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Completed

NCT Number: NCT03093363

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

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.

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Key information

Conditions

Asthma Bronchial Diseases Hypersensitivity Hypersensitivity, Immediate Immune System Diseases Lung Diseases Lung Diseases, Obstructive Respiratory Hypersensitivity Respiratory Tract Diseases

Sex eligibility

All sexes

Study type

Interventional

Phase

Not applicable

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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)

Treatment and study plan

Pharmacist's intervention

Other

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

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

Primary outcomes

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

    Time frame: 3 months

    Fractional exhaled nitric oxide

Secondary outcomes

  1. Change from Baseline FEV1 (forced expiratory volume in 1 second) at 3 months

    Time frame: 3 months

  2. Change from Baseline FVC (forced vital capacity) at 3 months

    Time frame: 3 months

  3. Change from Baseline FEV1/FVC at 3 months

    Time frame: 3 months

  4. Change from Baseline ACQ (Asthma Control Questionnaire) at 3 months

    Time frame: 3 months

  5. Change from Baseline ACT (Asthma Control Test) at 3 months

    Time frame: 3 months

  6. Change from Baseline miniAQLQ (Asthma Quality of Life Questionnaire) at 3 months

    Time frame: 3 months

  7. Change from Baseline MARS (Medication Adherence Report Scale) at 3 months

    Time frame: 3 months

    Measure of treatment adherence

  8. Change from Baseline MRA (Medication Refill Adherence) at 3 months

    Time frame: 3 months

    Measure of treatment adherence

  9. Change from Baseline score of the inhalation technique at 3 months

    Time frame: 3 months

  10. Change from Baseline number of severe exacerbations (during the 3 previous months) at 3 months

    Time frame: 3 months

    Severe exacerbations are asthma exacerbations requiring oral corticosteroids

  11. Change from Baseline smoking status at 3 months

    Time frame: 3 months

    Smoking status is recorded as non-smoker, ex-smoker, current smoker

  12. Satisfaction of patients with the pharmacist's intervention, with a scale from 0 to 10

    Time frame: 3 months after intervention

  13. Changes in lifestyle related to asthma (free text field to complete by the patient)

    Time frame: 3 months after intervention

Sponsors and collaborators

Lead sponsor

University of Liege

Other

Registry information

Official study 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

Important dates

Study start
2016
Primary completion
2017
Study completion
2017
First posted
Mar 28, 2017
Registry last updated
Oct 25, 2017

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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