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A Randomised, Parallel-group, Open-label, Multicentre, 3-month Phase IV, Efficacy and Tolerability Study of Budesonide/Formoterol (Symbicort Turbuhaler 160/4.5 microg/Inhalation, 2 Inhalations Twice Daily) Added to Tiotropium (SpirivaTM 18 microg/Inhalation, 1 Inhalation Once Daily) Compared With Tiotropium (SpirivaTM18 microg/Inhalation, 1 Inhalation Once Daily) Alone in Severe Chronic Obstructive Pulmonary Disease (COPD) Patients

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Trial Profile

A Randomised, Parallel-group, Open-label, Multicentre, 3-month Phase IV, Efficacy and Tolerability Study of Budesonide/Formoterol (Symbicort Turbuhaler 160/4.5 microg/Inhalation, 2 Inhalations Twice Daily) Added to Tiotropium (SpirivaTM 18 microg/Inhalation, 1 Inhalation Once Daily) Compared With Tiotropium (SpirivaTM18 microg/Inhalation, 1 Inhalation Once Daily) Alone in Severe Chronic Obstructive Pulmonary Disease (COPD) Patients

Status: Completed
Phase of Trial: Phase IV

Latest Information Update: 29 Sep 2015

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At a glance

  • Drugs Budesonide/formoterol (Primary) ; Tiotropium bromide
  • Indications Chronic obstructive pulmonary disease
  • Focus Therapeutic Use
  • Acronyms SECURE 1
  • Sponsors AstraZeneca

    • Most Recent Events

    • 23 Sep 2015 Results published in the Respirology.
    • 01 Jun 2013 Status changed from active, no longer recruiting to completed as reported by ClinicalTrials.gov.
    • 15 Mar 2013 Planned number of patients changed from 560 to 570 as reported by ClinicalTrials.gov.
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