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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
History of Changes
  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:

MedlinePlus related topics: Asthma
U.S. FDA Resources

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
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

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 May 19, 2013