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

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.

Study Overview

• Status: Completed
• Conditions: Asthma
• Intervention / Treatment: Other: Pharmacist's intervention; Other: Questionnaires for control group

• Study Type: Interventional
• Enrollment (Actual): 68
• Phase: Not Applicable

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: Child; Adult; Older Adult
• Accepts Healthy Volunteers: No
• Genders Eligible for Study: All

Description

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)

Study Plan

How is the study designed?

Design Details

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

Number of Arms

2

Arms and Interventions

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

What is the study measuring?

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

Collaborators and Investigators

• Sponsor: University of Liege

Study record dates

Study Major Dates

• Study Start (Actual): October 31, 2016
• Primary Completion (Actual): April 30, 2017
• Study Completion (Actual): April 30, 2017

Study Registration Dates

• First Submitted: March 11, 2017
• First Submitted That Met QC Criteria: March 21, 2017
• First Posted (Actual): March 28, 2017

Study Record Updates

• Last Update Posted (Actual): October 25, 2017
• Last Update Submitted That Met QC Criteria: October 24, 2017
• Last Verified: October 1, 2017

More Information

Terms related to this study

• Additional Relevant MeSH Terms: Respiratory Tract Diseases; Immune System Diseases; Lung Diseases; Hypersensitivity, Immediate; Bronchial Diseases; Lung Diseases, Obstructive; Respiratory Hypersensitivity; Hypersensitivity; Asthma
• Other Study ID Numbers: B707201629850

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: Undecided

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No