AsthmaNCT03093363
Impact of a Hospital Pharmacist's Intervention on FENO (Fractional Exhaled Nitric Oxide) in Asthmatic Patients
A study testing Pharmacist's intervention in people with Asthma, run by University of Liege.
Trial summary
The impact of a pharmacist's intervention on asthma control has now been well demonstrated, but its effect on inflammatory markers of FENO (Fractional exhaled nitric oxide) in asthmatic patients has been little studied in the literature. Read more about this study
- Who is it for?
- Any age
- Conditions the study is for
- Asthma
- What is being tested?
- Pharmacist's intervention
- Type of treatment
- Vaccines
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 68 participants
- Where
- No sites listed yet
- Study dates
- 31 Oct 2016to 30 Apr 2017
- 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 Any age
- All sexes
- No healthy volunteers
- Child, Adult, Older adult
Who may be able to join
- Adult asthmatics (definition of asthma: FEV1 [forced expiratory volume in 1 second] reversibility of at least 12% and 200 mL after 400 mcg of salbutamol and/or PC20M [provocative concentration of methacholine causing a 20% fall in FEV1]<16 mg/mL)
- unchanged or increased dose of inhaled corticosteroids prescribed by the pneumologist at the visit
- FENO (fractional exhaled nitric oxide) > or = 25 ppb
Who cannot join
- Treatment with oral corticosteroids to treat an asthma exacerbation within 4 weeks before the visit with the pneumologist
- Change of the dose of ICS (inhaled corticosteroids) during the follow-up of 3 months after the pharmacist's intervention
- Severe asthma exacerbation requiring oral corticosteroids within the 4 weeks before the follow-up visit (3 months after the pharmacist's intervention)
About this study
Official title: Study of the Impact of a Hospital Pharmacist's Intervention in Collaboration With Pneumologists on Bronchial Inflammation of Outpatient Asthmatic Patients Seen in University Hospital of Liege
The impact of a pharmacist's intervention on asthma control has now been well demonstrated, but its effect on inflammatory markers of FENO (Fractional exhaled nitric oxide) in asthmatic patients has been little studied in the literature. The aim of this study is to investigate the impact of a pharmacist's intervention on FENO in patients seen in clinical practice by a pneumologist in a secondary university center.
- Conditions
- Asthma
- Being tested
- Pharmacist's intervention, Questionnaires for control group
- Medical subject headings
- Asthma
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Pharmacist's interventionOther
Pharmacist's intervention with asthmatic patients:
- Detailed questionnaire on asthma and treatments (atopy, comorbidities, smoking status, asthma control, adverse effects of treatments, etc.)
- Explanation of asthma and inflammation
- Explanation of triggers and how to avoid it
- Explanation of asthma treatments
- Explanation of the inhalation technique with a physical demonstration
- Emphasis on treatment adherence
- Assessment of comorbidities and their treatment
- Emphasis on influenza vaccination
Questionnaires for control groupOther
- Detailed questionnaire on asthma and treatments (atopy, comorbidities, smoking status, asthma control, adverse effects of treatments, etc.)
| Study group | Role | What they receive |
|---|---|---|
| Intervention group | Other | Asthmatic patients with the pharmacist's intervention Receives: Other: Pharmacist's intervention |
| Control group | Other | Asthmatic patients without the pharmacist's intervention (only questionnaires) Receives: Other: Questionnaires for control group |
What is being measured
The primary outcome is the main question the study is designed to answer.
Change from Baseline FENO (fractional exhaled nitric oxide) at 3 months
Fractional exhaled nitric oxide
Measured: 3 months
Secondary outcomes (13)
Change from Baseline FEV1 (forced expiratory volume in 1 second) at 3 months
Measured: 3 months
Change from Baseline FVC (forced vital capacity) at 3 months
Measured: 3 months
Change from Baseline FEV1/FVC at 3 months
Measured: 3 months
Change from Baseline ACQ (Asthma Control Questionnaire) at 3 months
Measured: 3 months
Change from Baseline ACT (Asthma Control Test) at 3 months
Measured: 3 months
Change from Baseline miniAQLQ (Asthma Quality of Life Questionnaire) at 3 months
Measured: 3 months
Change from Baseline MARS (Medication Adherence Report Scale) at 3 months
Measure of treatment adherence
Measured: 3 months
Change from Baseline MRA (Medication Refill Adherence) at 3 months
Measure of treatment adherence
Measured: 3 months
Change from Baseline score of the inhalation technique at 3 months
Measured: 3 months
Change from Baseline number of severe exacerbations (during the 3 previous months) at 3 months
Severe exacerbations are asthma exacerbations requiring oral corticosteroids
Measured: 3 months
Change from Baseline smoking status at 3 months
Smoking status is recorded as non-smoker, ex-smoker, current smoker
Measured: 3 months
Satisfaction of patients with the pharmacist's intervention, with a scale from 0 to 10
Measured: 3 months after intervention
Changes in lifestyle related to asthma (free text field to complete by the patient)
Measured: 3 months after intervention
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted28 Mar 2017
- Study start31 Oct 2016
- Primary completion30 Apr 2017
- Study completion30 Apr 2017
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
- Supportive care
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Single blind
- Who is masked
- Participant
- Enrolment
- 68 participants (actual)
Sponsor and investigators
- Lead sponsor
- University of Liege
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Renaud Louis, University of Liege
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT03093363
- Sponsor's protocol ID
- B707201629850
- Status last verified
- Oct 2017
- First submitted
- 11 Mar 2017
- Last updated
- 25 Oct 2017
- Results posted
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- Undecided
Study at a glance
From the registry record, last updated by the sponsor on 25 Oct 2017. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Study of the Impact of a Hospital Pharmacist's Intervention in Collaboration With Pneumologists on Bronchial Inflammation of Outpatient Asthmatic Patients Seen in University Hospital of Liege
- ClinicalTrials.gov ID
- NCT03093363
- Acronym / sponsor ID
- B707201629850
- Conditions
- Asthma
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 68 participants (actual)
- Lead sponsor
- University of LiegeUniversity, hospital or other
- Study start
- 31 Oct 2016 (actual)
- Primary completion
- 30 Apr 2017 (actual)
- Study completion
- 30 Apr 2017 (actual)
- First posted
- 28 Mar 2017 (actual)
- 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 impact of a pharmacist's intervention on asthma control has now been well demonstrated, but its effect on inflammatory markers of FENO (Fractional exhaled nitric oxide) in asthmatic patients has been little studied in the literature. The aim of this study is to investigate the impact of a pharmacist's intervention on FENO in patients seen in clinical practice by a pneumologist in a secondary university center.
