- ICH GCP
- US Clinical Trials Registry
- Clinical Trial NCT01476059
Pediatric Study to Evaluate Treatment of Persistent Moderate or Severe Asthma With the Association Fluticasone 250 mcg/Dose and Salmeterol 50 mcg/Dose - ADERE PROJECT (ADERE (Ped))
Prospective, Parallel-group, Randomized Study to Evaluate the Compliance to the Treatment of Children Aged Between 6 and 14 Years Old With Persistent Moderate or Severe Asthma, Receiving the Association Fluticasone 250 mcg/Dose and Salmeterol 50 mcg/Dose Twice a Day. ADERE PROJECT
Prospective, parallel-group, randomized study to evaluate the compliance to the treatment of children aged between 6 and 14 years old with persistent moderate or severe asthma, receiving the association Fluticasone 250 mcg/dose and Salmeterol 50 mcg/dose twice a day.
ADERE PROJECT (Pediatric)
Study Overview
Status
Conditions
Intervention / Treatment
Detailed Description
Objectives
General:
To evaluate the compliance degree to the treatment of asthmatic children, according to the attention received.
Specific:
- To study asthmatic compliance to the treatment proposed, aiming at an association with other factors, such as: parents' instruction, hospitalizations, personal and family history of atopy, co-morbidities, severity of the disease and use of other drugs.
- To study asthmatic compliance to the treatment proposed, associating it with the impact in quality of life, though the application of a specific questionnaire.
Outcomes
The main outcome, compliance, is being measured by the number of doses used of the drug salmeterol combined with fluticasone (Seretide Diskus) divided by the number of doses foreseen for the time considered.
The following will be considered as secondary outcomes:
- Disease control, evaluated by information in the questionnaires.
- Regular medical attention sought, evaluated by information in the questionnaires.
- Additional resources in the event of attacks, increase in the weekly number of nocturnal awakening or the number of awakenings per night, increase in the use of rescue drug.
- Improvement in the quality of life.
Casuistic and Method
Study groups
Asthmatic children aged 6 to 14 years old from both sexes, with persistent mild, moderate or sever asthma classified according to the criteria from the III - Brazilian Consensus on Asthma Management.
Group I - Asthmatic children being treated, who will be given medical guidance and therapeutic guidance through telephone calls at every fifteen days to the parents or guardians, performed by trained professionals.
Group II - Asthmatic children being treated, who will be given medical guidance without telephone follow-up calls to parents or guardians.
Study Design
This is a prospective, controlled, randomized, parallel-group study, with the inclusion of 472 children presenting persistent moderate or severe asthma. Our researchers developed the study, and it will be performed only in Brazil, solely by our Clinical Research Center. The drug to be used is in accordance with the main International Consensus on Asthma Treatment and with the III - Brazilian Consensus on Asthma Management, being marketed for some years in Brazil.
During patient recruitment and screening, their parents or guardians will fill out the free informed consent form. At this time, they will also be given the drug (Seretide Diskus® 50/250) with doses enough for a 90-day treatment, twice a day, in addition to instructions on the use of the device to apply the drug and guidance from his/her physician on how to act in the event of an attack.
After study inclusion, the study will receive a number which will randomly include him/her in group 1 or 2 of this study.
Patients included in group 1 will receive two types of telephone calls:
A. Investigation telephone call - TI: that will be made by a trained health professional from the Centro de Pesquisa Clínica e Medicina Avançada, aiming at: presentation, data collection on asthma, including demographics and relevant clinical history (details on asthma, previous exacerbations, drugs used, etc), submission of a standardized checking questionnaire (questionnaire 1 - attachment 1) and quality of life questionnaire (questionnaire 2 - attachment 2). By 90 days, the patient's guardian will receive the last investigation telephone call (TI -2) in order to apply the quality of life questionnaire and standardized evaluation questionnaire (questionnaire 1 - attachment 1)
B. Compliance telephone call - TA: A specifically trained professional will make follow-up telephone calls at every fifteen days, according to a pre-established guide (Attachment 4), requesting the patient to answer the questions pursuant to the follow-up questionnaire (attachment 3) and clarifying probable doubts on the drug application, however, without interfering with the treatment prescribed by the physician.
Patients included in group 2 will receive only the Investigation Telephone call (TI) All telephone contacts will be made for the same person: mother, father or guardian.
By the end of week 12, the persons responsible for the patients will return, by mail, the drug to Centro de Pesquisa Clínica e Medicina Avançada.
Study Type
Enrollment (Actual)
Phase
- Phase 4
Participation Criteria
Eligibility Criteria
Ages Eligible for Study
Accepts Healthy Volunteers
Genders Eligible for Study
Description
Inclusion criteria:
- Signature of a informed consent form
- Age between 6 and 14 years old
- Diagnosis of persistent moderate or severe asthma, according to III Brazilian Consensus on Asthma Management.
