AsthmaPhase 3NCT00747318
A Phase 3, Multicenter, Open-label Continuation Study in Moderate to Severe Asthmatic Subjects Who Completed FlutiForm HFA pMDI Study SKY2028-3-005
A Phase 3 study testing SKP FlutiForm HFA pMDI in people with Asthma, run by SkyePharma AG at 39 sites in 5 countries.
Trial summary
The objective of this study is to assess the long-term safety and efficacy of FlutiForm HFA pMDI 250/10 mcg bid in adolescents and adults with moderate to severe asthma who have completed the study SKY2028-3-005. Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Asthma
- What is being tested?
- SKP FlutiForm HFA pMDI
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 280 participants
- Where
- 39 sitesin 5 countries
- Study dates
- Sep 2008to Jun 2010
- 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 18 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- 1. Documented use of an inhaled corticosteroid for at least 4 weeks prior to the Day 1 (Baseline) visit and at a dose not greater than 500 mcg/day fluticasone propionate inhalation (or equivalent dose for other inhaled corticosteroids). Subjects who enroll in this study SKY2028-3-006 immediately upon completion of study SKY2028-3-005 have automatically satisfied this criterion. Subjects who enroll in this study SKY2028-3-006 after completion of study SKY2028-3-005 within 24 weeks must use inhaled corticosteroid therapy at a dose not greater than 500 mcg/day fluticasone propionate inhalation (or equivalent dose for other inhaled corticosteroids) for at least 4 weeks prior to the Day 1 (Baseline) visit.
- 2. Females of childbearing potential must have a negative urine beta-human chorionic gonadotropin (beta-HCG) pregnancy test at the Day 1 Visit
- 3. Subject is judged to be in good general health as determined by the investigator.
- 4. Demonstrate satisfactory technique in the use of pMDI.
Who cannot join
- 1. Subjects who prematurely discontinued from the study SKY2028-3-005.
- 2. Life-threatening asthma within the past year.
- 3. History of systemic (oral or injectable) corticosteroid use within the past 12 weeks,
- 4. An upper or lower respiratory infection within 4 weeks prior to the Day 1 (Baseline) visit.
- 5. Significant, non-reversible, pulmonary disease (e.g., chronic obstructive pulmonary disease, cystic fibrosis, bronchiectasis).
- 6. Recent history of smoking, alcohol, substance abuse and/or psychiatric illness,
- 7. Subjects who have taken beta-blocking agents, tricyclic antidepressants, monoamine oxidase inhibitors, quinidine type antiarrhythmics, or potent CYP 3A4 inhibitors such as ketoconazole within the past 1 week.
Trial locations and contacts
39 sites in 5 countries.
39 sites in 5 countries
Ukraine12 sites
Investigational site
Dnipropetrovsk, 49026
Investigational site
Dnipropetrovsk, 49101
Investigational site
Donetsk, 83017
Investigational site
Donetsk, 83099
Investigational site
Kharkiv, 61035
Investigational site
Kiev, 3680
Investigational site
Kyiv, 02125
Investigational site
Kyiv, 02232
Investigational site
Kyiv, 03680
Investigational site
Lviv, 79010
Investigational site
Vinnytsia, 21029
Investigational site
Zaporizhzhya, 69118
United States10 sites
Investigational Site
Colorado Springs, Colorado, 80907
Investigational Site
East Providence, Rhode Island, 02914
Investigational Site
Elizabeth City, North Carolina, 27909
Investigational Site
Medford, Oregon, 97504
Investigational Site
Orange County, California, 92868
Investigational Site
Portland, Oregon, 97213
Investigational Site
Providence, Rhode Island, 02906
Investigational Site
Scottsdale, Arizona, 85251
Investigational Site
Valrico, Florida, 33596
Investigational Site
West Allis, Wisconsin, 53227
Peru6 sites
Investigational site
Lima, Lima Province, Lima-01
Investigational site
Lima, Lima Province, Lima-27
Investigational site
Lima, Lima Province, Lima-29
Investigational site
Lima, Lima Province, Lima-31
Investigational site
Lima, Lima Province, Lima-32
Investigational site
Lima, Lima Province, Lima-33
Romania6 sites
Investigational site
Bucharest, Sector 1, 010457
Investigational site
Bucharest, Sector 3, 030303
Investigational site
Bucharest, Sector 5, 050042
Investigational site
Constanța, Jud. Constanta, 900002
Investigational site
Craiova, Jud. Dolj, 200515
Investigational site
Timișoara, Jud. Timis, 300359
Mexico5 sites
Investigational Site
Guadalajara, Jalisco, 44100
Investigational site
Mexico City, Mexico City, 14050
Investigational Site
Toluca, State of Mexico, 50080
Investigational Site
Villahermosa, Tabasco Mexico, 86100
Investigational Site
Zapopan, Zapopan Jalisco, 45200
About this study
Official title: A Phase 3, Multicenter, Open-label Continuation Study in Moderate to Severe Asthmatic Subjects Who Completed FlutiForm HFA pMDI Study SKY2028-3-005, Incorporating Amendment 1 and 2
The objective of this study is to assess the long-term safety and efficacy of FlutiForm HFA pMDI 250/10 mcg bid in adolescents and adults with moderate to severe asthma who have completed the study SKY2028-3-005.
