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AsthmaPhase 2NCT00830102

Single-dose Crossover Study to Compare the Safety and Efficacy of FlutiForm With Fluticasone and Formoterol Concurrently or Alone in Asthma Patients

A Phase 2 study testing fluticasone propionate, formoterol fumarate in people with Asthma, run by SkyePharma AG at 6 sites in 2 countries.

Completed

Finished. The study has ended and is not enrolling. Results may be posted on the official record.

Official record
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Trial summary

The primary purpose was to evaluate the efficacy of SKP FlutiForm HFA MDI compared to placebo or fluticasone and formoterol administered concurrently or alone in asthma patients. Read more about this study

Who is it for?
Ages 18 to 65 years
Conditions the study is for
Asthma
What is being tested?
fluticasone propionate, formoterol fumarate
Could I receive a placebo?
No, everyone receives an active treatment
How many people
64 participants
Where
6 sitesin 2 countries
Study dates
Oct 2004to Jan 2005
Phase
Phase 2
Are there results?
None posted in the registry

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 65 years
  • All sexes
  • No healthy volunteers
  • Adult, Older adult

Who may be able to join

  • Subjects with documented history of mild to moderate asthma currently taking a stable dose of inhaled corticosteroid

Who cannot join

  • Smoking history within the last 12 months
  • No history of respiratory tract infection within 4 weeks
  • No history or evidence of any clinically significant disease or abnormality

Trial locations and contacts

6 sites in 2 countries.

6 sites in 2 countries

United Kingdom5 sites

  • Investigational site

    Derbyshire

  • Investigational site

    London

  • Investigational site

    Manchester

  • Investigational site

    Plymouth

  • Investigational site

    Slough

Other trials in United Kingdom

Ireland1 site

  • Investigational site

    Belfast

Other trials in Ireland

About this study

Official title: A Randomized, Placebo-controlled, Double-blind, Six-way Crossover, Single-dose Exposure Study to Compare the Safety and Efficacy of Fluticasone and Formoterol Combination (FlutiForm™100/10μg and 250/10μg) in a Single Inhaler (SkyePharma HFA MDI) With the Administration of Fluticasone (250μg) and Formoterol (12μg) Concurrently or Alone in Patients With Asthma

The primary purpose was to evaluate the efficacy of SKP FlutiForm HFA MDI compared to placebo or fluticasone and formoterol administered concurrently or alone in asthma patients.

Conditions
Asthma
Being tested
fluticasone propionate, formoterol fumarate
Keywords
Mild to Moderate Asthma
Medical subject headings
Asthma

What participants receive

What participants receive. In a randomised study each person is assigned to one group by chance.

  • fluticasone propionate, formoterol fumarateDrug

    Also called FlutiForm

    • Period 1 Treatment Regimen E: Foradil Aerolizer 12 ug (One inhalation of formoterol 12 ug)
    • Period 2 Treatment Regimen F: Placebo (Two actuations of Placebo HFA pMDI
    • Period 3 Treatment Regimen A: FlutiForm 100/10 ug (Two actuations of fluticasone/formoterol HFA pMDI 50/5 ug/actuation)
    • Period 4 Treatment Regimen B: FlutiForm 250/10 ug (Two actuations of fluticasone/formoterol HFA pMDI 125/5 ug/actuation)

  • fluticasone propionate, formoterol fumarateDrug

    Also called FlutiForm

    • Period 1 Treatment Regimen D: Flixotide Evohaler 250 ug (Two actuations of fluticasone HFA pMDI 125ug/actuation)
    • Period 2 Treatment Regimen C: Flixotide Evohaler 250 ug + Foradil Aerolizer 12 ug (Two actuations of fluticasone HFA pMDI 125ug/actuation and one inhalation of formoterol DPI 12ug/inhalation)
    • Period 3 Treatment Regimen B: FlutiForm 250/10 ug (Two actuations of fluticasone/formoterol HFA pMDI 125/5 ug/actuation)
    • Period 4 Treatment Regimen A: FlutiForm 100/10 ug (Two actuations of fluticasone/formoterol HFA pMDI 50/5 ug/actuation)

