A Study to Assess the Safety and Efficacy of Different AD 237 Doses in Adults With COPD

Sosei300 enrolled

Overview

The purpose of this study is to investigate the efficacy, safety and tolerability of AD 237 in patients with chronic obstructive pulmonary disease (COPD).

Study Type

INTERVENTIONAL

Allocation

RANDOMIZED

Purpose

TREATMENT

Masking

DOUBLE

Enrollment

300

Conditions

COPD

Interventions

AD 237DRUG

Eligibility

Sex: ALLMin age: 40 Years

Medical Language ↔ Plain English

Inclusion Criteria: * Diagnosed with COPD, with symptoms of cough and chronic sputum production and/or dyspnea. * Post-bronchodilator FEV1 at no more than 65% and at least 30% of the predicted normal value. * Pre-bronchodilator FEV1/FVC ratio of less than 70%. * Current or ex-smokers with a smoking history of at least 10 pack years. Exclusion Criteria: * History of asthma, atopy or allergic rhinitis. * Other serious respiratory or other medical conditions which may interfere with the outcome of the study.

Locations (33)

Outcomes

Primary Outcomes

Pulmonary function

Secondary Outcomes

Pulmonary function

Data from ClinicalTrials.gov

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Specialized Hospital for Active Treatment Pneumophthysiatric Disease "Kudoglu"

Plovdiv, Bulgaria

Regional Dispensary for Pulmonary Diseases Rousse

Rousse, Bulgaria

5-th Multiprofile Hospital for Active Treatment

Sofia, Bulgaria

MHAT "Alexandrovska"

Sofia, Bulgaria

Specialized Hospital for Active Treatment of Pulmonary Diseases "Sveta Sofia"

Sofia, Bulgaria

Central Clinical Base - Medical Institute - Ministry of the Interior

Sofia, Bulgaria

Military Medical Academy

Sofia, Bulgaria

UMHAT "Stara Zagora" EAD

Stara Zagora, Bulgaria

University Hospital

Varna, Bulgaria

Tudogyintezete Nodradgardony

Balassagyarmat, Hungary

...and 23 more locations