Clinical, Functional and Inflammatory Evaluation in Asthmatic Patients After a Simple Short-Term Educational Program

University of Sao Paulo

Status: Completed

Conditions: Spirometry; Inflammation; Asthma; Patient Relations, Nurse

Treatments: Diagnostic Test: Peak flow measure; Other: Questionnaires ACT, ACQ, AQLQ, BDI; Diagnostic Test: Induced sputum collection; Diagnostic Test: Spirometry; Diagnostic Test: Exhaled breath condensate air measurement; Diagnostic Test: Nitric oxide measure; Other: Symptoms Diary; Behavioral: Individualized educational program

Study type: Interventional

Funder types: Other

Identifiers

NCT03655392

IAMSPE

Details and patient eligibility

About

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.

Full 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).

Enrollment: 64 patients

Sex: All

Ages: 18 to 69 years old

Volunteers: No Healthy Volunteers

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

Trial design

Primary purpose: Prevention

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: None (Open label)

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64 participants in 2 patient groups

Intervention Group

Experimental group

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 a individualized educational program: three 30-minutes intervention of a shortterm educational program delivered by a nurse at 3 monthly visits. CG group did not receive educational intervention. All patients were submitted to a spirometry, induced sputum collection, nitric oxide measure, exhaled breath condensate air measurement, and answered the questionnaires ACT, ACQ, AQLQ, BDI: Asthma Control Test (ACT), Asthma Control Questionnaire (ACQ), Asthma Quality Life Questionnaire (AQLQ), Beck Depression Inventory (BDI). All participants also answered a symptoms diary about asthma symptoms and peak flow measure.

Treatment:

Behavioral: Individualized educational program

Diagnostic Test: Exhaled breath condensate air measurement

Diagnostic Test: Nitric oxide measure

Other: Questionnaires ACT, ACQ, AQLQ, BDI

Diagnostic Test: Spirometry

Diagnostic Test: Induced sputum collection

Other: Symptoms Diary

Diagnostic Test: Peak flow measure

Control Group

Experimental group

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 montly visits. CG group did not receive educational intervention. All patients were submitted to a spirometry, induced sputum collection, nitric oxide measure, exhaled breath condensate air measurement, and answered the questionnaires: Asthma Control Test (ACT), Asthma Control Questionnaire (ACQ), Asthma Quality Life Questionnaire (AQLQ), Beck Depression Inventory (BDI). All participants also answered a symptoms diary about asthma symptoms and peak flow measure.

Treatment:

Diagnostic Test: Exhaled breath condensate air measurement

Diagnostic Test: Nitric oxide measure

Other: Questionnaires ACT, ACQ, AQLQ, BDI

Diagnostic Test: Spirometry

Diagnostic Test: Induced sputum collection

Other: Symptoms Diary

Diagnostic Test: Peak flow measure