AsthmaPhase 1NCT00657774
A Phase I Study in Asthma Patients Evaluating the Effect of Doses of FlutiForm™ on the Amount, if Any, of Cortisol Produced by the Adrenal Glands
A Phase 1 study testing FlutiForm 250/10 ug, FlutiForm 100/10 ug and Oral Prednisone 10mg in people with Asthma, run by SkyePharma AG at 19 sites in United States.
Trial summary
The medications being used in this study are individually approved by the Food and Drug Administration (FDA). The medication under investigation is a combination of the two medications in one inhaler. Read more about this study
- Who is it for?
- Ages 18 to 65 years
- Conditions the study is for
- Asthma
- What is being tested?
- FlutiForm 250/10 ug, FlutiForm 100/10 ug and Oral Prednisone 10mg
- Type of treatment
- Pill or oral medicine
- Could I receive a placebo?
- Yes, some participants may receive a placebo
- How many people
- 160 participants
- Where
- 19 sitesUnited States
- Study dates
- Apr 2008to Sep 2008
- Phase
- Phase 1
- 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
- Age 18-65 at the Screening Visit;
- History of asthma for at least 6 months prior to Screening Visit
- Well controlled asthma with rescue short acting beta agonist (albuterol) and or stable doses of other medications for at least 4 weeks prior to Screening Visit
- Female subjects that are not pregnant or lactating
- Otherwise healthy as determined by the Investigator.
Who cannot join
- Life-threatening asthma within the past year or visit to emergency room for asthma in the past 3 months prior to the Screening Visit;
- Significant,nonreversible pulmonary disease (e.g. chronic obstructive pulmonary disease, cystic fibrosis or bronchiectasis)
- Use of any steroid medications, topical or inhaled steroids within 4 weeks or systemic (oral or injectable) steroids within 3 months of dosing
- An upper or lower respiratory tract infection within the last 4 weeks pior to Screening Visit or acute illness or infection within 6 weeks prior to dosing
- Any significant disease or major disorder that may jeopardize subject safety
- History of tabacco use within 6 months prior to dosing and/or smoking history > 10 pack-years
- Female subjects on hormone replacement therapy or using birth control involving hormones in the past 6 months
- Additional inclusion and exclusion criteria will evaluated by the investigator.
Trial locations and contacts
19 sites in 1 country.
19 sites in 1 country
United States19 sites
Investigational site
Anaheim, California, 92801
Investigational site
Centennial, Colorado, 80112
Investigational site
Colorado Springs, Colorado, 80907
Investigational site
DeLand, Florida, 32720
Investigational site
Denver, Colorado, 80206
Investigational site
El Paso, Texas, 79902
Investigational Site
Lake Oswego, Oregon, 97035
Investigational site
Lakewood, Colorado, 80401
Investigational site
Long Beach, California, 90806
Investigational site
New Braunfels, Texas, 78130
Investigational site
North Dartmouth, Massachusetts, 02747
Investigational site
Omaha, Nebraska, 68154
Investigational Site
Pasadena, Maryland, 21122
Investigational site
Phoenix, Arizona, 85006
Investigational site
Portland, Oregon, 97213
Investigational site
San Antonio, Texas, 78229
Investigational site
San Diego, California, 92120
Investigational site
Skillman, New Jersey, 08558
Investigational site
Spartanburg, South Carolina, 29303
About this study
Official title: A Randomized, Double-Blind, Placebo- and Active-Controlled, Parallel Group, 6-Week Study to Evaluate the Effect of Multiple Doses of FlutiForm™ 250/10 Microgram HFA pMDI Twice Daily, FlutiForm™ 100/10 Microgram HFA pMDI Twice Daily, Prednisone and Placebo on the Hypothalmic-Pituitary-Adrenal Axis in Adult Subjects With Mild to Moderate Asthma.
The medications being used in this study are individually approved by the Food and Drug Administration (FDA). The medication under investigation is a combination of the two medications in one inhaler. The purpose of the study is to determine how the medication affects the amount, if any, of cortisol produced by the adrenal glands.