- Home telephone available
Exclusion criteria:
- Co-morbidities that may interfere with the study evaluation or that require continuous drugs, e.g., cardiopathy, gastro-esophageal reflux or diabetes.
- Continuous systemic corticosteroid use for more than seven days
- The patient has been treated or is being treated with allergen-specific immunetherapy
Study Plan
How is the study designed?
Design Details
- Primary Purpose: Treatment
- Allocation: Randomized
- Interventional Model: Parallel Assignment
- Masking: None (Open Label)
Arms and Interventions
Participant Group / Arm |
Intervention / Treatment |
---|---|
Other: telephone follow-up
Asthmatic children being treated, who will be given medical guidance and therapeutic guidance through telephone calls at every fifteen days to the parents or guardians, performed by trained professionals.
|
Asthmatic children being treated, who will be given medical guidance and therapeutic guidance through telephone calls at every fifteen days to the parents or guardians, performed by trained professionals.
|
Other: No telephone follow-up
Asthmatic children being treated, who will be given medical guidance without telephone follow-up calls to parents or guardians.
|
Asthmatic children being treated, who will be given medical guidance without telephone follow-up calls to parents or guardians.
|
What is the study measuring?
Primary Outcome Measures
Outcome Measure |
Time Frame |
---|---|
The main outcome, compliance, is being measured by the number of doses used of the drug salmeterol combined with fluticasone (Seretide Diskus) divided by the number of doses foreseen for the time considered.
Time Frame: After 90 days of treatment
|
After 90 days of treatment
|
Secondary Outcome Measures
Outcome Measure |
Time Frame |
---|---|
Disease control, evaluated by information in the questionnaires.
Time Frame: After 90 days of treatment
|
After 90 days of treatment
|
Regular medical attention sought, evaluated by information in the questionnaires
Time Frame: After 90 days of treatment
|
After 90 days of treatment
|
Additional resources in the event of attacks
Time Frame: After 90 days of treatment
|
After 90 days of treatment
|
Improvement in the quality of life.
Time Frame: After 90 days of treatment
|
After 90 days of treatment
|
Increase in the weekly number of nocturnal awakening or the number of awakenings per night
Time Frame: After 90 days of treatment
|
After 90 days of treatment
|
Increase in the use of rescue drug
Time Frame: After 90 days of treatment
|
After 90 days of treatment
|
Collaborators and Investigators
Sponsor
Study record dates
Study Major Dates
Study Start
Primary Completion (Actual)
Study Completion (Actual)
Study Registration Dates
First Submitted
First Submitted That Met QC Criteria
First Posted (Estimate)
Study Record Updates
Last Update Posted (Actual)
Last Update Submitted That Met QC Criteria
Last Verified
More Information
Terms related to this study
Keywords
Additional Relevant MeSH Terms
Other Study ID Numbers
- 113244
This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.
Clinical Trials on Asthma
-
Vanderbilt University Medical CenterNot yet recruitingAsthma in Children | Asthma Attack | Asthma Acute | Acute Asthma Exacerbation | Asthma; StatusUnited States
-
University of California, San FranciscoCompletedAsthma in Children | Asthma Attack | Asthma Acute | Asthma ChronicUnited States
-
Johann Wolfgang Goethe University HospitalCompleted
-
SingHealth PolyclinicsNot yet recruitingAsthma | Asthma in Children | Asthma Attack | Asthma Acute | Asthma Chronic
-
Parc de Salut MarActive, not recruitingAsthma in Children | Persistent Asthma | Asthma ExacerbationSpain
-
Universita di VeronaCompleted
-
Forest LaboratoriesCompleted
-
Brunel UniversityKarolinska InstitutetUnknown
-
Value Outcomes Ltd.AstraZenecaCompletedAsthma, Bronchial | Bronchial Asthma | Asthma Chronic | Asthma; EosinophilicCzechia
-
Johann Wolfgang Goethe University HospitalCompletedExercise-induced AsthmaGermany
Clinical Trials on Telephone follow-up
-
Connolly Hospital BlanchardstownCompletedGeneral Surgery | Outpatients | Virtual Clinic | Text MessagingIreland
-
St. Justine's HospitalCompleted
-
Zealand University HospitalNot yet recruitingNon-Functional Pituitary Adenoma
-
Brandon UniversityRecruiting
-
University Hospital, ToulouseFondation de l'AvenirCompletedSwallowing DisordersFrance
-
Massachusetts General HospitalCompletedDeep Vein Thrombosis | Pulmonary EmbolismUnited States
-
University of Southern DenmarkUniversity Hospital, Gentofte, CopenhagenCompleted
-
Peking University Third HospitalRecruitingNon-specific Chronic Low Back PainChina
-
Queensland Centre for Gynaecological CancerCompleted
-
University of WashingtonCenters for Disease Control and PreventionCompletedBrain ConcussionUnited States