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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

This study is a multicentre, open, randomised, parallel-group study with formoterol  9 μg one inhalation b.i.d, or standard COPD therapy. Standard (reference) COPD treatment arm should be the group to refer to when safety results of formoterol arm will be evaluated. 240 patients with moderate-to-severe COPD will be randomised (120 patients in the formoterol-arm and 120 patients on standard COPD therapy).

Study to evaluate the safety and efficacy of formoterol in a daily dose of 18 µg (9 µg twice daily) in Japanese chronic obstructive pulmonary disease (COPD) patients

9 μg/dose, Inhaled, twice daily for 52 weeks

Research Site

An open phase III, multi-centre 52-week, parallel-group study evaluating the safety and efficacy of formoterol 18 μg daily dose compared with standard COPD treatment, in Japanese patients with chronic obstructive pulmonary disease (COPD)

Age Continuous

Gender, Male/Female

All randomised subjects who received at least one dose of formoterol or standard COPD
treatment for each treatment group respectively and for whom any safety data after
randomisation were available were included in the safety population.

clinical laboratory test: Haematology -Erythrocytes

clinical laboratory test: Haematology -Haemoglobin

clinical laboratory test: Haematology-Leucocytes

clinical laboratory test: Haematology-Platelet count

Clinical laboratory test: Haematology Eosinophils

clinical laboratory test: Haematology Basophil

Clinical laboratory test: Haematology-Lymphocytes

Clinical laboratory test: Haematology-Monocytes

Clinical laboratory test: Haematology -Neutrophils

Clinical laboratory test: Clinical chemistry- S-Alanine Aminotransferase

Clinical laboratory test: Clinical chemistry-S-Aspartate Aminotransferase

Clinical laboratory test: Clinical chemistry-S-Alkaline Phosphatase (ALP)

Clinical laboratory test: Clinical chemistry-S-Creatinine

Clinical laboratory test: Clinical chemistry-S-Total bilirubin

Clinical laboratory test: Clinical chemistry-S-Sodium

Clinical laboratory test: Clinical chemistry-S-Potassium

Clinical laboratory test: Clinical chemistry-S- Calcium

Clinical laboratory test: Clinical chemistry-S-Albumin

Clinical laboratory test: Clinical chemistry-S-Total protein

Clinical laboratory test: Clinical chemistry - S-Blood Urea Nitrogen (BUN)

Vital signs- Sitting SBP

Vital signs- Sitting DBP

Vital signs - Pulse Rate

ECG variables - Heart rate

ECG variables - QT interval

ECG variables - QTcB interval

ECG variables QTcF interval

ECG variables RR interval

The ratio of the average value of available data for mean from Weeks 0, 4, 8, 17, 26, 34, 43 and 52 to the baseline for each treatment group

All randomised subjects who received at least one dose of formoterol or standard COPD
treatment for each treatment group respectively and for whom any efficacy data after
randomisation were available were included in the efficacy population (Full Analysis Set:
FAS).

Forced Expiratory Volume in one second (FEV1)

The ratio of the average value of available data for Weeks 0, 4, 8, 17, 26, 34, 43 and 52 to the baseline for each treatment group

Forced Vital Capacity (FVC)

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

Morning Peak Expiratory Flow(PEF)

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

Evening Peak Expiratory Flow (PEF)

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

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

Daytime breathlessness due to Chronic Obstructive Pulmonary Disease (COPD) symptoms

Daytime 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

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 52-week randomization treatment was presented here.

Number of COPD exacerbations over the treatment period

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

Use of SABA (salbutamol) as reliever medication

SGRQ total score shows the impact of COPD on patient's health status, and expressed as a percentage of impairment with scale from 0 (best health status) to 100 (worst possible status). A negative rate of decline shows decreasing SGRQ total score (or improved health) over time, while a positive value shows increasing score (or worsen health). The change from Run-in period average to Treatment period average for each treatment group

St George’s Respiratory Questionnaire (SGRQ) total score

Overall Study

The study started with an enrolment visit, Visit 1, 1 week prior to Visit 2, and 1 week run-in period before randomization. At Visit 2 participants had to have pre-bronchodilatory forced expiratory volume in one second (FEV1) less than  80 percent of the predicted normal value.

Study to evaluate the safety and efficacy of formoterol in a daily dose of 18 µg (9 µg twice daily) in Japanese chronic obstructive pulmonary disease (COPD) patients

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=370&filename=CSR-D5122C00002.pdf

CSR-D5122C00002.pdf

Trial Results Summaries

Contacts

Contact