Special Drug Use Investigation for ADOAIR Metered-dose Inhaler (Pediatric)

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

COMPLETED

Total Enrollment

300 participants

Study Classification

OBSERVATIONAL

Study Start Date

2009-11-30

Study Completion Date

2012-11-30

Brief Summary

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To investigate possible problems or questions in safety and efficacy of ADOAIR 100 DISKUS and ADOAIR 50 AEROSOL 120 in Japanese pediatric patients with bronchial asthma for a long term under the practical use conditions. In this special drug use investigation, the following items shall be handled as the priority investigation items for information collection.

1. Systemic effects accompanying steroid administration; influences on adrenocortical function, influences on bone metabolisms (fracture, osteoporosis, etc.), cataract, glaucoma
2. Events related to nervous system, musculoskeletal system and circulatory system; tremor, headache, cramp, tachycardia, etc.

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Detailed Description

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Conditions

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Asthma

Study Design

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Study Time Perspective

PROSPECTIVE

Study Groups

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Pediatric patients prescribed ADOAIR

Pediatric patients with asthma prescribed ADOAIR during study period

Salmeterol and Fluticasone

Intervention Type DRUG

Collection of safety data

Interventions

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Salmeterol and Fluticasone

Collection of safety data

Intervention Type DRUG

Eligibility Criteria

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Inclusion Criteria

* ADOAIR must be used for the first time
* ADOAIR used for a long-term

Exclusion Criteria

* Patients with hypersensitivity to salmeterol and fluticasone
* Patients with infection which salmeterol and fluticasone is not effective
* Patients with deep mycosis

Maximum Eligible Age

14 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No