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))

This study has been completed.
Sponsor:
Information provided by:
GlaxoSmithKline
ClinicalTrials.gov Identifier:
NCT01476059
First received: March 4, 2010
Last updated: November 17, 2011
Last verified: November 2011
  Purpose

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 Intervention Phase
Asthma
Other: Telephone follow-up
Other: No telephone follow-up
Phase 4

Study Type: Interventional
Study Design: Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: 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

Resource links provided by NLM:


Further study details as provided by GlaxoSmithKline:

Primary Outcome Measures:
  • 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 ] [ Designated as safety issue: No ]

Secondary Outcome Measures:
  • Disease control, evaluated by information in the questionnaires. [ Time Frame: After 90 days of treatment ] [ Designated as safety issue: No ]
  • Regular medical attention sought, evaluated by information in the questionnaires [ Time Frame: After 90 days of treatment ] [ Designated as safety issue: No ]
  • Additional resources in the event of attacks [ Time Frame: After 90 days of treatment ] [ Designated as safety issue: No ]
  • Improvement in the quality of life. [ Time Frame: After 90 days of treatment ] [ Designated as safety issue: No ]
  • Increase in the weekly number of nocturnal awakening or the number of awakenings per night [ Time Frame: After 90 days of treatment ] [ Designated as safety issue: No ]
  • Increase in the use of rescue drug [ Time Frame: After 90 days of treatment ] [ Designated as safety issue: No ]

Enrollment: 472
Study Start Date: May 2004
Study Completion Date: December 2004
Primary Completion Date: December 2004 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
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.

  Show Detailed Description

  Eligibility

Ages Eligible for Study:   6 Years to 14 Years
Genders Eligible for Study:   Both
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
  Contacts and Locations
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

Please refer to this study by its ClinicalTrials.gov identifier: NCT01476059

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

No publications provided

Responsible Party: Cheri Hudson; Clinical Disclosure Advisor, GSK Clinical Disclosure
ClinicalTrials.gov Identifier: NCT01476059     History of Changes
Other Study ID Numbers: 113244
Study First Received: March 4, 2010
Last Updated: November 17, 2011
Health Authority: Brazil: Institutional Review Board

Keywords provided by GlaxoSmithKline:
Treatment compliance
Pediatric
Asthma

Additional relevant MeSH terms:
Asthma
Bronchial Diseases
Hypersensitivity
Hypersensitivity, Immediate
Immune System Diseases
Lung Diseases
Lung Diseases, Obstructive
Respiratory Hypersensitivity
Respiratory Tract Diseases
Fluticasone
Anti-Allergic Agents
Anti-Asthmatic Agents
Anti-Inflammatory Agents
Autonomic Agents
Bronchodilator Agents
Dermatologic Agents
Peripheral Nervous System Agents
Pharmacologic Actions
Physiological Effects of Drugs
Respiratory System Agents
Therapeutic Uses

ClinicalTrials.gov processed this record on October 20, 2014