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Asthma control evaluation with inhaled corticosteroid spray aided by non valved homemade spacer.

Asthma control evaluation with inhaled corticosteroid spray aided by non valved homemade spacer.

Status
Active, not recruiting
Phases
Unknown
Study type
Interventional
Source
REBEC
Registry ID
RBR-5x4dc9
Enrollment
Unknown
Registered
2015-07-28
Start date
2010-07-26
Completion date
Unknown
Last updated
2025-10-27

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

asthma

Interventions

All the recruited patients are to be diagnosed as asthmaticsby the specialyst (allergist or pneumologist) and requiring use of beclomethasone for control. All will be assessed by the "asthma control t
Device
E07.605.500.500
E07.605.500

Sponsors

Pós Graduação em Ciências da Saúde da Universidade Federal de Pernambuco
Lead Sponsor
Pós Graduação em Ciências da Saúde da Universidade Federal de Pernambuco
Collaborator

Eligibility

Age
18 Years to 65 Years

Inclusion criteria

Inclusion criteria: 180 Volunteers with asthma poorly or partially controlled as defined by GINA (Global Initiative for Asthma); aged between 18 and 65; who had inhaled corticosteroid prescription for daily use by the attending physician.

Exclusion criteria

Exclusion criteria: Patients unable to use the inhaled drug due to motors or mental problems; with other lung diseases diagnosed or reported; who can not perform spirometry, unable to properly use the homemade or commercial spacers after watching educational film three times; patients who refuse to participate and sign the consent form.

Design outcomes

Primary

MeasureTime frame
Change in score on a standardized questionnaire called the Asthma Control Test (ACT). The evaluations will be carried out before, thirty and sixty days after the start of medication. It is expected an increase of 3 or more points in this questionnaire.;Both groups showed a statistically significant change compared to basal values(p <0.001) 30 and 60 days after starting the experiment (beclomethasone spray aided by homemade spacer -Hm - or by commercial valved spacer - CV), with an increase of 7.0 and 7,8 points for the Hm group and 5.9 and 7.0 for the CV group (p = 0.261 between groups) respectively at days 30 and 60.

Secondary

MeasureTime frame
Changes in the Forced expiratory volume in the first second (FEV1) compared to basal values at 30 and 60 days evaluation;In the Hms group FEV1 increased from a Mean of 1,75 liter/second to 2,12 and 2,15 at days 30 and 60. in VCS group it rose from 1,86L/sec. to 2,19 and 2,21 at day 30 and 60, with difference from basal values but no difference between groups.

Countries

Brazil

Contacts

Public ContactDeborah Schor

Pos Graduação em Ciencias da Saúde da UFPE, Brasil

deborah.schor@gmail.com55-81-91829927

Outcome results

None listed

Source: REBEC (via WHO ICTRP) · Data processed: Mar 10, 2026