Trial Outcomes & Findings for Long-term Use of Spiolto Respimat in Japanese Patients With Chronic Obstructive Pulmonary Disease (NCT NCT02850978)
NCT ID: NCT02850978
Last Updated: 2019-12-06
Results Overview
Percentage of participants with adverse drug reactions (ADR). An adverse drug reaction (ADR) is defined as an adverse event (AE) for which either the investigator or the sponsor (or both) assess the causal relationship to Spiolto® Respimat® as "Yes".
Recruitment status
COMPLETED
Target enrollment
1335 participants
Primary outcome timeframe
From the first drug administration until 21 days after the last drug administration, up to approximately 82 weeks.
Results posted on
2019-12-06
Participant Flow
This was an observational study based on newly collected data under real-world practice in participants diagnosed with chronic obstructive pulmonary disease (COPD) (chronic bronchitis, emphysema) in Japan.
This non-randomized, post marketing surveillance (PMS) was a prospective study using a continuous investigation system. No specific criteria (e.g. demographic, baseline, concomitant drug in use) were defined for participant enrollment. Participants were enrolled from August 2016 to August 2017.
Participant milestones
| Measure |
Spiolto®
Participants suffering from COPD were treated with a Fixed Dose Combination (FDC) of Tiotropium (Tio) 5 microgram (μg)/ + Olodaterol (Olo) 5 μg; solution for oral inhalation via Respimat® inhaler once daily, for 52 weeks or until discontinuation of administration.
|
|---|---|
|
Overall Study
STARTED
|
1335
|
|
Overall Study
Case Report Form (CRF) Collected
|
1308
|
|
Overall Study
Treated
|
1308
|
|
Overall Study
COMPLETED
|
909
|
|
Overall Study
NOT COMPLETED
|
426
|
Reasons for withdrawal
| Measure |
Spiolto®
Participants suffering from COPD were treated with a Fixed Dose Combination (FDC) of Tiotropium (Tio) 5 microgram (μg)/ + Olodaterol (Olo) 5 μg; solution for oral inhalation via Respimat® inhaler once daily, for 52 weeks or until discontinuation of administration.
|
|---|---|
|
Overall Study
Uncollectable CRF
|
27
|
|
Overall Study
No visit since the first visit
|
35
|
|
Overall Study
Adverse Event
|
81
|
|
Overall Study
Lack of Efficacy
|
40
|
|
Overall Study
Improvement in condition
|
34
|
|
Overall Study
Lost to Follow-up
|
121
|
|
Overall Study
Reason not listed
|
88
|
Baseline Characteristics
Race and Ethnicity were not collected from any participant.
Baseline characteristics by cohort
| Measure |
Spiolto®
n=1273 Participants
Participants suffering from COPD were treated with a Fixed Dose Combination (FDC) of Tiotropium (Tio) 5 microgram (μg)/ + Olodaterol (Olo) 5 μg; solution for oral inhalation via Respimat® inhaler once daily, for 52 weeks or until discontinuation of administration.
|
|---|---|
|
Age, Continuous
|
73.3 Years
STANDARD_DEVIATION 9.1 • n=1273 Participants
|
|
Sex: Female, Male
Female
|
206 Participants
n=1273 Participants
|
|
Sex: Female, Male
Male
|
1067 Participants
n=1273 Participants
|
PRIMARY outcome
Timeframe: From the first drug administration until 21 days after the last drug administration, up to approximately 82 weeks.Population: Safety set: This patient set includes all patients who were documented to have taken at least one dose of Spiolto® Respimat® excluding no visit after Spiolto® Respimat® administration.
Percentage of participants with adverse drug reactions (ADR). An adverse drug reaction (ADR) is defined as an adverse event (AE) for which either the investigator or the sponsor (or both) assess the causal relationship to Spiolto® Respimat® as "Yes".
