Clinical Trials Logo
  1. Home
  2. Other
  3. NCT01332409
  4. Details
NCT01332409 Clinical Trial

Special Drug Use Investigation for ADOAIR DISKUS COPD (Salmeterol and Fluticasone)

Pulmonary Disease, Chronic Obstructive Clinical Trial

Official title:
Special Drug Use Investigation for ADOAIR DISKUS COPD (Salmeterol and Fluticasone)

Clinical Trial Details — Status: Completed

Administrative data
NCT number NCT01332409
Other study ID # 113095
Secondary ID
Status Completed
Phase N/A
First received April 7, 2011
Last updated June 6, 2013
Start date August 2009
Est. completion date January 2013

Study information
Verified date June 2013
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 effectiveness of salmeterol and fluticasone in patients with chronic obstructive pulmonary disease (bronchitis chronic / emphysema). In this special drug use investigation, onset of pneumonia shall be handled as the priority investigation item.

Recruitment information / eligibility
Status Completed
Enrollment 2000
Est. completion date January 2013
Est. primary completion date April 2012
Accepts healthy volunteers No
Gender Both
Age group N/A and older
Eligibility Inclusion Criteria:

- Must use salmeterol and fluticasone for the first time

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

Intervention

Drug:
• Salmeterol and Fluticasone
Administered according to the prescribing information in the locally approved label by the authorities.

Locations
Country Name City State
Japan GSK Investigational Site Chiba

Sponsors (1)
Lead Sponsor Collaborator
GlaxoSmithKline

Country where clinical trial is conducted

Japan, 

References & Publications (1)

Yoriko Morioka, Hiroharu Abe, Terufumi Hara, Pascal Yoshida. Post-marketing Surveillance of Salmeterol Xinafoate / Fluticasone Propionate (Adoair®250Diskus®) - Interim Report -. Resp Med - Kokyuki Naika. 2013;23(1):111-122.

Outcome
Type Measure Description Time frame Safety issue
Primary The incidence of adverse events in Japanese patients treated with salmeterol and fluticasone based on prescribing information under the conditions of general clinical practice. 1 year No
See also
  Status Clinical Trial Phase
Completed NCT05043428 - The Roles of Peers and Functional Tasks in Enhancing Exercise Training for Adults With COPD N/A
Completed NCT00528996 - An Efficacy and Safety Study to Compare Three Doses of BEA 2180 BR to Tiotropium and Placebo in the Respimat Inhaler. Phase 2
Completed NCT03740373 - A Study to Assess the Pulmonary Distribution of Budesonide, Glycopyrronium and Formoterol Fumarate Phase 1
Completed NCT05402020 - Effectiveness of Tiotropium + Olodaterol Versus Inhaled Corticosteroids (ICS) + Long-acting β2-agonists (LABA) Among COPD Patients in Taiwan
Completed NCT05393245 - Safety of Tiotropium + Olodaterol in Chronic Obstructive Pulmonary Disease (COPD) Patients in Taiwan: a Non-interventional Study Based on the Taiwan National Health Insurance (NHI) Data
Completed NCT04011735 - Re-usable Respimat® Soft MistTM Inhaler Study
Enrolling by invitation NCT03075709 - The Development, Implementation and Evaluation of Clinical Pathways for Chronic Obstructive Pulmonary Disease (COPD) in Saskatchewan
Completed NCT03764163 - Image and Model Based Analysis of Lung Disease Early Phase 1
Completed NCT00515268 - Endotoxin Challenge Study For Healthy Men and Women Phase 1
Completed NCT04085302 - TARA Working Prototype Engagement Evaluation: Feasibility Study N/A
Completed NCT03691324 - Training of Inhalation Technique in Hospitalized Chronic Obstructive Pulmonary Disease (COPD) Patients - a Pilot Study N/A
Completed NCT02236611 - A 12-week Study to Evaluate the Efficacy and Safety of Umeclidinium 62.5 Microgram (mcg) Compared With Glycopyrronium 44 mcg in Subjects With Chronic Obstructive Pulmonary Disease (COPD) Phase 4
Completed NCT00153075 - Flow Rate Effect Respimat Inhaler Versus a Metered Dose Inhaler Using Berodual in Patients With Chronic Obstructive Pulmonary Disease (COPD) Phase 4
Completed NCT01009463 - A Study to Evaluate the Efficacy and Safety of Fluticasone Furoate (FF)/GW642444 Inhalation Powder in Subjects With Chronic Obstructive Pulmonary Disease (COPD) Phase 3
Completed NCT01017952 - A Study to Evaluate Annual Rate of Exacerbations and Safety of 3 Dosage Strengths of Fluticasone Furoate (FF)/GW642444 Inhalation Powder in Subjects With Chronic Obstructive Pulmonary Disease (COPD) Phase 3
Completed NCT04882124 - Study of Effect of CSJ117 on Symptoms, Pharmacodynamics and Safety in Patients With COPD Phase 2
Completed NCT02853123 - Effect of Tiotropium + Olodaterol on Breathlessness in COPD Patients Phase 4
Completed NCT02619357 - Method Validation Study to Explore the Sensitivity of SenseWear Armband Gecko for Measuring Physical Activity in Subjects With Chronic Obstructive Pulmonary Disease (COPD) & Asthma Phase 1
Recruiting NCT05858463 - High Intensity Interval Training and Muscle Adaptations During PR N/A
Not yet recruiting NCT05032898 - Acute Exacerbation of Chronic Obstructive Pulmonary Disease Inpatient Registry Study Stage II