Last updated: 11/04/2018 11:07:39

SERETIDE 100/50 bd (twice daily) Versus FLIXOTIDE 100 bd As Initial Maintenance Therapy In Moderate Asthma In Adults

GSK study ID
SAM108037
See study documents
Clinicaltrials.gov ID
NCT00461500
See results summary
EudraCT ID
Not applicable
EU CT Number
Not applicable
Trial status
Study complete
Study complete
Overview
Eligibility
Locations
Study documents
Results summary
Plain language summaries
Additional information

Trial overview

Official title: Seretide 100 DK vs Flixotide 100 DK in IMT in moderate asthma in adults on static lung volumes (mechanistic study)
Trial description: This study will compare during 12 weeks, two treatment strategies for Initial Maintenance Therapy : fluticasone propionate alone or the salmeterol/fluticasone propionate combination in adults with moderate persistent asthma
Primary purpose:
Treatment
Trial design:
Parallel Assignment
Masking:
Not applicable
Allocation:
Randomized
Primary outcomes:

Change from Baseline in Mean morning Peak Expiratory Flow (PEF) over Weeks 5-12

Timeframe: Baseline, Weeks 5-12

Secondary outcomes:

Change from Baseline in pre-dose FEV1 (Forced Expiratory Volume in one second) through Week 12 (Using Last Observation Carried Forward [LOCF] Approach)

Timeframe: Baseline through Week 12

Change from Baseline in pre-dose (Percent predicted) FEV1 through Week 12 (Using Last Observation Carried Forward [LOCF] Approach)

Timeframe: Baseline through Week 12

Change from Baseline in FEV1 reversibility through Week 12 (Using Last Observation Carried Forward [LOCF] Approach)

Timeframe: Baseline through Week 12

Change from Baseline in pre-dose forced expiratory vital capacity (FVC) through Week 12 (Using Last Observation Carried Forward [LOCF] Approach)

Timeframe: Baseline through Week 12

Change from Baseline (BL) in pre-dose FEF 25-75% (Forced Expiratory Flow) through Week 12 (Using Last Observation Carried Forward [LOCF] Approach)

Timeframe: Baseline through Week 12

Number of Participants With at Least One Exacerbation during 12-Week Treatment Period

Timeframe: 12-Week Treatment Period (Week 1 through Week 12)

Number of Participants who Achieved Well-Controlled Asthma During Weeks 5-12

Timeframe: Weeks 5 -12

Median Number of Weeks to First Achieve Well-Controlled Asthma during Weeks 5-12

Timeframe: Weeks 5 - 12

Number of Participants who Achieved Total-controlled asthma during Weeks 5-12

Timeframe: Weeks 5 - 12

Change from Baseline in Asthma Control Test (ACT) score at Week 12

Timeframe: Baseline, Week 12

ACT Score in Classes at Week 12

Timeframe: Week 12

Change from Baseline in Overall Asthma Quality of Life Questionnaire (AQLQ) Score at Week 12

Timeframe: Baseline, Week 12

Interventions:
  • Drug: Salmeterol xinafoate/fluticasone propionate combination
  • Drug: Fluticasone propionate
    • Enrollment:
    81
    Primary completion date:
    2007-26-12
    Observational study model:
    Not applicable
    Time perspective:
    Not applicable
    Clinical publications:
    Not applicable
    Medical condition
    Asthma
    Product
    fluticasone propionate, fluticasone propionate/salmeterol, salmeterol
    Collaborators
    Not applicable
    Study date(s)
    March 2007 to December 2007
    Type
    Interventional
    Phase
    4

    Participation criteria

    Sex
    Female & Male
    Age
    18 - 40 Years
    Accepts healthy volunteers
    No
    • male or female ≥ 18
    • documented history of asthma
    • respiratory disorder
    • FEV1<60% predicted
    Inclusion and exclusion criteria
    Inclusion criteria:
    • male or female ≥ 18
    • documented history of asthma
    • reversibility FEV1 or PEF ≥ 12% (post 400µg salbu)
    • moderate asthma (daily symptoms, daily rescue use, PEF = 60-80% predicted value)
    • naive or ≥ 4weeks-free ICS (inhaled corticosteroids)
    Exclusion criteria:
    • respiratory disorder
    • FEV1<60% predicted
    • exacerbation/respiratory infection ≤ 4 weeks
    • oral/parenteral/depot corticosteroids ≤ 6 months
    • LABA/oral β2 agonist/ ALT/ theophylline ≤ 4 weeks
    • smoker or former smoker ≥ 5 packs year

    Trial location(s)

    This study does not involve prospective enrollment of participants.

    Study documents

    Scientific result summary
    Available language(s): English
    Download document(s)

    If you wish to request for full study report, please contact - [email protected]

    Results overview

    Results posted on ClinicalTrials.gov

    Recruitment status
    Study complete
    Actual primary completion date
    2007-26-12
    Actual study completion date
    2007-26-12

    Plain language summaries

    Plain language summaries of clinical trial results for Phase 2-4 clinical trials that were initiated on or after January 2022 will be posted by GSK within one year following study completion.

    Additional information about the trial

    Additional information
    Not applicable
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