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Completed

NCT Number: NCT00128440

High Dose Trial in COPD

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.

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Key information

Conditions

Pulmonary Disease, Chronic Obstructive Chronic Disease Disease Attributes Lung Diseases Lung Diseases, Obstructive Pathologic Processes Pathological Conditions, Signs and Symptoms Respiratory Tract Diseases

Age range

40 year–84 year

Sex eligibility

All sexes

Study type

Interventional

Phase

Phase 2

Primary location

Boehringer Ingelheim Investigational Site, Lakewood, California, United States

Loading trial locations.

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

  • 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).
  • 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.
  • Male or female patients 40 years of age or older.
  • Smoker or ex-smoker with a history of more than 10 pack years.
  • Patients with any other significant disease will be excluded. 2. Patients with a history of asthma or allergic rhinitis will be excluded.

Treatment and study plan

BEA 2180 BR

Drug

Tiotropium

Drug

Primary outcomes

  1. Trough forced expiratory volume (FEV1) response

    Time frame: baseline to 24 hours post drug administration

  2. 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

  1. Trough FVC response after 4 weeks

    Time frame: after 4 weeks

  2. FEV1 and FVC peak response after 0 and 4 weeks

    Time frame: after 0 and 4 weeks

  3. FVC AUC0-6h after 0 and 4 weeks

    Time frame: after 0 and 4 weeks

  4. Individual FEV1 and FVC measurements at each time point

    Time frame: 4 weeks

  5. Weekly mean pre-dose morning and evening PEFR

    Time frame: 4 weeks

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

    Time frame: 4 weeks

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

    Time frame: 4 weeks

  8. Physician's Global Evaluation

    Time frame: 4 weeks

  9. All adverse events

    Time frame: 28 weeks

  10. Pulse rate and blood pressure (seated) recorded in conjunction with spirometry for the first three hours following dosing

    Time frame: 28 weeks

  11. 12-lead ECGs at baseline (-10 minutes) and at 25 minutes, 2 and 6 hours post dose on Day 1 and 29 of each treatment period (Visits 2-9)

    Time frame: 28 weeks

Sponsors and collaborators

Lead sponsor

Boehringer Ingelheim

Industry

Registry information

Official study title

A Randomized, Multiple-dose, Double-Blind, Crossover Study to Compare the Efficacy and Safety of 200 μg and 400 μg of BEA 2180 BR to Tiotropium 5 μg and Placebo When Each is Delivered by the Respimat® Inhaler in Patients With Chronic Obstructive Pulmonary Disease (COPD)

Important dates

Study start
2005
Primary completion
2006
First posted
Aug 10, 2005
Registry last updated
Oct 29, 2013

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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