Inhaled GDC-6988 for Obstructive Lung Disease

Phase 1 & 2

Recruiting

Research Sponsored by Genentech, Inc.

Eligibility Criteria Checklist

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

Must have

- Diagnosis of bronchiectasis on the basis of prior chest CT, involving at least 2 lobes, with at least one lobe of involvement in the right lung as assessed by the investigator * COPD defined as post-bronchodilator FEV1/forced vital capacity (FVC) ratio of \<0.7

* Chronic bronchitis, with a definition including chronic cough and excessive sputum production for more than 3 months per year for at least 2 years prior to screening

Timeline

Screening 3 weeks

Treatment Varies

Follow Up from baseline up to 6 weeks

Awards & highlights

No Placebo-Only Group

Summary

"This trial will test if inhaled GDC-6988 is safe and effective for patients with muco-obstructive disease."

Who is the study for?

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.

What is being tested?

The 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.

What are the potential side effects?

While specific side effects are not listed here, common ones associated with inhaled medications may include throat irritation, coughing, dry mouth or throat, headache, voice changes (hoarseness), and possibly increased risk of respiratory infections.

Eligibility Criteria

Inclusion Criteria

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

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I have been diagnosed with bronchiectasis in at least 2 lobes, including the right lung, and have COPD.

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I have had a chronic cough and excessive sputum for over 3 months a year, for the last 2 years.

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I smoked the equivalent of 10 packs a year for some time.

Timeline

Screening ~ 3 weeks3 visits

Treatment ~ Varies

Follow Up ~ from baseline up to 6 weeks

Screening ~ 3 weeks

Treatment ~ Varies

Follow Up ~from baseline up to 6 weeks

This trial's timeline: 3 weeks for screening, Varies for treatment, and from baseline up to 6 weeks for reporting.

Treatment Details

Study Objectives

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

Primary study objectives

Percentage of Participants with Adverse events (AEs), with Severity assessed by Division of AIDS (DAIDS) Toxicity Grading Scale

Secondary study objectives

Percentage of Participants with Spirometry Abnormalities Without and With Albuterol Pretreatment

Awards & Highlights

No Placebo-Only Group

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

Trial Design

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.

0 / 3Eligibility criteria met