- Conditions
- Asthma
- Being tested
- SKP FlutiForm HFA pMDI
- Keywords
- Moderate to Severe
- Medical subject headings
- Asthma
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
SKP FlutiForm HFA pMDIDrug
Also called FlutiForm, fluticasone propionate/formoterol fumarate
Each subject will receive SKP FlutiForm HFA pMDI 250/10 microgram twice daily for 60 weeks (two actuations of SKP FlutiForm HFA pMDI 125/5 microgram/actuation) for a total daily dose of 500 microgram fluticasone propionate and 20 microgram formoterol fumarate.
| Study group | Role | What they receive |
|---|---|---|
| 1 | Experimental | Not described Receives: Drug: SKP FlutiForm HFA pMDI |
What is being measured
The primary outcome is the main question the study is designed to answer.
To assess the long-term safety and efficacy of FlutiForm HFA pMDI 250/10 mcg bid in adolescents and adults with moderate to severe asthma who have completed the study SKY2028-3-005
Measured: week 60
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted5 Sep 2008 (estimated)
- Study startSep 2008
- Primary completionMay 2010
- Study completionJun 2010
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- 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
- Single group
- Masking
- None (open label)
- Enrolment
- 280 participants (actual)
Sponsor and investigators
- Lead sponsor
- SkyePharma AG
- Sponsor type
- Industry (pharma, biotech, devices)
- Collaborators
- Abbott
- Investigators
- Thao T Doan, MD, Study director, Abbott Labs PPD R&D
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT00747318
- Sponsor's protocol ID
- SKY2028-3-006
- Status last verified
- Jun 2011
- First submitted
- 4 Sep 2008
- Last updated
- 23 Jun 2011
- Results posted
- No
- Data monitoring committee
- No
Study at a glance
From the registry record, last updated by the sponsor on 23 Jun 2011. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- A Phase 3, Multicenter, Open-label Continuation Study in Moderate to Severe Asthmatic Subjects Who Completed FlutiForm HFA pMDI Study SKY2028-3-005, Incorporating Amendment 1 and 2
- ClinicalTrials.gov ID
- NCT00747318
- Acronym / sponsor ID
- SKY2028-3-006
- Conditions
- Asthma
- Keywords
- Moderate to Severe
- Phase
- Phase 3
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 280 participants (actual)
- Lead sponsor
- SkyePharma AGIndustry (pharma, biotech, devices)
- Collaborators
- Abbott
- Study start
- Sep 2008
- Primary completion
- May 2010 (actual)
- Study completion
- Jun 2010 (actual)
- First posted
- 5 Sep 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 objective of this study is to assess the long-term safety and efficacy of FlutiForm HFA pMDI 250/10 mcg bid in adolescents and adults with moderate to severe asthma who have completed the study SKY2028-3-005.
Study design
- Primary purpose
- Treatment
- Allocation
- Non-randomised
- Intervention model
- Single group
- Masking
- None (open label)
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| 1 | Experimental | Drug: SKP FlutiForm HFA pMDI |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (4 listed)
- 1. Documented use of an inhaled corticosteroid for at least 4 weeks prior to the Day 1 (Baseline) visit and at a dose not greater than 500 mcg/day fluticasone propionate inhalation (or equivalent dose for other inhaled corticosteroids). Subjects who enroll in this study SKY2028-3-006 immediately upon completion of study SKY2028-3-005 have automatically satisfied this criterion. Subjects who enroll in this study SKY2028-3-006 after completion of study SKY2028-3-005 within 24 weeks must use inhaled corticosteroid therapy at a dose not greater than 500 mcg/day fluticasone propionate inhalation (or equivalent dose for other inhaled corticosteroids) for at least 4 weeks prior to the Day 1 (Baseline) visit.
- 2. Females of childbearing potential must have a negative urine beta-human chorionic gonadotropin (beta-HCG) pregnancy test at the Day 1 Visit
- 3. Subject is judged to be in good general health as determined by the investigator.
- 4. Demonstrate satisfactory technique in the use of pMDI.
Key exclusion criteria (7 listed)
- 1. Subjects who prematurely discontinued from the study SKY2028-3-005.
- 2. Life-threatening asthma within the past year.
- 3. History of systemic (oral or injectable) corticosteroid use within the past 12 weeks,
- 4. An upper or lower respiratory infection within 4 weeks prior to the Day 1 (Baseline) visit.
- 5. Significant, non-reversible, pulmonary disease (e.g., chronic obstructive pulmonary disease, cystic fibrosis, bronchiectasis).
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 |
|---|---|---|
| SKP FlutiForm HFA pMDIAlso: FlutiForm, fluticasone propionate/formoterol fumarateEach subject will receive SKP FlutiForm HFA pMDI 250/10 microgram twice daily for 60 weeks (two actuations of SKP FlutiForm HFA pMDI 125/5 microgram/actuation) for a total daily dose of 500 microgram fluticasone propionate and 20 microgram formoterol fumarate. | Drug | 1 |
Primary outcome
To assess the long-term safety and efficacy of FlutiForm HFA pMDI 250/10 mcg bid in adolescents and adults with moderate to severe asthma who have completed the study SKY2028-3-005
Time frame: week 60
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 23 Jun 2011.
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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.
Thao T Doan, MD study director
Abbott Labs PPD R&D
39 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 SKP FlutiForm HFA pMDI in people with Asthma, run by SkyePharma AG at 39 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 4 inclusion and 7 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 39 sites in Ukraine, United States, Peru, Romania, Mexico. 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?
To assess the long-term safety and efficacy of FlutiForm HFA pMDI 250/10 mcg bid in adolescents and adults with moderate to severe asthma who have completed the study SKY2028-3-005 (time frame: week 60). 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 23 Jun 2011.