Asthma Clinical Trial
Official title:
Clinical, Functional and Inflammatory Evaluation in Asthmatic Patients After a Simple Short-Term Educational Program
NCT number | NCT03655392 |
Other study ID # | IAMSPE |
Secondary ID | |
Status | Completed |
Phase | N/A |
First received | |
Last updated | |
Start date | July 1, 2015 |
Est. completion date | December 12, 2017 |
Verified date | September 2018 |
Source | University of Sao Paulo |
Contact | n/a |
Is FDA regulated | No |
Health authority | |
Study type | Interventional |
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.
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 |
Country | Name | City | State |
---|---|---|---|
n/a |
Lead Sponsor | Collaborator |
---|---|
University of Sao Paulo | Instituto de Assistencia Medica ao Servidor Publico Estadual, Sao Paulo, Universidade Cidade de Sao Paulo |
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 |
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