Read the detailed description
This is a Phase-1 randomized, double-blind, placebo- and active-controlled, parallel group 6 week study to evaluate the effect on the HPA axis of treatment with SKP FlutiForm 250/10 mg HFA pMDI twice daily administered over 6 weeks, FlutiForm 100/10 mg HFA pMDI twice daily administered over 6 weeks and 10 mg prednisone administered over 7 days compared to placebo. All subjects will undergo a Screening Visit to determine eligibility for the study and training on pMDI use. Eligible subjects will meet all of the following criteria: at least 6 month history of asthma, demonstrate an FEV1 of at least ≥ 60 % of predicted normal values at both Screening and Baseline visits, and stable asthma without the use of inhaled steroids for the past month or oral or parenteral corticosteroids for the past three months. All subjects will be admitted to the study site on the morning of Study Day -1 to begin a 24-hour urine collection and undergo Baseline trough PK sampling. On the morning of Study Day 1, subjects will be randomized to one of four treatment groups: SKP FlutiForm 250/10 mg twice daily + placebo capsule for six weeks, SKP FlutiForm 100/10 mg twice daily + placebo capsule for six weeks, Placebo inhaler + placebo capsule for six weeks or Placebo inhaler for six weeks + placebo capsule for 5 weeks followed by one week of 10 mg prednisone QD. After the first dose, subjects will be discharged from the study site to continue dosing at home for 6 weeks. Subjects will be required to record their compliance with their twice daily inhaler dosing and once daily oral medication dosing in a diary. Subjects will also record their predose morning and evening Peak Expiratory Flow Rate (PEFR) in a diary. Clinic visits will occur at Study Days 7, 14 and 35 during which safety assessments (AEs and vital signs) will be made, trough PK samples will be obtained and pMDI training will be continued. Also, subjects will return to the study site in the morning on Study Days 40 to 41 for observed dosing of prednisone or placebo. Subjects will be readmitted to the study site in the morning on Study Day 42 for trough PK sampling, observed dosing of prednisone or placebo and to begin a 24-hour urine collection. A safety follow-up phone call will occur 7 days later.
- Conditions
- Asthma
- Being tested
- FlutiForm 250/10 ug, FlutiForm 100/10 ug, Oral Prednisone 10mg, Placebo
- Keywords
- 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.
FlutiForm 250/10 ugDrug
SKP FlutiForm 250/10ug is a HFA pMDI that delivers 125ug of Fluticasone propionate per actuation and 5ug of Formoterol fumarate per actuation. Patients will take 2 actuations BID for 6 weeks.
FlutiForm 100/10 ugDrug
SKP FlutiForm 100/10ug is a HFA pMDI that delivers 50ug of Fluticasone propionate per actuation and 5ug of Formoterol fumarate per actuation. Patients will take 2 actuations BID for 6 weeks.
Oral Prednisone 10mgDrug
2 x 5 mg oral prednisone tablets, over encapsulated, once a day for one week.
PlaceboDrug
2 x 5 mg placebo tablets, over encapsulated, once a day for six weeks. SKP FlutiForm placebo HFA pMDI. Two actuations BID for six weeks.
| Study group | Role | What they receive |
|---|---|---|
| 1 | Experimental | FlutiForm 250/10 ug Receives: Drug: FlutiForm 250/10 ug |
| 2 | Experimental | FlutiForm 100/10 ug Receives: Drug: FlutiForm 100/10 ug |
| 3 | Active comparator | Oral Prednisone 10 mg Receives: Drug: Oral Prednisone 10mg |
| 4 | Placebo comparator | Placebo inhaler and/or placebo tablets Receives: Drug: Placebo |
What is being measured
The primary outcome is the main question the study is designed to answer.
Investigate effect of SKP FlutiForm 250/10 ug HFA pMDI BID for 6 weeks, FlutiForm 100/10 ug HFA pMDI BID, 10 mg prednisone for 7 days, compared to Placebo on the hypothalamic-pituitary-adrenal (HPA) axis using measurement of 24-hours UFC
Measured: Baseline and Study days 42-43
Secondary outcomes (1)
To assess the safety profile of SKP FlutiForm HFA pMDI using incidence of adverse events (AEs) and changes in electrocardiograms (ECGs), vital signs and clinical laboratory tests.
