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

Asthma Clinical Trial

Official title:

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

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT01085474
• Other study ID #: NIS-RES-DUM-2009/1
• Status: Completed
• Phase: N/A
• First received: March 11, 2010
• Last updated: January 25, 2013
• Start date: April 2010
• Est. completion date: July 2011

Study information

• Verified date: January 2013
• Source: AstraZeneca
• Contact: n/a
• Is FDA regulated: No
• Health authority: Spain: Ethics Committee
• Study type: Observational

Clinical Trial Summary

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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 384
• Est. completion date: July 2011
• Est. primary completion date: July 2011
• Accepts healthy volunteers: No
• Gender: Both
• Age group: 18 Years and older

Eligibility

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.

Study Design

Time Perspective: Prospective

Related Conditions & MeSH terms

• Asthma

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
The best intervention used in the pilot study will be chosen and included in the main study.

Locations

Country	Name	City	State
Spain	Research Site	Madrid
Spain	Malaga	Malaga

Sponsors (1)

Lead Sponsor	Collaborator
AstraZeneca

Country where clinical trial is conducted

Spain, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	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.		First a Pilot in 3 months and then the final study in 6 months	No
Secondary	Compare disease control in patients who know their medication and those who doesn't.		First a Pilot in 3 months and then the final study in 6 months	No
Secondary	Compare disease control in patients who comply with their medication with those who doesn't.		First a Pilot in 3 months and then the final study in 6 months	No