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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

The purpose of this study is to determine if SYMBICORT® delivered via a pressurized metered-dose inhaler, referred to as a pMDI, is effective in preventing COPD exacerbations.

A comparison of SYMBICORT® pMDI with Formoterol Turbuhaler® in subjects with COPD

Research Site

A Phase IIIB, 12-Month, Double-blind, Double-dummy,Randomised, Parallel-group, Multicentre Exacerbation Study of SYMBICORT® pMDI 160/4.5 μg x 2 Actuations Twice-daily and 80/4.5 μg x 2 Actuations Twice-daily Compared to Formoterol Turbuhaler® 4.5 μg x 2 Inhalations Twice-daily in COPD Subjects

Number of COPD-related exacerbations per patient-treatment year. COPD-related exacerbation was defined as worsening COPD that required a course of oral steriods for treatment and/or hospitalization.

Age Continuous

Gender, Male/Female

Total number of Chronic Obstructive Pulmonary Disease (COPD) exacerbations per patient-treatment year

Change in pre-dose FEV1 from baseline to the average of the randomized treatment
period, as calculated by averaging treatment period FEV1 values and subtracting
the pre-dose value.

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

Change in morning PEF from baseline to the average of the randomized treatment
period, as calculated by averaging treatment period PEF values and subtracting the baseline morning PEF value.

Morning Peak Expiratory Flow (PEF)

Change in evening PEF from baseline to the average of the randomized treatment
period, as calculated by averaging treatment period PEF values and subtracting the baseline evening PEF value.

Evening PEF

Change from baseline of Dyspnea symptoms evaluated using the breathlessness diary, a 5-point Likert-type scale, ranging from 0 to 4 with higher scores indicating a more severe manifestation of the Dyspnea symptom. Change from baseline was calculated by averaging treatment period Dyspnea scores and subtracting the baseline Dyspnea scores.

Dyspnea symptom scores

Change from baseline in the use of beta-2 agonists, as calculated by averaging treatment period inhalations per day and subtracting the baseline number of inhalations per day.

Use of rescue medication

Change from baseline in the SGRQ overall score, as calculated by averaging treatment period SGRQ scores and subtracting the baseline SGRQ scores.  The SGRQ contains 3 domains: Symptoms (distress due to respiratory symptoms, 8 questions), Activity (disturbance of physical activity, 16 questions), and Impacts (overall impact on daily life and well-being, 26 questions).  Lower scores are associated with less severe symptoms.

St. George's Respiratory Questionnaire (SGRQ) score

Rate of exacerbations per subject-year

Overall Study

The study consisted of an initial screening visit (Visit 1) and 2-week run-in enrollment visits (Visits 2 and 3) prior to being randomized to 1 of 3 treatment groups

A comparison of SYMBICORT® pMDI with Formoterol Turbuhaler® in subjects with 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

http://www.copdclinicalresearch.com/

https://filehosting.pharmacm.com/DownloadService.ashx?client=CTR_MED_6111&studyid=395&filename=CSR-D589CC00003.pdf

CSR-D589CC00003.pdf

Trial Results Summaries

Contacts

Contact

Contact Backup

Investigators

Principal Investigator