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OpenTrials
Completed

NCT Number: NCT00496470

Evaluation of Efficacy and Safety of Symbicort® as an add-on Treatment to Spiriva® in Patients With Severe COPD.

The purpose of this study is to investigate the effect of combined treatment with Symbicort and Spiriva, in terms of improvement of lung function, symptoms and inflammatory markers, in patients with severe 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, Concord, New South Wales, Australia

Loading trial locations.

Who can participate

Healthy volunteers accepted: No

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

Inclusion criteria

  • >=40 years of age, diagnosed COPD with symptoms >=2 years, pre-bronchodilatory FEV1 <=50% of PN

Exclusion criteria

  • Current respiratory tract disorder other than COPD, history of asthma or rhinitis, significant or unstable cardiovascular disorder

Treatment and study plan

Symbicort (budesonide/formoterol turbuhaler 320/9ug)

Drug

Symbicort (budesonide/formoterol turbuhaler 320/9ug)

Spiriva (tiotropium bromide 18ug)

Drug

Spiriva (tiotropium bromide 18ug)

Primary outcomes

  1. Forced Expiratory Volume in 1 Second (FEV1) Pre-dose

    Time frame: Baseline to 12 weeks

    Change in the pre-dose FEV1from baseline to week 12 (calculated as a mean using all available data of treatment period between week 1 and week 12)

Secondary outcomes

  1. Forced Expiratory Volume in 1 Second (FEV1) 5 Min Post-dose

    Time frame: Baseline to 12 weeks

    Change in the 5 min post-dose FEV1from baseline to week 12 (calculated as a mean using all available data of treatment period between week 1 and week 12)

  2. Forced Expiratory Volume in 1 Second (FEV1) 60 Min Post-dose

    Time frame: Baseline to 12 weeks

    Change in the 60 min post-dose FEV1from baseline to week 12 (calculated as a mean using all available data of treatment period between week 1 and week 12)

  3. Forced Vital Capacity (FVC) Pre-dose

    Time frame: Baseline to 12 weeks

    Change in the pre-dose FVC from baseline to week 12 (calculated as a mean using all available data of treatment period between week 1 and week 12)

  4. Forced Vital Capacity (FVC) 5 Minutes Post-dose

    Time frame: Baseline to 12 weeks

    Change in the 5 min post-dose FVC from baseline to week 12 (calculated as a mean using all available data of treatment period between week 1 and week 12)

  5. Forced Vital Capacity (FVC) 60 Minutes Post-dose

    Time frame: Baseline to 12 weeks

    Change in the 60 min post-dose FVC from baseline to week 12 (calculated as a mean using all available data of treatment period between week 1 and week 12

  6. Inspiratory Capacity (IC) Pre-dose

    Time frame: Baseline to 12 weeks

    Change in the pre-dose IC from baseline to week 12 (calculated as a mean using all available data of treatment period between week 1 and week 12)

  7. Inspiratory Capacity (IC) 60 Minutes Post-dose

    Time frame: Baseline to 12 weeks

    Change in the 60 min post-dose IC from baseline to week 12 (calculated as a mean using all available data of treatment period between week 1 and week 12)

  8. St George's Respiratory Questionnaire for COPD Patients (SGRQ-C) Score

    Time frame: Baseline and 12 weeks

    Change in total score from baseline (Visit 3) to end of treatment (Visit 6, or last available visit).

    SGRQ-C is a health related quality of life questionnaire consisting of 40 items divided into two components: 1) symptoms, 2) activity& impacts. The lowest possible value is zero and the highest 100. Higher values correspond to greater impairment in quality of life.

  9. Morning Peak Expiratory Flow (PEF) Pre-dose

    Time frame: Baseline to 12 weeks

    Daily diary record. Change in average values from run-in to the full treatment period

  10. Evening Peak Expiratory Flow (PEF) Pre-dose

    Time frame: Baseline to 12 weeks

    Daily diary record. Change in average values from run-in to the full treatment period

  11. Morning Peak Expiratory Flow (PEF) 5 Min Post-dose

    Time frame: Baseline to 12 weeks

    Daily diary record. Change in average values from run-in to the full treatment period

  12. Morning Peak Expiratory Flow (PEF) 15 Min Post-dose

    Time frame: Baseline to 12 weeks

    Daily diary record. Change in average values from run-in to the full treatment period

  13. Morning Diary FEV1 Pre-dose

    Time frame: Baseline to 12 weeks

    Daily diary record. Change in average values from run-in to the full treatment period

  14. Evening Diary FEV1, Pre-dose

    Time frame: Baseline to 12 weeks

    Daily diary record. Change in average values from run-in to the full treatment period

  15. Morning Diary FEV1, 5 Minutes Post-dose

    Time frame: Baseline to 12 weeks

    Daily diary record. Change in average values from run-in to the full treatment period

  16. Morning Diary FEV1, 15 Minutes Post-dose

    Time frame: Baseline to 12 weeks

    Daily diary record. Change in average values from run-in to the full treatment period

  17. Global Chest Symptoms Questionnaire (GCSQ) Score, Pre-dose

    Time frame: Baseline to 12 weeks

    Daily diary record. Change in average values from run-in to the full treatment period.

