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OpenTrials
Completed

NCT Number: NCT00062582

Effect of Roflumilast on Pulmonary Function and Respiratory Symptoms in Patients With Chronic Obstructive Pulmonary Disease (COPD) (BY217/M2-110)

The aim of the study is to compare the effect of roflumilast and placebo on the lung function in patients with COPD.

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Key information

Conditions

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

Age range

18 year and older

Sex eligibility

All sexes

Study type

Interventional

Phase

Phase 3

Primary location

ALTANA Pharma, Cities in Argentina, Argentina

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Who can participate

Healthy volunteers accepted: No

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

Main Inclusion Criteria:

  • Clinical diagnosis of COPD (Chronic Obstructive Pulmonary Disease)
  • Currently stable COPD with no change in COPD treatment in the prior 4 weeks

Main Exclusion Criteria:

  • Clinical diagnosis of asthma
  • Poorly controlled COPD
  • Regular need for daily oxygen therapy

Treatment and study plan

Roflumilast

Drug

Primary outcomes

  1. pulmonary function.

Secondary outcomes

  1. exacerbation rate

  2. quality of life

  3. symptoms

  4. use of rescue medication

  5. safety and tolerability.

Sponsors and collaborators

Lead sponsor

AstraZeneca

Industry

Registry information

Official study title

A 24 Week, Placebo-Controlled, Randomized, Parallel Group Study Comparing Roflumilast 500 mcg Daily vs Placebo on Pulmonary Function and Respiratory Symptoms in Patients With Chronic Obstructive Pulmonary Disease (COPD)

Important dates

Study start
2003
First posted
Jun 10, 2003
Registry last updated
Nov 23, 2016

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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