Outcome measures
| Measure |
Spiolto®
n=1273 Participants
Participants suffering from COPD were treated with a Fixed Dose Combination (FDC) of Tiotropium (Tio) 5 microgram (μg)/ + Olodaterol (Olo) 5 μg; solution for oral inhalation via Respimat® inhaler once daily, for 52 weeks or until discontinuation of administration.
|
|---|---|
|
Percentage of Participants With Adverse Drug Reactions
|
3.93 Percentage of participants (%)
|
SECONDARY outcome
Timeframe: Baseline and Week 12Population: Effectiveness set: The effectiveness set included all patients in the safety set except for those patients who had no any values of CAT, Forced Expiratory Volume in one second (FEV1) and Forced Vital Capacity (FVC) after Spiolto® Respimat® administration.
The COPD Assessment Test™ (CAT) is a short 8-item questionnaire for assessment and monitoring of COPD health status in routine practice. Its scale is 0-40 (high score = poor health). The CAT questionnaire has the advantage of a reduced number of items and could be used to assess the effects of inhaled therapies. The CAT score was the sum of the values corresponding to the answers to the eight questions.
Outcome measures
| Measure |
Spiolto®
n=1255 Participants
Participants suffering from COPD were treated with a Fixed Dose Combination (FDC) of Tiotropium (Tio) 5 microgram (μg)/ + Olodaterol (Olo) 5 μg; solution for oral inhalation via Respimat® inhaler once daily, for 52 weeks or until discontinuation of administration.
|
|---|---|
|
Change of COPD Assessment Test (CAT) Score From Baseline to Week 12
|
-3.7 Unit on a scale
Standard Deviation 7.1
|
Adverse Events
Spiolto®
Serious events: 94 serious events
Other events: 0 other events
Deaths: 38 deaths
Serious adverse events
| Measure |
Spiolto®
n=1273 participants at risk
Participants suffering from COPD were treated with a Fixed Dose Combination (FDC) of Tiotropium (Tio) 5 microgram (μg)/ + Olodaterol (Olo) 5 μg; solution for oral inhalation via Respimat® inhaler once daily, for 52 weeks or until discontinuation of administration.
|
|---|---|
|
Blood and lymphatic system disorders
Anaemia
|
0.16%
2/1273 • From the first drug administration until 21 days after the last drug administration, up to approximately 82 weeks.
|
|
Cardiac disorders
Cardiac failure
|
0.39%
5/1273 • From the first drug administration until 21 days after the last drug administration, up to approximately 82 weeks.
|
|
Cardiac disorders
Cardiac failure congestive
|
0.24%
3/1273 • From the first drug administration until 21 days after the last drug administration, up to approximately 82 weeks.
|
|
Cardiac disorders
Cardio-respiratory arrest
|
0.16%
2/1273 • From the first drug administration until 21 days after the last drug administration, up to approximately 82 weeks.
|
|
Cardiac disorders
Acute myocardial infarction
|
0.08%
1/1273 • From the first drug administration until 21 days after the last drug administration, up to approximately 82 weeks.
|
|
Cardiac disorders
Angina pectoris
|
0.08%
1/1273 • From the first drug administration until 21 days after the last drug administration, up to approximately 82 weeks.
|
|
Cardiac disorders
Atrioventricular block second degree
|
0.08%
1/1273 • From the first drug administration until 21 days after the last drug administration, up to approximately 82 weeks.
|
|
Cardiac disorders
Cardiac arrest
|
0.08%
1/1273 • From the first drug administration until 21 days after the last drug administration, up to approximately 82 weeks.
|
|
Cardiac disorders
Cardiac failure acute
|
0.08%
1/1273 • From the first drug administration until 21 days after the last drug administration, up to approximately 82 weeks.
|
|
Cardiac disorders
Cardiac failure chronic
|
0.08%
1/1273 • From the first drug administration until 21 days after the last drug administration, up to approximately 82 weeks.
|
|
Cardiac disorders
Cardiovascular disorder
|
0.08%
1/1273 • From the first drug administration until 21 days after the last drug administration, up to approximately 82 weeks.
|
|
Cardiac disorders
Pericarditis
|
0.08%
1/1273 • From the first drug administration until 21 days after the last drug administration, up to approximately 82 weeks.
|
|
Cardiac disorders
Right ventricular failure
|
0.08%
1/1273 • From the first drug administration until 21 days after the last drug administration, up to approximately 82 weeks.
|
|
Congenital, familial and genetic disorders
Tracheo-oesophageal fistula
|
0.08%
1/1273 • From the first drug administration until 21 days after the last drug administration, up to approximately 82 weeks.
