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Trial record 46 of 318 for:    FLUTICASONE AND SALMETEROL

Clinical Assessment Of GW815SF Salmeterol/Fluticasone Propionate(HFA MDI) In Pediatric Patients With Bronchial Asthma -A Long Term (24-week) Study-

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ClinicalTrials.gov Identifier: NCT00449046
Recruitment Status : Completed
First Posted : March 19, 2007
Results First Posted : August 4, 2009
Last Update Posted : May 6, 2015
Sponsor:
Information provided by:
GlaxoSmithKline

Study Type Interventional
Study Design Allocation: Non-Randomized;   Intervention Model: Single Group Assignment;   Masking: None (Open Label);   Primary Purpose: Treatment
Condition Bronchial Asthma
Intervention Drug: GW815SF Salmeterol/Fluticasone propionate(HFA MDI)
Enrollment 40
Recruitment Details  
Pre-assignment Details  
Arm/Group Title Salmeterol/Fluticasone Propionate
Hide Arm/Group Description Salmeterol/fluticasone propionate patients received 2 inhalations twice daily each inhalation was 25/50mcg for 24 weeks(Total daily dose was 100/200mcg)
Period Title: Overall Study
Started 40
Completed 40
Not Completed 0
Arm/Group Title Salmeterol/Fluticasone Propionate
Hide Arm/Group Description Salmeterol/fluticasone propionate patients received 2 inhalations twice daily each inhalation was 25/50mcg for 24 weeks(Total daily dose was 100/200mcg)
Overall Number of Baseline Participants 40
Hide Baseline Analysis Population Description
[Not Specified]
Age, Continuous  
Mean (Standard Deviation)
Unit of measure:  Years
Number Analyzed 40 participants
8.7  (2.50)
Sex: Female, Male  
Measure Type: Count of Participants
Unit of measure:  Participants
Number Analyzed 40 participants
Female
16
  40.0%
Male
24
  60.0%
Race/Ethnicity, Customized   [1] 
Measure Type: Number
Unit of measure:  Participants
Number Analyzed 40 participants
Asian 39
White 1
[1]
Measure Description: One participant counted twice due to having multiple races.
1.Primary Outcome
Title Most Frequent Adverse Events - On Therapy
Hide Description Adverse events, Clinical laboratory tests, Adrenocortical function test, Physical examinations, 12-lead electrocardiogram (ECG), Oropharyngeal examination were included.
Time Frame Baseline to Week 24
Hide Outcome Measure Data
Hide Analysis Population Description
Safety analysis was performed on the primary outcome measures, adverse events and on the safety population defined as all subjects who entered the treatment period and received at least one dose of study medication
Arm/Group Title Salmeterol/Fluticasone Propionate
Hide Arm/Group Description:
Salmeterol/fluticasone propionate patients received 2 inhalations twice daily each inhalation was 25/50mcg for 24 weeks(Total daily dose was 100/200mcg)
Overall Number of Participants Analyzed 40
Measure Type: Number
Unit of Measure: Participants
Laryngopharyngitis 8
Bronchitis 8
Nasopharyngitis 8
Asthma 8
Pharyngitis 6
Pyrexia 5
Otitis media 4
Pharyngotonsillitis 3
Laryngotracheo bronchitis 3
Molluscum contagiosum 3
Stomatitis 3
2.Primary Outcome
Title Serious Adverse Events (SAEs) - On Therapy
Hide Description

Number of participants considered by the investigator to be related to study medication.

Adverse events, Clinical laboratory tests, Adrenocortical function test, Physical examinations, 12-lead ECG, Oropharyngeal examination were included. Frequency threshold of reported SAE's is 0%(100% reported)

