Pharmaceutical Care for Chronic Obstructive Pulmonary Disease (COPD) Study.

NCT01260389 | Completed

• 1 other identifier: EC/2010/587
• Study Type: interventional
• Target: 734
• Locations: 1 country
• Sites: 2

Brief Summary

This study would like to test the hypothesis that a pharmaceutical care intervention would result in an improved drug adherence and inhalation technique in Chronic Obstructive Pulmonary Disease (COPD) patients over a 3 month-period.

Conditions

Chronic Obstructive Pulmonary Disease (COPD)

Keywords

Chronic Obstructive Pulmonary Disease; COPD

Outcome Measures

Primary Outcomes (4)

• inhalation technique baseline

  Inhalation technique with Chronic Obstructive Pulmonary Disease (COPD) controller medication at baseline.

  baseline

• inhalation technique 1 month

  Inhalation technique with Chronic Obstructive Pulmonary Disease (COPD) controller medication after 1 month.

  after 1 month

• inhalation technique 3 months

  Inhalation technique with Chronic Obstructive Pulmonary Disease (COPD) controller medication after 3 months.

  after 3 months

• drug adherence

  Adherence to Chronic Obstructive Pulmonary Disease (COPD) controller medication after 3 months.

  after 3 months

Secondary Outcomes (5)

• health status

  baseline

• health status

  after 1 month

• health status

  after 3 months

• exacerbations

  after 3 months

• Emergency Room visits and hospitalizations.

  after 3 months

Study Arms (2)

control group

NO INTERVENTION

Usual pharmacist care in patients with Chronic Obstructive Pulmonary Disease (COPD).

pharmaceutical care intervention

EXPERIMENTAL

A pharmaceutical care intervention, focused at improving inhalation technique and drug adherence in patients with Chronic Obstructive Pulmonary Disease (COPD).

Behavioral: pharmaceutical care intervention

Interventions

pharmaceutical care intervention BEHAVIORAL

Pharmaceutical care intervention, focused at improving inhalation technique and drug adherence in patients with Chronic Obstructive Pulmonary Disease (COPD).

pharmaceutical care intervention

Eligibility Criteria

• Age: 50 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• daily use of Chronic Obstructive Pulmonary Disease (COPD)-medication: (Global initiative for chronic Obstructive Lung Disease: GOLD stadia I-IV)
• years of age or older
• smoking history of at least 10 pack-years

You may not qualify if:

• having asthma
• analphabetism

Sponsors & Collaborators

• University Hospital, Ghent: lead
• University Ghent: collaborator
• GlaxoSmithKline: collaborator

Study Sites (2)

Ghent University

Ghent, Belgium

Location

Centre Hospitalier Universitaire du Sart Tilman

Liège, Belgium

Location

Related Links

• Related Info

MeSH Terms

Conditions

Pulmonary Disease, Chronic Obstructive

Condition Hierarchy (Ancestors)

Lung Diseases, Obstructive; Lung Diseases; Respiratory Tract Diseases; Chronic Disease; Disease Attributes; Pathologic Processes; Pathological Conditions, Signs and Symptoms

Study Officials

• Guy Brusselle, M.D., Ph.D.

  University Hospital, Ghent

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: December 13, 2010
• First Posted: December 15, 2010
• Study Start: December 1, 2010
• Primary Completion: May 1, 2011
• Study Completion: July 1, 2011
• Last Updated: July 13, 2021

Record last verified: 2021-07

Locations

BE (2)