AsthmaPhase 4NCT00517634
Study Of Fluticasone Propionate/Salmeterol In Asthmatic Subjects
A Phase 4 study testing FP and SFC in people with Asthma, run by GlaxoSmithKline at 2 sites in 2 countries.
Trial 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. Read more about this study
- Who is it for?
- Ages 18 to 55 years
- Conditions the study is for
- Asthma
- What is being tested?
- FP and SFC
- Could I receive a placebo?
- Yes, some participants may receive a placebo
- How many people
- 23 participants
- Where
- 2 sitesin 2 countries
- Study dates
- Aug 2007to Jul 2008
- Phase
- Phase 4
- Are there results?
- Yes, posted in the registrySummary in the doctors' view
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 to 55 years
- All sexes
- No healthy volunteers
- Adult
Who may be able to join
- Informed consent.
- Outpatient.
- Male or non-pregnant/non-lactating female.
- Aged 18-55.
- Diagnosis of asthma.
- Pre-bronchodilatory FEV1 > 75% predicted.
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- 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
Who cannot join
- 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.
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- 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.
Trial locations and contacts
2 sites in 2 countries.
2 sites in 2 countries
About this study
Official title: 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.
Read the 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
- Conditions
- Asthma
- Being tested
- FP, SFC, Placebo
- Keywords
- asthma, allergen challenge, IL-5, eosinophils
- Medical subject headings
- Asthma
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
FPDrug
Fluticasone Propionate 100 mcg BD
SFCDrug
Salmeterol/Fluticasone Propionate Combination 50/100 mcg BD
PlaceboDrug
Matching Placebo
| Study group | Role | What they receive |
|---|---|---|
| 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 Receives: 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 Receives: 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 Receives: 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 Receives: 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 Receives: 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 Receives: Drug: FP; Drug: SFC; Drug: Placebo |
What is being measured
The primary outcome is the main question the study is designed to answer.
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
Measured: 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
Number of peripheral blood eosinophils measured from blood draws
Measured: 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
Amount of serum interleukin (IL)-5 measured from blood draws
Measured: 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
Amount of serum IL-5 measured from blood draws
Measured: 0-6 hours post allergen challenge, 1 hour after dosing, Day 14
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted17 Aug 2007 (estimated)
- Study startAug 2007
- Primary completionJul 2008
- Study completionJul 2008
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Posted resultsParticipant flow, outcome measures and adverse events reported by the sponsor.
- Other trials for AsthmaStudies of the same condition, open and under way.
- More trials run by GlaxoSmithKlineThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase 4
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Double blind
- Who is masked
- Participant, Investigator
- Enrolment
- 23 participants (actual)
Sponsor and investigators
- Lead sponsor
- GlaxoSmithKline
- Sponsor type
- Industry (pharma, biotech, devices)
- Responsible party
- Sponsor
- Investigators
- GSK Clinical Trials, Study director, GlaxoSmithKline
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT00517634
- Sponsor's protocol ID
- HZA109912
- Status last verified
- Nov 2016
- First submitted
- 16 Aug 2007
- Last updated
- 16 Dec 2016
- Results posted
- Yes, on ClinicalTrials.gov
- Data monitoring committee
- No
- Individual data sharing
- Yes: Patient-level data for this study will be made available through www.clinicalstudydatarequest.com following the timelines and process described on this site.
Study at a glance
From the registry record, last updated by the sponsor on 16 Dec 2016. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- 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
- ClinicalTrials.gov ID
- NCT00517634
- Acronym / sponsor ID
- HZA109912
- Conditions
- Asthma
- Keywords
- asthma, allergen challenge, IL-5, eosinophils
- Phase
- Phase 4
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 23 participants (actual)
- Lead sponsor
- GlaxoSmithKlineIndustry (pharma, biotech, devices)
- Study start
- Aug 2007
- Primary completion
- Jul 2008 (actual)
- Study completion
- Jul 2008 (actual)
- First posted
- 17 Aug 2007 (estimated)
- Results
- Posted 2 Sep 2009
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
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 design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Double blind (participant, investigator)
- Number of arms
- 6
| Arm | Type | Receives |
|---|---|---|
| Sequence 1: FP, SFC, Placebo | Experimental | Drug: FP, Drug: SFC, Drug: PlaceboFluticasone 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 |
| Sequence 2: Placebo, SFC, FP | Experimental | Drug: FP, Drug: SFC, Drug: PlaceboPlacebo 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 |
| Sequence 3: SFC, FP, Placebo | Experimental | Drug: FP, Drug: SFC, Drug: PlaceboSalmeterol/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 |
| Sequence 4: SFC, Placebo, FP | Experimental | Drug: FP, Drug: SFC, Drug: PlaceboSalmeterol/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 |
| Sequence 5: FP, Placebo, SFC | Experimental | Drug: FP, Drug: SFC, Drug: PlaceboFluticasone 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 |
| Sequence 6: Placebo, FP, SFC | Experimental | Drug: FP, Drug: SFC, Drug: PlaceboPlacebo 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 |
Who may qualify
- Ages
- 18 to 55 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult
Key inclusion criteria (10 listed)
- Informed consent.
- Outpatient.
- Male or non-pregnant/non-lactating female.
- Aged 18-55.
- Diagnosis of asthma.
Key exclusion criteria (17 listed)
- 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.
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| FPFluticasone Propionate 100 mcg BD | Drug | 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 |
| SFCSalmeterol/Fluticasone Propionate Combination 50/100 mcg BD | Drug | 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 |
| PlaceboMatching Placebo | Drug | 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 |
Primary outcome
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
3 secondary outcomes
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
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
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
Results and safety
Loading the posted results from ClinicalTrials.gov…
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 16 Dec 2016.
- Posted resultsParticipant flow, baseline, all outcome measures and adverse events.
- Researchers can use this site to request access to anonymised patient level data and/or supporting documents from clinical studies to conduct further research.Link provided by the sponsor.
- Individual participant dataSharing planned: Yes. Patient-level data for this study will be made available through www.clinicalstudydatarequest.com following the timelines and process described on this site.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
GSK Clinical Trials study director
GlaxoSmithKline
2 sites in 2 countries: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 4 study testing FP and SFC in people with Asthma, run by GlaxoSmithKline at 2 sites in 2 countries.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 10 inclusion and 17 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 16 Dec 2016. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 2 sites in United States, United Kingdom. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
What does this phase mean?
Phase 4 studies take place after a treatment is approved, to learn more about its long-term benefits and risks in everyday use.
Not every study follows the same path, and some studies (observational studies, device studies) have no phase.
Are results available for this study?
Yes. Results are posted in the registry (first posted 2 Sep 2009). A summary is in the For doctors view, and the full results are on ClinicalTrials.gov.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
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). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 16 Dec 2016.