Last updated: 05/01/2019 14:10:22
Asthma Control in Latin America StudyASLA
Clinicaltrials.gov ID
Not applicable
EudraCT ID
Not applicable
EU CT Number
Not applicable
Trial status
Study complete
Study complete
Trial overview
Official title: Asthma Control in Latin America Study
Trial description: This is a multi-country, observational, cross-sectional study. The study population will include diagnosed and treated asthma patients ages 12 years or older who are being examined by a physician. The study is comprised of two related parts: Part 1: Self-reported questionnaires and interview applied during a medical visit and Part 2: Retrospective medical record reviewThe current study will provide updated information on real-life data of asthma patients aged 12 years and older in Latin America.
Primary purpose:
Not applicable
Trial design:
Not applicable
Masking:
Not applicable
Allocation:
Not applicable
Primary outcomes:
Asthma Control
Timeframe: 1 time
Prescribed Asthma Medication
Timeframe: 1 time
Asthma Adherence
Timeframe: 1 time
Health care resource use due to other causes
Timeframe: 1 time
Spirometry and Peak Expiratory flow (PEF)
Timeframe: 1 time
Health care resource use due to asthma:
Timeframe: 1 time
Current Asthma Medication in use
Timeframe: 1 time
Asthma exacerbation
Timeframe: 1 time
Asthma Medication Access
Timeframe: 1 time
Secondary outcomes:
Not applicable
Interventions:
Not applicable
Enrollment:
775
Primary completion date:
2015-03-12
Observational study model:
Other
Time perspective:
Cross-Sectional
Clinical publications:
Hugo Neffen, Marco Chahuàn, Dante D Hernández, Edith Vallejo-Perez, Fabio Bolivar, Marco H Sánchez, Fabian Galleguillos, Claudio Castaños, Rafael S. Orellana, Eduardo Giugno,Juana Pavie, Ruben Contreras, Flavia Lamarao,Felipe Moraes Santos,Cristian Rodriguez, Juliana Tobler,Karynna Viana,Claudia Vieira,Claudia Soares. Key factors associated with uncontrolled asthma – the Asthma Control in Latin America Study. J Asthma. 2019;:1-10
Hugo Neffen, Marco Chahuàn, Dante D Hernández, Edith Vallejo-Perez, Fabio Bolivar, Marco H Sánchez, Fabian Galleguillos, Claudio Castaños, Rafael S. Orellana, Eduardo Giugno,Juana Pavie, Ruben Contreras, Flavia Lamarao,Felipe Moraes Santos,Cristian Rodriguez, Juliana Tobler,Karynna Viana,Claudia Vieira,Claudia Soares.Key factors associated with uncontrolled asthma – the Asthma Control in Latin America Study.J Asthma.2019;57(2):113-122
DOI: 10.1080/02770903.2018.1553050
PMID: 30915868
Medical condition
Asthma
Product
fluticasone furoate, fluticasone furoate/vilanterol, fluticasone propionate, fluticasone propionate/salmeterol, fluticasone propionate/salmeterol/norflurane, norflurane, salmeterol, vilanterol
Collaborators
Not applicable
Study date(s)
December 2013 to December 2015
Type
Observational
Phase
Not applicable
Participation criteria
Sex
Female & Male
Age
12+ years
Accepts healthy volunteers
none
- 1. Male or female, age ≥ 12 years at the moment of the patient sign the ICF or assent form;
- 2. Medical asthma diagnosis registered in medical records;
- 1. Patient is currently participating in a clinical trial.
- 2. Patient, Parents, or legal guardians, as applicable, is/are unable or not willing to comply with study requirements.
Inclusion and exclusion criteria
Inclusion criteria:
- 1. Male or female, age ≥ 12 years at the moment of the patient sign the ICF or assent form; 2. Medical asthma diagnosis registered in medical records; 3. Have any register of a prescription of asthma medication within the last 6 months before the current date of visit; 4. Being under medical care with at least one previous medical visit for asthma at the center at any time in the past 6 months; 5. For adults (≥18 years): Patient having read the informed consent and agreeing to participate; For minors(<18 years): Patient signs and dates the assent form (in accordance with applicable regulations) after receiving study information according to her/his ability to understand, and the parent or legal guardian (or emancipated minor) that has the ability to understand the requirements of the study, provides written informed consent that the patient will comply with the study protocol procedures
Exclusion criteria:
- 1. Patient is currently participating in a clinical trial. 2. Patient, Parents, or legal guardians, as applicable, is/are unable or not willing to comply with study requirements. -
Trial location(s)
Location
GSK Investigational Site
Buenos Aires, Buenos Aires, Argentina, 1272
Status
Study Complete
Location
GSK Investigational Site
Buenos Aires, Buenos Aires, Argentina, 1405
Status
Study Complete
Location
GSK Investigational Site
Ciudad Autónoma de Buenos Aires, Buenos Aires, Argentina, C1428DDE
Status
Study Complete
Showing 1 - 6 of 14 Results
Study documents
Scientific result summary
Available language(s): English
If you wish to request for full study report, please contact - [email protected]
Results overview
Refer to study documents
Recruitment status
Study complete
Actual primary completion date
2015-03-12
Actual study completion date
2015-03-12
Plain language summaries
Not applicable. GSK’s transparency policy provides for Plain Language Summaries for Interventional studies.
Additional information about the trial
Not applicable
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