Trial Outcomes & Findings for ADESPI: Adherence to Spiriva® in Patients With COPD (Chronic Obstructive Pulmonary Disease), Measured by Morisky-8 (MMAS-8) Scale, in Routine Medical Practice (NCT NCT01388166)
NCT ID: NCT01388166
Last Updated: 2014-12-04
Results Overview
The MMAS-8 scale is a recognized indicator of medication adherence, consisting of 8 questions with a sum score ranging between 0 and 8 points. The higher score indicates higher adherence to the prescribed therapy recommendation. It has been agreed that the score of 8 could be categorized as having high adherence, score between 6 and 7 as medium adherence and scores of 5 and less as low adherence. The change is presented as the score on visit 3 minus the score at baseline. Therefore, a positive change score reflects an improvement in the adherence.
COMPLETED
1253 participants
Baseline and 6 months
2014-12-04
Participant Flow
Participant milestones
| Measure |
Patients With COPD
Patients with a clinical diagnosis of chronic obstructive pulmonary disease (COPD) being treated with the maintenance therapy with long-acting anticholinergic (Tiotropium) for at least 1 month and within product label.
|
|---|---|
|
Overall Study
STARTED
|
1253
|
|
Overall Study
COMPLETED
|
1194
|
|
Overall Study
NOT COMPLETED
|
59
|
Reasons for withdrawal
| Measure |
Patients With COPD
Patients with a clinical diagnosis of chronic obstructive pulmonary disease (COPD) being treated with the maintenance therapy with long-acting anticholinergic (Tiotropium) for at least 1 month and within product label.
|
|---|---|
|
Overall Study
Adverse Event
|
16
|
|
Overall Study
Lost to Follow-up
|
30
|
|
Overall Study
Others than specified above
|
13
|
Baseline Characteristics
ADESPI: Adherence to Spiriva® in Patients With COPD (Chronic Obstructive Pulmonary Disease), Measured by Morisky-8 (MMAS-8) Scale, in Routine Medical Practice
Baseline characteristics by cohort
| Measure |
Patients With COPD
n=1253 Participants
Patients with a clinical diagnosis of chronic obstructive pulmonary disease (COPD) being treated with the maintenance therapy with long-acting anticholinergic (Tiotropium) for at least 1 month and within product label.
|
|---|---|
|
Age, Continuous
|
63.7 years
STANDARD_DEVIATION 9.95 • n=5 Participants
|
|
Sex: Female, Male
Female
|
480 Participants
n=5 Participants
|
|
Sex: Female, Male
Male
|
773 Participants
n=5 Participants
|
PRIMARY outcome
Timeframe: Baseline and 6 monthsPopulation: This patient set includes all patients in the TS who have valid MMAS-8 questionnaire results both at baseline and after 6 months.
The MMAS-8 scale is a recognized indicator of medication adherence, consisting of 8 questions with a sum score ranging between 0 and 8 points. The higher score indicates higher adherence to the prescribed therapy recommendation. It has been agreed that the score of 8 could be categorized as having high adherence, score between 6 and 7 as medium adherence and scores of 5 and less as low adherence. The change is presented as the score on visit 3 minus the score at baseline. Therefore, a positive change score reflects an improvement in the adherence.
Outcome measures
| Measure |
Patients With COPD
n=1168 Participants
Patients with a clinical diagnosis of chronic obstructive pulmonary disease (COPD) being treated with the maintenance therapy with long-acting anticholinergic (Tiotropium) for at least 1 month and within product label.
|
|---|---|
|
Mean Change of Morisky Medication Adherence Scale -8 (MMAS-8) Score at the End of the Educational Period After 6 Months From Baseline
|
0.6 units on a scale
Standard Deviation 1.84
|
SECONDARY outcome
Timeframe: 6 months and 12 monthsPopulation: This patient set includes all patients in the TS who have valid MMAS-8 questionnaire results after 6 and 12 months.
The MMAS-8 scale is a recognized indicator of medication adherence, consisting of 8 questions with a sum score ranging between 0 and 8 points. The higher score indicates higher adherence to the prescribed therapy recommendation. It has been agreed that the score of 8 could be categorized as having high adherence, score between 6 and 7 as medium adherence and scores of 5 and less as low adherence. The change is presented as the score on visit 4 minus the score at visit 3. Therefore, a positive change score reflects an improvement in the adherence.
