AsthmaNCT01085474
Effect of a Pharmaceutical Intervention on the Level of Control of the Asthmatic Patient
An observational study of Asthma, run by AstraZeneca at 2 sites in Spain.
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. Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Asthma
- What is being tested?
- 1 and 2
- How many people
- 384 participants
- Where
- 2 sitesSpain
- Study dates
- Apr 2010to Jul 2011
- Phase
- Observational
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Study population: 60 community pharmacies 10 patients per pharmacy
Who may be able to join
- Patients who have given their informed consent and expressed interest in participating in the study
- Asthmatic Patients
Who cannot join
- 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.
Trial locations and contacts
2 sites in 1 country.
About this study
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.
- Conditions
- Asthma
- Being tested
- 1, 2
- Keywords
- Asthma, Pharmaceutical intervention, Effect of a pharmaceutical intervention on the level of control of the asthmatic patient
- Medical subject headings
- Asthma
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
1Other
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.
2Other
The best intervention used in the pilot study will be chosen and included in the main study.
| Study group | Role | What they receive |
|---|---|---|
| 1 | 1. Pilot Study: 60 patients (all in the intervention group) 30 patients with intervention A and 30 patients with B intervention) Receives: Other: 1 | |
| 2 | Main Study: 600 patients (30 pharmacies control group and 30 pharmacies intervention group, 10 patients per pharmacy) Receives: Other: 2 |
What is being measured
The primary outcome is the main question the study is designed to answer.
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.
Measured: First a Pilot in 3 months and then the final study in 6 months
Secondary outcomes (2)
Compare disease control in patients who know their medication and those who doesn't.
Measured: First a Pilot in 3 months and then the final study in 6 months
Compare disease control in patients who comply with their medication with those who doesn't.
Measured: First a Pilot in 3 months and then the final study in 6 months
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted12 Mar 2010 (estimated)
- Study startApr 2010
- Primary completionJul 2011
- Study completionJul 2011
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (1)Papers the sponsor has linked to this study.
- Other trials for AsthmaStudies of the same condition, open and under way.
- More trials run by AstraZenecaThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Observational
- Time perspective
- Prospective
- Enrolment
- 384 participants (actual)
Sponsor and investigators
- Lead sponsor
- AstraZeneca
- Sponsor type
- Industry (pharma, biotech, devices)
- Responsible party
- Sponsor
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT01085474
- Sponsor's protocol ID
- NIS-RES-DUM-2009/1
- Status last verified
- Jan 2013
- First submitted
- 11 Mar 2010
- Last updated
- 28 Jan 2013
- Results posted
- No
- Data monitoring committee
- No
Publications
Garcia-Cardenas V, Sabater-Hernandez D, Kenny P, Martinez-Martinez F, Faus MJ, Benrimoj SI. Effect of a pharmacist intervention on asthma control. A cluster randomised trial. Respir Med. 2013 Sep;107(9):1346-55. doi: 10.1016/j.rmed.2013.05.014. Epub 2013 Jun 28.
PubMed 23810267
Study at a glance
From the registry record, last updated by the sponsor on 28 Jan 2013. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Effect of a Pharmaceutical Intervention on the Level of Control of the Asthmatic Patient
- ClinicalTrials.gov ID
- NCT01085474
- Acronym / sponsor ID
- NIS-RES-DUM-2009/1
- Conditions
- Asthma
- Keywords
- Asthma, Pharmaceutical intervention, Effect of a pharmaceutical intervention on the level of control of the asthmatic patient
- Study type
- Observational
- Recruitment status
- Completed
- Enrolment
- 384 participants (actual)
- Lead sponsor
- AstraZenecaIndustry (pharma, biotech, devices)
- Study start
- Apr 2010
- Primary completion
- Jul 2011 (actual)
- Study completion
- Jul 2011 (actual)
- First posted
- 12 Mar 2010 (estimated)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Study design
- Time perspective
- Prospective
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| 1 | – | Other: 11. Pilot Study: 60 patients (all in the intervention group) 30 patients with intervention A and 30 patients with B intervention) |
| 2 | – | Other: 2Main Study: 600 patients (30 pharmacies control group and 30 pharmacies intervention group, 10 patients per pharmacy) |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
- Study population
- 60 community pharmacies 10 patients per pharmacy
Key inclusion criteria (2 listed)
- Patients who have given their informed consent and expressed interest in participating in the study
- Asthmatic Patients
Key exclusion criteria (7 listed)
- 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.
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| 1In 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. | Other | 1 |
| 2The best intervention used in the pilot study will be chosen and included in the main study. | Other | 2 |
Primary outcome
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
2 secondary outcomes
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
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
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 28 Jan 2013.
- Derived from this study: PubMed 23810267Garcia-Cardenas V, Sabater-Hernandez D, Kenny P, Martinez-Martinez F, Faus MJ, Benrimoj SI. Effect of a pharmacist intervention on asthma control. A cluster randomised trial. Respir Med. 2013 Sep;107(9):1346-55. doi: 10.1016/j.rmed.2013.05.014. Epub 2013 Jun 28.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
The record lists no contact. Use the official record to reach the sponsor.
2 sites in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
An observational study of Asthma, run by AstraZeneca at 2 sites in Spain.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 2 inclusion and 7 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 28 Jan 2013. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 2 sites in Spain. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
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). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT01085474, which also lists 1 linked publication.
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 28 Jan 2013.