Text Size

Treatment Of Symptomatic Asthma In Children

This study has been completed.
Sponsor:
Information provided by (Responsible Party):
GlaxoSmithKline
ClinicalTrials.gov Identifier:
NCT00197106
First received: September 9, 2005
Last updated: May 31, 2012
Last verified: April 2012
History of Changes
Results First Received: September 11, 2009  
Study Type: Interventional
Study Design: Allocation: Randomized;   Endpoint Classification: Efficacy Study;   Intervention Model: Parallel Assignment;   Masking: Double Blind (Subject, Investigator);   Primary Purpose: Treatment
Condition: Asthma
Interventions: Drug: Salmeterol/ fluticasone propionate Diskus® inhaler 50/100 mcg
Drug: fluticasone propionate 2 x 100 mcg

  Participant Flow
  Hide Participant Flow

Recruitment Details
Key information relevant to the recruitment process for the overall study, such as dates of the recruitment period and locations
Participants were eligible to enter the run-in period if they had a documented clinical history of asthma with hyperresponsiveness. Only participants who were symptomatic after this period were eligible to be enrolled into the study and were randomized into either the Salmeterol/Fluticasone propionate (FP) 50/100 mcg plus placebo or FP groups.

Pre-Assignment Details
Significant events and approaches for the overall study following participant enrollment, but prior to group assignment
257 participants started the run-in phase of the study, and 99 of these did not meet the inclusion criteria to be entered into the treatment phase. Only baseline characteristics for the 158 participants meeting the inclusion criteria and randomized to either salmeterol/fluticasone propionate 50/100 mcg BID or fluticasone 200 mcg BID are provided.

Reporting Groups
  Description
Fluticasone Propionate (FP) 100 Mcg Fluticasone propionate (FP) 100 mcg (micrograms) twice daily (BID) via DISKUS inhaler
Salmeterol/FP 50/100 Mcg Plus Placebo One puff Salmeterol/FP 50/100 mcg plus one puff placebo (matching one puff of FP in the 200 mcg group) BID via DISKUS inhaler
FP 200 Mcg FP 200 mcg (delivered as two 100 mcg puffs) BID via DISKUS inhaler

Participant Flow for 2 periods

 Period 1:   4-Week Run-In Period
    Fluticasone Propionate (FP) 100 Mcg     Salmeterol/FP 50/100 Mcg Plus Placebo     FP 200 Mcg  
STARTED     257     0     0  
COMPLETED     158     0     0  
NOT COMPLETED     99     0     0  
Did not meet entry criteria                 99                 0                 0  

Period 2:   Overall Treatment Period
    Fluticasone Propionate (FP) 100 Mcg     Salmeterol/FP 50/100 Mcg Plus Placebo     FP 200 Mcg  
STARTED     0     78     80  
COMPLETED     0     77     74  
NOT COMPLETED     0     1     6  
Lack of Efficacy                 0                 1                 0  
Lost to Follow-up                 0                 0                 2  
Protocol Violation                 0                 0                 2  
Withdrawal by Subject                 0                 0                 2  



  Baseline Characteristics
  Hide Baseline Characteristics

Reporting Groups
  Description
Salmeterol/FP 50/100 Mcg Plus Placebo Salmeterol/FP 50/100 mcg plus placebo BID via DISKUS inhaler
FP 200 Mcg FP 200 mcg BID via DISKUS inhaler
Total Total of all reporting groups

Baseline Measures
    Salmeterol/FP 50/100 Mcg Plus Placebo     FP 200 Mcg     Total  
Number of Participants  
[units: participants]
 		  78     80     158  
Age  
[units: years]
Mean ± Standard Deviation 		  9.4  ± 1.8     9.3  ± 1.9     9.3  ± 1.8  
Gender  
[units: participants]
 		     
Female     36     31     67  
Male     42     49     91  
Race/Ethnicity, Customized  
[units: participants]
 		     
Caucasian     73     75     148  
Mixed     4     3     7  
African-American     0     1     1  
African     1     1     2  
Asthma duration [1]
[units: years]
Mean ± Standard Deviation 		  5.7  ± 3.1     5.5  ± 3.0     5.6  ± 3.0  
[1] Mean asthma duration before enrollment in study



