NCT00461500

Brief Summary

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

Trial Health

100
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
81

participants targeted

Target at P50-P75 for phase_4 asthma

Timeline
Completed

Started Mar 2007

Shorter than P25 for phase_4 asthma

Status
completed

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

Study Start

First participant enrolled

March 1, 2007

Completed
2 months until next milestone

First Submitted

Initial submission to the registry

April 17, 2007

Completed
1 day until next milestone

First Posted

Study publicly available on registry

April 18, 2007

Completed
8 months until next milestone

Primary Completion

Last participant's last visit for primary outcome

December 1, 2007

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

December 1, 2007

Completed
4.3 years until next milestone

Results Posted

Study results publicly available

March 23, 2012

Completed
Last Updated

March 3, 2017

Status Verified

January 1, 2017

Enrollment Period

9 months

First QC Date

April 17, 2007

Results QC Date

December 19, 2008

Last Update Submit

January 19, 2017

Conditions

Asthma

Keywords

persistentmoderateasthmaadultsInitialMaintenanceTherapy

Outcome Measures

Primary Outcomes (1)

  • Change From Baseline in Mean Morning Peak Expiratory Flow (PEF) Over Weeks 5-12

    Mini Wright Peak Flow Meter used to allow patients to monitor their asthma - Peak Flow (or PEF - peak expiratory flow) is a measurement of how fast you can blow out. When someone is well, their PEF is higher - when the airways are narrow (as in asthma), PEF is lower. Readings based on age, height and gender.

    Baseline, Weeks 5-12

Secondary Outcomes (12)

  • Change From Baseline in Pre-dose FEV1 (Forced Expiratory Volume in One Second) Through Week 12 (Using Last Observation Carried Forward [LOCF] Approach)

    Baseline through Week 12

  • Change From Baseline in Pre-dose (Percent Predicted) FEV1 Through Week 12 (Using Last Observation Carried Forward [LOCF] Approach)

    Baseline through Week 12

  • Change From Baseline in FEV1 Reversibility Through Week 12 (Using Last Observation Carried Forward [LOCF] Approach)

    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)

    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)

    Baseline through Week 12

  • +7 more secondary outcomes

Interventions

Salmeterol xinafoate/fluticasone propionate combinationDRUG

SFC 100

Also known as: SERETIDE FLIXOTIDE
Fluticasone propionateDRUG

FP 100

Eligibility Criteria

Age18 Years - 40 Years
Sexall
Healthy VolunteersNo
Age GroupsAdult (18-64)

You may qualify if:

  • 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)

You may not qualify if:

  • 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

Contact the study team to confirm eligibility.

Sponsors & Collaborators

MeSH Terms

Conditions

AsthmaLymphoma, Follicular

Interventions

Fluticasone-Salmeterol Drug CombinationFluticasone

Condition Hierarchy (Ancestors)

Bronchial DiseasesRespiratory Tract DiseasesLung Diseases, ObstructiveLung DiseasesRespiratory HypersensitivityHypersensitivity, ImmediateHypersensitivityImmune System DiseasesLymphoma, Non-HodgkinLymphomaNeoplasms by Histologic TypeNeoplasmsLymphoproliferative DisordersLymphatic DiseasesHemic and Lymphatic DiseasesImmunoproliferative Disorders

Intervention Hierarchy (Ancestors)

Salmeterol XinafoateAlbuterolEthanolaminesAmino AlcoholsAlcoholsOrganic ChemicalsAminesPhenethylaminesEthylaminesAndrostadienesAndrostenesAndrostanesSteroidsFused-Ring CompoundsPolycyclic CompoundsDrug CombinationsPharmaceutical Preparations

Results Point of Contact

Title
GSK Response Center
Organization
GlaxoSmithKline
866-435-7343

Study Officials

  • GSK Clinical Trials, MD

    GlaxoSmithKline

    STUDY DIRECTOR

Publication Agreements

PI is Sponsor Employee
No
Restriction Type
OTHER
Restrictive Agreement
Yes

Study Design

Study Type
interventional
Phase
phase 4
Allocation
RANDOMIZED
Masking
DOUBLE
Purpose
TREATMENT
Intervention Model
PARALLEL
Sponsor Type
INDUSTRY

Study Record Dates

First Submitted

April 17, 2007

First Posted

April 18, 2007

Study Start

March 1, 2007

Primary Completion

December 1, 2007

Study Completion

December 1, 2007

Last Updated

March 3, 2017

Results First Posted

March 23, 2012

Record last verified: 2017-01