A Phase Ic, Open-Label, Multicenter Study to Evaluate the Safety, Tolerability, and Activity of Inhaled GDC-6988 in Patients With Muco-Obstructive Disease
This study evaluates the safety, tolerability, and activity of inhaled GDC-6988 in participants with muco-obstructive disease.
• Percent predicted FEV1 ≥ 40% by spirometry during screening
• Ability to demonstrate correct use of the Smart DPI at screening, in the investigator's judgment
• On a stable treatment regimen for muco-obstructive diseases for ≥ 28 days prior to initiation of study treatment and willingness to remain on the stable treatment regimen through completion of study
• Stable disease for ≥ 28 days prior to screening and through to initiation of study treatment
⁃ Additional Inclusion Criteria for Participants with non-cystic fibrosis bronchiectasis (NCFB) (Cohort 1, Cohort 2, and Cohort 3):
⁃ \- Diagnosis of bronchiectasis on the basis of prior chest computed tomography (CT), involving at least 2 lobes, with at least one lobe of involvement in the right lung as assessed by the investigator
⁃ Additional Inclusion Criteria for Participants with chronic obstructive pulmonary disease (COPD) (Cohort 1 and Cohort 4):
• COPD defined as post-bronchodilator FEV1/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
• Former smoker with a minimum of 10 pack-year history (e.g., 20 cigarettes/day for 10 years) or non-smoker with at least one documented COPD risk factor