High Dose Trial in COPD

Boehringer Ingelheim78 enrolled

Overview

The primary objective of this study was to compare the efficacy and safety of 200 μg and 400 μg of BEA 2180 BR to tiotropium 5 μg and placebo when each was delivered by the Respimat® Inhaler once daily for four weeks in patients with COPD.

Study Type

INTERVENTIONAL

Allocation

RANDOMIZED

Purpose

TREATMENT

Masking

DOUBLE

Enrollment

Conditions

Pulmonary Disease, Chronic Obstructive

Interventions

BEA 2180 BRDRUG

tiotropiumDRUG

Eligibility

Sex: ALLMin age: 40 YearsMax age: 84 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 (13)

Boehringer Ingelheim Investigational Site

Lakewood, California, United States

Boehringer Ingelheim Investigational Site

Wheat Ridge, Colorado, United States

Boehringer Ingelheim Investigational Site

Outcomes

Primary Outcomes

Trough forced expiratory volume (FEV1) response

Time frame: baseline to 24 hours post drug administration

forced expiratory volume in one second (FEV1) area under curve 3 to 6 hours (AUC0-6h) after four weeks of treatment.

Time frame: after 4 weeks

Secondary Outcomes

Trough FVC response after 4 weeks

Time frame: after 4 weeks

FEV1 and FVC peak response after 0 and 4 weeks

Time frame: after 0 and 4 weeks

FVC AUC0-6h after 0 and 4 weeks

Time frame: after 0 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: 28 weeks

Data from ClinicalTrials.gov

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