This trial is active, not recruiting.

Condition pulmonary disease, chronic obstructive
Sponsor Boehringer Ingelheim
Start date December 2015
End date July 2017
Trial identifier NCT02689492, 1237.51


The present study will explore the patients satisfaction to COPD medical treatment (i.e. pharmacological and not pharmacological treatment) in a clinical real-world setting and how the satisfaction for medical treatment is related to clinical parameters, quality of life, illness perception and treatment adherence evolution.

Moreover health care resource consumption will be observed during the observation period.

United States No locations recruiting
Other countries No locations recruiting

Study Design

Observational model cohort
Time perspective prospective

Primary Outcomes

Patients' satisfaction to COPD medical treatments by means of the TSQM9 after 12 months of observation in real-world setting
time frame: 12 months

Secondary Outcomes

Patient disease perception by means of brief illness perception questionnaire B-IPQ
time frame: 12 months
patient's dyspnea by means of Modified Medical Research Council Dyspnea Scale
time frame: 12 months
patient adherence to COPD treatment by means of MMAS4
time frame: 12 months
patient health status by means of CAT questionnaire
time frame: 12 months

Eligibility Criteria

Male or female participants from 40 years up to 99 years old.

Inclusion criteria: 1. Patients aged equal or more than 40 years 2. Patients must have a documented diagnosis of chronic obstructive pulmonary disease (COPD) 3. Patients with no exacerbations in the last 3 months 4. Patients requiring regular treatment according to GOLD guidelines, i.e.: undergoing stable pharmacological treatment for COPD since at least 3 months 5. Written informed consent to both participation in the study and privacy form 6. Patients capable of discernment and able to read or write in Italian language. Exclusion criteria: 1. Patients who are currently participating in a clinical trial on experimental drugs. 2. Patients naïve to pharmacological treatment for COPD 3. Diagnosis of Asthma COPD Overlap Syndrome (ACOS)

Additional Information

Official title SATisfaction and Adherence to COPD Treatment
Trial information was received from ClinicalTrials.gov and was last updated in September 2016.
Information provided to ClinicalTrials.gov by Boehringer Ingelheim.