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OpenTrials
Completed

NCT Number: NCT00206154

A Comparison of Symbicort® pMDI 2 x 160/4.5 μg Bid and Symbicort® pMDI 2 x 80/4.5 μg Bid With Formoterol Turbuhaler®, Budesonide pMDI, the Combination of Formoterol Turbuhaler® and Budesonide pMDI, and Placebo in COPD Patients

The purpose of this study is to compare a combination asthma drug (Symbicort) with its two components, budesonide and formoterol, taken individually or in combination, and with placebo in the long-term maintenance treatment of patients with chronic obstructive pulmonary disease (COPD)

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Key information

Conditions

Chronic Obstructive Pulmonary Disease 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

40 year and older

Sex eligibility

All sexes

Study type

Interventional

Phase

Phase 3

Primary location

Research Site, Prague, CZ, Czechia

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Who can participate

Healthy volunteers accepted: No

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

Inclusion criteria

  • A clinical diagnosis of COPD with symptoms for more than 2 years
  • Smoking history of 10 or more pack years
  • A history of at least one COPD exacerbation requiring a course of oral steroids and/or antibiotics within 1-12 months before first visit.

Exclusion criteria

  • A history of asthma
  • Patients taking oral steroids.
  • Any significant disease or disorder that may jeopardize the safety of the patient

Treatment and study plan

Budesonide/formoterol pMDI

Drug

Budesonide pMDI

Drug

formoterol Turbuhaler

Drug

Primary outcomes

  1. Pre-dose and 1-hour post-dose FEV1 over the 6 months treatment period

Secondary outcomes

  1. Patient-reported outcome variables regarding disease status (incl. PEF), collected via questionnaires and diaries

  2. Health care utilization

  3. Pharmacokinetics (subgroup)

  4. Safety variables, including adverse events, vital signs, ECG, physical examination, hematology, and clinical chemistry.

  5. - all variables assessed over the 6 months treatment period

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Sponsors and collaborators

Lead sponsor

AstraZeneca

Industry

Registry information

Official study title

A 6-Month Double-Blind, Double-Dummy, Randomized, Parallel Group, Multicenter Efficacy & Safety Study of SYMBICORT® pMDI 2 x 160/4.5 µg & 80/4.5 µg Bid Compared to Formoterol TBH, Budesonide pMDI (& the Combination) & Placebo in COPD Patients

Important dates

Study start
2005
Study completion
2006
First posted
Sep 21, 2005
Registry last updated
Mar 27, 2009

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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