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Trial record 4 of 319 for:    FLUTICASONE AND SALMETEROL

Special Drug Use Investigation for ADOAIR (Fluticasone/Salmeterol)

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details.
 
ClinicalTrials.gov Identifier: NCT01395862
Recruitment Status : Completed
First Posted : July 18, 2011
Last Update Posted : August 21, 2013
Sponsor:
Information provided by (Responsible Party):
GlaxoSmithKline

Tracking Information
First Submitted Date July 14, 2011
First Posted Date July 18, 2011
Last Update Posted Date August 21, 2013
Study Start Date November 2007
Actual Primary Completion Date September 2012   (Final data collection date for primary outcome measure)
Current Primary Outcome Measures
 (submitted: July 14, 2011)
The number of incidence of adverse events in Japanese asthma patients treated with fluticasone and salmeterol for long-term [ Time Frame: 1 year ]
Original Primary Outcome Measures Same as current
Change History Complete list of historical versions of study NCT01395862 on ClinicalTrials.gov Archive Site
Current Secondary Outcome Measures Not Provided
Original Secondary Outcome Measures Not Provided
Current Other Pre-specified Outcome Measures Not Provided
Original Other Pre-specified Outcome Measures Not Provided
 
Descriptive Information
Brief Title Special Drug Use Investigation for ADOAIR (Fluticasone/Salmeterol)
Official Title Special Drug Use Investigation for ADOAIR (Fluticasone/Salmeterol)
Brief Summary The purpose of this study is to detect adverse drug reactions for long-term use (particularly clinically significant adverse drug reactions) occurring in clinical settings, to examine factors likely to affect the safety and efficacy in the Japanese asthma patients who are treated with fluticasone propionate/salmeterol xinafoate.
Detailed Description Not Provided
Study Type Observational
Study Design Time Perspective: Prospective
Target Follow-Up Duration Not Provided
Biospecimen Not Provided
Sampling Method Probability Sample
Study Population Japanese patients with asthma who are expected to use fluticasone and salmeterol for long-term.
Condition Respiratory Disorders
Intervention Drug: Salmeterol and Fluticasone
Study Groups/Cohorts Patients prescribed fluticasone and salmeterol
Patients with asthma prescribed fluticasone and salmeterol for long-term use during study period
Intervention: Drug: Salmeterol and Fluticasone
Publications * Not Provided

*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Recruitment Information
Recruitment Status Completed
Actual Enrollment
 (submitted: July 14, 2011)
1001
Original Actual Enrollment Same as current
Actual Study Completion Date September 2012
Actual Primary Completion Date September 2012   (Final data collection date for primary outcome measure)
Eligibility Criteria

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
Sex/Gender
Sexes Eligible for Study: All
Ages Child, Adult, Older Adult
Accepts Healthy Volunteers No
Contacts Contact information is only displayed when the study is recruiting subjects
Listed Location Countries Not Provided
Removed Location Countries  
 
Administrative Information
NCT Number NCT01395862
Other Study ID Numbers 112278
Has Data Monitoring Committee No
U.S. FDA-regulated Product Not Provided
IPD Sharing Statement Not Provided
Responsible Party GlaxoSmithKline
Study Sponsor GlaxoSmithKline
Collaborators Not Provided
Investigators
Study Director: GSK Clinical Trials GlaxoSmithKline
PRS Account GlaxoSmithKline
Verification Date August 2013