Special Drug Use Investigation for ADOAIR (Fluticasone/Salmeterol)
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ClinicalTrials.gov Identifier: NCT01395862 |
Recruitment Status :
Completed
First Posted : July 18, 2011
Last Update Posted : August 21, 2013
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Condition or disease | Intervention/treatment |
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Respiratory Disorders | Drug: Salmeterol and Fluticasone |
Study Type : | Observational |
Actual Enrollment : | 1001 participants |
Time Perspective: | Prospective |
Official Title: | Special Drug Use Investigation for ADOAIR (Fluticasone/Salmeterol) |
Study Start Date : | November 2007 |
Actual Primary Completion Date : | September 2012 |
Actual Study Completion Date : | September 2012 |

Group/Cohort | Intervention/treatment |
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Patients prescribed fluticasone and salmeterol
Patients with asthma prescribed fluticasone and salmeterol for long-term use during study period
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Drug: Salmeterol and Fluticasone |
- The number of incidence of adverse events in Japanese asthma patients treated with fluticasone and salmeterol for long-term [ Time Frame: 1 year ]

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Ages Eligible for Study: | Child, Adult, Older Adult |
Sexes Eligible for Study: | All |
Accepts Healthy Volunteers: | No |
Sampling Method: | Probability Sample |
Inclusion Criteria:
- Must use fluticasone and salmeterol for the first time
- Must use fluticasone and salmeterol for 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

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.
Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT01395862
Study Director: | GSK Clinical Trials | GlaxoSmithKline |
Responsible Party: | GlaxoSmithKline |
ClinicalTrials.gov Identifier: | NCT01395862 |
Other Study ID Numbers: |
112278 |
First Posted: | July 18, 2011 Key Record Dates |
Last Update Posted: | August 21, 2013 |
Last Verified: | August 2013 |
Respiration Disorders Respiratory Tract Diseases Fluticasone Salmeterol Xinafoate Fluticasone-Salmeterol Drug Combination Anti-Inflammatory Agents Bronchodilator Agents Autonomic Agents Peripheral Nervous System Agents Physiological Effects of Drugs Anti-Asthmatic Agents Respiratory System Agents |
Dermatologic Agents Anti-Allergic Agents Adrenergic beta-2 Receptor Agonists Adrenergic beta-Agonists Adrenergic Agonists Adrenergic Agents Neurotransmitter Agents Molecular Mechanisms of Pharmacological Action Glucocorticoids Hormones Hormones, Hormone Substitutes, and Hormone Antagonists Sympathomimetics |