco-obstructive disease.
Do I need to stop my current medications for the trial?
No, you do not need to stop your current medications. Participants must be on a stable treatment regimen for muco-obstructive diseases for at least 28 days before starting the study and must remain on it throughout the trial.
What data supports the idea that Inhaled GDC-6988 for Obstructive Lung Disease is an effective treatment?
The available research does not provide specific data on the effectiveness of Inhaled GDC-6988 for Obstructive Lung Disease. Instead, it discusses other inhalation therapies for COPD, such as triple and dual bronchodilator therapies, without mentioning GDC-6988. Therefore, there is no direct evidence from the provided information to support the effectiveness of GDC-6988 for this condition.12345
What safety data is available for the treatment Inhaled GDC-6988 for Obstructive Lung Disease?
The provided research does not contain specific safety data for GDC-6988, ETD-002, or RG-6421. The studies focus on other treatments for COPD, such as glycopyrronium/formoterol combinations and nebulized glycopyrrolate, assessing their safety and efficacy. Therefore, no direct safety data for GDC-6988 is available in the given research.678910
Research Team
CT
Clinical Trials
Principal Investigator
Genentech, Inc.
Eligibility Criteria
This trial is for adults with obstructive lung diseases like asthma, COPD, or bronchiectasis. Participants must have a certain level of lung function (FEV1 ≥ 40%), stable disease for at least 28 days, and be able to use the Smart DPI inhaler correctly. Smokers or former smokers with a significant smoking history are eligible if they meet other criteria such as chronic cough and sputum production.Inclusion Criteria
My lung function test shows at least 40% normal airflow.
I have been on a stable treatment for my lung condition for at least 28 days and am willing to continue it during the study.
I can correctly use the Smart DPI as judged by the investigator.
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Trial Timeline
Screening
Participants are screened for eligibility to participate in the trial
2-4 weeks
Treatment
Participants receive inhaled GDC-6988. Cohort 1 receives low dose on Day 1 and high dose on Day 2. Cohort 2 receives high dose for 14 days. Cohorts 3 and 4 receive low dose for 14 days.
2 weeks
Follow-up
Participants are monitored for safety and effectiveness after treatment
4 weeks
Treatment Details
Interventions
- GDC-6988 (Kinase Inhibitor)
Trial OverviewThe trial is testing GDC-6988, an inhaled medication for people with muco-obstructive diseases. It aims to assess the safety and effects of this treatment on patients' conditions.
Participant Groups
1Treatment groups
Experimental Treatment
Group I: GDC-6988Experimental Treatment1 Intervention
Participants in cohort 1 will receive low dose GDC-6988 twice a day (BID) on Day 1 followed by high dose BID on Day 2. Participants in cohort 2 will receive high dose GDC-6988 BID for 14 days. Participants in Cohorts 3 and 4 will receive low dose GDC-6988 BID for 14-days.
Find a Clinic Near You
Research Locations NearbySelect from list below to view details:
Texas Research Institute/TTSBoerne, TX
TTS ResearchBoerne, TX
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Who Is Running the Clinical Trial?
Genentech, Inc.
