Dose Finding Study in COPD

Boehringer Ingelheim389 enrolled

Overview

The primary objective of this study is to determine the optimum dose of BEA 2180 BR inhalation solut ion delivered by the Respimat ? inhaler once daily for four weeks in patients with COPD.

Study Type

INTERVENTIONAL

Allocation

RANDOMIZED

Purpose

TREATMENT

Masking

DOUBLE

Enrollment

389

Conditions

Pulmonary Disease, Chronic Obstructive

Interventions

BEA 2180 BRDRUG

tiotropiumDRUG

Eligibility

Sex: ALLMin age: 40 YearsMax age: 83 Years

Medical Language ↔ Plain English

1. Patients must have relatively stable, moderate to severe airway obstruction with an FEV1 \>=30% and \<= 60% of predicted normal and FEV1 \<=70% of FVC at the baseline PFTs at Visit 1 (at both timepoints). 2. All patients must have an increase in FEV1 of at least 12% from baseline (th e -10 minute measurement) 45 min after inhalation of 80 ?g Atrovent MDI. 3. Male or female patients 40 years of age or older. 4. Smoker or ex-smoker with a history of more than 10 pack years. 1\. Patients with any other significant disease will be excluded. 2. Patients with a history of asthma or allergic rhinitis will be excluded.

Locations (43)

Outcomes

Primary Outcomes

Trough forced expiratory volume (FEV1) response after four weeks of treatment.

Time frame: 4 weeks

Secondary Outcomes

Trough FEV1 response after 1 and 2 weeks

Time frame: after 1 and 2 weeks

Trough FVC response after 1, 2 and 4 weeks

Time frame: after 1, 2 and 4 weeks

FEV1, FVC AUC0-6h and peak response after 0, 1, 2 and 4 weeks

Time frame: after 0, 1, 2 and 4 weeks

Individual FEV1 and FVC measurements at each time point

Time frame: 4 weeks

Weekly mean pre-dose morning and evening PEFR

Time frame: 4 weeks

Weekly mean number of occasions of rescue therapy used per day [as occasion requires (PRN) albuterol]

Time frame: 4 weeks

COPD symptom scores (wheezing, shortness of breath, coughing and tightness of chest)

Time frame: 4 weeks

Physician's Global Evaluation

Time frame: 4 weeks

All adverse events

Time frame: 7 weeks

Pulse rate and blood pressure (seated) recorded in conjunction with spirometry up to the three hour pulmonary function test (PFT)

Time frame: 4 weeks

Data from ClinicalTrials.gov

This platform is for informational purposes only and does not constitute medical advice. Always consult a qualified healthcare professional.

UAB Lung Health Center

Birmingham, Alabama, United States

Vapahcs 111P

Palo Alto, California, United States

Boehringer Ingelheim Investigational Site

San Diego, California, United States

GLAHS Sepulveda

Sepulveda, California, United States

Rehabilitation Clinical Trial Center

Torrance, California, United States

Boehringer Ingelheim Investigational Site

Wheat Ridge, Colorado, United States

Hospital for Special Care

New Britain, Connecticut, United States

Bay Pines VA Medical Center

Bay Pines, Florida, United States

Boehringer Ingelheim Investigational Site

Panama City, Florida, United States

Boehringer Ingelheim Investigational Site

Pembroke Pines, Florida, United States

...and 33 more locations