Study design
- Primary purpose
- Supportive care
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Single blind (participant)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Intervention group | Other | Other: Pharmacist's interventionAsthmatic patients with the pharmacist's intervention |
| Control group | Other | Other: Questionnaires for control groupAsthmatic patients without the pharmacist's intervention (only questionnaires) |
Who may qualify
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Child, Adult, Older adult
Key inclusion criteria (3 listed)
- Adult asthmatics (definition of asthma: FEV1 [forced expiratory volume in 1 second] reversibility of at least 12% and 200 mL after 400 mcg of salbutamol and/or PC20M [provocative concentration of methacholine causing a 20% fall in FEV1]<16 mg/mL)
- unchanged or increased dose of inhaled corticosteroids prescribed by the pneumologist at the visit
- FENO (fractional exhaled nitric oxide) > or = 25 ppb
Key exclusion criteria (3 listed)
- Treatment with oral corticosteroids to treat an asthma exacerbation within 4 weeks before the visit with the pneumologist
- Change of the dose of ICS (inhaled corticosteroids) during the follow-up of 3 months after the pharmacist's intervention
- Severe asthma exacerbation requiring oral corticosteroids within the 4 weeks before the follow-up visit (3 months after the pharmacist's intervention)
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's interventionPharmacist's intervention with asthmatic patients: * Detailed questionnaire on asthma and treatments (atopy, comorbidities, smoking status, asthma control, adverse effects of treatments, etc.) * Explanation of asthma and inflammation * Explanation of triggers and how to avoid it * Explanation of asthma treatments * Explanation of the inhalation technique with a physical demonstration * Emphasis on treatment adherence * Assessment of comorbidities and their treatment * Emphasis on influenza vaccination | Other | Intervention group |
| Questionnaires for control group- Detailed questionnaire on asthma and treatments (atopy, comorbidities, smoking status, asthma control, adverse effects of treatments, etc.) | Other | Control group |
Primary outcome
Change from Baseline FENO (fractional exhaled nitric oxide) at 3 months
Time frame: 3 months
Fractional exhaled nitric oxide
13 secondary outcomes
Change from Baseline FEV1 (forced expiratory volume in 1 second) at 3 months
Time frame: 3 months
Change from Baseline FVC (forced vital capacity) at 3 months
Time frame: 3 months
Change from Baseline FEV1/FVC at 3 months
Time frame: 3 months
Change from Baseline ACQ (Asthma Control Questionnaire) at 3 months
Time frame: 3 months
Change from Baseline ACT (Asthma Control Test) at 3 months
Time frame: 3 months
Change from Baseline miniAQLQ (Asthma Quality of Life Questionnaire) at 3 months
Time frame: 3 months
Change from Baseline MARS (Medication Adherence Report Scale) at 3 months
Time frame: 3 months
Change from Baseline MRA (Medication Refill Adherence) at 3 months
Time frame: 3 months
Change from Baseline score of the inhalation technique at 3 months
Time frame: 3 months
Change from Baseline number of severe exacerbations (during the 3 previous months) at 3 months
Time frame: 3 months
Change from Baseline smoking status at 3 months
Time frame: 3 months
Satisfaction of patients with the pharmacist's intervention, with a scale from 0 to 10
Time frame: 3 months after intervention
Changes in lifestyle related to asthma (free text field to complete by the patient)
Time frame: 3 months after intervention
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 25 Oct 2017.
- Individual participant dataSharing planned: Undecided
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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.
Questions about this trial
What is this clinical trial studying?
A study testing Pharmacist's intervention in people with Asthma, run by University of Liege.
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 25 Oct 2017. Status can change between updates, so confirm with the study contact before making plans.
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?
Change from Baseline FENO (fractional exhaled nitric oxide) at 3 months (time frame: 3 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 25 Oct 2017.