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

Key requirements

Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.

• Ages 18 to 69 years
• All sexes
• No healthy volunteers
• Adult, Older adult

About this study

Conditions

Asthma, Inflammation, Patient Relations, Nurse, Spirometry

Being tested

Individualized educational program, Induced sputum collection, Spirometry, Nitric oxide measure, Questionnaires ACT, ACQ, AQLQ, BDI

Keywords

asthma, inflammation, patients education, spirometry

Medical subject headings

Asthma, Inflammation

What participants receive

What participants receive. In a randomised study each person is assigned to one group by chance.

• Individualized educational programBehavioural

  Also called Short term 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

• Induced sputum collectionDiagnostic test

  Also called Induced sputum

  All participants performed induced sputum collection

• SpirometryDiagnostic test

  Also called Lung function test

  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 measureDiagnostic test

  Also called NO 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.

• Questionnaires ACT, ACQ, AQLQ, BDIOther

  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 DiaryOther

  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

• Peak flow measureDiagnostic test

  Also called Peak flow

  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 measurementDiagnostic test

  Also called EBC collection

  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.

What is being measured

The primary outcome is the main question the study is designed to answer.

1. 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.

   Measured: One day

2. 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

   Measured: One day

3. 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.

   Measured: One day

4. 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

   Measured: One day

5. 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.

   Measured: One day

6. 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.

   Measured: One day

7. 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.

   Measured: One day

Timeline

From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.

1. First posted31 Aug 2018
2. Study start1 Jul 2015
3. Primary completion1 Aug 2016
4. Study completion12 Dec 2017

Resources

• Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
• Publications (1)Papers the sponsor has linked to this study.
• Other trials for AsthmaStudies of the same condition, open and under way.
• More trials run by University of Sao PauloThe sponsor's other registered studies.
• What the trial phases meanHow a treatment moves from first tests in people to approval.

More details

For doctors and researchers: how the study is designed, who runs it, and its registry IDs.