  • fluticasone propionate, formoterol fumarateDrug

    Also called FlutiForm

    • Period 1 Treatment Regimen B: FlutiForm 250/10 ug (Two actuations of fluticasone/formoterol HFA pMDI 125/5 ug/actuation)
    • Period 2 Treatment Regimen A: FlutiForm 100/10 ug (Two actuations of fluticasone/formoterol HFA pMDI 50/5 ug/actuation)
    • Period 3 Treatment Regimen F: Placebo (Two actuations of placebo HFA pMDI)
    • Period 4 Treatment Regimen E: Foradil Aerolizer 12 ug (One inhalation of formoterol DPI 12 ug)

  • fluticasone propionate, formoterol fumarateDrug

    Also called FlutiForm

    • Period 1 Treatment Regimen E: Foradil Aerolizer 12 ug (One inhalation of formoterol DPI 12 ug)
    • Period 2 Treatment Regimen F: Placebo (Two actuations of Placebo HFA pMDI)
    • Period 3 Treatment Regimen A: FlutiForm 100/10 ug (Two actuations of fluticasone/formoterol HFA pMDI 50/5 ug/actuation)
    • Period 4 Treatment Regimen B: FlutiForm 250/10 ug (Two actuations of fluticasone/formoterol HFA pMDI 125/5 ug/actuation)

  • fluticasone propionate, formoterol fumarateDrug

    Also called FlutiForm

    • Period 1 Treatment Regimen C: Flixotide Evohaler 250 ug + Foradil Aerolizer 12 ug (Two actuations of fluticasone HFA pMDI 125ug/actuation and one inhalation of formoterol DPI 12ug/inhalation)
    • Period 2 Treatment Regimen D: Flixotide Evohaler 250 ug (Two actuations of fluticasone HFA pMDI 125 ug/actuation)
    • Period 3 Treatment Regimen E: Foradil Aerolizer 12 ug (One inhalation of formoterol DPI 12 ug)
    • Period 4 Treatment Regimen F: Placebo (Two actuations of Placebo HFA pMDI)

  • fluticasone propionate, formoterol fumarateDrug

    Also called FlutiForm

    • Period 1 Treatment Regimen F: Placebo (Two actuations of Placebo HFA pMDI
    • Period 2 Treatment Regimen E: Foradil Aerolizer 12 ug (One inhalation of formoterol DPI 12 ug)
    • Period 3 Treatment Regimen D: Flixotide Evohaler 250 ug (Two actuations of fluticasone HFA MDI 125 ug)
    • Period 4 Treatment Regimen C: Flixotide Evohaler 250 ug + Foradil Aerolizer 12 ug (Two actuations of fluticasone HFA pMDI 125ug/actuation and one inhalation of formoterol DPI 12ug/inhalation)
Study groups in NCT00830102
Study groupRoleWhat they receive
1Active comparator* Period 1 Treatment Regimen A: FlutiForm 100/10 ug * Period 2 Treatment Regimen B: FlutiForm 250/10 ug * Period 3 Treatment Regimen C: Flixotide Evohaler 250 ug + Foradil Aerolizer 12 ug * Period 4 Treatment Regimen D: Flixotide Evohaler 250 ug
Receives: Drug: fluticasone propionate, formoterol fumarate
2Active comparator* Period 1 Treatment Regimen D: Flixotide Evohaler 250 ug * Period 2 Treatment Regimen C: Flixotide Evohaler 250 ug + Foradil Aerolizer 12 ug * Period 3 Treatment Regimen B: FlutiForm 250/10 ug * Period 4 Treatment Regimen A: FlutiForm 100/10 ug
Receives: Drug: fluticasone propionate, formoterol fumarate
3Active comparator* Period 1 Treatment Regimen B: FlutiForm 250/10 ug * Period 2 Treatment Regimen A: FlutiForm 100/10 ug * Period 3 Treatment Regimen F: Placebo * Period 4 Treatment Regimen E: Foradil Aerolizer 12 ug
Receives: Drug: fluticasone propionate, formoterol fumarate
4Active comparator* Period 1 Treatment Regimen E: Foradil Aerolizer 12 ug * Period 2 Treatment Regimen F: Placebo * Period 3 Treatment Regimen A: FlutiForm 100/10 ug * Period 4 Treatment Regimen B: FlutiForm 250/10 ug
Receives: Drug: fluticasone propionate, formoterol fumarate
5Active comparator* Period 1 Treatment Regimen C: Flixotide Evohaler 250 ug + Foradil Aerolizer 12 ug * Period 2 Treatment Regimen D: Flixotide Evohaler 250 ug * Period 3 Treatment Regimen E: Foradil Aerolizer 12 ug * Period 4 Treatment Regimen F: Placebo
Receives: Drug: fluticasone propionate, formoterol fumarate
6Active comparator* Period 1 Treatment Regimen F: Placebo * Period 2 Treatment Regimen E: Foradil Aerolizer 12 ug * Period 3 Treatment Regimen D: Flixotide Evohaler 250 ug * Period 4 Treatment Regimen C: Flixotide Evohaler 250 ug + Foradil Aerolizer 12 ug
Receives: Drug: fluticasone propionate, formoterol fumarate

