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

NCT01476059 | Completed Phase 4

• 1 other identifier: 113244
• Study Type: interventional
• Target: 472
• Locations: 0 countries
• Sites: N/A

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)

Conditions

Asthma

Keywords

Treatment compliance; Pediatric; Asthma

Outcome Measures

Primary Outcomes (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.

  After 90 days of treatment

Secondary Outcomes (6)

• Disease control, evaluated by information in the questionnaires.

  After 90 days of treatment

• Regular medical attention sought, evaluated by information in the questionnaires

  After 90 days of treatment

• Additional resources in the event of attacks

  After 90 days of treatment

• Improvement in the quality of life.

  After 90 days of treatment

• Increase in the weekly number of nocturnal awakening or the number of awakenings per night

  After 90 days of treatment

Study Arms (2)

telephone follow-up

OTHER

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

No telephone follow-up

OTHER

Asthmatic children being treated, who will be given medical guidance without telephone follow-up calls to parents or guardians.

Other: No telephone follow-up

Interventions

Telephone follow-up OTHER

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.

telephone follow-up

No telephone follow-up OTHER

Asthmatic children being treated, who will be given medical guidance without telephone follow-up calls to parents or guardians.

No telephone follow-up

Eligibility Criteria

• Age: 6 Years - 14 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Child (0-17)

You may qualify if:

• 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

You may not qualify if:

• 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

Sponsors & Collaborators

• GlaxoSmithKline: lead

MeSH Terms

Conditions

Asthma; Patient Compliance

Condition Hierarchy (Ancestors)

Bronchial Diseases; Respiratory Tract Diseases; Lung Diseases, Obstructive; Lung Diseases; Respiratory Hypersensitivity; Hypersensitivity, Immediate; Hypersensitivity; Immune System Diseases; Patient Acceptance of Health Care; Treatment Adherence and Compliance; Health Behavior; Behavior

Study Officials

• GSK Clinical Trials

  GlaxoSmithKline

  STUDY DIRECTOR

Study Design

• Study Type: interventional
• Phase: phase 4
• Allocation: RANDOMIZED
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: INDUSTRY
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: March 4, 2010
• First Posted: November 22, 2011
• Study Start: May 1, 2004
• Primary Completion: December 1, 2004
• Study Completion: December 1, 2004
• Last Updated: June 27, 2017

Record last verified: 2017-06