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

Asthma Clinical Trial

Official title:

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

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT01332422
• Other study ID #: 113405
• Status: Completed
• Phase: N/A
• First received: April 7, 2011
• Last updated: July 3, 2014
• Start date: November 2009
• Est. completion date: November 2012

Study information

• Verified date: June 2014
• Source: GlaxoSmithKline
• Contact: n/a
• Is FDA regulated: No
• Health authority: Japan: Pharmaceuticals and Medical Devices Agency
• Study type: Observational

Clinical Trial 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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 300
• Est. completion date: November 2012
• Est. primary completion date: November 2012
• Accepts healthy volunteers: No
• Gender: Both
• Age group: N/A to 14 Years

Eligibility

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

Study Design

Time Perspective: Prospective

Related Conditions & MeSH terms

• Asthma

Intervention

Drug:
• Salmeterol and Fluticasone
Collection of safety data

Locations

Country	Name	City	State
n/a

Sponsors (1)

Lead Sponsor	Collaborator
GlaxoSmithKline

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	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	Yes