Mild to Moderate AsthmaPhase 2NCT00734292
Single-dose Crossover Study to Evaluate the Early Bronchodilating Effect of FlutiForm HFA pMDI in Adult Subjects With Mild to Moderate Asthma
A Phase 2 study testing fluticasone propionate, formoterol fumarate in people with Mild to Moderate Asthma, run by SkyePharma AG at 8 sites in United States.
Trial summary
The primary purpose of this study is to evaluate the early bronchodilating effect of SKP FlutiForm HFA pMDI compared to placebo. Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Mild to Moderate Asthma
- What is being tested?
- fluticasone propionate, formoterol fumarate
- Could I receive a placebo?
- Yes, some participants may receive a placebo
- How many people
- 39 participants
- Where
- 8 sitesUnited States
- Study dates
- Sep 2008to Oct 2008
- 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 years and older
- 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
- Participation in a prior FlutiForm study
- Smoking history within the last 12 months,
- Significant, non-reversible, pulmonary disease
- Life-threatening asthma within the last year
Trial locations and contacts
8 sites in 1 country.
8 sites in 1 country
United States8 sites
Investigational Site
Anaheim, California, 92801
Investigational Site
Denver, Colorado, 80230
Investigational Site
Medford, Oregon, 97504
Investigational Site
Mission Viejo, California, 92691
Investigational Site
Portland, Oregon, 97213
Investigational Site
Richmond, Virginia, 23229
Investigational Site
Valrico, Florida, 33594
Investigational Site
West Allis, Wisconsin, 53227
About this study
Official title: A Randomized, Placebo-controlled, Double-blind, Crossover, Single-dose Exposure Study to Evaluate the Early Bronchodilating Effect of FlutiForm 100/10 µg HFA pMDI and FlutiForm 250/10 µg HFA pMDI, Compared to Placebo in Adult Subjects With Mild to Moderate Asthma
The primary purpose of this study is to evaluate the early bronchodilating effect of SKP FlutiForm HFA pMDI compared to placebo.
- Conditions
- Mild to Moderate Asthma
- Being tested
- fluticasone propionate, formoterol fumarate
- Keywords
- Asthma, Asthma Mild to Moderate
- 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 A: FlutiForm 250/10 ug
FlutiForm HFA pMDI (250/10 ug); (two actuations of FlutiForm HFA pMDI 125/5 ug/actuation)
● Period 2 Treatment Regimen B: FlutiForm 100/10 ug
FlutiForm HFA pMDI (100/10 ug); (two actuations of FlutiForm HFA pMDI 50/5 ug/actuation)
● Period 3 Treatment Regimen C: placebo
SKP placebo; (two actuations)
fluticasone propionate, formoterol fumarateOther
Also called FlutiForm
● Period 1 Treatment Regimen B: FlutiForm 100/10 ug
FlutiForm HFA pMDI (100/10 ug); (two actuations of FlutiForm HFA pMDI 50/5 ug/actuation)
● Period 2 Treatment Regimen C: placebo
SKP placebo; (two actuations)
● Period 3 Treatment Regimen A: FlutiForm 250/10 ug
FlutiForm HFA pMDI (250/10 ug); (two actuations of FlutiForm HFA pMDI 125/5 ug/actuation)
fluticasone propionate, formoterol fumarateOther
Also called FlutiForm
● Period 1 Treatment Regimen C: placebo
SKP placebo; (two actuations)
● Period 2 Treatment Regimen A: FlutiForm 250/10 ug
FlutiForm HFA pMDI (250/10 ug); (two actuations of FlutiForm HFA pMDI 125/5 ug/actuation)
● Period 3 Treatment Regimen B: FlutiForm 100/10 ug
FlutiForm HFA pMDI (100/10 ug); (two actuations of FlutiForm HFA pMDI 50/5 ug/actuation)
| Study group | Role | What they receive |
|---|---|---|
| I | Placebo comparator | * Period 1 Treatment Regimen A: FlutiForm 250/10 ug
* Period 2 Treatment Regimen B: FlutiForm 100/10 ug
* Period 3 Treatment Regimen C: placebo Receives: Drug: fluticasone propionate, formoterol fumarate |
| II | Placebo comparator | * Period 1 Treatment Regimen B: FlutiForm 100/10 ug
* Period 2 Treatment Regimen C: placebo
* Period 3 Treatment Regimen A: FlutiForm 250/10 ug Receives: Other: fluticasone propionate, formoterol fumarate |
| III | Placebo comparator | * Period 1 Treatment Regimen C: placebo
* Period 2 Treatment Regimen A: FlutiForm 250/10 ug
* Period 3 Treatment Regimen B: FlutiForm 100/10 ug Receives: Other: fluticasone propionate, formoterol fumarate |
What is being measured
The primary outcome is the main question the study is designed to answer.
Change from baseline FEV1 to post study drug dosing FEV1
Measured: 3 minutes
Secondary outcomes (1)
Change from baseline FEV1 to post study drug dosing FEV1
Measured: 8, 15, 30, and 60 minutes
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted14 Aug 2008 (estimated)
- Study startSep 2008
- Primary completionSep 2008
- Study completionOct 2008
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Mild to Moderate AsthmaStudies of the same condition, open and under way.
