Clinical, functional and inflammatory evaluation in asthmatic patients after a simple short-term educational program: a randomized trial

Soraia Nogueira Felix, Rosana Câmara Agondi, Marcelo Vivolo Aun, Clarice Rosa Olivo, Francine Maria de Almeida, Thais Santos Amorim, Julia Caroline Cezario, Pedro Giavina-Bianchi, Iolanda de Fátima Lopes Calvo Tiberio, Milton de Arruda de Martins, Beatriz Mangueira Saraiva Romanholo, Soraia Nogueira Felix, Rosana Câmara Agondi, Marcelo Vivolo Aun, Clarice Rosa Olivo, Francine Maria de Almeida, Thais Santos Amorim, Julia Caroline Cezario, Pedro Giavina-Bianchi, Iolanda de Fátima Lopes Calvo Tiberio, Milton de Arruda de Martins, Beatriz Mangueira Saraiva Romanholo

Abstract

This study aimed to evaluate the clinical evolution, functional parameters and inflammatory activity of asthma in patients who submitted to an educational intervention. 58 adult patients over 18 years of age with partly controlled and uncontrolled asthma were randomized into an intervention group (IG) (N = 32) and a control group (CG) (N = 26) and evaluated for 12 weeks. The Asthma Control Test (ACT), Asthma Control Questionnaire (ACQ), Asthma Quality Life Questionnaire (AQLQ) and Beck Depression Inventory (BDI) questionnaires were applied. Spirometry, exhaled nitric oxide (NO), exhaled breath condensate (EBC) and induced sputum (IS), measurement of the peak flow and symptoms were performed. The IG patients received an educational activity for 30 min applied by a nurse. Statistical analysis: analysis of variance with repeated intragroup measures. IG presented a decreased number of eosinophils in IS and IL-17A in EBC, an increase in the percentage of FEV1 before and after bronchodilator and an improvement in quality of life compared to the CG. There was an improvement in depression levels and a decrease in IL-4 and IL-5 in the IS and in the EBC in both groups. Our results suggest that an educational intervention can bring benefits concerning the control of inflammation, lung function alterations, quality of life and levels of depression in asthmatic patients. Registration: ClinicalTrials.gov; NCT03655392.

Conflict of interest statement

The authors declare no competing interests.

© 2021. The Author(s).

Figures

Figure 1
Figure 1
Study design. * Phone calls were made to the IG group every two weeks during the study to remind them about the correct use of medication and to remember the date of the study visit.
Figure 2
Figure 2
Enrollment (CONSORT diagram, 2010).
Figure 3
Figure 3
Data were compared in the three evaluations (T1, T2 and T3). IG = intervention group. CG = control group. T1 = day 0 (baseline). T2 = day 28. T3 = day 56. FEV1 = Forced expiratory volume in one second. AQLQ = Asthma Quality Life Questionnaire. BDI = Beck Depression Inventory. (a) Induced sputum eosinophils (%). (b) FEV1 before β2 (%). (c) FEV1 before β2 (%). (d) Quality of life (AQLQ score). (e) Depression levels (BDI score). *Compared to T1. The boxes represent the 25th to 75th percentiles (SD), the lines within the boxes represent the median values, and the bars represent the 10th and 90th percentiles. Statistical analysis: One-way ANOVA (intragroup analysis).
Figure 4
Figure 4
Total cytokine count in the three evaluations (T1, T2 and T3). IG = intervention group. CG = control group. T1 = day 0 (baseline). T2 = day 28. T3 = day 56. EBC = exhaled breath condensate. IS = induced sputum. (a, b) IL-4 and IL-5 in IS. (c, d) IL-4 and IL-5 in EBC. (e) IL-17A in EBC. *Compared to T1. **Compared to T2. ***Compared to T2 and T1. The boxes represent the 25th to 75th percentiles (SD), the lines inside the boxes represent the median values, and the bars represent the 10th and 90th percentiles. Statistical analysis: One-way ANOVA (intragroup analysis).

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