|
|
Endocrine disorders
Adrenocortical insufficiency acute
|
0.08%
1/1273 • From the first drug administration until 21 days after the last drug administration, up to approximately 82 weeks.
|
|
Endocrine disorders
Thyrotoxic crisis
|
0.08%
1/1273 • From the first drug administration until 21 days after the last drug administration, up to approximately 82 weeks.
|
|
Gastrointestinal disorders
Colitis ulcerative
|
0.08%
1/1273 • From the first drug administration until 21 days after the last drug administration, up to approximately 82 weeks.
|
|
Gastrointestinal disorders
Gastric ulcer
|
0.08%
1/1273 • From the first drug administration until 21 days after the last drug administration, up to approximately 82 weeks.
|
|
Gastrointestinal disorders
Gastric ulcer haemorrhage
|
0.08%
1/1273 • From the first drug administration until 21 days after the last drug administration, up to approximately 82 weeks.
|
|
Gastrointestinal disorders
Ileus
|
0.08%
1/1273 • From the first drug administration until 21 days after the last drug administration, up to approximately 82 weeks.
|
|
General disorders
Death
|
0.31%
4/1273 • From the first drug administration until 21 days after the last drug administration, up to approximately 82 weeks.
|
|
General disorders
Sudden death
|
0.16%
2/1273 • From the first drug administration until 21 days after the last drug administration, up to approximately 82 weeks.
|
|
General disorders
Pyrexia
|
0.08%
1/1273 • From the first drug administration until 21 days after the last drug administration, up to approximately 82 weeks.
|
|
Hepatobiliary disorders
Bile duct stone
|
0.08%
1/1273 • From the first drug administration until 21 days after the last drug administration, up to approximately 82 weeks.
|
|
Hepatobiliary disorders
Cholangitis
|
0.08%
1/1273 • From the first drug administration until 21 days after the last drug administration, up to approximately 82 weeks.
|
|
Hepatobiliary disorders
Cholecystitis chronic
|
0.08%
1/1273 • From the first drug administration until 21 days after the last drug administration, up to approximately 82 weeks.
|
|
Hepatobiliary disorders
Hepatic function abnormal
|
0.08%
1/1273 • From the first drug administration until 21 days after the last drug administration, up to approximately 82 weeks.
|
|
Hepatobiliary disorders
Jaundice cholestatic
|
0.08%
1/1273 • From the first drug administration until 21 days after the last drug administration, up to approximately 82 weeks.
|
|
Infections and infestations
Pneumonia
|
0.94%
12/1273 • From the first drug administration until 21 days after the last drug administration, up to approximately 82 weeks.
|
|
Infections and infestations
Respiratory tract infection
|
0.24%
3/1273 • From the first drug administration until 21 days after the last drug administration, up to approximately 82 weeks.
|
|
Infections and infestations
Gastroenteritis
|
0.16%
2/1273 • From the first drug administration until 21 days after the last drug administration, up to approximately 82 weeks.
|
|
Infections and infestations
Bronchitis
|
0.08%
1/1273 • From the first drug administration until 21 days after the last drug administration, up to approximately 82 weeks.
|
|
Infections and infestations
Staphylococcal sepsis
|
0.08%
1/1273 • From the first drug administration until 21 days after the last drug administration, up to approximately 82 weeks.
|
|
Infections and infestations
Pneumonia bacterial
|
0.08%
1/1273 • From the first drug administration until 21 days after the last drug administration, up to approximately 82 weeks.
|
|
Infections and infestations
Lung infection
|
0.08%
1/1273 • From the first drug administration until 21 days after the last drug administration, up to approximately 82 weeks.
|
|
Infections and infestations
Infectious pleural effusion
|
0.08%
1/1273 • From the first drug administration until 21 days after the last drug administration, up to approximately 82 weeks.
|
|
Injury, poisoning and procedural complications
Fall
|
0.24%
3/1273 • From the first drug administration until 21 days after the last drug administration, up to approximately 82 weeks.
|
|
Injury, poisoning and procedural complications
Femur fracture
|
0.16%
2/1273 • From the first drug administration until 21 days after the last drug administration, up to approximately 82 weeks.
