Clinical trial NCT03093363: Impact of a Hospital Pharmacist's Intervention on FENO (Fractional Exhaled Nitric Oxide) in Asthmatic Patients
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
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Asthma
Lead sponsor: University of Liege
Sponsor class: OTHER
First posted: 2017-03-28
Enrollment: 68
Sex: ALL
Standard ages: CHILD
ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: SUPPORTIVE_CARE

Brief 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. 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.


Eligibility criteria: Inclusion Criteria:

* 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

Exclusion Criteria:

* Treatment with oral corticosteroids to treat an asthma exacerbation within 4 weeks before the visit with the pneumologist

Exclusion Criteria during the study:

* 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)

Primary outcomes:
measure: Change from Baseline FENO (fractional exhaled nitric oxide) at 3 months
timeFrame: 3 months
Secondary outcomes:
measure: Change from Baseline FEV1 (forced expiratory volume in 1 second) at 3 months
timeFrame: 3 months
measure: Change from Baseline FVC (forced vital capacity) at 3 months
timeFrame: 3 months
measure: Change from Baseline FEV1/FVC at 3 months
timeFrame: 3 months
measure: Change from Baseline ACQ (Asthma Control Questionnaire) at 3 months
timeFrame: 3 months
measure: Change from Baseline ACT (Asthma Control Test) at 3 months
timeFrame: 3 months
measure: Change from Baseline miniAQLQ (Asthma Quality of Life Questionnaire) at 3 months
timeFrame: 3 months
measure: Change from Baseline MARS (Medication Adherence Report Scale) at 3 months
timeFrame: 3 months
measure: Change from Baseline MRA (Medication Refill Adherence) at 3 months
timeFrame: 3 months
measure: Change from Baseline score of the inhalation technique at 3 months
timeFrame: 3 months
measure: Change from Baseline number of severe exacerbations (during the 3 previous months) at 3 months
timeFrame: 3 months
measure: Change from Baseline smoking status at 3 months
timeFrame: 3 months
measure: Satisfaction of patients with the pharmacist's intervention, with a scale from 0 to 10
timeFrame: 3 months after intervention
measure: Changes in lifestyle related to asthma (free text field to complete by the patient)
timeFrame: 3 months after intervention
Other outcomes:
Locations:
Study officials:
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