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

Primary Purpose

Asthma

Status
Completed
Phase
Not Applicable
Locations
Study Type
Interventional
Intervention
Pharmacist's intervention
Questionnaires for control group
Sponsored by
University of Liege
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional supportive care trial for Asthma

Eligibility Criteria

undefined - undefined (Child, Adult, Older Adult)All SexesDoes not accept healthy volunteers

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)

Sites / Locations

    Arms of the Study

    Arm 1

    Arm 2

    Arm Type

    Other

    Other

    Arm Label

    Intervention group

    Control group

    Arm Description

    Asthmatic patients with the pharmacist's intervention

    Asthmatic patients without the pharmacist's intervention (only questionnaires)

    Outcomes

    Primary Outcome Measures

    Change from Baseline FENO (fractional exhaled nitric oxide) at 3 months
    Fractional exhaled nitric oxide

    Secondary Outcome Measures

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

    Full Information

    First Posted
    March 11, 2017
    Last Updated
    October 24, 2017
    Sponsor
    University of Liege
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    1. Study Identification

    Unique Protocol Identification Number
    NCT03093363
    Brief Title
    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

    2. Study Status

    Record Verification Date
    October 2017
    Overall Recruitment Status
    Completed
    Study Start Date
    October 31, 2016 (Actual)
    Primary Completion Date
    April 30, 2017 (Actual)
    Study Completion Date
    April 30, 2017 (Actual)

    3. Sponsor/Collaborators

    Responsible Party, by Official Title
    Principal Investigator
    Name of the Sponsor
    University of Liege

    4. Oversight

    Studies a U.S. FDA-regulated Drug Product
    No
    Studies a U.S. FDA-regulated Device Product
    No

    5. Study Description

    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.

    6. Conditions and Keywords

    Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
    Asthma

    7. Study Design

    Primary Purpose
    Supportive Care
    Study Phase
    Not Applicable
    Interventional Study Model
    Parallel Assignment
    Masking
    Participant
    Allocation
    Randomized
    Enrollment
    68 (Actual)

    8. Arms, Groups, and Interventions

    Arm Title
    Intervention group
    Arm Type
    Other
    Arm Description
    Asthmatic patients with the pharmacist's intervention
    Arm Title
    Control group
    Arm Type
    Other
    Arm Description
    Asthmatic patients without the pharmacist's intervention (only questionnaires)
    Intervention Type
    Other
    Intervention Name(s)
    Pharmacist's intervention
    Intervention Description
    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
    Intervention Type
    Other
    Intervention Name(s)
    Questionnaires for control group
    Intervention Description
    - Detailed questionnaire on asthma and treatments (atopy, comorbidities, smoking status, asthma control, adverse effects of treatments, etc.)
    Primary Outcome Measure Information:
    Title
    Change from Baseline FENO (fractional exhaled nitric oxide) at 3 months
    Description
    Fractional exhaled nitric oxide
    Time Frame
    3 months
    Secondary Outcome Measure Information:
    Title
    Change from Baseline FEV1 (forced expiratory volume in 1 second) at 3 months
    Time Frame
    3 months
    Title
    Change from Baseline FVC (forced vital capacity) at 3 months
    Time Frame
    3 months
    Title
    Change from Baseline FEV1/FVC at 3 months
    Time Frame
    3 months
    Title
    Change from Baseline ACQ (Asthma Control Questionnaire) at 3 months
    Time Frame
    3 months
    Title
    Change from Baseline ACT (Asthma Control Test) at 3 months
    Time Frame
    3 months
    Title
    Change from Baseline miniAQLQ (Asthma Quality of Life Questionnaire) at 3 months
    Time Frame
    3 months
    Title
    Change from Baseline MARS (Medication Adherence Report Scale) at 3 months
    Description
    Measure of treatment adherence
    Time Frame
    3 months
    Title
    Change from Baseline MRA (Medication Refill Adherence) at 3 months
    Description
    Measure of treatment adherence
    Time Frame
    3 months
    Title
    Change from Baseline score of the inhalation technique at 3 months
    Time Frame
    3 months
    Title
    Change from Baseline number of severe exacerbations (during the 3 previous months) at 3 months
    Description
    Severe exacerbations are asthma exacerbations requiring oral corticosteroids
    Time Frame
    3 months
    Title
    Change from Baseline smoking status at 3 months
    Description
    Smoking status is recorded as non-smoker, ex-smoker, current smoker
    Time Frame
    3 months
    Title
    Satisfaction of patients with the pharmacist's intervention, with a scale from 0 to 10
    Time Frame
    3 months after intervention
    Title
    Changes in lifestyle related to asthma (free text field to complete by the patient)
    Time Frame
    3 months after intervention

    10. Eligibility

    Sex
    All
    Accepts Healthy Volunteers
    No
    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)

    12. IPD Sharing Statement

    Plan to Share IPD
    Undecided

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

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