|
|
Injury, poisoning and procedural complications
Ankle fracture
|
0.08%
1/1273 • From the first drug administration until 21 days after the last drug administration, up to approximately 82 weeks.
|
|
Injury, poisoning and procedural complications
Compression fracture
|
0.08%
1/1273 • From the first drug administration until 21 days after the last drug administration, up to approximately 82 weeks.
|
|
Injury, poisoning and procedural complications
Shunt occlusion
|
0.08%
1/1273 • From the first drug administration until 21 days after the last drug administration, up to approximately 82 weeks.
|
|
Injury, poisoning and procedural complications
Ulna fracture
|
0.08%
1/1273 • From the first drug administration until 21 days after the last drug administration, up to approximately 82 weeks.
|
|
Investigations
C-reactive protein increased
|
0.08%
1/1273 • From the first drug administration until 21 days after the last drug administration, up to approximately 82 weeks.
|
|
Metabolism and nutrition disorders
Hypoglycaemia
|
0.08%
1/1273 • From the first drug administration until 21 days after the last drug administration, up to approximately 82 weeks.
|
|
Metabolism and nutrition disorders
Hyperphosphatasaemia
|
0.08%
1/1273 • From the first drug administration until 21 days after the last drug administration, up to approximately 82 weeks.
|
|
Musculoskeletal and connective tissue disorders
Lumbar spinal stenosis
|
0.08%
1/1273 • From the first drug administration until 21 days after the last drug administration, up to approximately 82 weeks.
|
|
Musculoskeletal and connective tissue disorders
Trigger finger
|
0.08%
1/1273 • From the first drug administration until 21 days after the last drug administration, up to approximately 82 weeks.
|
|
Neoplasms benign, malignant and unspecified (incl cysts and polyps)
Malignant neoplasm progression
|
0.47%
6/1273 • From the first drug administration until 21 days after the last drug administration, up to approximately 82 weeks.
|
|
Neoplasms benign, malignant and unspecified (incl cysts and polyps)
Lung adenocarcinoma
|
0.24%
3/1273 • From the first drug administration until 21 days after the last drug administration, up to approximately 82 weeks.
|
|
Neoplasms benign, malignant and unspecified (incl cysts and polyps)
Prostate cancer
|
0.16%
2/1273 • From the first drug administration until 21 days after the last drug administration, up to approximately 82 weeks.
|
|
Neoplasms benign, malignant and unspecified (incl cysts and polyps)
Colon cancer
|
0.08%
1/1273 • From the first drug administration until 21 days after the last drug administration, up to approximately 82 weeks.
|
|
Neoplasms benign, malignant and unspecified (incl cysts and polyps)
Lung adenocarcinoma recurrent
|
0.08%
1/1273 • From the first drug administration until 21 days after the last drug administration, up to approximately 82 weeks.
|
|
Neoplasms benign, malignant and unspecified (incl cysts and polyps)
Metastases to bone
|
0.08%
1/1273 • From the first drug administration until 21 days after the last drug administration, up to approximately 82 weeks.
|
|
Neoplasms benign, malignant and unspecified (incl cysts and polyps)
Small cell lung cancer
|
0.08%
1/1273 • From the first drug administration until 21 days after the last drug administration, up to approximately 82 weeks.
|
|
Neoplasms benign, malignant and unspecified (incl cysts and polyps)
Squamous cell carcinoma of lung
|
0.08%
1/1273 • From the first drug administration until 21 days after the last drug administration, up to approximately 82 weeks.
|
|
Neoplasms benign, malignant and unspecified (incl cysts and polyps)
Lung neoplasm malignant
|
0.08%
1/1273 • From the first drug administration until 21 days after the last drug administration, up to approximately 82 weeks.
|
|
Neoplasms benign, malignant and unspecified (incl cysts and polyps)
Hepatocellular carcinoma
|
0.08%
1/1273 • From the first drug administration until 21 days after the last drug administration, up to approximately 82 weeks.
|
|
Nervous system disorders
Cerebral infarction
|
0.16%
2/1273 • From the first drug administration until 21 days after the last drug administration, up to approximately 82 weeks.
