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Explanation of how the number of participants for analysis was determined. Includes whether analysis was per protocol, intention to treat, or another method. Also provides relevant details such as imputation technique, as appropriate.

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Official Title

Symbicort Turbuhaler® (budesonide/formoterol) 
320/9 mcg, one inhalation twice daily and Spiriva® (tiotropium) 18 mcg, one inhalation once daily

Spiriva® (tiotropium) 18 mcg, one inhalation once daily and placebo Turbuhaler one inhalation once daily

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.

Evaluation of efficacy and safety of Symbicort® as an add-on treatment to Spiriva® in patients with severe COPD.

Symbicort (budesonide/formoterol turbuhaler 320/9ug)

Research Site

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

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)

Age Continuous

Gender, Male/Female

Full analysis set (FAS) was performed and was based on data from all subjects who were randomized, took at least 1 dose of study medication, and contributed sufficient data for calculation of this outcome Measure.

Forced Expiratory Volume in 1 second (FEV1) pre-dose

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)

Forced Expiratory Volume in 1 second (FEV1) 5 min post-dose

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)

Forced Expiratory Volume in 1 second (FEV1) 60 min post-dose

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)

Forced Vital Capacity (FVC) pre-dose

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)

Forced Vital Capacity (FVC) 5 minutes post-dose

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

Forced Vital Capacity (FVC) 60 minutes post-dose

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)

Inspiratory capacity (IC) pre-dose

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)

Inspiratory capacity (IC) 60 minutes post-dose

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.

St George's Respiratory Questionnaire for COPD Patients (SGRQ-C) score

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

Morning Peak Expiratory Flow (PEF) Pre-dose

Evening Peak Expiratory Flow (PEF) pre-dose

Morning Peak Expiratory Flow (PEF) 5 min post-dose

Morning Peak Expiratory Flow (PEF) 15 min post-dose

Morning Diary FEV1 pre-dose

Evening diary FEV1, pre-dose

Morning diary FEV1, 5 minutes post-dose

Morning diary FEV1, 15 minutes post-dose

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.

Global Chest Symptoms Questionnaire (GCSQ) score, pre-dose

GCSQ score, 5 minutes post-dose

GCSQ score, 15 minutes post-dose

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.

Capacity of Day Living in the Morning (CDLM) score

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

Use of rescue medication, night

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

Use of rescue medication, morning

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

Use of rescue medication, day

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

Use of rescue medication, total

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

COPD symptoms, breathing score

COPD symptoms, sleeping score

COPD symptoms, chest score

COPD symptoms, cough score

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

Arms	Assigned Interventions
Active Comparator: Symbicort+TIO Symbicort Turbuhaler® (budesonide/formoterol) 320/9 mcg, one inhalation twice daily and Spiriva® (tiotropium) 18 mcg, one inhalation once daily	Drug: Symbicort (budesonide/formoterol turbuhaler 320/9ug) Symbicort (budesonide/formoterol turbuhaler 320/9ug)
Active Comparator: Spiriva® + Placebo Turbuhaler Spiriva® (tiotropium) 18 mcg, one inhalation once daily and placebo Turbuhaler one inhalation once daily	Drug: Spiriva (tiotropium bromide 18ug) Spiriva (tiotropium bromide 18ug)

Evaluation of efficacy and safety of Symbicort® as an add-on treatment to Spiriva® in patients with severe COPD.

Official Title

Medical condition

Phase

Healthy volunteers

Study drug

Sex

Actual Enrollment

Study type

Age

Date

Study design

Verification:

Sponsors

Collaborators

Inclusion Criteria

Exclusion Criteria

Documents available

https://filehosting.pharmacm.com/DownloadService.ashx?client=CTR_MED_6111&studyid=389&filename=CSR-D5892C00015.pdf

CSR-D5892C00015.pdf

Trial Results Summaries

Contacts

Contact

Contact Backup

Investigators

Principal Investigator