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Results Of Patient Rated Asthma Control Test In Comparison To Diary Card Data

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ClinicalTrials.gov Identifier: NCT00363480
Recruitment Status : Completed
First Posted : August 15, 2006
Results First Posted : March 9, 2018
Last Update Posted : March 9, 2018
Sponsor:
Information provided by (Responsible Party):
GlaxoSmithKline

Study Type: Interventional
Study Design: Allocation: Non-Randomized;   Intervention Model: Single Group Assignment;   Masking: None (Open Label);   Primary Purpose: Treatment
Condition: Asthma
Interventions: Drug: Salmeterol/Fluticasone 50/250 mcg
Drug: Salbutamol 100 mcg
Device: DISKUS™ powder inhalers

  Participant Flow

Recruitment Details
Key information relevant to the recruitment process for the overall study, such as dates of the recruitment period and locations
Study was conducted at 27 centers in Germany from 17 May 2006 to 6 September 2007 on participants diagnosed with perennial bronchial asthma.

Pre-Assignment Details
Significant events and approaches for the overall study following participant enrollment, but prior to group assignment
A total of 261 participants were screened, of which 40 were screen failure, remaining 221 participants entered the treatment period.

Reporting Groups
  Description
SFC 50/250 mcg Participants received the combination product, fluticasone 250 microgram (mcg) plus salmeterol 50 mcg (SFC 50/250 mcg) for 12 weeks. Study treatment was received using DISKUS™ powder inhalers, one dose in morning and evening. Study medication was dispensed at visits 3, 4, and 5 for 30 days each. The participants were provided with salbutamol rescue medication if they developed acute asthmatic symptoms. This medication was provided in metered dose inhalers containing at least 200 puffs of 100 mcg salbutamol. Use of rescue medications was recorded in the participant’s asthma diaries. Stable dosages of other concomitant medications were allowed if they had no impact on the outcome criteria.

Participant Flow:   Overall Study
    SFC 50/250 mcg
STARTED   221 
COMPLETED   204 
NOT COMPLETED   17 
Criteria for treatment period not fulfil                1 
Adverse Event                4 
Lost to Follow-up                5 
Withdrawal by Subject                5 
Non-compliance of subject                1 
Participant discontinued on its own                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
SFC 50/250 mcg Participants received SFC 50/250 mcg for 12 weeks. Study treatment was received using DISKUS powder inhalers, one dose in morning and evening. Study medication was dispensed at visits 3, 4, and 5 for 30 days each. The participants were provided with salbutamol rescue medication if they developed acute asthmatic symptoms. This medication was provided in metered dose inhalers containing at least 200 puffs of 100 mcg salbutamol. Use of rescue medications was recorded in the participant’s asthma diaries. Stable dosages of other concomitant medications were allowed if they had no impact on the outcome criteria.

Baseline Measures
   SFC 50/250 mcg 
Overall Participants Analyzed 
[Units: Participants]
 221 
Age 
[Units: Years]
Mean (Standard Deviation)
 49.5  (15.5) 
Sex: Female, Male 
[Units: Participants]
Count of Participants
 
Female      142  64.3% 
Male      79  35.7% 


  Outcome Measures

1.  Primary:   Percentage of Well Controlled Participants as Per Gaining Optimal Asthma Control (GOAL) Criteria After 12 Week Compared to Percentage of Participants With Asthma Control Test (ACT) Score of 20-25 for Week 9 to Week 12   [ Time Frame: Week 9 to Week 12 ]

2.  Secondary:   Change From Baseline in Percentage of Participants With ACT Score of 20-25 at Week 12   [ Time Frame: Baseline (Visit 3) and Week 12 ]

3.  Secondary:   Change From Baseline in Mean ACT Score at Visit 6   [ Time Frame: Baseline (Viait 3) and Week 12 ]

4.  Secondary:   Number of Participants With Well Controlled and Totally Controlled Asthma at Week 12   [ Time Frame: Week 12 ]

5.  Secondary:   Change From Baseline in Quality of Life Using the Asthma Quality of Life Questionnaire (AQLQ)   [ Time Frame: Baseline (Visit 3) up to Week 12 ]

6.  Secondary:   Correlation of Change in AQLQ Score and Change in ACT Score   [ Time Frame: Week 12 ]

7.  Secondary:   Change From Baseline in Forced Expiratory Volume (FEV1) to Week 12   [ Time Frame: Baseline (Visit 3) up to Week 12 ]

8.  Secondary:   Change From Baseline in Mean Morning Percent Predicted Peak Expiratory Flow (PEF) at Week 12   [ Time Frame: Baseline (Visit 3) and Week 12 ]

9.  Secondary:   Change From Baseline in Mean 24-hour Symptom Score at Week 12   [ Time Frame: Baseline (Visit 3) and Week 12 ]

10.  Secondary:   Change From Baseline in Number of Additional Usage of Salbutamol at Week 12   [ Time Frame: Baseline (Visit 3) and week 12 ]

11.  Secondary:   Percent Change From Baseline in Number of Nights With no Nocturnal Awakening at Week 12   [ Time Frame: Baseline (Visit 3) and week 12 ]

12.  Secondary:   Number of Participants With Emergency Visits Due to Asthma   [ Time Frame: Up to week 12 ]

13.  Secondary:   Number of Participants With Adverse Events (AE) Leading to a Change in Asthma Treatment   [ Time Frame: Up to Week 12 ]

14.  Secondary:   Assessment of Tolerability by Number of Participants With at Least One Treatment Emergent Serious and, Non-serious AE   [ Time Frame: Up to Week 12 ]

15.  Secondary:   Assessment of Tolerability by Change From Baseline of Systolic Blood Pressure (SBP) and Diastolic Blood Pressure (DBP)   [ Time Frame: Baseline (Visit 3) up to Week 12 ]

16.  Secondary:   Assessment of Tolerability by Change From Baseline of Pulse Rate   [ Time Frame: Baseline (Visit 3) up to Week 12 ]

17.  Secondary:   Number of Participants With Occurrence of (Near-) Incidents Associated With Peak Flow Measurements   [ Time Frame: Up to Week 12 ]


  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: NCT00363480     History of Changes
Other Study ID Numbers: SAM 106538
First Submitted: August 10, 2006
First Posted: August 15, 2006
Results First Submitted: February 21, 2017
Results First Posted: March 9, 2018
Last Update Posted: March 9, 2018