- 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 2
- Allocation
- Randomised
- Intervention model
- Crossover
- Masking
- Double blind
- Who is masked
- Participant, Investigator
- Enrolment
- 39 participants (estimated)
Sponsor and investigators
- Lead sponsor
- SkyePharma AG
- Sponsor type
- Industry (pharma, biotech, devices)
- Collaborators
- Abbott
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT00734292
- Sponsor's protocol ID
- SKY2028-2-002
- Status last verified
- Aug 2010
- First submitted
- 4 Aug 2008
- Last updated
- 27 Aug 2010
- Results posted
- No
- Data monitoring committee
- No
Study at a glance
From the registry record, last updated by the sponsor on 27 Aug 2010. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- A Randomized, Placebo-controlled, Double-blind, Crossover, Single-dose Exposure Study to Evaluate the Early Bronchodilating Effect of FlutiForm 100/10 µg HFA pMDI and FlutiForm 250/10 µg HFA pMDI, Compared to Placebo in Adult Subjects With Mild to Moderate Asthma
- ClinicalTrials.gov ID
- NCT00734292
- Acronym / sponsor ID
- SKY2028-2-002
- Conditions
- Mild to Moderate Asthma
- Keywords
- Asthma, Asthma Mild to Moderate
- Phase
- Phase 2
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 39 participants (estimated)
- Lead sponsor
- SkyePharma AGIndustry (pharma, biotech, devices)
- Collaborators
- Abbott
- Study start
- Sep 2008
- Primary completion
- Sep 2008 (actual)
- Study completion
- Oct 2008 (actual)
- First posted
- 14 Aug 2008 (estimated)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
The primary purpose of this study is to evaluate the early bronchodilating effect of SKP FlutiForm HFA pMDI compared to placebo.
Study design
- Allocation
- Randomised
- Intervention model
- Crossover
- Masking
- Double blind (participant, investigator)
- Number of arms
- 3
| Arm | Type | Receives |
|---|---|---|
| I | Placebo comparator | Drug: fluticasone propionate, formoterol fumarate* Period 1 Treatment Regimen A: FlutiForm 250/10 ug * Period 2 Treatment Regimen B: FlutiForm 100/10 ug * Period 3 Treatment Regimen C: placebo |
| II | Placebo comparator | Other: fluticasone propionate, formoterol fumarate* Period 1 Treatment Regimen B: FlutiForm 100/10 ug * Period 2 Treatment Regimen C: placebo * Period 3 Treatment Regimen A: FlutiForm 250/10 ug |
| III | Placebo comparator | Other: fluticasone propionate, formoterol fumarate* Period 1 Treatment Regimen C: placebo * Period 2 Treatment Regimen A: FlutiForm 250/10 ug * Period 3 Treatment Regimen B: FlutiForm 100/10 ug |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (1 listed)
- Subjects with documented history of mild to moderate asthma currently taking a stable dose of inhaled corticosteroid
Key exclusion criteria (4 listed)
- Participation in a prior FlutiForm study
- Smoking history within the last 12 months,
- Significant, non-reversible, pulmonary disease
- Life-threatening asthma within the last year
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 |
|---|---|---|
| fluticasone propionate, formoterol fumarateAlso: FlutiForm● Period 1 Treatment Regimen A: FlutiForm 250/10 ug FlutiForm HFA pMDI (250/10 ug); (two actuations of FlutiForm HFA pMDI 125/5 ug/actuation) ● Period 2 Treatment Regimen B: FlutiForm 100/10 ug FlutiForm HFA pMDI (100/10 ug); (two actuations of FlutiForm HFA pMDI 50/5 ug/actuation) ● Period 3 Treatment Regimen C: placebo SKP placebo; (two actuations) | Drug | I |
| fluticasone propionate, formoterol fumarateAlso: FlutiForm● Period 1 Treatment Regimen B: FlutiForm 100/10 ug FlutiForm HFA pMDI (100/10 ug); (two actuations of FlutiForm HFA pMDI 50/5 ug/actuation) ● Period 2 Treatment Regimen C: placebo SKP placebo; (two actuations) ● Period 3 Treatment Regimen A: FlutiForm 250/10 ug FlutiForm HFA pMDI (250/10 ug); (two actuations of FlutiForm HFA pMDI 125/5 ug/actuation) | Other | II |
| fluticasone propionate, formoterol fumarateAlso: FlutiForm● Period 1 Treatment Regimen C: placebo SKP placebo; (two actuations) ● Period 2 Treatment Regimen A: FlutiForm 250/10 ug FlutiForm HFA pMDI (250/10 ug); (two actuations of FlutiForm HFA pMDI 125/5 ug/actuation) ● Period 3 Treatment Regimen B: FlutiForm 100/10 ug FlutiForm HFA pMDI (100/10 ug); (two actuations of FlutiForm HFA pMDI 50/5 ug/actuation) | Other | III |
Primary outcome
Change from baseline FEV1 to post study drug dosing FEV1
Time frame: 3 minutes
1 secondary outcome
Change from baseline FEV1 to post study drug dosing FEV1
Time frame: 8, 15, 30, and 60 minutes
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 27 Aug 2010.
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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.
The record lists no contact. Use the official record to reach the sponsor.
8 sites in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 2 study testing fluticasone propionate, formoterol fumarate in people with Mild to Moderate Asthma, run by SkyePharma AG at 8 sites in United States.
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 4 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 27 Aug 2010. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 8 sites in United States. 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. Some participants in this study may receive a placebo. 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 FEV1 to post study drug dosing FEV1 (time frame: 3 minutes). 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 27 Aug 2010.