Effect of a Pharmaceutical Intervention on the Level of Control of the Asthmatic Patient

This study has been completed.
Sponsor:
Information provided by (Responsible Party):
AstraZeneca
ClinicalTrials.gov Identifier:
NCT01085474
First received: March 11, 2010
Last updated: January 25, 2013
Last verified: January 2013
  Purpose

Measurement of disease control, treatment adherence and patient knowledge of his/her medication in patients that are receiving a pharmaceutical intervention compared with those patients who receive regular pharmaceutical care.


Condition Intervention
Asthma
Other: 1
Other: 2

Study Type: Observational
Study Design: Time Perspective: Prospective
Official Title: Effect of a Pharmaceutical Intervention on the Level of Control of the Asthmatic Patient

Resource links provided by NLM:


Further study details as provided by AstraZeneca:

Primary Outcome Measures:
  • Evaluate the effect of the pharmaceutical intervention on the disease control, treatment adherence and patient knowledge of his/her medication using the MEF, treatment adherence and patient knowledge of the medication indicators. [ Time Frame: First a Pilot in 3 months and then the final study in 6 months ] [ Designated as safety issue: No ]

Secondary Outcome Measures:
  • Compare disease control in patients who know their medication and those who doesn't. [ Time Frame: First a Pilot in 3 months and then the final study in 6 months ] [ Designated as safety issue: No ]
  • Compare disease control in patients who comply with their medication with those who doesn't. [ Time Frame: First a Pilot in 3 months and then the final study in 6 months ] [ Designated as safety issue: No ]

Enrollment: 384
Study Start Date: April 2010
Study Completion Date: July 2011
Primary Completion Date: July 2011 (Final data collection date for primary outcome measure)
Groups/Cohorts Assigned Interventions
1
1. Pilot Study: 60 patients (all in the intervention group) 30 patients with intervention A and 30 patients with B intervention)
Other: 1
In the pilot study the objective is to compare 2 different pharmaceutical interventions (A and B) and to assess which one improves disease control, patient adherence and patient knowledge of the medication.
2
Main Study: 600 patients (30 pharmacies control group and 30 pharmacies intervention group, 10 patients per pharmacy)
Other: 2
The best intervention used in the pilot study will be chosen and included in the main study.

  Eligibility

Ages Eligible for Study:   18 Years and older
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   No
Sampling Method:   Probability Sample
Study Population

60 community pharmacies 10 patients per pharmacy

Criteria

Inclusion Criteria:

  • Patients who have given their informed consent and expressed interest in participating in the study
  • Asthmatic Patients

Exclusion Criteria:

  • Patients with communication difficulties.
  • Persons who obtain symbicort but not for their own use.
  • Patients with other major diseases: Heart problems, COPD, EMPHYSEMA, lung cancer, AIDS.
  • Patients with a respiratory infection.
  • Patients with seasonal asthma.
  • Pregnant women
  • Patients who have previously participated in a health education study in asthma.
  Contacts and Locations
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

Please refer to this study by its ClinicalTrials.gov identifier: NCT01085474

Locations
Spain
Research Site
Madrid, Spain
Malaga
Malaga, Spain
Sponsors and Collaborators
AstraZeneca
  More Information

No publications provided by AstraZeneca

Additional publications automatically indexed to this study by ClinicalTrials.gov Identifier (NCT Number):
Responsible Party: AstraZeneca
ClinicalTrials.gov Identifier: NCT01085474     History of Changes
Other Study ID Numbers: NIS-RES-DUM-2009/1
Study First Received: March 11, 2010
Last Updated: January 25, 2013
Health Authority: Spain: Ethics Committee

Keywords provided by AstraZeneca:
Asthma
Pharmaceutical intervention
Effect of a pharmaceutical intervention on the level of control of the asthmatic patient

Additional relevant MeSH terms:
Asthma
Bronchial Diseases
Respiratory Tract Diseases
Lung Diseases, Obstructive
Lung Diseases
Respiratory Hypersensitivity
Hypersensitivity, Immediate
Hypersensitivity
Immune System Diseases

ClinicalTrials.gov processed this record on August 18, 2014