Outcome measures
| Measure |
Patients With COPD
n=1125 Participants
Patients with a clinical diagnosis of chronic obstructive pulmonary disease (COPD) being treated with the maintenance therapy with long-acting anticholinergic (Tiotropium) for at least 1 month and within product label.
|
|---|---|
|
Mean Change of Morisky Medication Adherence Scale -8 (MMAS-8) Score at the End of the Observational Period After 12 Months From End of Educational Period After 6 Months.
|
0.2 units on a scale
Standard Deviation 1.46
|
SECONDARY outcome
Timeframe: 12 months and baselinePopulation: This patient set includes all patients in the TS who have valid MMAS-8 questionnaire results both at baseline and after 6 months.
The MMAS-8 scale is a recognized indicator of medication adherence, consisting of 8 questions with a sum score ranging between 0 and 8 points. The higher score indicates higher adherence to the prescribed therapy recommendation. It has been agreed that the score of 8 could be categorized as having high adherence, score between 6 and 7 as medium adherence and scores of 5 and less as low adherence. The change is presented as the score on visit 4 minus the score at visit 1 (baseline). Therefore, a positive change score reflects an improvement in the adherence.
Outcome measures
| Measure |
Patients With COPD
n=1130 Participants
Patients with a clinical diagnosis of chronic obstructive pulmonary disease (COPD) being treated with the maintenance therapy with long-acting anticholinergic (Tiotropium) for at least 1 month and within product label.
|
|---|---|
|
Mean Change of Morisky Medication Adherence Scale -8 (MMAS-8) Score at the End of the Observational Period After 12 Months From Baseline
|
0.7 units on a scale
Standard Deviation 1.82
|
Adverse Events
Patients With COPD
Serious adverse events
| Measure |
Patients With COPD
n=1253 participants at risk
Patients with a clinical diagnosis of chronic obstructive pulmonary disease (COPD) being treated with the maintenance therapy with long-acting anticholinergic (Tiotropium) at least 1 months and within product label.
|
|---|---|
|
Blood and lymphatic system disorders
Anaemia
|
0.32%
4/1253 • 12 months
|
|
Blood and lymphatic system disorders
Metastases to lymph nodes
|
0.08%
1/1253 • 12 months
|
|
Cardiac disorders
Atrial fibrillation
|
0.16%
2/1253 • 12 months
|
|
Cardiac disorders
Atrial flutter
|
0.08%
1/1253 • 12 months
|
|
Cardiac disorders
Cardiac failure
|
0.16%
2/1253 • 12 months
|
|
Cardiac disorders
Cor pulmonale
|
0.08%
1/1253 • 12 months
|
|
Cardiac disorders
Myocardial infarction
|
0.16%
2/1253 • 12 months
|
|
Cardiac disorders
Myocardial ischaemia
|
0.08%
1/1253 • 12 months
|
|
Cardiac disorders
Syncope
|
0.08%
1/1253 • 12 months
|
|
Gastrointestinal disorders
Diarrhoea
|
0.08%
1/1253 • 12 months
|
|
Gastrointestinal disorders
Gastroenteritis
|
0.08%
1/1253 • 12 months
|
|
Gastrointestinal disorders
Ileus
|
0.08%
1/1253 • 12 months
|
|
Gastrointestinal disorders
Pancreatitis
|
0.08%
1/1253 • 12 months
|
|
Gastrointestinal disorders
Varices oesophageal
|
0.08%
1/1253 • 12 months
|
|
General disorders
Death
|
0.32%
4/1253 • 12 months
|
|
General disorders
Pain
|
0.08%
1/1253 • 12 months
|
|
General disorders
Pyrexia
|
0.08%
1/1253 • 12 months
|
|
Hepatobiliary disorders
Cholecystitis acute
|
0.08%
1/1253 • 12 months
|
|
Hepatobiliary disorders
Hepatic cirrhosis
|
0.08%
1/1253 • 12 months
|
|
Hepatobiliary disorders
Metastases to liver
|
0.08%
1/1253 • 12 months
|
|
Infections and infestations
Bronchopneumonia
|
0.08%
1/1253 • 12 months
|
|
Infections and infestations
Influenza
|
0.16%
2/1253 • 12 months
|
|
Infections and infestations
Pneumonia
|
0.32%
4/1253 • 12 months
|
|
Injury, poisoning and procedural complications