Time Frame Baseline to Week 24
Hide Outcome Measure Data
Hide Analysis Population Description
Safety analysis was performed on the primary outcome measures, adverse events and on the safety population defined as all subjects who entered the treatment period and received at least one dose of study medication.
Arm/Group Title Salmeterol/Fluticasone Propionate
Hide Arm/Group Description:
Salmeterol/fluticasone propionate patients received 2 inhalations twice daily each inhalation was 25/50mcg for 24 weeks(Total daily dose was 100/200mcg)
Overall Number of Participants Analyzed 40
Measure Type: Number
Unit of Measure: Participants
1
3.Secondary Outcome
Title Change From Baseline in Morning Peak Expiratory Flow (PEF) During Weeks 1-24
Hide Description PEF taken daily and average used for week 1-24 value. The peak expiratory flow rate measures how fast a person can (exhale) air. Then, compares it to normal flow rates to predict obstruction and disease. The average PEF for a child or adolescent whose height is 43" is 147 L/min, whose height is 66" is 454 L/min.
Time Frame Baseline and during Weeks 1-24
Hide Outcome Measure Data
Hide Analysis Population Description
Efficacy analyses were performed on the secondary outcome measures and Full analysis set, defined as all the subjects who entered the treatment period, excluding all those who received no dose of study medication or who had no post-baseline data.
Arm/Group Title Salmeterol/Fluticasone Propionate
Hide Arm/Group Description:
Salmeterol/fluticasone propionate patients received 2 inhalations twice daily each inhalation was 25/50mcg for 24 weeks(Total daily dose was 100/200mcg)
Overall Number of Participants Analyzed 40
Mean (Standard Deviation)
Unit of Measure: L/min
32.9  (34.48)
4.Secondary Outcome
Title Change From Baseline in Percent Predicted Morning Peak Expiratory Flow (PEF) During Weeks 1-24
Hide Description Percent Predicted Morning Peak Expiratory flow were the percent of patients that were predicted to have their Peak expiratory flow in the morning.
Time Frame Baseline and during Weeks 1-24
Hide Outcome Measure Data
Hide Analysis Population Description
Efficacy analyses were performed on the secondary outcome measures and Full analysis set, defined as all the subjects who entered the treatment period, excluding all those who received no dose of study medication or who had no post-baseline data.
Arm/Group Title Salmeterol/Fluticasone Propionate
Hide Arm/Group Description:
Salmeterol/fluticasone propionate patients received 2 inhalations twice daily each inhalation was 25/50mcg for 24 weeks(Total daily dose was 100/200mcg)
Overall Number of Participants Analyzed 40
Mean (Standard Deviation)
Unit of Measure: Percent Change
12.50  (11.294)
5.Secondary Outcome
Title Change From Baseline in Evening Peak Expiratory Flow (PEF) During Weeks 1-24
Hide Description The peak expiratory flow rate measures how fast a person can (exhale) air. Then compares it to normal flow rates to predict obstruction and disease. The average PEF for a child or adolescent whose height is 43" is 147 L/min, whose height is 66" is 454 L/min.
Time Frame Baseline and during Weeks 1-24
Hide Outcome Measure Data
Hide Analysis Population Description
Efficacy analyses were performed on the secondary outcome measures and Full analysis set, defined as all the subjects who entered the treatment period, excluding all those who received no dose of study medication or who had no post-baseline data.
Arm/Group Title Salmeterol/Fluticasone Propionate
Hide Arm/Group Description:
Salmeterol/fluticasone propionate patients received 2 inhalations twice daily each inhalation was 25/50mcg for 24 weeks(Total daily dose was 100/200mcg)
Overall Number of Participants Analyzed 40
Mean (Standard Deviation)
Unit of Measure: L/min
31.2  (29.28)
6.Secondary Outcome
Title Change From Baseline in Circadian Variation in Peak Expiratory Flow (PEF) During Weeks 1-24
Hide Description Circadian Variation means the various changes in a day. The peak expiratory flow rate measures how fast a person can (exhale) air using a mini-Wright peak flow meter. The average PEF for a child or adolescent whose height is 43" is 147 L/min, whose height is 66" is 454 L/min.
Time Frame Baseline and during Weeks 1-24
Hide Outcome Measure Data
Hide Analysis Population Description
Efficacy analyses were performed on the secondary outcome measures and Full analysis set, defined as all the subjects who entered the treatment period, excluding all those who received no dose of study medication or who had no post-baseline data.
Arm/Group Title Salmeterol/Fluticasone Propionate
Hide Arm/Group Description:
Salmeterol/fluticasone propionate patients received 2 inhalations twice daily each inhalation was 25/50mcg for 24 weeks(Total daily dose was 100/200mcg)
Overall Number of Participants Analyzed 40
Mean (Standard Deviation)
Unit of Measure: Percent Change
-1.62  (3.583)
7.Secondary Outcome
Title Number of Participants With Symptom-Free Nights and Days
Hide Description [Not Specified]
Time Frame Baseline and Week 24
Hide Outcome Measure Data
Hide Analysis Population Description
Efficacy analyses were performed on the secondary outcome measures and Full analysis set, defined as all the subjects who entered the treatment period, excluding all those who received no dose of study medication or who had no post-baseline data.
Arm/Group Title Salmeterol/Fluticasone Propionate
Hide Arm/Group Description:
Salmeterol/fluticasone propionate patients received 2 inhalations twice daily each inhalation was 25/50mcg for 24 weeks(Total daily dose was 100/200mcg)
Overall Number of Participants Analyzed 40
Measure Type: Number
Unit of Measure: Participants
Baseline 29
Week 24 31
8.Secondary Outcome
Title Number of Participants With Rescue Medication-Free Nights and Days
Hide Description Rescue free means without the use of other medication.
Time Frame Baseline and Week 24
Hide Outcome Measure Data
Hide Analysis Population Description
Efficacy analyses were performed on the secondary outcome measures and Full analysis set, defined as all the subjects who entered the treatment period, excluding all those who received no dose of study medication or who had no post-baseline data.
Arm/Group Title Salmeterol/Fluticasone Propionate
Hide Arm/Group Description:
Salmeterol/fluticasone propionate patients received 2 inhalations twice daily each inhalation was 25/50mcg for 24 weeks(Total daily dose was 100/200mcg)
Overall Number of Participants Analyzed 40
Measure Type: Number
Unit of Measure: Participants
Baseline 33
Week 24 32
Time Frame [Not Specified]
Adverse Event Reporting Description [Not Specified]
 
