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Completed

NCT Number: NCT01397890

Efficacy and Tolerability of Symbicort as an add-on Treatment to Spiriva Compare With Spiriva Alone in Patients With Severe Chronic Obstructive Pulmonary Disease (COPD)

This is a multicentre study with a randomised, parallel group, open-label, 3-month phase IV design to assess the efficacy and tolerability of Symbicort as an add-on treatment to Spiriva compare with Spiriva alone in patients with severe chronic obstructive pulmonary disease (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

40 year and older

Sex eligibility

All sexes

Study type

Interventional

Phase

Phase 4

Primary location

Research Site, Beijing, Beijing Municipality, China

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Who can participate

Healthy volunteers accepted: No

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

Inclusion criteria

  • Signed and dated informed consent
  • Men or women patients ≥40 years of age
  • Diagnosis of COPD with symptoms for more than 2 years and there is a history of at least one COPD exacerbation requiring a course of oral steroids and/or antibiotics within 1-12 months before Visit 2
  • Forced Expiratory Volume in 1 second (FEV1) ≤50% of predicted normal value, pre-bronchodilator and Forced Expiratory Volume in 1 second (FEV1) / Forced Vital Capacity (FVC) < 70%, pre-bronchodilator
  • Total symptom score of 2 or more per day for at least half of run-in period (breathing, cough and sputum scores from the diary card) and complete morning recordings of Digital Peak Flow Meter data at least 7 out of the last 10 days of the run-in period

Exclusion criteria

  • A history of asthma and seasonal allergic rhinitis before 40 years of age
  • Patients who have experienced exacerbation of COPD requiring hospitalisation and /or emergency room treatment and/or a course of oral steroids and/or intravenous corticosteroids and/or antibiotics within 4 weeks prior to Visit 2 and/or during run-in period and also the patients who use of systemic glucocorticosteroids (GCS) within 4 weeks and/or inhaled GCS within 2 weeks prior to Visit 2 and/or during run-in period
  • Patients with relevant cardiovascular disorder judged by the investigator
  • Patients with glaucoma, prostatic hyperplasia or bladder-neck obstruction judged by the investigator
  • Women who are pregnant, breast-feeding or of child-bearing potential judged by the investigator

Treatment and study plan

Budesonide/formoterol (Symbicort® Turbuhaler®)

Drug

Budesonide/formoterol (Symbicort® Turbuhaler®) 160/4.5μg/inhalation, 2 inhalations twice daily

Tiotropium (SpirivaTM)

Drug

Tiotropium (SpirivaTM) 18 μg/inhalation, 1 inhalation once daily

Primary outcomes

  1. Pre-dose FEV1

    Time frame: Baseline (week 0) and mean in treatment period (weeks 1, 6, 12) measured before inhalation of study drug

    Ratio of pre-dose FEV1 (Forced Expiratory Volume in 1 second) in treatment period to baseline value

Secondary outcomes

  1. Post-dose FEV1 at 5 Minutes

    Time frame: Baseline (-2 weeks) and mean in treatment period (1, 6, 12 weeks) measured at 5 minutes after inhalation of study drug

    Ratio of post-dose FEV1 at 5 minutes to baseline value

  2. Post-dose FEV1 at 60 Minutes

    Time frame: Baseline (measured before inhalation of study drug at week 0) and mean in treatment period (measured at 1 hour after inhalation of study drug at weeks 0, 1, 6, 12)

    Ratio of post-dose FEV1 at 60 minutes to baseline value

  3. Pre-dose FVC

    Time frame: Baseline (measured before inhalation of study drug at week 0) and mean in treatment period (measured at 1 hour after inhalation of study drug at weeks 0, 1, 6, 12)

    Ratio of pre-dose FVC (Forced Vital Capacity) in treatment period to baseline value

  4. Post-dose FVC at 5 Minutes

    Time frame: Baseline (measured before inhalation of study drug at week 0) and mean in treatment period (measured at 5 minutes after inhalation of study drug at weeks 0, 1, 6, 12)

    Ratio of post-dose FVC at 5 minutes to baseline value

  5. Post-dose FVC at 60 Minutes

    Time frame: Baseline (measured before inhalation of study drug at week 0) and mean in treatment period (measured at 1 hour after inhalation of study drug at weeks 0, 1, 6, 12)

    Ratio of post-dose FVC at 60 minutes to baseline value

  6. Pre-dose IC

    Time frame: Baseline (week 0) and mean in treatment period (weeks 1, 6, 12) measured before inhalation of study drug

    Ratio of pre-dose IC (Inspiratory Capacity) in treatment period to baseline value

  7. Post-dose IC at 60 Minutes

    Time frame: Baseline (measured before inhalation of study drug at week 0) and mean in treatment period (measured at 1 hour after inhalation of study drug at weeks 0, 1, 6, 12)

