Phase 3
Completed N=251
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
Source: ClinicalTrials.gov NCT01047553 ↗Enrolled (actual)
251
Serious AEs
15.1%
Results posted
Jan 2013
Primary outcomePrimary: Clinical Laboratory Test: Haematology -Erythrocytes — -6.25; -5.2 erythrocytes counts x10000/μl
Summary
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).
Outcome Measures
| Outcome | Result | p-value |
|---|---|---|
| PRIMARY Clinical Laboratory Test: Haematology -Erythrocytes |
-6.25; -5.2 | — |
| PRIMARY Clinical Laboratory Test: Haematology -Haemoglobin |
-0.29; -0.20 | — |
| PRIMARY Clinical Laboratory Test: Haematology-Leucocytes |
-132.1; -289.5 | — |
| PRIMARY Clinical Laboratory Test: Haematology-Platelet Count |
0.17; -0.40 | — |
| PRIMARY Clinical Laboratory Test: Haematology Eosinophils |
0.49; 0.45 | — |
| PRIMARY Clinical Laboratory Test: Haematology Basophil |
0.05; 0.01 | — |
| PRIMARY Clinical Laboratory Test: Haematology-Lymphocytes |
-1.31; -0.43 | — |
| PRIMARY Clinical Laboratory Test: Haematology-Monocytes |
-0.01; -0.03 | — |
| PRIMARY Clinical Laboratory Test: Haematology -Neutrophils |
1.92; -0.28 | — |
| PRIMARY Clinical Laboratory Test: Clinical Chemistry- S-Alanine Aminotransferase |
-0.3; 4.9 | — |
| PRIMARY Clinical Laboratory Test: Clinical Chemistry-S-Aspartate Aminotransferase |
0.4; 2.6 | — |
| PRIMARY Clinical Laboratory Test: Clinical Chemistry-S-Alkaline Phosphatase (ALP) |
3.8; -4.4 | — |
| PRIMARY Clinical Laboratory Test: Clinical Chemistry-S-Creatinine |
0.009; 0.021 | — |
| PRIMARY Clinical Laboratory Test: Clinical Chemistry-S-Total Bilirubin |
0.05; 0.02 | — |
| PRIMARY Clinical Laboratory Test: Clinical Chemistry-S-Sodium |
-0.3; -0.2 | — |
| PRIMARY Clinical Laboratory Test: Clinical Chemistry-S-Potassium |
-0.15; -0.07 | — |
| PRIMARY Clinical Laboratory Test: Clinical Chemistry-S- Calcium |
-0.02; -0.03 | — |
| PRIMARY Clinical Laboratory Test: Clinical Chemistry-S-Albumin |
0.00; 0.00 | — |
| PRIMARY Clinical Laboratory Test: Clinical Chemistry-S-Total Protein |
-0.05; -0.09 | — |
| PRIMARY Clinical Laboratory Test: Clinical Chemistry - S-Blood Urea Nitrogen (BUN) |
-0.48; 0.07 | — |
| PRIMARY Vital Signs- Sitting SBP |
-2.1; -2.1 | — |
| PRIMARY Vital Signs- Sitting DBP |
-2.7; -3.5 | — |
| PRIMARY Vital Signs - Pulse Rate |
1.5; -0.1 | — |
| PRIMARY ECG Variables - Heart Rate |
2.0; 0.6 | — |
| PRIMARY ECG Variables - QT Interval |
-2.0; 2.6 | — |
| PRIMARY ECG Variables - QTcB Interval |
2.1; 1.2 | — |
| PRIMARY ECG Variables QTcF Interval |
0.5; 1.7 | — |
| PRIMARY ECG Variables RR Interval |
-12.1; 131.7 | — |
| SECONDARY Forced Expiratory Volume in One Second (FEV1) |
101.46; 99.42 | — |
| SECONDARY Forced Vital Capacity (FVC) |
101.62; 99.13 | — |
| SECONDARY Morning Peak Expiratory Flow(PEF) |
12.2; 7.3 | — |
| SECONDARY Evening Peak Expiratory Flow (PEF) |
9.6; 7.9 | — |
| SECONDARY Night-time Awakening Due to Chronic Obstructive Pulmonary Disease (COPD) Symptoms |
0.0; -0.1 | — |
| SECONDARY Daytime Breathlessness Due to Chronic Obstructive Pulmonary Disease (COPD) Symptoms |
-0.2; -0.2 | — |
| SECONDARY Daytime Cough Due to Chronic Obstructive Pulmonary Disease (COPD) Symptoms |
-0.2; -0.1 | — |
| SECONDARY Total Chronic Obstructive Pulmonary Disease (COPD) Symptom Score |
-0.5; -0.4 | — |
| SECONDARY Number of COPD Exacerbations Over the Treatment Period |
27; 19 | — |
| SECONDARY Use of SABA (Salbutamol) as Reliever Medication |
-0.2; 0.0 | — |
| SECONDARY St George's Respiratory Questionnaire (SGRQ) Total Score |
-1.34; -0.57 | — |
Eligibility Criteria
Inclusion Criteria
- Outpatients, men or women ≥ 40 years
- A clinical diagnosis of COPD according to guidelines, and current COPD symptoms.
- Post-bronchodilator FEV1 < 80% of predicted normal value and FEV1/FVC < 70%, post-bronchodilator
Exclusion Criteria
- A history and/or current clinical diagnosis of asthma and atopic diseases such as Allergic rhinitis
- Patients who have experienced COPD exacerbation requiring at least one of the following treatment, hospitalisation and/or a course of systemic steroid within 4 weeks prior to the study start.
- Significant or unstable ischaemic heart disease, arrhythmia, cardiomyopathy, heart failure, uncontrolled hypertension as defined by the investigator, or any other relevant cardiovascular disorder as judged by the investigator
Data sourced from ClinicalTrials.gov (NCT01047553). Outcome figures and adverse-event rates are extracted automatically from the registry's posted results and are provided for clinician reference, not as a substitute for the primary publication. Informational only — not medical advice.