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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 160/4.5 microgram, 2 inhalations twice daily

Oxis Turbuhaler 4.5 microgram, 2 inhalations twice daily

The primary purpose of the study is to investigate if Symbicort is more effective than Oxis in increasing forced expiratory volume in one second (FEV1), measured at the clinics, in patients with COPD.

Efficacy and safety study of Symbicort® Turbuhaler® versus Oxis® Turbuhaler®  in Chronic Obstructive Pulmonary Disease (COPD) patients

2x160/4.5 microgram, inhalation, twice daily, 12 weeks

2 X 4.5 microgram, inhalation, twice daily, 12 weeks

Research Site

A phase III, 12-week, double-blind, randomised, parallel-group, active-controlled, multinational, efficacy and safety study of Symbicort® Turbuhaler® 160/4.5 μg 2 inhalations twice daily (bid) compared to Oxis® Turbuhaler®  4.5 μg 2 inhalations twice daily (bid) in patients with chronic obstructive pulmonary disease

The ratio, expressed as percentage, of the geometric mean of available data for Weeks 0, 4, 8 and 12 to the baseline for each treatment group

Age Continuous

Gender, Male/Female

The analysis set for efficacy was based on the Full Analysis Set (FAS). Available data represent patients who had both baseline and on treatment data which is required to be included in the analysis.

Pre-dose Forced Expiratory Volume in one second (FEV1)

1 hour post dose Forced Expiratory Volume in one second (FEV1)

Pre-dose Forced Vital Capacity (FVC)

The analysis set for efficacy was based on the Full Analysis Set (FAS. Available data represent patients who had both baseline and on treatment data which is required to be included in the analysis.

1 hour post-dose Forced Vital Capacity (FVC)

A Chronic Obstructive Pulmonary Disease (COPD) exacerbation was defined as worsening in COPD symptoms requiring treatment with either a course of systemic steroid or hospitalisation. The percentage of participants who had experienced COPD exacerbation at the end of the study for each treatment group.

The analysis set for efficacy was based on the Full Analysis Set (FAS).Available data represent patients who had both baseline and on treatment data which is required to be included in the analysis.

Percentage of participants with exacerbations

A Chronic Obstructive Pulmonary Disease (COPD) exacerbation was defined as worsening in COPD symptoms requiring treatment with either a course of systemic steroid or hospitalisation. Number of COPD exacerbation during 12-week randomization treatment

Number of Chronic Obstructive Pulmonary Disease (COPD) exacerbation

The change from Run-in period average to Treatment period average for each treatment group

Morning Peak Expiratory Flow(PEF)

Evening Peak Expiratory Flow (PEF)

Total number of days with COPD exacerbation for each treatment group

Total number of day with exacerbation

Morning Forced Expiratory Volume in one second (FEV1)

Evening Forced Expiratory Volume in one second (FEV1)

Scored 0 to 1 (0 = no awakening and 1 = awakening). The change from Run-in period average to Treatment period average for each treatment group

Night-time awakening due to Chronic Obstructive Pulmonary Disease (COPD) symptoms

There are 5 alternatives (scored 0 to 4, with 4 being the most severe condition). The change from Run-in period average to Treatment period average for each treatment group

Breathlessness due to Chronic Obstructive Pulmonary Disease (COPD) symptoms

Cough due to Chronic Obstructive Pulmonary Disease (COPD) symptoms

The Total COPD Symptom score is the sum of the measures night-time
awakening, breathlessness and cough, ranges from 0 to 12 with 12 being the most severe. The change from Run-in period average to Treatment period average for each treatment group.

Total Chronic Obstructive Pulmonary Disease (COPD) symptom score

The change from Run-in period average to Treatment period average for each treatment group.

Use of rescue medication

The change from Run-in period average to Treatment period average for each treatment group. The SGRQ ranges from 0 (no impairment of quality of life) to 100 (highest impairment of quality of life).

St George’s Respiratory Questionnaire (SGRQ) total score

Overall Study

The study started with an enrolment visit, Visit 1, 0 to 4 weeks prior to Visit 2, and 1-2 week run-in period before randomization. At Visit 2 participants had to have pre-bronchodilatory forced expiratory volume in one second (FEV1) less than or equal to 50 percent of the predicted normal value.

Arms	Assigned Interventions
Experimental: 1 Symbicort Turbuhaler 160/4.5 microgram, 2 inhalations twice daily	Drug: Budesonide/formoterol (Symbicort Turbuhaler) 2x160/4.5 microgram, inhalation, twice daily, 12 weeks Other Name: Symbicort Turbuhaler
Active Comparator: 2 Oxis Turbuhaler 4.5 microgram, 2 inhalations twice daily	Drug: Formoterol (Oxis Turbuhaler) 2 X 4.5 microgram, inhalation, twice daily, 12 weeks Other Name: Oxis Turbuhaler

Efficacy and safety study of Symbicort® Turbuhaler® versus Oxis® Turbuhaler® in Chronic Obstructive Pulmonary Disease (COPD) patients - SUMIRE

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=396&filename=CSR-D589DC00007.pdf

CSR-D589DC00007.pdf

Trial Results Summaries

Contacts

Contact

Investigators

Principal Investigator