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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))

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ClinicalTrials.gov Identifier: NCT01476059
Recruitment Status : Completed
First Posted : November 22, 2011
Last Update Posted : June 27, 2017
Sponsor:
Information provided by (Responsible Party):
GlaxoSmithKline

Brief Summary:

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)


Condition or disease Intervention/treatment Phase
Asthma Other: Telephone follow-up Other: No telephone follow-up Phase 4

  Show Detailed Description

Study Type : Interventional  (Clinical Trial)
Actual Enrollment : 472 participants
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: None (Open Label)
Primary Purpose: Treatment
Official Title: 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
Study Start Date : May 2004
Primary Completion Date : December 2004
Study Completion Date : December 2004

Resource links provided by the National Library of Medicine

MedlinePlus related topics: Asthma
U.S. FDA Resources

Arm Intervention/treatment
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.
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.
No telephone follow-up
Asthmatic children being treated, who will be given medical guidance without telephone follow-up calls to parents or guardians.
Other: No telephone follow-up
Asthmatic children being treated, who will be given medical guidance without telephone follow-up calls to parents or guardians.



Primary Outcome Measures :
  1. 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 ]

Secondary Outcome Measures :
  1. Disease control, evaluated by information in the questionnaires. [ Time Frame: After 90 days of treatment ]
  2. Regular medical attention sought, evaluated by information in the questionnaires [ Time Frame: After 90 days of treatment ]
  3. Additional resources in the event of attacks [ Time Frame: After 90 days of treatment ]
  4. Improvement in the quality of life. [ Time Frame: After 90 days of treatment ]
  5. Increase in the weekly number of nocturnal awakening or the number of awakenings per night [ Time Frame: After 90 days of treatment ]
  6. Increase in the use of rescue drug [ Time Frame: After 90 days of treatment ]


Information from the National Library of Medicine

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Ages Eligible for Study:   6 Years to 14 Years   (Child)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
Criteria

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

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT01476059


Sponsors and Collaborators
GlaxoSmithKline
Investigators
Study Director: GSK Clinical Trials GlaxoSmithKline

Responsible Party: GlaxoSmithKline
ClinicalTrials.gov Identifier: NCT01476059     History of Changes
Other Study ID Numbers: 113244
First Posted: November 22, 2011    Key Record Dates
Last Update Posted: June 27, 2017
Last Verified: June 2017

Keywords provided by GlaxoSmithKline:
Treatment compliance
Pediatric
Asthma

Additional relevant MeSH terms:
Asthma
Bronchial Diseases
Respiratory Tract Diseases
Lung Diseases, Obstructive
Lung Diseases
Respiratory Hypersensitivity
Hypersensitivity, Immediate
Hypersensitivity
Immune System Diseases
Fluticasone
Salmeterol Xinafoate
Anti-Inflammatory Agents
Bronchodilator Agents
Autonomic Agents
Peripheral Nervous System Agents
Physiological Effects of Drugs
Anti-Asthmatic Agents
Respiratory System Agents
Dermatologic Agents
Anti-Allergic Agents
Adrenergic beta-2 Receptor Agonists
Adrenergic beta-Agonists
Adrenergic Agonists
Adrenergic Agents
Neurotransmitter Agents
Molecular Mechanisms of Pharmacological Action