Clinical trial NCT03655392: Clinical, Functional and Inflammatory Evaluation in Asthmatic Patients After a Simple Short-Term Educational Program
Official title: Clinical, Functional and Inflammatory Evaluation in Asthmatic Patients After a Simple Short-Term Educational Program
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Asthma
Inflammation
Patient Relations, Nurse
Spirometry
Keywords: asthma
inflammation
patients education
spirometry
Lead sponsor: University of Sao Paulo
Sponsor class: OTHER
Collaborators: name: Instituto de Assistencia Medica ao Servidor Publico Estadual, Sao Paulo
name: Universidade Cidade de Sao Paulo
First posted: 2018-08-31
Enrollment: 64
Sex: ALL
Minimum age (years): 18
Maximum age (years): 69
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Intervention model description: 64 adult asthmatic patients (18-70 years old) were randomized into two groups: intervention group (IG) (n=38) or control group (CG) (n=26). IG patients were submitted to three 30-minutes intervention of a shortterm educational program delivered by a nurse at 3 mensal intervals. CG group did not receive educational intervention. All patients were submitted to a spirometry, induced sputum collection, nitric oxide measure, collecting exhaled condensed (cytokine analysis) air and it's ph measure, Asthma Control Test (ACT), Asthma Control Questionnaire (ACQ), Asthma Quality Life Questionnaire (AQLQ), Beck Depression Inventory (BDI), and answered a symptoms diary, Statistical analysis: repeated measures (Sigma Plot Software 3.0).
Primary purpose: PREVENTION

Brief summary: Background: Patient education is one of the pillars of asthma treatment according to GINA guidelines. It has considered essential for adherence to treatment and for correct technique of inhaled devices.

Detailed description: Objective: analyze clinical, functional and inflammatory features of adult patients with partly controlled and uncontrolled asthma, before and after an educational intervention. Methods: 58 adult asthmatic patients (18-70 years old) were randomized into two groups: intervention group (IG) (n=38) or control group (CG) (n=26). IG patients were submitted to three 30-minutes intervention of a shortterm educational program delivered by a nurse in 3 visits with a one-month interval. CG group did not receive educational intervention. All patients were submitted to a spirometry, induced sputum collection, nitric oxide measure, collecting exhaled condensed (cytokine analysis) air and it's ph measure, Asthma Control Test (ACT), Asthma Control Questionnaire (ACQ), Asthma Quality Life Questionnaire (AQLQ), Beck Depression Inventory (BDI), and answered a symptoms diary, Statistical analysis: repeated measures (Sigma Plot Software 3.0).

Eligibility criteria: Inclusion criteria:

* Non-smokers or those who stopped smoking more than five years ago
* Age between 18-69 years
* Be legally capable
* Response to the short-acting bronchodilator FEV1\> 12% and\> 200 mL
* Absence of upper airway infection during 30 days and associated systemic diseases

Exclusion criteria:

* Smokers
* Over 70 years old
* Airway infection
* Legally incapable persons
* Diseases that may affect respiratory function

Primary outcomes:
measure: Induced sputum samples to assess airway inflammation
timeFrame: One day
measure: Pulmonary function by spirometry
timeFrame: One day
measure: Asthma control by Asthma Control Test (ACT)
timeFrame: One day
measure: Depression symptoms by Beck Depression Inventory II (BDI II)
timeFrame: One day
measure: Asthma quality of life by Asthma Quality of Life Questionnaire (AQLQ)
timeFrame: One day
measure: Fractional exhaled nitric oxide (FeNO)
timeFrame: One day
measure: Exhaled breath condensate (EBC)
timeFrame: One day
Secondary outcomes:
Other outcomes:
Locations:
Study officials:
affiliation: IAMPSE
name: Soraia N Felix, Master
role: PRINCIPAL_INVESTIGATOR
References:
citation: Felix SN, Agondi RC, Aun MV, Olivo CR, de Almeida FM, Amorim TS, Cezario JC, Giavina-Bianchi P, Tiberio IFLC, de Martins MA, Romanholo BMS. Clinical, functional and inflammatory evaluation in asthmatic patients after a simple short-term educational program: a randomized trial. Sci Rep. 2021 Sep 14;11(1):18267. doi: 10.1038/s41598-021-97846-8.