Lead Sponsor
Trials
1578
Patients Recruited
569,000+
Findings from Research
NCBI (Pubmed)
pubmed.ncbi.nlm.nih.gov
Extrafine inhaled triple therapy versus dual bronchodilator therapy in chronic obstructive pulmonary disease (TRIBUTE): a double-blind, parallel group, randomised controlled trial.Papi, A., Vestbo, J., Fabbri, L., et al.[2022]
NCBI (Pubmed)
pubmed.ncbi.nlm.nih.gov
Inhaled treatment of COPD: a Delphi consensus statement.Ninane, V., Corhay, JL., Germonpré, P., et al.[2022]
NCBI (Pubmed)
pubmed.ncbi.nlm.nih.gov
Prognostic Properties of the GOLD 2023 Classification System.Brat, K., Svoboda, M., Zatloukal, J., et al.[2023]
NCBI (Pubmed)
pubmed.ncbi.nlm.nih.gov
Evaluation of changes in guidelines for medication management of stable chronic obstructive pulmonary disease.Lin, FJ., Lee, TA., Wong, PS., et al.[2015]
NCBI (Pubmed)
pubmed.ncbi.nlm.nih.gov
The effects of different inhalation therapies on less symptomatic chronic obstructive pulmonary disease patients in a Chinese population: a real-world study.Song, Q., Lin, L., Zhou, A., et al.[2023]
NCBI (Pubmed)
pubmed.ncbi.nlm.nih.gov
Comparative efficacy and safety of glycopyrronium/formoterol fixed-dose combination versus glycopyrronium monotherapy in patients with moderate-to-severe COPD.Salvi, S., Jain, MK., Krishnamurthy, S., et al.[2023]
NCBI (Pubmed)
pubmed.ncbi.nlm.nih.gov
Glycopyrrolate/eFlow CS: The First Nebulized Long-Acting Muscarinic Antagonist Approved to Treat Chronic Obstructive Pulmonary Disease.Pleasants, RA.[2020]
NCBI (Pubmed)
pubmed.ncbi.nlm.nih.gov
Efficacy and Safety of Nebulized Glycopyrrolate/eFlow® Closed System in Patients with Moderate-to-Very-Severe Chronic Obstructive Pulmonary Disease with Pre-Existing Cardiovascular Risk Factors.Ferguson, GT., Tosiello, R., Sanjar, S., et al.[2020]
NCBI (Pubmed)
pubmed.ncbi.nlm.nih.gov
Pharmacokinetics of a novel agent, R667, in patients with emphysema.Chiu, YY., Roth, MD., Kolis, S., et al.[2018]
In a study involving 65 patients with moderate-to-severe COPD, glycopyrronium bromide (GB) significantly improved lung function (FEV1) compared to placebo, with higher doses showing greater efficacy.
GB was found to be safe, with all adverse events being mild to moderate in severity and a lower incidence compared to placebo, suggesting that a dose of 25 μg twice daily may be optimal for treating COPD.
NCBI (Pubmed)
pubmed.ncbi.nlm.nih.gov
Bronchodilator efficacy of extrafine glycopyrronium bromide: the Glyco 2 study.Singh, D., Scuri, M., Collarini, S., et al.[2018]
NCBI (Pubmed)
pubmed.ncbi.nlm.nih.gov
Efficacy And Safety Of Glycopyrrolate/Formoterol Fumarate Metered Dose Inhaler (GFF MDI) Formulated Using Co-Suspension Delivery Technology In Chinese Patients With COPD.Chen, R., Zhong, N., Wang, HY., et al.[2021]
In a study involving 30 subjects with moderate-to-severe COPD, glycopyrronium bromide (GLY) delivered via a nebulizer (eFlow) showed similar bronchodilation effects compared to a dry powder inhaler (DPI), despite lower systemic drug levels from the nebulizer.
Fewer adverse events were reported with the nebulizer (15 events) compared to the DPI (18 events), suggesting that nebulized GLY may be a safer alternative for patients who struggle with conventional inhalers.
NCBI (Pubmed)
pubmed.ncbi.nlm.nih.gov
Evaluation of systemic absorption and bronchodilator effect of glycopyrronium bromide delivered by nebulizer or a dry powder inhaler in subjects with chronic obstructive pulmonary disease.Leaker, BR., Singh, D., Nicholson, GC., et al.[2020]
In a study involving 150 Japanese patients with moderate-to-very severe COPD, the fixed-dose combination of glycopyrrolate/formoterol fumarate (GFF MDI) significantly improved lung function compared to both its individual components and placebo, with a notable increase in forced expiratory volume (FEV1).
The GFF MDI also showed positive trends in patient-reported outcomes related to dyspnea and quality of life, while treatment-related adverse events were low, occurring in 4.5% or fewer patients, indicating a favorable safety profile.
NCBI (Pubmed)
pubmed.ncbi.nlm.nih.gov
Efficacy and safety of glycopyrrolate/formoterol fumarate metered dose inhaler delivered using co-suspension delivery technology in Japanese patients with moderate-to-very severe chronic obstructive pulmonary disease.Gon, Y., Nishi, K., Sato, K., et al.[2022]
The study evaluated the pharmacokinetics and safety of a fixed-dose combination of glycopyrronium and formoterol (GFF MDI) in healthy Japanese subjects, showing that the addition of formoterol did not significantly change the pharmacokinetic profile of glycopyrronium.
