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

Asthma Clinical Trial

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

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT03093363
• Other study ID #: B707201629850
• Status: Completed
• Phase: N/A
• First received: March 11, 2017
• Last updated: October 24, 2017
• Start date: October 31, 2016
• Est. completion date: April 30, 2017

Study information

• Verified date: October 2017
• Source: University Hospital of Liege
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical 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. 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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 68
• Est. completion date: April 30, 2017
• Est. primary completion date: April 30, 2017
• Accepts healthy volunteers: No
• Gender: All
• Age group: N/A and older

Eligibility

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)

Related Conditions & MeSH terms

• Asthma

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
• Questionnaires for control group
- Detailed questionnaire on asthma and treatments (atopy, comorbidities, smoking status, asthma control, adverse effects of treatments, etc.)

Locations

Country	Name	City	State
n/a

Sponsors (1)

Lead Sponsor	Collaborator
University Hospital of Liege

Outcome

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