Study Of Fluticasone Propionate/Salmeterol In Asthmatic Subjects

NCT00517634 | Completed Phase 4 Results

• 1 other identifier: HZA109912
• Study Type: interventional
• Target: 23
• Locations: 2 countries
• Sites: 2

Brief Summary

The aim of the present study is to investigate whether the effects of salmeterol in combination with fluticasone propionate on blood markers of airway inflammation are maintained after chronic dosing and whether the effect is influenced by the time of allergen challenge relative to the time of dosing.

Conditions

Asthma

Keywords

asthma; allergen challenge; IL-5; eosinophils

Outcome Measures

Primary Outcomes (1)

• Weighted Mean Change From Baseline Over 0-6 Hours in Blood Eosinophils Post-Allergen Challenge on Day 35

  Number of peripheral blood eosinophils measured from blood draws

  0-6 hours post allergen challenge, 10-11 hours post treatment, Day 35

Secondary Outcomes (3)

• Weighted Mean Change From Baseline Over 0-6 Hours in Blood Eosinophils Post-Allergen Challenge on Day 14

  0-6 hours, post allergen challenge, 1 hour post treatment, Day 14

• Weighted Mean Change From Baseline Over 0-6 Hours in Serum IL-5 Post-Allergen Challenge on Day 35

  0-6 hours post allergen challenge, 10-11 hours post treatment, Day 35

• Weighted Mean Change From Baseline Over 0-6 Hours in Serum IL-5 Post-Allergen Challenge on Day 14

  0-6 hours post allergen challenge, 1 hour after dosing, Day 14

Study Arms (6)

Sequence 1: FP, SFC, Placebo

EXPERIMENTAL

Fluticasone Propionate (FP) 100 micrograms (mcg) twice daily (BID) in the first treatment period: Salmeterol/Fluticasone Propionate Combination (SFC) 50/100 mcg BID in the second treatment period: Placebo in the third treatment period

Drug: FP; Drug: SFC; Drug: Placebo

Sequence 2: Placebo, SFC, FP

EXPERIMENTAL

Placebo in the first treatment period: Salmeterol/Fluticasone Propionate Combination 50/100 mcg BID in the second treatment period: Fluticasone Propionate 100 mcg BID in the third treatment period

Drug: FP; Drug: SFC; Drug: Placebo

Sequence 3: SFC, FP, Placebo

EXPERIMENTAL

Salmeterol/Fluticasone Propionate 50/100 Combination mcg BID in the first treatment period: Fluticasone Propionate 100 mcg BID in the second treatment period: Placebo in the third treatment period

Drug: FP; Drug: SFC; Drug: Placebo

Sequence 4: SFC, Placebo, FP

EXPERIMENTAL

Salmeterol/Fluticasone Propionate Combination 50/100 mcg BID in the first treatment period: Placebo in the second treatment period: Fluticasone Propionate 100 mcg BID in the third treatment period

Drug: FP; Drug: SFC; Drug: Placebo

Sequence 5: FP, Placebo, SFC

EXPERIMENTAL

Fluticasone Propionate 100 mcg BID in the first treatment period: Placebo in the second treatment period: Salmeterol/Fluticasone Propionate Combination 50/100 mcg BID in the third treatment period

Drug: FP; Drug: SFC; Drug: Placebo

Sequence 6: Placebo, FP, SFC

EXPERIMENTAL

Placebo in the first treatment period: Fluticasone Propionate 100 mcg BID in the second treatment period: Salmeterol/Fluticasone Propionate Combination 50/100 mcg BID in the third treatment period

Drug: FP; Drug: SFC; Drug: Placebo

Interventions

FP DRUG

Fluticasone Propionate 100 mcg BD

Sequence 1: FP, SFC, Placebo; Sequence 2: Placebo, SFC, FP; Sequence 3: SFC, FP, Placebo; Sequence 4: SFC, Placebo, FP; Sequence 5: FP, Placebo, SFC; Sequence 6: Placebo, FP, SFC

SFC DRUG

Salmeterol/Fluticasone Propionate Combination 50/100 mcg BD

Sequence 1: FP, SFC, Placebo; Sequence 2: Placebo, SFC, FP; Sequence 3: SFC, FP, Placebo; Sequence 4: SFC, Placebo, FP; Sequence 5: FP, Placebo, SFC; Sequence 6: Placebo, FP, SFC

Placebo DRUG

Matching Placebo

Sequence 1: FP, SFC, Placebo; Sequence 2: Placebo, SFC, FP; Sequence 3: SFC, FP, Placebo; Sequence 4: SFC, Placebo, FP; Sequence 5: FP, Placebo, SFC; Sequence 6: Placebo, FP, SFC

Eligibility Criteria

• Age: 18 Years - 55 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64)

You may qualify if:

• Informed consent.
• Outpatient.
• Male or non-pregnant/non-lactating female.
• Aged 18-55.
• Diagnosis of asthma.
• Pre-bronchodilatory FEV1 \> 75% predicted.
• Using inhaled short-acting beta-2-agonists (SABA) with no inhaled corticosteroids.
• Judged capable of withholding SABA for at least 6 hours prior to visits.
• Reversibility of \>12% and 200mL or PC20 of \<8mg/mL.
• Demonstration of atopy

You may not qualify if:

• History of life-threatening asthma.
• Use of proscribed asthma medications.
• Use of anti-histamines or potent inhibitors of CYP3A4.
• Respiratory tract infection.
• Asthma exacerbation with 4 weeks of Visit 1.
• Subjects with exercise induced asthma only.
• Concurrent respiratory disease.
• Other clinically significant, uncontrolled condition or disease.
• Use of any investigational drug within 30 days.
• Allergic to beta-2-agonists, inhaled corticosteroids or excipients.
• Positive pregnancy test.
• Using immunosuppressive medications.
• Milk protein allergy.
• Factors likely to interfere with attendance.
• Current smokers or ex-smokers with a history of \>10 pack years.

Sponsors & Collaborators

• GlaxoSmithKline: lead

Study Sites (2)

GSK Investigational Site

Madison, Wisconsin, 53792, United States

Location

GSK Investigational Site

Manchester, M23 9QZ, United Kingdom

Location

Related Links

• Researchers can use this site to request access to anonymised patient level data and/or supporting documents from clinical studies to conduct further research.

MeSH Terms

Conditions

Asthma

Condition Hierarchy (Ancestors)

Bronchial Diseases; Respiratory Tract Diseases; Lung Diseases, Obstructive; Lung Diseases; Respiratory Hypersensitivity; Hypersensitivity, Immediate; Hypersensitivity; Immune System Diseases

Results Point of Contact

• Title: GSK Response Center
• Organization: GlaxoSmithKline

866-435-7343

Study Officials

• GSK Clinical Trials

  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
• Who Masked: PARTICIPANT, INVESTIGATOR
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: INDUSTRY
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: August 16, 2007
• First Posted: August 17, 2007
• Study Start: August 1, 2007
• Primary Completion: July 1, 2008
• Study Completion: July 1, 2008
• Last Updated: December 16, 2016
• Results First Posted: September 2, 2009

Record last verified: 2016-11

Data Sharing

• IPD Sharing: Will share

Locations

US (1); GB (1)