Special Drug Use Investigation for ADOAIR Metered-dose Inhaler (Pediatric)
This study is ongoing, but not recruiting participants.
Sponsor:
GlaxoSmithKline
Information provided by (Responsible Party):
GlaxoSmithKline
ClinicalTrials.gov Identifier:
NCT01332422
First received: April 7, 2011
Last updated: January 24, 2013
Last verified: January 2013
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Purpose
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.
- Systemic effects accompanying steroid administration; influences on adrenocortical function, influences on bone metabolisms (fracture, osteoporosis, etc.), cataract, glaucoma
- Events related to nervous system, musculoskeletal system and circulatory system; tremor, headache, cramp, tachycardia, etc.
| Condition | Intervention |
|---|---|
|
Asthma |
Drug: Salmeterol and Fluticasone |
| Study Type: | Observational |
| Study Design: | Time Perspective: Prospective |
| Official Title: | Special Drug Use Investigation for ADOAIR Metered-dose Inhaler (Pediatric) |
Resource links provided by NLM:
Further study details as provided by GlaxoSmithKline:
Primary Outcome Measures:
- 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 [ Time Frame: One year ] [ Designated as safety issue: Yes ]
| Estimated Enrollment: | 300 |
| Study Start Date: | November 2009 |
| Estimated Study Completion Date: | April 2013 |
| Primary Completion Date: | December 2011 (Final data collection date for primary outcome measure) |
| Groups/Cohorts | Assigned Interventions |
|---|---|
|
Pediatric patients prescribed ADOAIR
Pediatric patients with asthma prescribed ADOAIR during study period
|
Drug: Salmeterol and Fluticasone
Collection of safety data
|
Eligibility| Ages Eligible for Study: | up to 14 Years |
| Genders Eligible for Study: | Both |
| Accepts Healthy Volunteers: | No |
| Sampling Method: | Non-Probability Sample |
Study Population
Japanese pediatric patients (aged < 15 years) who diagnosed as having bronchial asthma for which the indication of ADOAIR has been approved and who are using ADOAIR for the first time and expected for a long-term use.
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
Contacts and Locations More Information
No publications provided
| Responsible Party: | GlaxoSmithKline |
| ClinicalTrials.gov Identifier: | NCT01332422 History of Changes |
| Other Study ID Numbers: | 113405 |
| Study First Received: | April 7, 2011 |
| Last Updated: | January 24, 2013 |
| Health Authority: | Japan: Pharmaceuticals and Medical Devices Agency |
Additional relevant MeSH terms:
|
Asthma Bronchial Diseases Respiratory Tract Diseases Lung Diseases, Obstructive Lung Diseases Respiratory Hypersensitivity Hypersensitivity, Immediate Hypersensitivity Immune System Diseases Salmeterol Fluticasone Adrenergic beta-2 Receptor Agonists Adrenergic beta-Agonists Adrenergic Agonists |
Adrenergic Agents Neurotransmitter Agents Molecular Mechanisms of Pharmacological Action Pharmacologic Actions Physiological Effects of Drugs Bronchodilator Agents Autonomic Agents Peripheral Nervous System Agents Anti-Asthmatic Agents Respiratory System Agents Therapeutic Uses Dermatologic Agents Anti-Allergic Agents Anti-Inflammatory Agents |
ClinicalTrials.gov processed this record on May 19, 2013