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ADESPI: Adherence to Spiriva® in Patients With COPD (Chronic Obstructive Pulmonary Disease), Measured by Morisky-8 (MMAS-8) Scale, in Routine Medical Practice

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ClinicalTrials.gov Identifier: NCT01388166
Recruitment Status : Completed
First Posted : July 6, 2011
Results First Posted : December 4, 2014
Last Update Posted : December 4, 2014
Sponsor:
Collaborator:
Pfizer
Information provided by (Responsible Party):
Boehringer Ingelheim

Study Type Observational
Study Design Observational Model: Cohort;   Time Perspective: Prospective
Condition Pulmonary Disease, Chronic Obstructive
Intervention Procedure: Education
Enrollment 1253
Recruitment Details  
Pre-assignment Details  
Arm/Group Title Patients With COPD
Hide Arm/Group Description 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.
Period Title: Overall Study
Started 1253
Completed 1194
Not Completed 59
Reason Not Completed
Adverse Event             16
Lost to Follow-up             30
Others than specified above             13
Arm/Group Title Patients With COPD
Hide Arm/Group Description 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 Number of Baseline Participants 1253
Hide Baseline Analysis Population Description
Patients from the Treated Set: This patient set includes all patients who were dispensed study medication and were documented to have taken at least one dose of investigational treatment. As it was an inclusion criterion that all patients were treated with Spiriva within the last month, TS consists of all patients involved in the trial.
Age, Continuous  
Mean (Standard Deviation)
Unit of measure:  Years
Number Analyzed 1253 participants
63.7  (9.95)
Sex: Female, Male  
Measure Type: Count of Participants
Unit of measure:  Participants
Number Analyzed 1253 participants
Female
480
  38.3%
Male
773
  61.7%
1.Primary Outcome
Title Mean Change of Morisky Medication Adherence Scale -8 (MMAS-8) Score at the End of the Educational Period After 6 Months From Baseline
Hide Description 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.
Time Frame Baseline and 6 months
Hide Outcome Measure Data
Hide Analysis Population Description
This patient set includes all patients in the TS who have valid MMAS-8 questionnaire results both at baseline and after 6 months.
Arm/Group Title Patients With COPD
Hide Arm/Group Description:
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 Number of Participants Analyzed 1168
Mean (Standard Deviation)
Unit of Measure: units on a scale
0.6  (1.84)
Show Statistical Analysis 1 Hide Statistical Analysis 1
Statistical Analysis Overview Comparison Group Selection Patients With COPD
Comments [Not Specified]
Type of Statistical Test Superiority or Other
Comments [Not Specified]
Statistical Test of Hypothesis P-Value <0.0001
Comments [Not Specified]
Method t-test, 2 sided
Comments [Not Specified]
2.Secondary Outcome
Title 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.
Hide Description 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.
Time Frame 6 months and 12 months
Hide Outcome Measure Data
Hide Analysis Population Description
This patient set includes all patients in the TS who have valid MMAS-8 questionnaire results after 6 and 12 months.
Arm/Group Title Patients With COPD
Hide Arm/Group Description:
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 Number of Participants Analyzed 1125
Mean (Standard Deviation)
Unit of Measure: units on a scale
0.2  (1.46)
Show Statistical Analysis 1 Hide Statistical Analysis 1
Statistical Analysis Overview Comparison Group Selection Patients With COPD
Comments [Not Specified]
Type of Statistical Test Superiority or Other
Comments [Not Specified]
Statistical Test of Hypothesis P-Value 0.0002
Comments [Not Specified]
Method t-test, 2 sided
Comments [Not Specified]
3.Secondary Outcome
Title Mean Change of Morisky Medication Adherence Scale -8 (MMAS-8) Score at the End of the Observational Period After 12 Months From Baseline
Hide Description 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.
Time Frame 12 months and baseline
Hide Outcome Measure Data
Hide Analysis Population Description
This patient set includes all patients in the TS who have valid MMAS-8 questionnaire results both at baseline and after 6 months.
Arm/Group Title Patients With COPD
Hide Arm/Group Description:
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 Number of Participants Analyzed 1130
Mean (Standard Deviation)
Unit of Measure: units on a scale
0.7  (1.82)
Show Statistical Analysis 1 Hide Statistical Analysis 1
Statistical Analysis Overview Comparison Group Selection Patients With COPD
Comments [Not Specified]
Type of Statistical Test Superiority or Other
Comments [Not Specified]
Statistical Test of Hypothesis P-Value <0.0001
Comments [Not Specified]
Method t-test, 2 sided
Comments [Not Specified]
Time Frame 12 months
Adverse Event Reporting Description [Not Specified]
 
