Last updated: 07/31/2020 01:30:23
COPD Severity and Adherence to GOLD Guidelines in the Community Pharmacy Setting
Clinicaltrials.gov ID
Not applicable
EudraCT ID
Not applicable
EU CT Number
Not applicable
Trial status
Finalized
Finalized
Trial overview
Official title: COPD Severity and Adherence to GOLD Guidelines in the Community Pharmacy Setting
Trial description: Missouri had one of the highest age-standardized death rates. Chronic obstructive pulmonary disease (COPD) and its related conditions caused 528 deaths in St. Louis City and County. It would be advantageous to link medication adherence data from community pharmacy profiles with current COPD diagnosis and risk stratification to assess the appropriateness of medication use according to the Global Initiative for Chronic Obstructive Lung Disease (GOLD) guidelinesThis study is a cross-sectional analysis of patients with COPD in 35 community pharmacies across the state of Missouri.
Primary purpose:
Not applicable
Trial design:
Not applicable
Masking:
Not applicable
Allocation:
Not applicable
Primary outcomes:
GOLD Combined Assessment Category
Timeframe: Up to 12 months
GOLD Classification of Airflow Limitation
Timeframe: Up to 36 months
Future Exacerbations Risk Assessment
Timeframe: Up to 12 months
COPD Assessment Test (CAT) score
Timeframe: Up to 1 day
Modified Medical Research Council Dyspnea Scale (mMRC) score
Timeframe: Up to 1 day
Secondary outcomes:
GOLD Combined Assessment Category
Timeframe: Up to 12 months
COPD Assessment Test (CAT) score
Timeframe: Up to 1 day
Modified Medical Research Council Dyspnea Scale (mMRC) score
Timeframe: Up to 1 day
Appropriate Treatment Category
Timeframe: Up to 12 months
Proportion of Days Covered (PDC)
Timeframe: Up to 12 months
PDC Threshold
Timeframe: Up to 12 months
Patient level variables
Timeframe: Up to 12 months
Pharmacy level variables
Timeframe: Up to 12 months
Interventions:
Other: Questionnaires
Enrollment:
1
Observational study model:
Ecologic or Community
Primary completion date:
2017-29-09
Time perspective:
Cross-Sectional
Clinical publications:
Bollmeier S, Seaton T, Prosser T, Chou Y-T, Reckenberg K, Hahn B, Stanford R, Ray R. Assessment of Symptom Burden and Adherence to Respiratory Medications in Individuals Self Reporting a Diagnosis of COPD Within a Community Pharmacy Setting. J Am Pharm Assoc. 2019;59(4):479–488
DOI: 10.1016/j.japh.2019.04.017
Medical condition
Pulmonary Disease, Chronic Obstructive
Product
umeclidinium bromide, umeclidinium bromide/vilanterol, vilanterol
Collaborators
St Louis School of Pharmacy
Study date(s)
June 2017 to September 2017
Type
Observational
Phase
Not applicable
Participation criteria
Sex
Female & Male
Age
40+ years
Accepts healthy volunteers
Not applicable
- Age 40 years and older
- Patient-reported history of COPD (International classification of disease [ICD]-9 = 491.20; ICD-10 = J44.9)
- Cognitive impairment that might limit their ability to participate in a face-to-face study
- visit and provide accurate information
Inclusion and exclusion criteria
Inclusion criteria:
- Age 40 years and older
- Patient-reported history of COPD (International classification of disease [ICD]-9 = 491.20; ICD-10 = J44.9)
- Using at least one medication to treat COPD within past 12 months (365 days)
- English-speaking
- Willing and able to participate in a face-to-face study visit with the community pharmacist and complete the participant questionnaire
Exclusion criteria:
- Cognitive impairment that might limit their ability to participate in a face-to-face study visit and provide accurate information
- Previous participation in this study at a different pharmacy site .
Trial location(s)
No location data available.
Study documents
Clinical study report
Available language(s): English
Protocol
Available language(s): English
Scientific result summary
Available language(s): English
If you wish to request for full study report, please contact - [email protected]
Results overview
Refer to study documents
Recruitment status
Finalized
Actual primary completion date
2017-29-09
Actual study completion date
2017-29-09
Plain language summaries
Not applicable. GSK’s transparency policy provides for Plain Language Summaries for Interventional studies.
Additional information about the trial
Not applicable
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