A PHASE II, RANDOMIZED, DOUBLE-BLIND, PLACEBO-CONTROLLED, PARALLEL GROUP STUDY TO EVALUATE THE EFFICACY AND SAFETY OF UK- 432,097 DRY POWDER FOR INHALATION IN ADULTS WITH MODERATE TO SEVERE CHRONIC OBSTRUCTIVE PULMONARY DISEASE

Phase 2

Completed

• Conditions: COPD; Obstructive lung disease; 10006436

• Registration Number: NL-OMON30744
• Lead Sponsor: Pfizer

Brief Summary

Not available

Detailed Description

Not available

Study Timeline

• Last Update Posted: 18 June 2024

Recruitment & Eligibility

• Status: Completed
• Sex: Not specified
• Target Recruitment: 40

Inclusion Criteria

1. Male or female subjects between, and including, the ages of 40 and 80 years. Females need to be of non-childbearing potential (criteria gespcificeerd).
2. Subjects with a diagnosis, for at least 6 months, of moderate to severe COPD (GOLD) and who meet the criteria for Stage II-III disease.
3. Subjects must have a smoking history of at least 10 pack-years* (criteria gespecificeerd).
4. Subjects must have stable disease for at least 1 month prior to screening.
5. Subjects must be able to give informed written consent prior to entering the study.

Exclusion Criteria

1. More than 2 exacerbations of COPD requiring treatment with oral steroids in the
preceding year or hospitalization for the treatment of COPD within 3 months of screening or more than twice during the preceding year.
2. History of a lower respiratory tract infection or significant disease instability during the month preceding screening or during the time between screening and randomization.
3. History or presence of respiratory failure, cor pulmonale or right ventricular failure.
4. Subjects with home oxygen therapy.
5. Any clearly documented history of adult asthma or other chronic respiratory disorders (e.g. bronchiectasis, pulmonary fibrosis, pneumoconiosis).
6. History of cancer (other than cutaneous basal cell) in the previous 5 years.
7. History within the previous year of: myocardial infarction, cardiac arrhythmia (e.g. atrial fibrillation, paroxysmal atrial fibrillation, atrial flutter, supraventricular tachycardia, ventricular tachycardia), left ventricular failure, unstable angina, coronary angioplasty, coronary artery bypass grafting (CABG) or cerebrovascular accident (including transient ischemic attacks)
8. A major surgical operation within 1 month of screening.
9. Screening systolic blood pressure < 90mmHg.
10. ECG abnormalities at screening or randomization (criteria specified).
11. Liver function test abnormalities (criteria specified)

Study & Design

• Study Type: Interventional
• Study Design: Not specified

Primary Outcome Measures

Name	Time	Method
<p>Change from baseline in trough (prior to administration of study drug) FEV1 at<br /><br>Week 6.</p><br>