Arm/Group Title Salmeterol/Fluticasone Propionate
Hide Arm/Group Description Salmeterol/fluticasone propionate patients received 2 inhalations twice daily each inhalation was 25/50mcg for 24 weeks(Total daily dose was 100/200mcg)
All-Cause Mortality
Salmeterol/Fluticasone Propionate
Affected / at Risk (%)
Total   --/-- 
Show Serious Adverse Events Hide Serious Adverse Events
Salmeterol/Fluticasone Propionate
Affected / at Risk (%)
Total   1 
Respiratory, thoracic and mediastinal disorders   
Asthma  1  1/40 (2.50%) 
Indicates events were collected by systematic assessment
1
Term from vocabulary, MedDRA
Show Other (Not Including Serious) Adverse Events Hide Other (Not Including Serious) Adverse Events
Frequency Threshold for Reporting Other Adverse Events 5%
Salmeterol/Fluticasone Propionate
Affected / at Risk (%)
Total   40 
Gastrointestinal disorders   
Stomatitis  1  3/40 (7.50%) 
Acetonaemic vomiting  1  2/40 (5.00%) 
Abdominal pain  1  2/40 (5.00%) 
General disorders   
Pyrexia  1  5/40 (12.50%) 
Infections and infestations   
Laryngopharyngitis  1  8/40 (20.00%) 
Bronchitis  1  8/40 (20.00%) 
Nasopharyngitis  1  8/40 (20.00%) 
Pharyngitis  1  6/40 (15.00%) 
Otitis Media  1  4/40 (10.00%) 
Pharyngotonsillitis  1  3/40 (7.50%) 
Laryngotracheo bronchitis  1  3/40 (7.50%) 
Molluscum contagiosum  1  3/40 (7.50%) 
Gastroenteritis  1  2/40 (5.00%) 
Sinusitus  1  2/40 (5.00%) 
tonsillitus  1  2/40 (5.00%) 
Respiratory, thoracic and mediastinal disorders   
Asthma  1  8/40 (20.00%) 
Skin and subcutaneous tissue disorders   
Heat Rash  1  2/40 (5.00%) 
Eczema  1  2/40 (5.00%) 
Indicates events were collected by systematic assessment
1
Term from vocabulary, MedDRA
Certain Agreements
Principal Investigators are NOT employed by the organization sponsoring the study.
There IS an agreement between Principal Investigators and the Sponsor (or its agents) that restricts the PI's rights to discuss or publish trial results after the trial is completed.
GSK agreements may vary with individual investigators, but will not prohibit any investigator from publishing. GSK supports the publication of results from all centres of a multi-centre trial but requests that reports based on single-site data not precede the primary publication of the entire clinical trial.
Results Point of Contact
Layout table for Results Point of Contact information
Name/Title: GSK Response Center
Organization: GlaxoSmithKline
Phone: 866-435-7343
Layout table for additonal information
ClinicalTrials.gov Identifier: NCT00449046     History of Changes
Other Study ID Numbers: 110101
First Submitted: March 16, 2007
First Posted: March 19, 2007
Results First Submitted: November 21, 2008
Results First Posted: August 4, 2009
Last Update Posted: May 6, 2015