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

Asthma Clinical Trial

Official title:

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

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT03655392
• Other study ID #: IAMSPE
• Status: Completed
• Phase: N/A
• Start date: July 1, 2015
• Est. completion date: December 12, 2017

Study information

• Verified date: September 2018
• Source: University of Sao Paulo
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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.

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).

Recruitment information / eligibility

• Status: Completed
• Enrollment: 64
• Est. completion date: December 12, 2017
• Est. primary completion date: August 1, 2016
• Accepts healthy volunteers: No
• Gender: All
• Age group: 18 Years to 69 Years

Eligibility

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

Related Conditions & MeSH terms

• Asthma
• Inflammation
• Patient Relations, Nurse
• Spirometry

Intervention

Behavioral:
• Individualized educational program
IG patients were submitted to three 30-minutes intervention of a individualized shortterm educational program delivered by a nurse, were given explanations about general aspects of the disease, prevention methods and about the importance and correct use of inhaled corticosteroids, with an educational video showing the use of the device

Diagnostic Test:
• Induced sputum collection
All participants performed induced sputum collection
• Spirometry
All participants performed spirometry test using a Koko spirometer. Pulmonary function was assessed by spirometry prebronchodilator, after withholding short-acting beta-agonists for = 6 hours and long-acting beta-agonist for = 24hours. Forced expiratory volume in one second (FEV1) % predicted was used as a proxy variable for overall lung function.
• Nitric oxide measure
All participants performed nitric oxide measure in three Mylar bags and measure was performed in a NOA280 Sievers equipment. For collection the patients blew in the balloons through a sterile nozzle in the equipment collector without prejudice or damage to the patient.

Other:
• Questionnaires ACT, ACQ, AQLQ, BDI
All participants answered standardized questionnaires about asthma symptoms and depression: Asthma Control Test (ACT), Asthma Control Questionnaire (ACQ), Asthma Quality Life Questionnaire (AQLQ), Beck Depression Inventory (BDI)
• Symptoms Diary
All participants were instructed to note in the morning and evening before the use of routine inhaled corticosteroids, asthma symptoms (coughing, wheezing, shortness of breath, use of emergency inhaled corticosteroids) and three measures of peak expiratory flow (individual, provided to patients) and to return this completed diary at each study visit

Diagnostic Test:
• Peak flow measure
All participants registered three peak flow measures in the symptoms diary by morning and night before the use of routine inhaled corticosteroids. Peak flow was measured by the electronic peak flow meter (Mini-Wright).
• Exhaled breath condensate air measurement
Exhaled breath condensate was collect during 15 to 20 minutes in a Turbo DECCS equipment (Medivac SRL, Italy) in a sterile buccal of the own apparatus with the aid of a nasal clip with the participant breathing normally without any effort or damage.

Locations

Country	Name	City	State
n/a

Sponsors (3)

Lead Sponsor	Collaborator
University of Sao Paulo	Instituto de Assistencia Medica ao Servidor Publico Estadual, Sao Paulo, Universidade Cidade de Sao Paulo

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Induced sputum samples to assess airway inflammation	Induced sputum samples were collected in 3 visits with a one-month interval to assess the degree of airway inflammation. Markers of inflammation included eosinophils, neutrophils, macrophages, lymphocytes and total cell counts, as well as cytokines in the sputum supernatant. In the processing performed the subjects received up to three nebulizations with 3% hypertonic saline, the aerosol was generated by an ultrasonic nebulizer (Ultraneb 99; DeVilbiss, Somerset, PA) each challenge was monitored with peak flow before, after and between nebulizations.	One day
Primary	Pulmonary function by spirometry	Pulmonary function was assessed by spirometry pre and after bronchodilator (Salbutamol, short action beta-agonist), according to ATS guidelines, in 3 visits with a one-month interval after withholding short-acting beta-agonists for = 6 hours and long-acting betaagonist for = 24hours. Forced expiratory volume in one second (FEV1) % predicted was used as a proxy variable for overall lung function	One day
Primary	Asthma control by Asthma Control Test (ACT)	Asthma Control Test (ACT) was used to assess clinical control of asthma in the last month; is a questionnaire composed of five questions (score varying from 5 to 25 points) assessing asthma in relation to physical activity limitation, nocturnal and diurnal symptoms, shortness of breath and use of rescue medication. The higher the overall score, the greater the asthma control, and a 3-point difference in the mean ACT score is considered a clinically relevant change.	One day
Primary	Depression symptoms by Beck Depression Inventory II (BDI II)	To evaluate the symptoms of depression reported in the last 30 days, BDI II was used, a questionnaire composed of 21 items with scores ranging from 0 to 63 points, the higher the score the worse the severity of the symptoms	One day
Primary	Asthma quality of life by Asthma Quality of Life Questionnaire (AQLQ)	Asthma quality of life was assessed using the AQLQ, which has four domains: activity limitations, symptoms, emotional function and environmental stimuli. A higher AQLQ score indicates a better quality of life.	One day
Primary	Fractional exhaled nitric oxide (FeNO)	FeNO was collected also to assess airway inflammation in acoordance with the ATS recommendations; all measurements were determinad by chemiluminscence (Sievers 280). This analysis procedure was performed by a blinded investigator. The patients were advised to blow into a Mylar bag, with a breath pressure of 12 cmH20, monitored by the pressure gauge, reaching a flow rate of 200 mL/s.	One day
Primary	Exhaled breath condensate (EBC)	A Turbo DECCS® condenser (Medivac SRL, Italy) (29) was used which was cooled to -20øC for at least thirty minutes prior to use. The subjects were instructed to perform oral breathing using the mouthpiece of the equipment and with the aid of a nasal clip. The EBC (exhaled breath condensate) was collected for 15 to 20 minutes in tidal volume for pH analysis and cytokine dosing.	One day