Impact of a Hospital Pharmacist's Intervention on FENO (Fractional Exhaled Nitric Oxide) in Asthmatic Patients

Study Overview
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Brief Summary
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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.

Official Title
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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

Conditions
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Asthma

Intervention / Treatment
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* Other: Pharmacist's intervention
* Other: Questionnaires for control group


Participation Criteria
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Eligibility Criteria
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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)
Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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No

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Supportive Care
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Single


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Other: Intervention group<br>Asthmatic patients with the pharmacist's intervention | Other: Pharmacist's intervention<br>* 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<br>|
| Other: Control group<br>Asthmatic patients without the pharmacist's intervention (only questionnaires) | Other: Questionnaires for control group<br>* - Detailed questionnaire on asthma and treatments (atopy, comorbidities, smoking status, asthma control, adverse effects of treatments, etc.)<br>|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Change from Baseline FENO (fractional exhaled nitric oxide) at 3 months | Fractional exhaled nitric oxide | 3 months | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Change from Baseline FEV1 (forced expiratory volume in 1 second) at 3 months |  | 3 months | 
| Change from Baseline FVC (forced vital capacity) at 3 months |  | 3 months | 
| Change from Baseline FEV1/FVC at 3 months |  | 3 months | 
| Change from Baseline ACQ (Asthma Control Questionnaire) at 3 months |  | 3 months | 
| Change from Baseline ACT (Asthma Control Test) at 3 months |  | 3 months | 
| Change from Baseline miniAQLQ (Asthma Quality of Life Questionnaire) at 3 months |  | 3 months | 
| Change from Baseline MARS (Medication Adherence Report Scale) at 3 months | Measure of treatment adherence | 3 months | 
| Change from Baseline MRA (Medication Refill Adherence) at 3 months | Measure of treatment adherence | 3 months | 
| Change from Baseline score of the inhalation technique at 3 months |  | 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 | 3 months | 
| Change from Baseline smoking status at 3 months | Smoking status is recorded as non-smoker, ex-smoker, current smoker | 3 months | 
| Satisfaction of patients with the pharmacist's intervention, with a scale from 0 to 10 |  | 3 months after intervention | 
| Changes in lifestyle related to asthma (free text field to complete by the patient) |  | 3 months after intervention |