Bronchial AsthmaNCT02046759
A Comparative Study of an Integrated Pharmaceutical Care Plan and a Routine Care in Bronchial Asthma
A study testing Pharmacist- Intervention and Routine Care in people with Bronchial Asthma, run by Ain Shams University at 1 site in Egypt.
Trial summary
The aim of the study is to compare the effect of asthma care by clinical pharmacist intervention versus routine care on asthma control. Read more about this study
- Who is it for?
- Ages 18 to 70 years
- Conditions the study is for
- Bronchial Asthma
- What is being tested?
- Pharmacist- Intervention and Routine Care
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 80 participants
- Where
- 1 siteEgypt
- Study dates
- Mar 2012to Jan 2013
- 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 70 years
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- patient with clinical diagnosis of bronchial asthma
- responsible for administering their own asthma medications.
Who cannot join
- patients who were not responsible for administering their own asthma medications.
- patients with cognitive defects, other pulmonary disease e.g. Chronic Obstructive Pulmonary Disease (COPD), experiencing illness with asthma-like symptoms e.g. Congestive Heart Failure, evidence of fixed airway obstruction
- patients unavailable for 2-month follow-up.
- patients who did not provide written informed consent.
Trial locations and contacts
1 site in 1 country.
About this study
The aim of the study is to compare the effect of asthma care by clinical pharmacist intervention versus routine care on asthma control.
- Conditions
- Bronchial Asthma
- Being tested
- Pharmacist- Intervention, Routine Care
- Medical subject headings
- Asthma
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Pharmacist- InterventionOther
Also called Patient Education, Asthma Action Plan, Shared Decision Making
Patients received additional education on basic facts about asthma, role of medications, the difference between long-term control medications and quick-relief medications, as well as patient skills in the first visit then reinforcement every two weeks.. The importance of proper inhaler technique, avoidance of asthma triggers and self-monitoring of asthma were also highlighted. Visual aids, physical demonstration as well as written information resources were supplied. Asthma care plans were tailored to patient needs and preferences. Patients were informed how to detect early signs of worsening asthma, when and how to seek medical care as appropriate.
Routine CareOther
Patients received usual care delivered by physician without pharmacist intervention. Patients were prescribed asthma medication with summarized basic information on asthma and medication use. Follow-up visits were not planned on consistent basis, but rather individually according to the disease status. No asthma action plans were provided.
| Study group | Role | What they receive |
|---|---|---|
| Pharmacist-Intervention | Experimental | Not described Receives: Other: Pharmacist- Intervention |
| Routine Care | Active comparator | Not described Receives: Other: Routine Care |
What is being measured
The primary outcome is the main question the study is designed to answer.
Asthma Control Questionnaire
Measured: at baseline & after 2 months of therapy
Secondary outcomes (5)
Forced Expiratory Volume in 1 second (FEV1%)
Measured: at baseline & after 2 months of therapy
Rescue Medication SABA (number of puffs used most days)
Measured: at baseline & after 2 months of therapy
Inhaled Corticosteroid Use (number of puffs used/day)
Measured: at baseline & after 2 months of therapy
Number of courses of systemic steroid used
Measured: During 2 months of therapy
Number of ER visits/ Hospitalization
Measured: During 2 months of therapy
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted28 Jan 2014 (estimated)
- Study startMar 2012
- Primary completionJan 2013
- Study completionJan 2013
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Bronchial AsthmaStudies of the same condition, open and under way.
- More trials run by Ain Shams UniversityThe 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
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Health services research
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Enrolment
- 80 participants (actual)
Sponsor and investigators
- Lead sponsor
- Ain Shams University
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Rana Rasheed Ibrahim Farrag, Ain Shams University
- Investigators
- Rana R Farrag, Principal investigator, Ahram Canadian University
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT02046759
- Sponsor's protocol ID
- Asthma-001
- Status last verified
- Jan 2014
- First submitted
- 24 Jan 2014
- Last updated
- 28 Jan 2014
- Results posted
- No
- Data monitoring committee
- Yes
Study at a glance
From the registry record, last updated by the sponsor on 28 Jan 2014. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- A Comparative Study of an Integrated Pharmaceutical Care Plan and a Routine Care in Bronchial Asthma
- ClinicalTrials.gov ID
- NCT02046759
- Acronym / sponsor ID
- Asthma-001
- Conditions
- Bronchial Asthma
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 80 participants (actual)
- Lead sponsor
- Ain Shams UniversityUniversity, hospital or other
- Study start
- Mar 2012
- Primary completion
- Jan 2013 (actual)
- Study completion
- Jan 2013 (actual)
- First posted
- 28 Jan 2014 (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 aim of the study is to compare the effect of asthma care by clinical pharmacist intervention versus routine care on asthma control.
Study design
- Primary purpose
- Health services research
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Pharmacist-Intervention | Experimental | Other: Pharmacist- Intervention |
| Routine Care | Active comparator | Other: Routine Care |
Who may qualify
- Ages
- 18 to 70 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (2 listed)
- patient with clinical diagnosis of bronchial asthma
- responsible for administering their own asthma medications.
Key exclusion criteria (4 listed)
- patients who were not responsible for administering their own asthma medications.
- patients with cognitive defects, other pulmonary disease e.g. Chronic Obstructive Pulmonary Disease (COPD), experiencing illness with asthma-like symptoms e.g. Congestive Heart Failure, evidence of fixed airway obstruction
- patients unavailable for 2-month follow-up.
- patients who did not provide written informed consent.
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 |
|---|---|---|
| Pharmacist- InterventionAlso: Patient Education, Asthma Action Plan, Shared Decision MakingPatients received additional education on basic facts about asthma, role of medications, the difference between long-term control medications and quick-relief medications, as well as patient skills in the first visit then reinforcement every two weeks.. The importance of proper inhaler technique, avoidance of asthma triggers and self-monitoring of asthma were also highlighted. Visual aids, physical demonstration as well as written information resources were supplied. Asthma care plans were tailored to patient needs and preferences. Patients were informed how to detect early signs of worsening asthma, when and how to seek medical care as appropriate. | Other | Pharmacist-Intervention |
| Routine CarePatients received usual care delivered by physician without pharmacist intervention. Patients were prescribed asthma medication with summarized basic information on asthma and medication use. Follow-up visits were not planned on consistent basis, but rather individually according to the disease status. No asthma action plans were provided. | Other | Routine Care |
Primary outcome
Asthma Control Questionnaire
Time frame: at baseline & after 2 months of therapy
5 secondary outcomes
Forced Expiratory Volume in 1 second (FEV1%)
Time frame: at baseline & after 2 months of therapy
Rescue Medication SABA (number of puffs used most days)
Time frame: at baseline & after 2 months of therapy
Inhaled Corticosteroid Use (number of puffs used/day)
Time frame: at baseline & after 2 months of therapy
Number of courses of systemic steroid used
Time frame: During 2 months of therapy
Number of ER visits/ Hospitalization
Time frame: During 2 months of therapy
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 2014.
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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.
Rana R Farrag principal investigator
Ahram Canadian University
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Pharmacist- Intervention and Routine Care in people with Bronchial Asthma, run by Ain Shams University at 1 site in Egypt.
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 4 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 2014. 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 Egypt. 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 Questionnaire (time frame: at baseline & after 2 months of therapy). 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 Jan 2014.