NCT03093363

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.

Trial Health

100
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
68

participants targeted

Target at P25-P50 for not_applicable asthma

Timeline
Completed

Started Oct 2016

Shorter than P25 for not_applicable asthma

Status
completed

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

Study Start

First participant enrolled

October 31, 2016

Completed
4 months until next milestone

First Submitted

Initial submission to the registry

March 11, 2017

Completed
17 days until next milestone

First Posted

Study publicly available on registry

March 28, 2017

Completed
1 month until next milestone

Primary Completion

Last participant's last visit for primary outcome

April 30, 2017

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

April 30, 2017

Completed
Last Updated

October 25, 2017

Status Verified

October 1, 2017

Enrollment Period

6 months

First QC Date

March 11, 2017

Last Update Submit

October 24, 2017

Conditions

Asthma

Outcome Measures

Primary Outcomes (1)

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

    Fractional exhaled nitric oxide

    3 months

Secondary Outcomes (13)

  • 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

  • +8 more secondary outcomes

Study Arms (2)

Intervention group

OTHER

Asthmatic patients with the pharmacist's intervention

Other: Pharmacist's intervention

Control group

OTHER

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

Other: Questionnaires for control group

Interventions

Pharmacist's interventionOTHER

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 group
Questionnaires for control groupOTHER

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

Control group

Eligibility Criteria

Sexall
Healthy VolunteersNo
Age GroupsChild (0-17), Adult (18-64), Older Adult (65+)

You may qualify if:

  • 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

You may not qualify if:

  • Treatment with oral corticosteroids to treat an asthma exacerbation within 4 weeks before the visit with the pneumologist
  • 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)

Contact the study team to confirm eligibility.

Sponsors & Collaborators

MeSH Terms

Conditions

Asthma

Interventions

Surveys and QuestionnairesControl Groups

Condition Hierarchy (Ancestors)

Bronchial DiseasesRespiratory Tract DiseasesLung Diseases, ObstructiveLung DiseasesRespiratory HypersensitivityHypersensitivity, ImmediateHypersensitivityImmune System Diseases

Intervention Hierarchy (Ancestors)

Data CollectionEpidemiologic MethodsInvestigative TechniquesHealth Care Evaluation MechanismsQuality of Health CareHealth Care Quality, Access, and EvaluationPublic HealthEnvironment and Public HealthEpidemiologic Research DesignResearch DesignMethods

Study Design

Study Type
interventional
Phase
not applicable
Allocation
RANDOMIZED
Masking
SINGLE
Who Masked
PARTICIPANT
Purpose
SUPPORTIVE CARE
Intervention Model
PARALLEL
Sponsor Type
OTHER
Responsible Party
PRINCIPAL INVESTIGATOR
PI Title
Professor, MD, PhD

Study Record Dates

First Submitted

March 11, 2017

First Posted

March 28, 2017

Study Start

October 31, 2016

Primary Completion

April 30, 2017

Study Completion

April 30, 2017

Last Updated

October 25, 2017

Record last verified: 2017-10