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

Status

Completed

Phases

Unknown

Study type

Observational

Source

ClinicalTrials.gov

Registry ID

NCT01332422

Enrollment

300

Registered

2011-04-11

Start date

2009-11-30

Completion date

2012-11-30

Last updated

2014-07-08

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Asthma

Brief summary

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.

Interventions

DRUGSalmeterol and Fluticasone

Collection of safety data

Study design

Time perspective

PROSPECTIVE

Eligibility

Sex/Gender

ALL

Age

No minimum to 14 Years

Healthy volunteers

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

Design outcomes

Primary

Measure	Time frame
Safety and efficacy for a long term under the practical use conditions. As the priority investigation items, (1)Systemic effects accompanying steroid administration (2) Events related to nervous system, musculoskeletal system and circulatory systems	One year

Outcome results

None listed

Source: ClinicalTrials.gov · Data processed: Feb 4, 2026