Both GFF MDI and glycopyrronium MDI were well tolerated, indicating a favorable safety profile, which supports further research on GFF MDI for treating COPD in Japanese patients.
NCBI (Pubmed)
pubmed.ncbi.nlm.nih.gov
Pharmacokinetics and safety of a single dose of the novel LAMA/LABA fixed-dose combination of glycopyrronium/formoterol fumarate dihydrate metered dose inhaler, formulated using co-suspension delivery technology, in Japanese healthy subjects.Reisner, C., Miller, J., DePetrillo, P., et al.[2019]
In a study involving 80 patients with moderate-to-very severe COPD, the fixed-dose combination inhaler GFF MDI showed similar bronchodilation effects whether used with or without the Aerochamber Plus® VHC, indicating flexibility in its use.
Both delivery methods were well tolerated, with comparable safety profiles, suggesting that the VHC can be beneficial for patients who struggle with using a metered dose inhaler correctly.
NCBI (Pubmed)
pubmed.ncbi.nlm.nih.gov
Randomized study of the effects of Aerochamber Plus® Flow-Vu® on the efficacy, pharmacokinetics and safety of glycopyrronium/formoterol fumarate dihydrate metered dose inhaler in patients with chronic obstructive pulmonary disease.Fakih, F., Spangenthal, S., Sigal, B., et al.[2022]
References
Extrafine inhaled triple therapy versus dual bronchodilator therapy in chronic obstructive pulmonary disease (TRIBUTE): a double-blind, parallel group, randomised controlled trial. [2022]
Inhaled treatment of COPD: a Delphi consensus statement. [2022]
Prognostic Properties of the GOLD 2023 Classification System. [2023]
Evaluation of changes in guidelines for medication management of stable chronic obstructive pulmonary disease. [2015]
The effects of different inhalation therapies on less symptomatic chronic obstructive pulmonary disease patients in a Chinese population: a real-world study. [2023]
Comparative efficacy and safety of glycopyrronium/formoterol fixed-dose combination versus glycopyrronium monotherapy in patients with moderate-to-severe COPD. [2023]
Glycopyrrolate/eFlow CS: The First Nebulized Long-Acting Muscarinic Antagonist Approved to Treat Chronic Obstructive Pulmonary Disease. [2020]
Efficacy and Safety of Nebulized Glycopyrrolate/eFlow® Closed System in Patients with Moderate-to-Very-Severe Chronic Obstructive Pulmonary Disease with Pre-Existing Cardiovascular Risk Factors. [2020]
Pharmacokinetics of a novel agent, R667, in patients with emphysema. [2018]
Bronchodilator efficacy of extrafine glycopyrronium bromide: the Glyco 2 study. [2018]
Efficacy And Safety Of Glycopyrrolate/Formoterol Fumarate Metered Dose Inhaler (GFF MDI) Formulated Using Co-Suspension Delivery Technology In Chinese Patients With COPD. [2021]
Evaluation of systemic absorption and bronchodilator effect of glycopyrronium bromide delivered by nebulizer or a dry powder inhaler in subjects with chronic obstructive pulmonary disease. [2020]
Efficacy and safety of glycopyrrolate/formoterol fumarate metered dose inhaler delivered using co-suspension delivery technology in Japanese patients with moderate-to-very severe chronic obstructive pulmonary disease. [2022]
Pharmacokinetics and safety of a single dose of the novel LAMA/LABA fixed-dose combination of glycopyrronium/formoterol fumarate dihydrate metered dose inhaler, formulated using co-suspension delivery technology, in Japanese healthy subjects. [2019]
Randomized study of the effects of Aerochamber Plus® Flow-Vu® on the efficacy, pharmacokinetics and safety of glycopyrronium/formoterol fumarate dihydrate metered dose inhaler in patients with chronic obstructive pulmonary disease. [2022]