Study Of Fluticasone Propionate/Salmeterol In Asthmatic Subjects

November 3, 2016 updated by: GlaxoSmithKline

A 12-week, Randomised, Double-blind, Placebo-controlled, Three-period, Cross-over Pilot Study Comparing the Effect of Salmeterol/Fluticasone Propionate, Fluticasone Propionate and Placebo on Perpheral Blood Eosinophils and Serum IL-5 in Response to Allergen Challenge in Asthma Subjects When Allergen Challenge is Administered at 1 Hour or 11-12 Hours Post-dose of the Dosing Interval

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.

Study Overview

Status

Status

Indicates the current recruitment status or the expanded access status.
Completed

Conditions

Conditions

The disease, disorder, syndrome, illness, or injury that is being studied. On ClinicalTrials.gov, conditions may also include other health-related issues, such as lifespan, quality of life, and health risks.

Intervention / Treatment

Intervention / Treatment

A process or action that is the focus of a clinical study. Interventions include drugs, medical devices, procedures, vaccines, and other products that are either investigational or already available. Interventions can also include noninvasive approaches, such as education or modifying diet and exercise.

Detailed Description

A 12-week, randomised, double-blind, placebo-controlled, three-period, cross-over pilot study comparing the effect of salmeterol/fluticasone propionate, fluticasone propionate and placebo on perpheral blood eosinophils and serum IL-5 in response to allergen challenge in asthma subjects when allergen challenge is administered at 1 hour or 11-12 hours post-dose of the dosing interval

Study Type

Study Type

Describes the nature of a clinical study. Study types include interventional studies (also called clinical trials), observational studies (including patient registries), and expanded access.
Interventional

Enrollment (Actual)

Enrollment

The number of participants in a clinical study. The "anticipated" enrollment is the target number of participants that the researchers need for the study.
23

Phase

Phase

The stage of a clinical trial studying a drug or biological product, based on definitions developed by the U.S. Food and Drug Administration (FDA). The phase is based on the study's objective, the number of participants, and other characteristics. There are five phases: Early Phase 1 (formerly listed as Phase 0), Phase 1, Phase 2, Phase 3, and Phase 4. Not Applicable is used to describe trials without FDA-defined phases, including trials of devices or behavioral interventions.
  • Phase 4

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

  • United Kingdom
      • Manchester, United Kingdom, M23 9QZ
        • GSK Investigational Site
  • United States
    • Wisconsin
      • Madison, Wisconsin, United States, 53792
        • GSK Investigational Site

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Eligibility Criteria

The key requirements that people who want to participate in a clinical study must meet or the characteristics they must have. Eligibility criteria consist of both inclusion criteria (which are required for a person to participate in the study) and exclusion criteria (which prevent a person from participating). Types of eligibility criteria include whether a study accepts healthy volunteers, has age or age group requirements, or is limited by sex.

Ages Eligible for Study

18 years to 55 years (Adult)

Accepts Healthy Volunteers

No

Genders Eligible for Study

All

Description

Inclusion Criteria:

  • 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

Exclusion Criteria:

  • 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.
  • Affiliation wih Investigator site.
  • Medications that may affect the course of asthma or interact with sympathomimetic amines.

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: Treatment
  • Allocation: Randomized
  • Interventional Model: Parallel Assignment
  • Masking: Double

Arms and Interventions

Participant Group / Arm

Participant Group / Arm

A group or subgroup of participants in a clinical trial that receives a specific intervention/treatment, or no intervention, according to the trial's protocol.
Intervention / Treatment

Intervention / Treatment

A process or action that is the focus of a clinical study. Interventions include drugs, medical devices, procedures, vaccines, and other products that are either investigational or already available. Interventions can also include noninvasive approaches, such as education or modifying diet and exercise.
Experimental: Sequence 1: FP, SFC, Placebo
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: Placebo
Matching Placebo
Drug: FP
Fluticasone Propionate 100 mcg BD
Drug: SFC
Salmeterol/Fluticasone Propionate Combination 50/100 mcg BD
Experimental: Sequence 2: Placebo, SFC, FP
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: Placebo
Matching Placebo
Drug: FP
Fluticasone Propionate 100 mcg BD
Drug: SFC
Salmeterol/Fluticasone Propionate Combination 50/100 mcg BD
Experimental: Sequence 3: SFC, FP, Placebo
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: Placebo
Matching Placebo
Drug: FP
Fluticasone Propionate 100 mcg BD
Drug: SFC
Salmeterol/Fluticasone Propionate Combination 50/100 mcg BD
Experimental: Sequence 4: SFC, Placebo, FP
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: Placebo
Matching Placebo
Drug: FP
Fluticasone Propionate 100 mcg BD
Drug: SFC
Salmeterol/Fluticasone Propionate Combination 50/100 mcg BD
Experimental: Sequence 5: FP, Placebo, SFC
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: Placebo
Matching Placebo
Drug: FP
Fluticasone Propionate 100 mcg BD
Drug: SFC
Salmeterol/Fluticasone Propionate Combination 50/100 mcg BD
Experimental: Sequence 6: Placebo, FP, SFC
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: Placebo
Matching Placebo
Drug: FP
Fluticasone Propionate 100 mcg BD
Drug: SFC
Salmeterol/Fluticasone Propionate Combination 50/100 mcg BD

What is the study measuring?

