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Clinical study to compare long term use of Fluticasone Propionate alone to Fluticasone Propionate and Salmeterol together in Asthma patients.

A 52-week, Randomized, Double-Blind, Parallel-Group Study of Fluticasone Propionate/Salmeterol DISKUS Combination Product (FSC) 250/50 mcg BID and Fluticasone Propionate (FP) DISKUS 250 mcg BID in Treatment of Subjects with Asthma

Status
Unknown
Phases
Phase 4
Study type
Interventional
Source
EU CTR
Registry ID
EUCTR2015-004867-35-Outside-EU/EEA
Enrollment
628
Registered
2016-12-21
Start date
Unknown
Completion date
Unknown
Last updated
2017-01-09

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Asthma

Interventions

Product Name: Fluticasone propionate Pharmaceutical Form: Inhalation powder INN or Proposed INN: FLUTICASONE PROPIONATE CAS Number: 80474-14-2 Other descriptive name: FLUTICASONE PROPIONATE Concentrat

Sponsors

GlaxoSmithKline Research and Development Ltd.
Lead Sponsor

Eligibility

Sex/Gender
All

Inclusion criteria

Inclusion criteria: -Have asthma for at least 3 months prior to the study - Have been using an allowed pre-study asthma therapy for at least 3 months prior to study - Currently have seasonal allergic rhinitis and have had seasonal onset of allergic rhinitis for at least the two previous allergy seasons - Hvae a positive allergy skin test Are the trial subjects under 18? yes Number of subjects for this age range: 90 F.1.2 Adults (18-64 years) yes F.1.2.1 Number of subjects for this age range 1053 F.1.3 Elderly (>=65 years) yes F.1.3.1 Number of subjects for this age range 34

Exclusion criteria

Exclusion criteria: -Have a history of life-threatening asthma -Been hospitalized for asthma within the 6 months prior to the study -Have certain conditions that would make study participation unsafe

Design outcomes

Primary

MeasureTime frame
Main Objective: The primary objectives of this study were to demonstrate that fluticasone propionate/salmeterol combination product (FSC) 100/50mcg BID (available as ADVAIR DISKUS®) was superior to montelukast (MON) 10mg QD (available as Singulair) as monotherapy for asthma. ;Secondary Objective: That MON administered concurrently with FSC added no additional benefit to FSC alone in improving asthma control in a population of subjects with allergic asthma.;Primary end point(s): The primary efficacy measures were the mean change from baseline at endpoint in AM PEF compared between the FSC 100/50mcg BID and MON 10mg QD treatment groups to assess superiority and compared between the FSC and FSC+MON treatment groups to assess equivalence.;Timepoint(s) of evaluation of this end point: Week 4—

Secondary

MeasureTime frame
Secondary end point(s): Total Nasal Symptom Scores Morning Forced Expiratory Volume in 1 Second Asthma Symptom-Free Days Asthma Rescue-Free Days;Timepoint(s) of evaluation of this end point: Week 4—

Countries

United Kingdom

Contacts

Public ContactGSK Clinical Support Help Desk

GlaxoSmithKline Research & Development Ltd

GSKClinicalSupportHD@gsk.com+4408007839733

Outcome results

None listed

Source: EU CTR (via WHO ICTRP) · Data processed: Feb 4, 2026