  Outcome Measures
  Show All Outcome Measures

1.  Primary:   Percentage of Symptom-free Days During the Last 10 Weeks of the Treatment Period   [ Time Frame: Last 10 weeks of the treatment period (Weeks 16-26) ]
  Show Outcome Measure 1

2.  Secondary:   Percentage of Symptom-free Days During the Entire Treatment Period   [ Time Frame: Baseline to Week 26 ]
  Show Outcome Measure 2

3.  Secondary:   Mean Change From Baseline in Percentage Predicted Forced Expiratory Volume in One Second (FEV1) at Week 26   [ Time Frame: Baseline and Week 26 ]
  Show Outcome Measure 3

4.  Secondary:   Mean Change From Baseline in Forced Vital Capacity (FVC) at Week 26   [ Time Frame: Baseline and Week 26 ]
  Show Outcome Measure 4

5.  Secondary:   Mean Change From Baseline in Midexpiratory Flow (MEF 50) at Week 26   [ Time Frame: Baseline and Week 26 ]
  Show Outcome Measure 5

6.  Secondary:   Geometric Means of Nitric Oxide (NO) at Week 26   [ Time Frame: Baseline and Week 26 ]
  Show Outcome Measure 6

7.  Secondary:   Percent Change From Baseline in RINT Measurements at Week 26   [ Time Frame: Baseline and Week 26 ]
  Show Outcome Measure 7

8.  Secondary:   Number of Asthma Exacerbations Per Treatment Group at Week 26   [ Time Frame: Week 26 ]
  Show Outcome Measure 8

9.  Secondary:   Mean Change From Baseline in Provocation Dose (PD20) Causing a 20% Fall in FEV1 at Week 26   [ Time Frame: Baseline and Week 26 ]
  Show Outcome Measure 9

10.  Secondary:   Bronchial Hyperresponsiveness With PD20 AMP in Selected Centres   [ Time Frame: 26 weeks ]
  Show Outcome Measure 10

11.  Secondary:   Daily FEV1 and PEF Via the Electronic Peak Flow/FEV1 Meter (PIKO-1)   [ Time Frame: 26 weeks ]
  Show Outcome Measure 11

12.  Secondary:   Frequency of Asthma Exacerbations (Discriminated on Severity)   [ Time Frame: 26 weeks ]
  Show Outcome Measure 12

13.  Secondary:   Cumulative Number of Symptom-free Weeks Until the End of Treatment   [ Time Frame: 26 weeks ]
  Show Outcome Measure 13

14.  Secondary:   Weekly Percentage of Participants With ‘Good Controlled Weeks’ and ‘Maximal Controlled Weeks’   [ Time Frame: 26 weeks ]
  Show Outcome Measure 14

15.  Secondary:   Time to Asthma Control, Defined as the Time to First ‘Good Controlled Week’ or ‘Maximum Controlled Week'   [ Time Frame: 26 weeks ]
  Show Outcome Measure 15


  Serious Adverse Events
  Show Serious Adverse Events


  Other Adverse Events
  Show Other Adverse Events


  More Information
  Hide More Information

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.
The agreement is:
unchecked The only disclosure restriction on the PI is that the sponsor can review results communications prior to public release and can embargo communications regarding trial results for a period that is less than or equal to 60 days. The sponsor cannot require changes to the communication and cannot extend the embargo.
unchecked The only disclosure restriction on the PI is that the sponsor can review results communications prior to public release and can embargo communications regarding trial results for a period that is more than 60 days but less than or equal to 180 days. The sponsor cannot require changes to the communication and cannot extend the embargo.


Limitations and Caveats
Limitations of the study, such as early termination leading to small numbers of participants analyzed and technical problems with measurement leading to unreliable or uninterpretable data
No text entered.  


Results Point of Contact:  
Name/Title: GSK Response Center
Organization: GlaxoSmithKline
phone: 866-435-7343


No publications provided by GlaxoSmithKline

Publications automatically indexed to this study:


Responsible Party: GlaxoSmithKline
ClinicalTrials.gov Identifier: NCT00197106     History of Changes
Other Study ID Numbers: SAM101667
Study First Received: September 9, 2005
Results First Received: September 11, 2009
Last Updated: May 31, 2012
Health Authority: Netherlands: Medicines Evaluation Board (MEB)