Study to Evaluate the Safety, Tolerability, and Activity of Inhaled GDC-6988 In Patients with non-cystic fibrosis bronchiectasis or chronic obstructive pulmonary disease

STUDY BASICS

Do you have non-cystic fibrosis bronchiectasis (NCFB) or chronic obstructive pulmonary disease (COPD)? You may be eligible for a research study to test an experimental drug at different doses to find out if it is safe and to understand the way your body processes the study drug. The study involves approximately 5 visits to UPMC in Oakland for screening and testing. Compensation is provided.

STUDY PURPOSE

The purpose of this study is to test an experimental drug for people with either non-cystic fibrosis (CF) bronchiectasis OR chronic obstructive pulmonary disease (COPD). The drug is intended to improve the clearance of mucus.  We will test the drug (GDC-6988) at different doses to find out if it is safe and to understand the way your body processes it .  This study is for people who have bronchiectasis not related to Cystic Fibrosis or Primary Ciliary Dyskinesia.  It is also for people with COPD with chronic bronchitis. GDC6988 is an experimental drug, which means health authorities, such as the U.S. Food and Drug Administration (FDA), has  not approved GDC6988.  This study is designed to determine whether the drug is safe and effective.   It is sponsored by the manufacturer of GDC-6988, Genentech, Inc. 

WHAT PARTICIPANTS CAN EXPECT

The study involves approximately 5 visits to UPMC in Oakland for screening and testing.  The total time of participation is 5-10 weeks.  You will receive the drug at the study site and use it at home for 14 days.  There is no placebo group. The drug is delivered twice per day using a dry powder inhaler.  You will also use albuterol as part of the study.  Testing performed as part of the study will include breathing tests, blood draws, vital sign measurements, electrocardiograms, completion of questionnaires, and the collection of urine and sputum.  You must be able to expectorate sputum regularly to participate.  The study also involves special imaging scans that measure how effectively you clear mucus from your lungs.