FindTrial
Sign In

Comparison of Fluticasone Propionate/Salmeterol and Fluticasone Propionate in Asthma Control and Measures of Airway Inflammation.

A Multicenter, Randomized, Double-Blind, Parallel Group, 52-Week Comparison of Asthma Control and Measures of Airway Inflammation in Subjects of African Descent Receiving Fluticasone Propionate/Salmeterol 100/50mcg DISKUS® BID or Fluticasone Propionate 100mcg DISKUS® BID Alone

Status
Unknown
Phases
Phase 4
Study type
Interventional
Source
EU CTR
Registry ID
EUCTR2015-004864-12-Outside-EU/EEA
Enrollment
479
Registered
2016-08-03
Start date
Unknown
Completion date
Unknown
Last updated
2016-08-08

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

Conditions

Asthma

Interventions

Trade Name: VENTOLIN HFA Product Name: Fluticasone Propionate/salmeterol Pharmaceutical Form: INN or Proposed INN: SALMETEROL XINAFOATE CAS Number: 94749-08-3 Other descriptive name: SALMETEROL XINAF

Sponsors

GlaxoSmithKline
Lead Sponsor

Eligibility

Sex/Gender
All

Inclusion criteria

Inclusion criteria: Subjects were male or female, of African descent, and 12 to 65 years of age with a diagnosis of persistent asthma for at least six months. Are the trial subjects under 18? yes Number of subjects for this age range: 111 F.1.2 Adults (18-64 years) yes F.1.2.1 Number of subjects for this age range 364 F.1.3 Elderly (>=65 years) no F.1.3.1 Number of subjects for this age range

Exclusion criteria

Exclusion criteria: 1. Current Diagnosis of Life-Threatening Asthma 2. Asthma Instability 3. Concurrent Respiratory Disease 4. Other Concurrent Conditions/ Diseases

Design outcomes

Primary

MeasureTime frame
Main Objective: The primary objective of this study was to demonstrate that fluticasone propionate/ salmeterol 100/50mcg DISKUS BID (FSC 100/50) was superior to fluticasone propionate 100mcg DISKUS BID (FP 100) in controlling the asthma exacerbation rate in subjects of African descent with persistent asthma. ;Secondary Objective: The secondary objective of this study was to determine whether the measures of asthma control (AM and PM PEF, asthma symptoms and use of rescue albuterol) differed in subjects of African descent who received FSC 100/50 compared with those who received FP 100 alone. ;Primary end point(s): Asthma exacerabtion rate per patient per year;Timepoint(s) of evaluation of this end point: Rate per year—

Secondary

MeasureTime frame
Secondary end point(s): Morning peak flow measurement, percent of asthma symptom-free days, percent of albuterol-free days;Timepoint(s) of evaluation of this end point: Percent of symptom or treatment free days—

Countries

United States

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