    Ratio of post-dose IC at 60 minutes to baseline value

  8. Pre-dose PEF in Last Week of Treatment

    Time frame: Mean of daily measurements in run-in period (the last 10 days before randomization) and mean of daily measurements measured before inhalation of study drug in the last week of treatment, up to 12 weeks

    Change in pre-dose morning PEF (Peak Expiratory Flow) from run-in period to last week of treatment

  9. Pre-dose PEF in First Week of Treatment

    Time frame: Mean of daily measurements in run-in period (the last 10 days before randomization) and mean of daily measurements measured before inhalation of study drug in the first week of treatment

    Change in pre-dose morning PEF (Peak Expiratory Flow) from run-in period to first week of treatment

  10. Pre-dose PEF in Whole Treatment Period

    Time frame: Mean of daily measurements in run-in period (the last 10 days before randomization) and mean of daily measurements measured before inhalation of study drug in whole treatment period of 12 weeks

    Change in pre-dose morning PEF from run-in period to whole treatment period

  11. Post-dose PEF in Last Week of Treatment

    Time frame: Mean of daily measurements in run-in period (the last 10 days before randomization) and mean of daily measurements measured at 5 minutes after inhalation of study drug in the last week of treatment, up to 12 weeks

    Change in post-dose morning PEF at 5 minutes from run-period to last week of treatment

  12. Post-dose PEF in First Week of Treatment

    Time frame: Mean of daily measurements in run-in period (the last 10 days before randomization) and mean of daily measurements measured at 5 minutes after inhalation of study drug in the first week of treatment

    Change in post-dose morning PEF at 5 minutes from run-in period to first week of treatment

  13. Post-dose PEF in Whole Treatment Period

    Time frame: Mean of daily measurements in run-in period (the last 10 days before randomization) and mean of daily measurements measured at 5 minutes after inhalation of study drug in whole treatment period of 12 weeks

    Change in post-dose morning PEF at 5 minutes from run-period to whole treatment period

  14. Use of Reliever Medication During Day in the Last Week on Treatment

    Time frame: Mean of daily measurements in run-in period (the last 10 days before randomization) and mean of daily measurements measured during day in the last week on treatment, up to 12 weeks

    Change in the number of inhalations of reliever medication during day from run-in period to the last week on treatment

  15. Use of Reliever Medication During Day in the First Week on Treatment

    Time frame: Mean of daily measurements in run-in period (the last 10 days before randomization) and mean of daily measurements measured during day in the first week on treatment

    Change in the number of inhalations of reliever medication during day from run-in period to the first week on treatment

  16. Use of Reliever Medication During Day in the Whole Treatment Period

    Time frame: Mean of daily measurements in run-in period (the last 10 days before randomization) and mean of daily measurements measured during day in the whole treatment period of 12 weeks

    Change in the number of inhalations of reliever medication during day from run-in period to the whole treatment period

  17. Use of Reliever Medication During Night in the Last Week on Treatment

    Time frame: Mean of daily measurements in run-in period (the last 10 days before randomization) and mean of daily measurements measured during day in the last week on treatment, up to 12 weeks

    Change in the number of inhalations of reliever medication during night from run-in period to the last week on treatment

  18. Use of Reliever Medication During Night in the First Week on Treatment

    Time frame: Mean of daily measurements in run-in period (the last 10 days before randomization) and mean of daily measurements measured during night in the first week on treatment

    Change in the number of inhalations of reliever medication during day from run-in period to the first week on treatment

  19. Use of Reliever Medication During Night in the Whole Treatment Period

    Time frame: Mean of daily measurements in run-in period (the last 10 days before randomization) and mean of daily measurements measured during day in the whole treatment period of 12 weeks

    Change in the number of inhalations of reliever medication during night from run-in period to the whole treatment period

  20. Change in COPD Symptoms - Breathing

    Time frame: Mean of daily measurements in run-in period (the last 10 days before randomization) and mean of daily measurements in the whole treatment period of 12 weeks

    Change in breathing symptom score (from 0:none to 4:severe) from run-in period

  21. Change in COPD Symptoms - Cough

    Time frame: Mean of daily measurements in run-in period (the last 10 days before randomization) and mean of daily measurements in the whole treatment period of 12 weeks

    Change in Cough symptom score (from 0:none to 4:severe) from run-in period

  22. Change in COPD Symptoms - Sputum

    Time frame: Mean of daily measurements in run-in period (the last 10 days before randomization) and mean of daily measurements in the whole treatment period of 12 weeks

    Change in Sputum symptom score (from 0:none to 4:severe) from run-in period

  23. COPD Exacerbations

    Time frame: Whole treatment period of 12 weeks

    Severe exacerbations requiring systemic steroids (oral ≥3 days or parenteral) or hospitalisation or emergency room treatment due to worsening of COPD symptoms

Sponsors and collaborators

Lead sponsor

AstraZeneca

Industry

Registry information

Official study title

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

Acronym: SECURE 1

Important dates

Study start
2011
Primary completion
2013
Study completion
2013
First posted
Jul 20, 2011
Registry last updated
Mar 27, 2015

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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