AsthmaPhase 3NCT00394121
New Combination Inhaler (FlutiForm HFA MDI 100/10 µg and 250/10 µg) in Patients With Asthma
A Phase 3 study testing Fluticasone propionate/formoterol fumarate in people with Asthma, run by SkyePharma AG at 28 sites in 5 countries.
Trial summary
The purpose of this study is to evaluate the long-term safety of the fixed combination asthma drug FlutiForm HFA MDI (containing fluticasone propionate and formoterol fumarate) in adult and adolescent patients with mild to moderate-severe asthma. Read more about this study
- Who is it for?
- Ages 12 years and older
- Conditions the study is for
- Asthma
- What is being tested?
- Fluticasone propionate/formoterol fumarate
- How many people
- 400 participants
- Where
- 28 sitesin 5 countries
- Study dates
- Mar 2006to Jul 2007
- Phase
- Phase 3
- 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 12 years and older
- All sexes
- No healthy volunteers
- Child, Adult, Older adult
Who may be able to join
- History of asthma for at least 12 months.
- Documented use of inhaled corticosteriod for at least 4 weeks prior to Screening Visit Demonstrate FEV-1 of 40-80% of predicted normal values at Screening and Baseline Visit.
- Documented reversibility of 15% within 6 months of Screening Visit or at Screening Visit (15% increase from pre-FEV-1 levels following albuterol inhalation).
- Symptoms of Asthma during Run-in.
- Females of childbearing potential must have a negative urine pregnancy test at Screening and Baseline Visits. Females are eligible only if they are not pregnant or lactating and are either sterile or using acceptable methods of contraception.
- Must otherwise be healthy.
- Provide written informed consent. Wishes of minors must be respected.
Who cannot join
- Life-threatening asthma within past year or during Run-in Period.
- History of systemic corticosteroid medication within 3 months before Screening Visit.
- History of omalizumab use within the past 6 months.
- History of leukotriene receptor antagonist use, e.g., montelukast, within the past week.
- Current evidence of history of any clinically significant disease or abnormality including uncontrolled hypertension, uncontrolled coronary artery disease, congestive heart failure, myocardial infarction, or cardiac dysrhythmia.
- Upper or lower respiratory infection within 4 weeks prior to Screening Visit or during Run-in Period.
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- Significant, non-reversible, pulmonary disease (e.g., chronic obstructive pulmonary disease [COPD], cystic fibrosis, bronchiectasis).
- Known Human Immunodeficiency Virus (HIV)-positive status.
- Smoking history equivalent to "10 pack years".
- Current smoking history within 12 months prior to Screening Visit.
Trial locations and contacts
28 sites in 5 countries.
28 sites in 5 countries
United Kingdom12 sites
Research Site
Birmingham
Research Site
Carrickfergus
Research Site
Chippenham
Research Site
Cottingham
Research Site
Coventry
Research Site
Downpatrick
Research Site
Heywood
Research Site
Manchester
Research Site
Sheffield
Research Site
Solihull
Research Site
Sunbury-on-Thames
Research Site
Swindon Wilts
Germany5 sites
Research Site
Berlin
Research Site
Hamburg
Research Site
Mainz
Research Site
Rüdersdorf
Research Site
Solingen
Hungary5 sites
Research Site
Budapest
Research Site
Deszk
Research Site
Kecskemét
Research Site
Miskolc
Research Site
Mosonmagyaróvár
Poland5 sites
Research Site
Bialystok
Research Site
Gdansk
Research Site
Krakow
Research Site
Lodz
Research Site
Wroclaw
About this study
Official title: Long-term Open-label Safety Study With SkyePharma FlutiForm HFA pMDI (100/10 µg and 250/10 µg) in Adult and Adolescent Patients With Asthma
The purpose of this study is to evaluate the long-term safety of the fixed combination asthma drug FlutiForm HFA MDI (containing fluticasone propionate and formoterol fumarate) in adult and adolescent patients with mild to moderate-severe asthma.
- Conditions
- Asthma
- Being tested
- Fluticasone propionate/formoterol fumarate
- Keywords
- Asthma, Fluticasone Propionate, Formoterol Fumarate, Pressurized metered does inhaler, Hydrofluoroalkane, Mild to moderate-severe 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
What is being measured
The primary outcome is the main question the study is designed to answer.
Long-term safety after twice daily treatment with FlutiForm HFA MDI over 12 months.
Secondary outcomes (1)
Long-term efficacy after twice daily treatment with FlutiForm HFA MDI over 12 months.