    The GCSQ consisted of two questions that required the patient to rate shortness of breath and feelings of chest tightness. The patients recorded their response on a five-point Likert-type scale ranging from 0 (not at all) to 4 (extremely), the total score being calculated as the average score of the two questions.

  18. GCSQ Score, 5 Minutes Post-dose

    Time frame: Baseline to 12 weeks

    Daily diary record. Change in average values from run-in to the full treatment period.

    The GCSQ consisted of two questions that required the patient to rate shortness of breath and feelings of chest tightness. The patients recorded their response on a five-point Likert-type scale ranging from 0 (not at all) to 4 (extremely), the total score being calculated as the average score of the two questions.

  19. GCSQ Score, 15 Minutes Post-dose

    Time frame: Baseline to 12 weeks

    Daily diary record. Change in average values from run-in to the full treatment period.

    The GCSQ consisted of two questions that required the patient to rate shortness of breath and feelings of chest tightness. The patients recorded their response on a five-point Likert-type scale ranging from 0 (not at all) to 4 (extremely), the total score being calculated as the average score of the two questions.

  20. Capacity of Day Living in the Morning (CDLM) Score

    Time frame: Baseline to 12 weeks

    Daily diary record. Change in average values from run-in to the full treatment period.

    The CDLM questionnaire is as a questionnaire to report on patient's ability to carry out each of six different morning activities (score ranging from 0 "not performed" to 1"performed") and rank the difficulty of performing each of those activities (score ranging from 0 "so difficult that the activity could not be carried out by the patient on their own" to 5 "activity was not at all difficult to carry out". Total score for each morning activity range from 0-6. Total score for whole CDLM questionnaire range from 0-36.

  21. Use of Rescue Medication, Night

    Time frame: Baseline to 12 weeks

    Daily diary record - Night, after evening measurement till morning. Change in average values from run-in to the full treatment period

  22. Use of Rescue Medication, Morning

    Time frame: Baseline to 12 weeks

    Daily diary record - Morning, after morning measurement till midday. Change in average values from run-in to the full treatment period

  23. Use of Rescue Medication, Day

    Time frame: Baseline to 12 weeks

    Daily diary record - Day, after morning measurement till evening. Change in average values from run-in to the full treatment period

  24. Use of Rescue Medication, Total

    Time frame: Baseline to 12 weeks

    Daily diary record - Total, 24 hours, during the night, and during the day. Change in average values from run-in to the full treatment period

  25. COPD Symptoms, Breathing Score

    Time frame: Baseline to 12 weeks

    Daily diary record. Change in average values from run-in to the full treatment period. Symptom scale 0 - 4 (0) None (1) Mild (2) Moderate (3) Marked (4) Severe

  26. COPD Symptoms, Sleeping Score

    Time frame: Baseline to 12 weeks

    Daily diary record. Change in average values from run-in to the full treatment period. Symptom scale 0 - 4 (0) None (1) Mild (2) Moderate (3) Marked (4) Severe

  27. COPD Symptoms, Chest Score

    Time frame: Baseline to 12 weeks

    Daily diary record. Change in average values from run-in to the full treatment period. Symptom scale 0 - 4 (0) None (1) Mild (2) Moderate (3) Marked (4) Severe

  28. COPD Symptoms, Cough Score

    Time frame: Baseline to 12 weeks

    Daily diary record. Change in average values from run-in to the full treatment period. Symptom scale 0 - 4 (0) None (1) Mild (2) Moderate (3) Marked (4) Severe

  29. Severe COPD Exacerbations

    Time frame: 12 weeks

    Patients with worsening of COPD leading to treatment with systemic steroids (oral or parenteral), emergency room treatment or hospitalisation

  30. Serum High-sensitivity C-reactive Protein (hsCRP)

    Time frame: Baseline to 12 weeks

    Ratio of treatment period mean to run-in value

  31. Serum Interleukin 6 (IL-6)

    Time frame: Baseline to 12 weeks

    Ratio of treatment period mean to run-in value

  32. Serum Interleukin 8 (IL-8)

    Time frame: Baseline to 12 weeks

    Ratio of treatment period mean to run-in value

  33. Serum Monocyte Chemoattractant Protein-1 (MCP-1)

    Time frame: Baseline to 12 weeks

    Ratio of treatment period mean to run-in value

  34. Serum Soluble Tumor Necrosis Factor-alpha (sTNF-alpha)

    Time frame: Baseline to 12 weeks

    Ratio of treatment period mean to run-in value

  35. Serum Tumor Necrosis Factor-alpha (TNF-alpha)

    Time frame: Baseline to 12 weeks

    Ratio of treatment period mean to run-in value

  36. Serum Vascular Cell Adhesion Molecule-1 (VCAM-1)

    Time frame: Baseline to 12 weeks

    Ratio of treatment period mean to run-in value

Sponsors and collaborators

Lead sponsor

AstraZeneca

Industry

Registry information

Official study title

A 12-week, Double-blind, Randomised, Parallel Group, Multi-centre, Study to Evaluate Efficacy and Safety of Budesonide/Formoterol (Symbicort Turbuhaler®) 320/9 µg One Inhalation Twice Daily on Top of Tiotropium (Spiriva®) 18 µg One Inhalation Once Daily

Important dates

Study start
2007
Primary completion
2008
Study completion
2008
First posted
Jul 4, 2007
Registry last updated
Nov 9, 2012

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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