Rib fracture
|
0.08%
1/1253 • 12 months
|
|
Injury, poisoning and procedural complications
Road traffic accident
|
0.08%
1/1253 • 12 months
|
|
Investigations
Blood pressure increased
|
0.08%
1/1253 • 12 months
|
|
Musculoskeletal and connective tissue disorders
Metastases to bone
|
0.08%
1/1253 • 12 months
|
|
Neoplasms benign, malignant and unspecified (incl cysts and polyps)
Adenoma benign
|
0.08%
1/1253 • 12 months
|
|
Neoplasms benign, malignant and unspecified (incl cysts and polyps)
Bladder cancer
|
0.08%
1/1253 • 12 months
|
|
Neoplasms benign, malignant and unspecified (incl cysts and polyps)
Colon cancer
|
0.08%
1/1253 • 12 months
|
|
Nervous system disorders
Cerebral infarction
|
0.08%
1/1253 • 12 months
|
|
Nervous system disorders
Cerebrovascular accident
|
0.16%
2/1253 • 12 months
|
|
Nervous system disorders
Dizziness
|
0.08%
1/1253 • 12 months
|
|
Nervous system disorders
Hemiparesis
|
0.08%
1/1253 • 12 months
|
|
Nervous system disorders
Vascular encephalopathy
|
0.08%
1/1253 • 12 months
|
|
Psychiatric disorders
Amnesia
|
0.08%
1/1253 • 12 months
|
|
Psychiatric disorders
Delirium
|
0.08%
1/1253 • 12 months
|
|
Psychiatric disorders
Panic disorder
|
0.08%
1/1253 • 12 months
|
|
Renal and urinary disorders
Renal failure
|
0.08%
1/1253 • 12 months
|
|
Renal and urinary disorders
Renal failure acute
|
0.08%
1/1253 • 12 months
|
|
Reproductive system and breast disorders
Ovarian neoplasm
|
0.08%
1/1253 • 12 months
|
|
Respiratory, thoracic and mediastinal disorders
Acute respiratory failure
|
0.08%
1/1253 • 12 months
|
|
Respiratory, thoracic and mediastinal disorders
Chronic obstructive pulmonary disease
|
2.2%
27/1253 • 12 months
|
|
Respiratory, thoracic and mediastinal disorders
Dyspnoea
|
0.08%
1/1253 • 12 months
|
|
Respiratory, thoracic and mediastinal disorders
Hydrothorax
|
0.08%
1/1253 • 12 months
|
|
Respiratory, thoracic and mediastinal disorders
Lung adenocarcinoma
|
0.24%
3/1253 • 12 months
|
|
Respiratory, thoracic and mediastinal disorders
Lung disorder
|
0.08%
1/1253 • 12 months
|
|
Respiratory, thoracic and mediastinal disorders
Lung neoplasm
|
0.08%
1/1253 • 12 months
|
|
Respiratory, thoracic and mediastinal disorders
Metastases to lung
|
0.08%
1/1253 • 12 months
|
|
Respiratory, thoracic and mediastinal disorders
Non-small cell lung cancer
|
0.08%
1/1253 • 12 months
|
|
Respiratory, thoracic and mediastinal disorders
Pneumonia bacterial
|
0.08%
1/1253 • 12 months
|
|
Respiratory, thoracic and mediastinal disorders
Respiratory failure
|
0.08%
1/1253 • 12 months
|
|
Respiratory, thoracic and mediastinal disorders
Respiratory tract inflammation
|
0.08%
1/1253 • 12 months
|
|
Surgical and medical procedures
Coronary arterial stent insertion
|
0.08%
1/1253 • 12 months
|
|
Surgical and medical procedures
Lung lobectomy
|
0.08%
1/1253 • 12 months
|
|
Vascular disorders
Haemoptysis
|
0.08%
1/1253 • 12 months
|
|
Vascular disorders
Venous thrombosis limb
|
0.08%
1/1253 • 12 months
|
Other adverse events
Adverse event data not reported
Additional Information
Boehringer Ingelheim Call Center
Boehringer Ingelheim Pharmaceuticals
Results disclosure agreements
- Principal investigator is a sponsor employee Other - Boehringer Ingelheim (BI) acknowledges that investigators have the right to publish the study results. Investigators shall provide BI with a copy of any publication or presentation for review prior to any submission. Such review will be done with regard to proprietary information, information related to patentable inventions, medical, scientific, and statistical accuracy within 60 days. BI may request a delay of the publication in order to protect BI's intellectual property rights.
- Publication restrictions are in place
Restriction type: OTHER