Arm/Group Title Patients With COPD
Hide Arm/Group Description 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.
All-Cause Mortality
Patients With COPD
Affected / at Risk (%)
Total   --/-- 
Show Serious Adverse Events Hide Serious Adverse Events
Patients With COPD
Affected / at Risk (%)
Total   59/1253 (4.71%) 
Blood and lymphatic system disorders   
Anaemia  1  4/1253 (0.32%) 
Metastases to lymph nodes  1  1/1253 (0.08%) 
Cardiac disorders   
Atrial fibrillation  1  2/1253 (0.16%) 
Atrial flutter  1  1/1253 (0.08%) 
Cardiac failure  1  2/1253 (0.16%) 
Cor pulmonale  1  1/1253 (0.08%) 
Myocardial infarction  1  2/1253 (0.16%) 
Myocardial ischaemia  1  1/1253 (0.08%) 
Syncope  1  1/1253 (0.08%) 
Gastrointestinal disorders   
Diarrhoea  1  1/1253 (0.08%) 
Gastroenteritis  1  1/1253 (0.08%) 
Ileus  1  1/1253 (0.08%) 
Pancreatitis  1  1/1253 (0.08%) 
Varices oesophageal  1  1/1253 (0.08%) 
General disorders   
Death  1  4/1253 (0.32%) 
Pain  1  1/1253 (0.08%) 
Pyrexia  1  1/1253 (0.08%) 
Hepatobiliary disorders   
Cholecystitis acute  1  1/1253 (0.08%) 
Hepatic cirrhosis  1  1/1253 (0.08%) 
Metastases to liver  1  1/1253 (0.08%) 
Infections and infestations   
Bronchopneumonia  1  1/1253 (0.08%) 
Influenza  1  2/1253 (0.16%) 
Pneumonia  1  4/1253 (0.32%) 
Injury, poisoning and procedural complications   
Rib fracture  1  1/1253 (0.08%) 
Road traffic accident  1  1/1253 (0.08%) 
Investigations   
Blood pressure increased  1  1/1253 (0.08%) 
Musculoskeletal and connective tissue disorders   
Metastases to bone  1  1/1253 (0.08%) 
Neoplasms benign, malignant and unspecified (incl cysts and polyps)   
Adenoma benign  1  1/1253 (0.08%) 
Bladder cancer  1  1/1253 (0.08%) 
Colon cancer  1  1/1253 (0.08%) 
Nervous system disorders   
Cerebral infarction  1  1/1253 (0.08%) 
Cerebrovascular accident  1  2/1253 (0.16%) 
Dizziness  1  1/1253 (0.08%) 
Hemiparesis  1  1/1253 (0.08%) 
Vascular encephalopathy  1  1/1253 (0.08%) 
Psychiatric disorders   
Amnesia  1  1/1253 (0.08%) 
Delirium  1  1/1253 (0.08%) 
Panic disorder  1  1/1253 (0.08%) 
Renal and urinary disorders   
Renal failure  1  1/1253 (0.08%) 
Renal failure acute  1  1/1253 (0.08%) 
Reproductive system and breast disorders   
Ovarian neoplasm  1  1/1253 (0.08%) 
Respiratory, thoracic and mediastinal disorders   
Acute respiratory failure  1  1/1253 (0.08%) 
Chronic obstructive pulmonary disease  1  27/1253 (2.15%) 
Dyspnoea  1  1/1253 (0.08%) 
Hydrothorax  1  1/1253 (0.08%) 
Lung adenocarcinoma  1  3/1253 (0.24%) 
Lung disorder  1  1/1253 (0.08%) 
Lung neoplasm  1  1/1253 (0.08%) 
Metastases to lung  1  1/1253 (0.08%) 
Non-small cell lung cancer  1  1/1253 (0.08%) 
Pneumonia bacterial  1  1/1253 (0.08%) 
Respiratory failure  1  1/1253 (0.08%) 
Respiratory tract inflammation  1  1/1253 (0.08%) 
Surgical and medical procedures   
Coronary arterial stent insertion  1  1/1253 (0.08%) 
Lung lobectomy  1  1/1253 (0.08%) 
Vascular disorders   
Haemoptysis  1  1/1253 (0.08%) 
Venous thrombosis limb  1  1/1253 (0.08%) 
Indicates events were collected by systematic assessment
1
Term from vocabulary, MEDDRA 17.0
Show Other (Not Including Serious) Adverse Events Hide Other (Not Including Serious) Adverse Events
Frequency Threshold for Reporting Other Adverse Events 5%
Patients With COPD
Affected / at Risk (%)
Total   0/1253 (0.00%) 
Certain Agreements
Principal Investigators are NOT employed by the organization sponsoring the study.
There IS an agreement between Principal Investigators and the Sponsor (or its agents) that restricts the PI's rights to discuss or publish trial results after the trial is completed.
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.
Results Point of Contact
Name/Title: Boehringer Ingelheim Call Center
Organization: Boehringer Ingelheim Pharmaceuticals
Phone: 1-800-243-0127
Responsible Party: Boehringer Ingelheim
ClinicalTrials.gov Identifier: NCT01388166     History of Changes
Other Study ID Numbers: 205.483
First Submitted: July 1, 2011
First Posted: July 6, 2011
Results First Submitted: November 28, 2014
Results First Posted: December 4, 2014
Last Update Posted: December 4, 2014