AsthmaNCT01644357
Effect of a 12-month Pharmaceutical Care Program on Control of Severe Asthma
A study testing Pharmaceutical care in people with Asthma and Quality of Life, run by Federal University of Bahia at 1 site in Brazil.
Trial summary
Only a few well-designed studies have investigated the effect of pharmaceutical care on asthma patients and to date there are no published studies investigating this effect specifically on severe and refractory asthma. Read more about this study
- Who is it for?
- Ages 18 to 80 years
- Conditions the study is for
- Asthma, Quality of Life
- What is being tested?
- Pharmaceutical care
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 40 participants
- Where
- 1 siteBrazil
- Study dates
- Aug 2008to Jul 2014
- Phase
- Interventional
- 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 to 80 years
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- Patients with severe/refractory asthma presenting other respiratory disease,
- ≥ 18 years of age,
- using high dose of inhaled corticosteroids (≥ 800mcg of budesonide or equivalent)
- FEV1<60%,
- regular visitor of the pharmacy and the physicians.
Who cannot join
- participation in other intervention study during this study,
- living in other cities,
- could not participate in all visits of the study
Trial locations and contacts
1 site in 1 country.
Brazil1 site
Program for Asthma Control (ProAR) of the Federal University of Bahia
Salvador, Estado de Bahia, 40060-330
About this study
Official title: Effect of a 12-month Pharmaceutical Care Program on Severe Asthma Patient. A Randomized Clinical Trial
Only a few well-designed studies have investigated the effect of pharmaceutical care on asthma patients and to date there are no published studies investigating this effect specifically on severe and refractory asthma.
The objective of this study is evaluate the effect of pharmaceutical care on asthma control and quality of life (QoL) of patients with severe or refractory asthma compared with pharmacist dispensation only.
- Conditions
- Asthma, Quality of Life
- Being tested
- Pharmaceutical care
- Medical subject headings
- Asthma
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Pharmaceutical careOther
Pharmacist intervention, focused on the optimization of drug therapy, identification and resolution of drug related problems, resulting in best asthma control and quality of life. Pharmacists document their initial and monthly follow up encounters using a specified form. An action plan for self management of these patients was prepared and discussed aiming at early identification and treatment of an exacerbation episode. Meetings will be held weekly with intervention team to discuss action plan and measure of outcomes of all problems identified.
| Study group | Role | What they receive |
|---|---|---|
| Dispensing only | No intervention | Non clinical pharmacists will dispense drugs to patients and usual care will be offered. |
| Pharmaceutical care | Experimental | Patients on experimental group will receive counseling and education on the asthma condition, medication and lifestyle issues. In all visits, the inhaler technique will be reviewed, adherence to treatment and drug related problems were checked. If necessary the patient will be referred to the respiratory specialist to change the medication or to prescribe dose adjustment. Pharmacists document their initial and monthly follow up encounters using a specified form. Receives: Other: Pharmaceutical care |
What is being measured
The primary outcome is the main question the study is designed to answer.
asthma control of symptoms
Measured by Asthma Control Questionnaire and medical evaluation
Measured: 12 months
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted19 Jul 2012 (estimated)
- Study startAug 2008
- Primary completionAug 2011
- Study completionJul 2014
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for AsthmaStudies of the same condition, open and under way.
- 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
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Health services research
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Enrolment
- 40 participants (actual)
Sponsor and investigators
- Lead sponsor
- Federal University of Bahia
- Sponsor type
- University, hospital or other
- Collaborators
- Conselho Nacional de Desenvolvimento Científico e Tecnológico
- Responsible party
- Principal investigator, Pablo de Moura Santos, Federal University of Bahia
- Investigators
- Pablo M Santos, Master, Principal investigator, Federal University of BahiaÁlvaro A Cruz, Professor, Study director, Federal University of BahiaLúcia B Noblat, Professor, Study chair, Federal University of Bahia
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT01644357
- Sponsor's protocol ID
- ATENFAR-PROAR
- Status last verified
- Sep 2023
- First submitted
- 17 Jul 2012
- Last updated
- 13 Sep 2023
- Results posted
- No
- Data monitoring committee
- No
- Individual data sharing
- No: Publish a paper in a cientific journal
Study at a glance
From the registry record, last updated by the sponsor on 13 Sep 2023. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Effect of a 12-month Pharmaceutical Care Program on Severe Asthma Patient. A Randomized Clinical Trial
- ClinicalTrials.gov ID
- NCT01644357
- Acronym / sponsor ID
- ATENFAR-PROAR
- Conditions
- Asthma, Quality of Life
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 40 participants (actual)
- Lead sponsor
- Federal University of BahiaUniversity, hospital or other
- Collaborators
- Conselho Nacional de Desenvolvimento Científico e Tecnológico
- Study start
- Aug 2008
- Primary completion
- Aug 2011 (actual)
- Study completion
- Jul 2014 (actual)
- First posted
- 19 Jul 2012 (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.
Only a few well-designed studies have investigated the effect of pharmaceutical care on asthma patients and to date there are no published studies investigating this effect specifically on severe and refractory asthma.
The objective of this study is evaluate the effect of pharmaceutical care on asthma control and quality of life (QoL) of patients with severe or refractory asthma compared with pharmacist dispensation only.
Study design
- Primary purpose
- Health services research
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Dispensing only | No intervention | –Non clinical pharmacists will dispense drugs to patients and usual care will be offered. |
| Pharmaceutical care | Experimental | Other: Pharmaceutical carePatients on experimental group will receive counseling and education on the asthma condition, medication and lifestyle issues. In all visits, the inhaler technique will be reviewed, adherence to treatment and drug related problems were checked. If necessary the patient will be referred to the respiratory specialist to change the medication or to prescribe dose adjustment. Pharmacists document their initial and monthly follow up encounters using a specified form. |
Who may qualify
- Ages
- 18 to 80 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (5 listed)
- Patients with severe/refractory asthma presenting other respiratory disease,
- ≥ 18 years of age,
- using high dose of inhaled corticosteroids (≥ 800mcg of budesonide or equivalent)
- FEV1<60%,
- regular visitor of the pharmacy and the physicians.
Key exclusion criteria (3 listed)
- participation in other intervention study during this study,
- living in other cities,
- could not participate in all visits of the study
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 |
|---|---|---|
| Pharmaceutical carePharmacist intervention, focused on the optimization of drug therapy, identification and resolution of drug related problems, resulting in best asthma control and quality of life. Pharmacists document their initial and monthly follow up encounters using a specified form. An action plan for self management of these patients was prepared and discussed aiming at early identification and treatment of an exacerbation episode. Meetings will be held weekly with intervention team to discuss action plan and measure of outcomes of all problems identified. | Other | Pharmaceutical care |
Primary outcome
asthma control of symptoms
Time frame: 12 months
Measured by Asthma Control Questionnaire and medical evaluation
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 13 Sep 2023.
- Individual participant dataSharing planned: No. Publish a paper in a cientific journal
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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.
Pablo M Santos, Master principal investigator
Federal University of Bahia
Álvaro A Cruz, Professor study director
Federal University of Bahia
Lúcia B Noblat, Professor study chair
Federal University of Bahia
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Pharmaceutical care in people with Asthma and Quality of Life, run by Federal University of Bahia at 1 site in Brazil.
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 5 inclusion and 3 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 13 Sep 2023. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in Brazil. 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?
asthma control of symptoms (time frame: 12 months). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
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 13 Sep 2023.