Last updated: 11/07/2018 06:04:17

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

GSK study ID
113405
See study documents
Clinicaltrials.gov ID
NCT01332422
EudraCT ID
Not applicable
EU CT Number
Not applicable
Trial status
Study complete
Study complete
Overview
Eligibility
Locations
Study documents
Results summary
Plain language summaries
Additional information

Trial overview

Official title: Special Drug Use Investigation for ADOAIR Metered-dose Inhaler (Pediatric)
Trial description: 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.
Primary purpose:
Not applicable
Trial design:
Not applicable
Masking:
Not applicable
Allocation:
Not applicable
Primary outcomes:

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

Timeframe: One year

Secondary outcomes:
Not applicable
Interventions:
  • Drug: Salmeterol and Fluticasone
    • Enrollment:
    300
    Primary completion date:
    Not applicable
    Observational study model:
    Other
    Time perspective:
    Prospective
    Clinical publications:
    Rie Otake, Junko Minami, Terufumi Hara, Pascal Yoshida.Post-Marketing Surveillance of Salmeterol Xinafoate /Fluticasone Propionate in Pediatric Asthma Patients with Long-Term Administration.Jpn J Pediatr.2014;67(3):107-119
    Medical condition
    Asthma
    Product
    fluticasone furoate, fluticasone furoate/vilanterol, fluticasone propionate, fluticasone propionate/salmeterol, salmeterol, vilanterol
    Collaborators
    Not applicable
    Study date(s)
    November 2009 to November 2012
    Type
    Observational
    Phase
    Not applicable

    Participation criteria

    Sex
    Female & Male
    Age
    Not applicable - 14 years
    Accepts healthy volunteers
    No
    • ADOAIR must be used for the first time
    • ADOAIR used for a long-term
    • Patients with hypersensitivity to salmeterol and fluticasone
    • Patients with infection which salmeterol and fluticasone is not effective
    Inclusion and exclusion 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

    Trial location(s)

    This study does not involve prospective enrollment of participants.

    Study documents

    Scientific result summary
    Available language(s): English
    Download document(s)

    If you wish to request for full study report, please contact - [email protected]

    Results overview

    Refer to study documents

    Recruitment status
    Study complete
    Actual primary completion date
    Not applicable
    Actual study completion date
    2012-01-11

    Plain language summaries

    Not applicable. GSK’s transparency policy provides for Plain Language Summaries for Interventional studies.

    Additional information about the trial

    Not applicable
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