What is being measured

The primary outcome is the main question the study is designed to answer.

  1. Change from Baseline in Actual FEV1, % change from Baseline in Actual FEV1, change from Baseline in FEV1 % predicted normal, FEV1 max and FEV1 AUC above the Baseline

    Measured: pre-dose and at 5, 15, 30, 45, 60, 90 minutes and 2, 3, 4, 6, 8, 10, 12, and 24 hours post-dose

Secondary outcomes (1)

  1. Treatment-emergent AEs, clinical laboratory data, 12-lead ECGs and vital signs

    Measured: 10 weeks including pre- and post-study assessments

Timeline

From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.

  1. First posted27 Jan 2009 (estimated)
  2. Study startOct 2004
  3. Primary completionJan 2005
  4. Study completionJan 2005

Resources

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 2
Primary purpose
Treatment
Allocation
Randomised
Intervention model
Crossover
Masking
Double blind
Who is masked
Participant, Investigator
Enrolment
64 participants (actual)
IDs, dates and publications
ClinicalTrials.gov ID
NCT00830102
Sponsor's protocol ID
SKY2028-2-001
Status last verified
Jun 2011
First submitted
26 Jan 2009
Last updated
23 Jun 2011
Results posted
No
Data monitoring committee
No

Questions about this trial

What is this clinical trial studying?

A Phase 2 study testing fluticasone propionate, formoterol fumarate in people with Asthma, run by SkyePharma AG at 6 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 1 inclusion and 3 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 23 Jun 2011. Status can change between updates, so confirm with the study contact before making plans.

Where is the study taking place?

The record lists 6 sites in United Kingdom, Ireland. 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 2 studies give the treatment to a larger group to see whether it has the intended effect and to keep checking safety.

Not every study follows the same path, and some studies (observational studies, device studies) have no phase.

Are results available for this study?

The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.

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?

Change from Baseline in Actual FEV1, % change from Baseline in Actual FEV1, change from Baseline in FEV1 % predicted normal, FEV1 max and FEV1 AUC above the Baseline (time frame: pre-dose and at 5, 15, 30, 45, 60, 90 minutes and 2, 3, 4, 6, 8, 10, 12, and 24 hours post-dose). It is what the study was designed to measure, not a finding.

Where can I read the original study information?

On the ClinicalTrials.gov record for NCT00830102.

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 23 Jun 2011.

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Clinical Trial NCT00830102 | AzTrials