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

A Multi-Center Randomized, Double-Blind, Parallel Group, Placebo Controlled Study, Including an Additional Open Label Tiotropium Group, to Assess the Efficacy, Safety and Tolerability of 4 Doses of AD 237 Inhaled Once Daily for 28 Days in Subjects With COPD.

Status

Completed

Phases

Phase 2

Study type

Interventional

Source

ClinicalTrials.gov

Registry ID

NCT00242333

Enrollment

300

Registered

2005-10-20

Start date

2005-10-31

Completion date

Unknown

Last updated

2006-05-16

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

COPD

Keywords

COPD, COAD, Chronic obstructive pulmonary disease, emphysema, chronic bronchitis

Brief summary

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

Interventions

DRUGAD 237

Study design

Allocation

RANDOMIZED

Intervention model

PARALLEL

Primary purpose

TREATMENT

Masking

DOUBLE

Eligibility

Sex/Gender

ALL

Age

40 Years to No maximum

Healthy volunteers

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.

Design outcomes

Primary

Measure	Time frame
Pulmonary function	—

Secondary

Measure	Time frame
Pulmonary function	—

Countries

Bulgaria, Hungary, Poland, Romania

Outcome results

None listed

Source: ClinicalTrials.gov · Data processed: Feb 4, 2026