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

Information source: GlaxoSmithKline
ClinicalTrials.gov processed this data on August 23, 2015
Link to the current ClinicalTrials.gov record.

Condition(s) targeted: Asthma

Intervention: Salmeterol and Fluticasone (Drug)

Phase: N/A

Status: Completed

Sponsored by: GlaxoSmithKline

Official(s) and/or principal investigator(s):
GSK Clinical Trials, Study Director, Affiliation: GlaxoSmithKline

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.

Clinical Details

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

Study design: Time Perspective: Prospective

Primary outcome: 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

Eligibility

Minimum age: N/A. Maximum age: 14 Years. Gender(s): Both.

Criteria:

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

Locations and Contacts

Additional Information

Starting date: November 2009
Last updated: July 3, 2014

Page last updated: August 23, 2015

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