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted31 Oct 2006 (estimated)
- Study startMar 2006
- Primary completionJul 2007
- Study completionJul 2007
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (1)Papers the sponsor has linked to this study.
- Other trials for 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 3
- Primary purpose
- Treatment
- Allocation
- Non-randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Enrolment
- 400 participants (estimated)
Sponsor and investigators
- Lead sponsor
- SkyePharma AG
- Sponsor type
- Industry (pharma, biotech, devices)
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT00394121
- Sponsor's protocol ID
- SKY2028-3-003
- Status last verified
- Aug 2010
- First submitted
- 27 Oct 2006
- Last updated
- 27 Aug 2010
- Results posted
- No
Publications
Mansur AH, Kaiser K. Long-term safety and efficacy of fluticasone/formoterol combination therapy in asthma. J Aerosol Med Pulm Drug Deliv. 2013 Aug;26(4):190-9. doi: 10.1089/jamp.2012.0977. Epub 2012 Oct 25.
PubMed 23098325
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
- Long-term Open-label Safety Study With SkyePharma FlutiForm HFA pMDI (100/10 µg and 250/10 µg) in Adult and Adolescent Patients With Asthma
- ClinicalTrials.gov ID
- NCT00394121
- Acronym / sponsor ID
- SKY2028-3-003
- Conditions
- Asthma
- Keywords
- Asthma, Fluticasone Propionate, Formoterol Fumarate, Pressurized metered does inhaler, Hydrofluoroalkane, Mild to moderate-severe asthma
- Phase
- Phase 3
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 400 participants (estimated)
- Lead sponsor
- SkyePharma AGIndustry (pharma, biotech, devices)
- Study start
- Mar 2006
- Primary completion
- Jul 2007 (actual)
- Study completion
- Jul 2007 (actual)
- First posted
- 31 Oct 2006 (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 purpose of this study is to evaluate the long-term safety of the fixed combination asthma drug FlutiForm HFA MDI (containing fluticasone propionate and formoterol fumarate) in adult and adolescent patients with mild to moderate-severe asthma.
Study design
- Primary purpose
- Treatment
- Allocation
- Non-randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
Who may qualify
- Ages
- 12 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Child, Adult, Older adult
Key inclusion criteria (7 listed)
- History of asthma for at least 12 months.
- Documented use of inhaled corticosteriod for at least 4 weeks prior to Screening Visit Demonstrate FEV-1 of 40-80% of predicted normal values at Screening and Baseline Visit.
- Documented reversibility of 15% within 6 months of Screening Visit or at Screening Visit (15% increase from pre-FEV-1 levels following albuterol inhalation).
- Symptoms of Asthma during Run-in.
- Females of childbearing potential must have a negative urine pregnancy test at Screening and Baseline Visits. Females are eligible only if they are not pregnant or lactating and are either sterile or using acceptable methods of contraception.
Key exclusion criteria (10 listed)
- Life-threatening asthma within past year or during Run-in Period.
- History of systemic corticosteroid medication within 3 months before Screening Visit.
- History of omalizumab use within the past 6 months.
- History of leukotriene receptor antagonist use, e.g., montelukast, within the past week.
- Current evidence of history of any clinically significant disease or abnormality including uncontrolled hypertension, uncontrolled coronary artery disease, congestive heart failure, myocardial infarction, or cardiac dysrhythmia.
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 fumarate | Drug | – |
Primary outcome
Long-term safety after twice daily treatment with FlutiForm HFA MDI over 12 months.
1 secondary outcome
Long-term efficacy after twice daily treatment with FlutiForm HFA MDI over 12 months.
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.
- Derived from this study: PubMed 23098325Mansur AH, Kaiser K. Long-term safety and efficacy of fluticasone/formoterol combination therapy in asthma. J Aerosol Med Pulm Drug Deliv. 2013 Aug;26(4):190-9. doi: 10.1089/jamp.2012.0977. Epub 2012 Oct 25.
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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.
28 sites in 5 countries: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 3 study testing Fluticasone propionate/formoterol fumarate in people with Asthma, run by SkyePharma AG at 28 sites in 5 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 7 inclusion and 10 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 28 sites in United Kingdom, Germany, Hungary, Poland, Romania. 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 3 studies compare the treatment with the current standard treatment or a placebo in a large group, to confirm how well it works and watch for side effects.
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?
Long-term safety after twice daily treatment with FlutiForm HFA MDI over 12 months.. 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 NCT00394121, which also lists 1 linked publication.
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.