Primary Outcome Measures

Primary Outcome Measures

In a clinical study's protocol, the planned outcome measure that is the most important for evaluating the effect of an intervention/treatment. Most clinical studies have one primary outcome measure, but some have more than one.
Outcome Measure
Measure Description
Time Frame
Weighted Mean Change From Baseline Over 0-6 Hours in Blood Eosinophils Post-Allergen Challenge on Day 35
Time Frame: 0-6 hours post allergen challenge, 10-11 hours post treatment, 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 Outcome Measures

Secondary Outcome Measures

In a clinical study's protocol, a planned outcome measure that is not as important as the primary outcome measure for evaluating the effect of an intervention but is still of interest. Most clinical studies have more than one secondary outcome measure.
Outcome Measure
Measure Description
Time Frame
Weighted Mean Change From Baseline Over 0-6 Hours in Blood Eosinophils Post-Allergen Challenge on Day 14
Time Frame: 0-6 hours, post allergen challenge, 1 hour post treatment, Day 14
Number of peripheral blood eosinophils measured from blood draws
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
Time Frame: 0-6 hours post allergen challenge, 10-11 hours post treatment, Day 35
Amount of serum interleukin (IL)-5 measured from blood draws
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
Time Frame: 0-6 hours post allergen challenge, 1 hour after dosing, Day 14
Amount of serum IL-5 measured from blood draws
0-6 hours post allergen challenge, 1 hour after dosing, Day 14

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Sponsor

The organization or person who initiates the study and who has authority and control over the study.
GlaxoSmithKline

Publications and helpful links

The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.

Helpful Links

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start

Study Start

The actual date on which the first participant was enrolled in a clinical study. The "anticipated" study start date is the date that the researchers think will be the study start date.
August 1, 2007

Primary Completion (Actual)

Primary Completion

The date on which the last participant in a clinical study was examined or received an intervention to collect final data for the primary outcome measure. Whether the clinical study ended according to the protocol or was terminated does not affect this date. For clinical studies with more than one primary outcome measure with different completion dates, this term refers to the date on which data collection is completed for all the primary outcome measures. The "anticipated" primary completion date is the date that the researchers think will be the primary completion date for the study.
July 1, 2008

Study Completion (Actual)

Study Completion

The date on which the last participant in a clinical study was examined or received an intervention/treatment to collect final data for the primary outcome measures, secondary outcome measures, and adverse events (that is, the last participant's last visit). The "anticipated" study completion date is the date that the researchers think will be the study completion date.
July 1, 2008

Study Registration Dates

First Submitted

First Submitted

The date on which the study sponsor or investigator first submitted a study record to ClinicalTrials.gov. There is typically a delay of a few days between the first submitted date and the record's availability on ClinicalTrials.gov (the first posted date).
August 16, 2007

First Submitted That Met QC Criteria

First Submitted That Met QC Criteria

The date on which the study sponsor or investigator first submits a study record that is consistent with National Library of Medicine (NLM) quality control (QC) review criteria. The sponsor or investigator may need to revise and submit a study record one or more times before NLM's QC review criteria are met. It is the responsibility of the sponsor or investigator to ensure that the study record is consistent with the NLM QC review criteria.
August 16, 2007

First Posted (Estimate)

First Posted

The date on which the study record was first available on ClinicalTrials.gov after National Library of Medicine (NLM) quality control (QC) review has concluded. There is typically a delay of a few days between the date the study sponsor or investigator submitted the study record and the first posted date.
August 17, 2007

Study Record Updates

Last Update Posted (Estimate)

Last Update Posted

The most recent date on which changes to a study record were made available on ClinicalTrials.gov. There may be a delay between when the changes were submitted to ClinicalTrials.gov by the study's sponsor or investigator (the last update submitted date) and the last update posted date.
December 16, 2016

Last Update Submitted That Met QC Criteria

Last Update Submitted That Met QC Criteria

The most recent date on which the study sponsor or investigator submitted changes to a study record that are consistent with National Library of Medicine (NLM) quality control (QC) review criteria. It is the responsibility of the sponsor or investigator to ensure that the study record is consistent with the NLM QC review criteria.
November 3, 2016

Last Verified

Last Verified

The most recent date on which the study sponsor or investigator confirmed the information about a clinical study on ClinicalTrials.gov as accurate and current. If a study with a recruitment status of recruiting; not yet recruiting; or active, not recruiting has not been confirmed within the past 2 years, the study's recruitment status is shown as unknown.
November 1, 2016

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

Other Study ID Numbers

Identifiers or ID numbers other than the NCT number that are assigned to a clinical study by the study's sponsor, funders, or others. These numbers may include unique identifiers from other trial registries and National Institutes of Health grant numbers.
  • HZA109912

Plan for Individual participant data (IPD)

Plan to Share Individual Participant Data (IPD)?

YES

IPD Plan Description

Patient-level data for this study will be made available through www.clinicalstudydatarequest.com following the timelines and process described on this site.

Study Data/Documents

  1. Individual Participant Data Set
    Information identifier: HZA109912
    Information comments: For additional information about this study please refer to the GSK Clinical Study Register
  2. Annotated Case Report Form
    Information identifier: HZA109912
    Information comments: For additional information about this study please refer to the GSK Clinical Study Register
  3. Study Protocol
    Information identifier: HZA109912
    Information comments: For additional information about this study please refer to the GSK Clinical Study Register
  4. Statistical Analysis Plan
    Information identifier: HZA109912
    Information comments: For additional information about this study please refer to the GSK Clinical Study Register
  5. Clinical Study Report
    Information identifier: HZA109912
    Information comments: For additional information about this study please refer to the GSK Clinical Study Register
  6. Dataset Specification
    Information identifier: HZA109912
    Information comments: For additional information about this study please refer to the GSK Clinical Study Register
  7. Informed Consent Form
    Information identifier: HZA109912
    Information comments: For additional information about this study please refer to the GSK Clinical Study Register

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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