AsthmaNCT00263159
Pharmaceutical Care for Asthma Control Improvement (PHARMACI)-Study
A study testing Pharmaceutical care for asthma patients in people with Asthma, run by University Ghent at 1 site in Belgium.
Trial summary
The objective of this study is to evaluate the therapeutic effectiveness and cost-effectivity of pharmaceutical care for asthma patients. Read more about this study
- Who is it for?
- Ages 18 to 50 years
- Conditions the study is for
- Asthma
- What is being tested?
- Pharmaceutical care for asthma patients
- Type of treatment
- Surgery or procedure
- How many people
- 221 participants
- Where
- 1 siteBelgium
- Study dates
- Jan 2006to Oct 2006
- 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 50 years
- All sexes
- No healthy volunteers
- Adult
Who may be able to join
- Patients with persistent asthma
- Asthma treatment for at least 12 months
- Regular visitors of the participating community pharmacy
Who cannot join
- Severe co-morbidity
- > 10 pack-years smoking history
- Asthma Control Test score < 15 or =25
Trial locations and contacts
1 site in 1 country.
About this study
Official title: Pharmaceutical Care for Asthma Control Improvement
The objective of this study is to evaluate the therapeutic effectiveness and cost-effectivity of pharmaceutical care for asthma patients.
Read the detailed description
The objective of this study is to evaluate the therapeutic effectiveness and cost-effectivity of pharmaceutical care for asthma patients. Patients will be randomly allocated to the control group (= no input from pharmacist) or intervention group (= with pharmaceutical care at baseline and follow-up visits over 6 months).
- Conditions
- Asthma
- Being tested
- Pharmaceutical care for asthma patients
- Medical subject headings
- Asthma
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Pharmaceutical care for asthma patientsProcedure or surgery
What is being measured
The primary outcome is the main question the study is designed to answer.
The difference between study groups in the change of asthma control from baseline and follow-up visits
Measured: after 1, 3 and 6 months
Secondary outcomes (9)
Peak flow
Measured: after 3 and 6 months
Knowledge of asthma and treatment
Measured: after 6 months
Asthma quality of life questionnaire (AQLQ)
Measured: after 6 months
Therapy adherence
Inhalation techniques
Measured: after 6 months
Smoking
Measured: after 6 months
Asthma exacerbations
Measured: after 6 months
General Practitioner (GP) visits, emergency room visits and hospitalisations
Working days lost and school days lost
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted7 Dec 2005 (estimated)
- Study startJan 2006
- Study completionOct 2006
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
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Enrolment
- 221 participants (actual)
Sponsor and investigators
- Lead sponsor
- University Ghent
- Sponsor type
- University, hospital or other
- Investigators
- Guy Brusselle, MD, PhD, Principal investigator, University Hospital, Ghent
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT00263159
- Sponsor's protocol ID
- 2005/320
- Status last verified
- Dec 2007
- First submitted
- 6 Dec 2005
- Last updated
- 28 Dec 2007
- Results posted
- No
- Data monitoring committee
- No
Study at a glance
From the registry record, last updated by the sponsor on 28 Dec 2007. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Pharmaceutical Care for Asthma Control Improvement
- ClinicalTrials.gov ID
- NCT00263159
- Acronym / sponsor ID
- 2005/320
- Conditions
- Asthma
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 221 participants (actual)
- Lead sponsor
- University GhentUniversity, hospital or other
- Study start
- Jan 2006
- Study completion
- Oct 2006 (actual)
- First posted
- 7 Dec 2005 (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.
The objective of this study is to evaluate the therapeutic effectiveness and cost-effectivity of pharmaceutical care for asthma patients.
Detailed description
The objective of this study is to evaluate the therapeutic effectiveness and cost-effectivity of pharmaceutical care for asthma patients. Patients will be randomly allocated to the control group (= no input from pharmacist) or intervention group (= with pharmaceutical care at baseline and follow-up visits over 6 months).
Study design
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
Who may qualify
- Ages
- 18 to 50 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult
Key inclusion criteria (3 listed)
- Patients with persistent asthma
- Asthma treatment for at least 12 months
- Regular visitors of the participating community pharmacy
Key exclusion criteria (3 listed)
- Severe co-morbidity
- > 10 pack-years smoking history
- Asthma Control Test score < 15 or =25
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 care for asthma patients | Procedure or surgery | – |
Primary outcome
The difference between study groups in the change of asthma control from baseline and follow-up visits
Time frame: after 1, 3 and 6 months
9 secondary outcomes
Peak flow
Time frame: after 3 and 6 months
Knowledge of asthma and treatment
Time frame: after 6 months
Asthma quality of life questionnaire (AQLQ)
Time frame: after 6 months
Therapy adherence
Inhalation techniques
Time frame: after 6 months
Smoking
Time frame: after 6 months
Asthma exacerbations
Time frame: after 6 months
General Practitioner (GP) visits, emergency room visits and hospitalisations
Working days lost and school days lost
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 Dec 2007.
- Website of the University GhentLink provided by the sponsor.
Related trials for Asthma
RecruitingObservational study
Asthma and Primary Arterial Hypertension: an Inflammatory Link?
Asthma Bronchial
RecruitingPhase 3
A Study to Learn About the Study Medicine Called Tilrekimig in People With Severe Asthma
Asthma
Enrolling by invitationObservational study
Firefighter's Longitudinal Airway and Respiratory Exposome/Multiome Study (FLARES)
Anosmia, Chronic Obstructive Pulmonary Disease
RecruitingPhase 2
Dose Range Finding Study to Assess Efficacy and Safety of Tozorakimab in Adults With Uncontrolled Asthma on Medium-to-High Dose Inhaled Corticosteroids
Asthma
Active, not recruitingPhase 1
A Phase 1, Randomized, Double-blind, Placebo-controlled Study Evaluating AMG 691 in Healthy Participants and Participants With Mild-to-Moderate Asthma
Asthma
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.
Guy Brusselle, MD, PhD principal investigator
University Hospital, Ghent
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 for asthma patients in people with Asthma, run by University Ghent at 1 site in Belgium.
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 3 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 28 Dec 2007. 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 Belgium. 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?
The difference between study groups in the change of asthma control from baseline and follow-up visits (time frame: after 1, 3 and 6 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 28 Dec 2007.