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SERETIDE Vs FLIXOTIDE In Mild Persistent Asthma (GINAII)

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ClinicalTrials.gov Identifier: NCT00455923
Recruitment Status : Completed
First Posted : April 4, 2007
Results First Posted : January 4, 2018
Last Update Posted : January 4, 2018
Sponsor:
Information provided by (Responsible Party):

Study Type: Interventional
Study Design: Allocation: Randomized;   Intervention Model: Parallel Assignment;   Primary Purpose: Treatment
Condition: Asthma
Interventions: Drug: Seretide
Drug: Flixotide

  Participant Flow

Recruitment Details
Key information relevant to the recruitment process for the overall study, such as dates of the recruitment period and locations
This study was conducted at a single center with two sites in Sweden from May 2005 to July 2007. Seretide Diskus®, Flixotide® and Ventoline Diskus® are the registered products of GlaxoSmithKline.

Pre-Assignment Details
Significant events and approaches for the overall study following participant enrollment, but prior to group assignment
No text entered.

Reporting Groups
  Description
Seretide Eligible participants received a starting dose of 50/100 micrograms (mcg) Seretide (combination of salmeterol/fluticasone propionate (Sal/FP) via Diskus inhaler, twice daily. During the first 6 months, when the asthma was unstable/uncontrolled, dose was increased in a stepwise fashion to 50/250 mcg and 50/500 mcg (if still unstable). After the initial 6 months, the treatment was fixed without further changes. The total treatment period was 18 months.
Flixotide Eligible participants received a starting dose of 100 mcg Flixotide (FP only) via Diskus inhaler, twice daily. During the first 6 months, when the asthma was unstable/uncontrolled, dose was increased in a stepwise fashion to 250 mcg and 500 mcg (if still unstable). After the initial 6 months, the treatment was fixed without further changes. The total treatment period was 18 months.

Participant Flow:   Overall Study
    Seretide   Flixotide
STARTED   50   50 
COMPLETED   47   47 
NOT COMPLETED   3   3 
Pregnancy                0                2 
Other                3                1 



  Baseline Characteristics

Population Description
Explanation of how the number of participants for analysis was determined. Includes whether analysis was per protocol, intention to treat, or another method. Also provides relevant details such as imputation technique, as appropriate.
No text entered.

Reporting Groups
  Description
Seretide Eligible participants received a starting dose of 50/100 mcg Seretide (combination of Sal/FP) via Diskus inhaler, twice daily. During the first 6 months, when the asthma was unstable/uncontrolled, dose was increased in a stepwise fashion to 50/250 mcg and 50/500 mcg (if still unstable). After the initial 6 months, the treatment was fixed without further changes. The total treatment period was 18 months.
Flixotide Eligible participants received a starting dose of 100 mcg Flixotide (FP only) via Diskus inhaler, twice daily. During the first 6 months, when the asthma was unstable/uncontrolled, dose was increased in a stepwise fashion to 250 mcg and 500 mcg (if still unstable). After the initial 6 months, the treatment was fixed without further changes. The total treatment period was 18 months.
Total Total of all reporting groups

Baseline Measures
   Seretide   Flixotide   Total 
Overall Participants Analyzed 
[Units: Participants]
 50   50   100 
Age, Customized 
[Units: Participants]
Count of Participants
     
>=18 to 70 years   50   50   100 
Sex: Female, Male 
[Units: Participants]
Count of Participants
     
Female      32  64.0%      31  62.0%      63  63.0% 
Male      18  36.0%      19  38.0%      37  37.0% 
Race (NIH/OMB) 
[Units: Participants]
Count of Participants
     
American Indian or Alaska Native      0   0.0%      0   0.0%      0   0.0% 
Asian      0   0.0%      0   0.0%      0   0.0% 
Native Hawaiian or Other Pacific Islander      0   0.0%      0   0.0%      0   0.0% 
Black or African American      0   0.0%      0   0.0%      0   0.0% 
White      50 100.0%      50 100.0%      100 100.0% 
More than one race      0   0.0%      0   0.0%      0   0.0% 
Unknown or Not Reported      0   0.0%      0   0.0%      0   0.0% 


  Outcome Measures

1.  Primary:   Number of Participants in Each Arm With a Need for an Increase in Study Medication   [ Time Frame: Up to 18 months ]

2.  Secondary:   Absolute Bronchial Hyper-responsiveness up to 18 Months   [ Time Frame: Up to 18 months ]

3.  Secondary:   Change in Bronchial Hyper-responsiveness From Baseline to 18 Months   [ Time Frame: Baseline (Day 0) to 18 months ]

4.  Secondary:   Number of Symptom-free Days and Nights Without Use of Rescue Medication   [ Time Frame: Up to 18 months ]

5.  Secondary:   Number of Exacerbations: in Total and by Degree of Severity   [ Time Frame: Up to 18 months ]

6.  Secondary:   Time to Increase of Study Medication   [ Time Frame: Up to 6 months ]


  Serious Adverse Events


  Other Adverse Events


  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.


  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.


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



Responsible Party: GlaxoSmithKline
ClinicalTrials.gov Identifier: NCT00455923     History of Changes
Other Study ID Numbers: SAM103976
First Submitted: April 3, 2007
First Posted: April 4, 2007
Results First Submitted: July 23, 2017
Results First Posted: January 4, 2018
Last Update Posted: January 4, 2018