|
|
Nervous system disorders
Dementia
|
0.08%
1/1273 • From the first drug administration until 21 days after the last drug administration, up to approximately 82 weeks.
|
|
Nervous system disorders
Seizure
|
0.08%
1/1273 • From the first drug administration until 21 days after the last drug administration, up to approximately 82 weeks.
|
|
Renal and urinary disorders
Dysuria
|
0.08%
1/1273 • From the first drug administration until 21 days after the last drug administration, up to approximately 82 weeks.
|
|
Respiratory, thoracic and mediastinal disorders
Chronic obstructive pulmonary disease
|
0.94%
12/1273 • From the first drug administration until 21 days after the last drug administration, up to approximately 82 weeks.
|
|
Respiratory, thoracic and mediastinal disorders
Pneumothorax
|
0.55%
7/1273 • From the first drug administration until 21 days after the last drug administration, up to approximately 82 weeks.
|
|
Respiratory, thoracic and mediastinal disorders
Pneumonia aspiration
|
0.31%
4/1273 • From the first drug administration until 21 days after the last drug administration, up to approximately 82 weeks.
|
|
Respiratory, thoracic and mediastinal disorders
Interstitial lung disease
|
0.24%
3/1273 • From the first drug administration until 21 days after the last drug administration, up to approximately 82 weeks.
|
|
Respiratory, thoracic and mediastinal disorders
Hypoxia
|
0.16%
2/1273 • From the first drug administration until 21 days after the last drug administration, up to approximately 82 weeks.
|
|
Respiratory, thoracic and mediastinal disorders
Respiratory failure
|
0.16%
2/1273 • From the first drug administration until 21 days after the last drug administration, up to approximately 82 weeks.
|
|
Respiratory, thoracic and mediastinal disorders
Acute respiratory failure
|
0.08%
1/1273 • From the first drug administration until 21 days after the last drug administration, up to approximately 82 weeks.
|
|
Respiratory, thoracic and mediastinal disorders
Aspiration
|
0.08%
1/1273 • From the first drug administration until 21 days after the last drug administration, up to approximately 82 weeks.
|
|
Respiratory, thoracic and mediastinal disorders
Asthma
|
0.08%
1/1273 • From the first drug administration until 21 days after the last drug administration, up to approximately 82 weeks.
|
|
Respiratory, thoracic and mediastinal disorders
Epistaxis
|
0.08%
1/1273 • From the first drug administration until 21 days after the last drug administration, up to approximately 82 weeks.
|
|
Respiratory, thoracic and mediastinal disorders
Haemoptysis
|
0.08%
1/1273 • From the first drug administration until 21 days after the last drug administration, up to approximately 82 weeks.
|
|
Respiratory, thoracic and mediastinal disorders
Hypercapnia
|
0.08%
1/1273 • From the first drug administration until 21 days after the last drug administration, up to approximately 82 weeks.
|
|
Respiratory, thoracic and mediastinal disorders
Idiopathic pulmonary fibrosis
|
0.08%
1/1273 • From the first drug administration until 21 days after the last drug administration, up to approximately 82 weeks.
|
|
Respiratory, thoracic and mediastinal disorders
Pulmonary hypertension
|
0.08%
1/1273 • From the first drug administration until 21 days after the last drug administration, up to approximately 82 weeks.
|
|
Respiratory, thoracic and mediastinal disorders
Pneumomediastinum
|
0.08%
1/1273 • From the first drug administration until 21 days after the last drug administration, up to approximately 82 weeks.
|
|
Respiratory, thoracic and mediastinal disorders
Asthma-chronic obstructive pulmonary disease overlap syndrome
|
0.08%
1/1273 • From the first drug administration until 21 days after the last drug administration, up to approximately 82 weeks.
|
|
Vascular disorders
Aortic dissection
|
0.08%
1/1273 • From the first drug administration until 21 days after the last drug administration, up to approximately 82 weeks.
|
Other adverse events
Adverse event data not reported
Additional Information
Boehringer Ingelheim, Call Center
Boehringer Ingelheim
Phone: 1-800-243-0127
Email: [email protected]
Results disclosure agreements
- Principal investigator is a sponsor employee
- Publication restrictions are in place