Last updated: 07/31/2020 01:30:23

COPD Severity and Adherence to GOLD Guidelines in the Community Pharmacy Setting

GSK study ID
205863
See study documents
Clinicaltrials.gov ID
Not applicable
EudraCT ID
Not applicable
EU CT Number
Not applicable
Trial status
Study complete
Study complete
Overview
Eligibility
Locations
Study documents
Results summary
Plain language summaries
Additional information

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) guidelines
This 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
    Primary completion date:
    2017-29-09
    Observational study model:
    Ecologic or Community
    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)

    This study does not involve prospective enrollment of participants.

    Study documents

    Clinical study report
    Available language(s): English
    Download document(s)
    Protocol
    Available language(s): English
    Download document(s)
    Scientific result summary
    Available language(s): English
    Download document(s)

    If you wish to request for full study report, please contact - [email protected]

    Results overview

    Refer to study documents

    Recruitment status
    Study complete
    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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