Measured: From Baseline up to 2 weeks after last dosing
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted14 Apr 2008 (estimated)
- Study startApr 2008
- Primary completionSep 2008
- Study completionSep 2008
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 1
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Triple blind
- Who is masked
- Participant, Care provider, Investigator
- Enrolment
- 160 participants (estimated)
Sponsor and investigators
- Lead sponsor
- SkyePharma AG
- Sponsor type
- Industry (pharma, biotech, devices)
- Collaborators
- Abbott
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT00657774
- Sponsor's protocol ID
- SKY2028-1-003
- Status last verified
- Nov 2008
- First submitted
- 8 Apr 2008
- Last updated
- 1 Dec 2008
- Results posted
- No
- Data monitoring committee
- No
Study at a glance
From the registry record, last updated by the sponsor on 1 Dec 2008. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- A Randomized, Double-Blind, Placebo- and Active-Controlled, Parallel Group, 6-Week Study to Evaluate the Effect of Multiple Doses of FlutiForm™ 250/10 Microgram HFA pMDI Twice Daily, FlutiForm™ 100/10 Microgram HFA pMDI Twice Daily, Prednisone and Placebo on the Hypothalmic-Pituitary-Adrenal Axis in Adult Subjects With Mild to Moderate Asthma.
- ClinicalTrials.gov ID
- NCT00657774
- Acronym / sponsor ID
- SKY2028-1-003
- Conditions
- Asthma
- Keywords
- Asthma, Mild to Moderate
- Phase
- Phase 1
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 160 participants (estimated)
- Lead sponsor
- SkyePharma AGIndustry (pharma, biotech, devices)
- Collaborators
- Abbott
- Study start
- Apr 2008
- Primary completion
- Sep 2008 (actual)
- Study completion
- Sep 2008 (actual)
- First posted
- 14 Apr 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 medications being used in this study are individually approved by the Food and Drug Administration (FDA). The medication under investigation is a combination of the two medications in one inhaler. The purpose of the study is to determine how the medication affects the amount, if any, of cortisol produced by the adrenal glands.
Detailed description
This is a Phase-1 randomized, double-blind, placebo- and active-controlled, parallel group 6 week study to evaluate the effect on the HPA axis of treatment with SKP FlutiForm 250/10 mg HFA pMDI twice daily administered over 6 weeks, FlutiForm 100/10 mg HFA pMDI twice daily administered over 6 weeks and 10 mg prednisone administered over 7 days compared to placebo. All subjects will undergo a Screening Visit to determine eligibility for the study and training on pMDI use. Eligible subjects will meet all of the following criteria: at least 6 month history of asthma, demonstrate an FEV1 of at least ≥ 60 % of predicted normal values at both Screening and Baseline visits, and stable asthma without the use of inhaled steroids for the past month or oral or parenteral corticosteroids for the past three months. All subjects will be admitted to the study site on the morning of Study Day -1 to begin a 24-hour urine collection and undergo Baseline trough PK sampling. On the morning of Study Day 1, subjects will be randomized to one of four treatment groups: SKP FlutiForm 250/10 mg twice daily + placebo capsule for six weeks, SKP FlutiForm 100/10 mg twice daily + placebo capsule for six weeks, Placebo inhaler + placebo capsule for six weeks or Placebo inhaler for six weeks + placebo capsule for 5 weeks followed by one week of 10 mg prednisone QD. After the first dose, subjects will be discharged from the study site to continue dosing at home for 6 weeks. Subjects will be required to record their compliance with their twice daily inhaler dosing and once daily oral medication dosing in a diary. Subjects will also record their predose morning and evening Peak Expiratory Flow Rate (PEFR) in a diary. Clinic visits will occur at Study Days 7, 14 and 35 during which safety assessments (AEs and vital signs) will be made, trough PK samples will be obtained and pMDI training will be continued. Also, subjects will return to the study site in the morning on Study Days 40 to 41 for observed dosing of prednisone or placebo. Subjects will be readmitted to the study site in the morning on Study Day 42 for trough PK sampling, observed dosing of prednisone or placebo and to begin a 24-hour urine collection. A safety follow-up phone call will occur 7 days later.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Triple blind (participant, care provider, investigator)
- Number of arms
- 4
| Arm | Type | Receives |
|---|---|---|
| 1 | Experimental | Drug: FlutiForm 250/10 ugFlutiForm 250/10 ug |
| 2 | Experimental | Drug: FlutiForm 100/10 ugFlutiForm 100/10 ug |
| 3 | Active comparator | Drug: Oral Prednisone 10mgOral Prednisone 10 mg |
| 4 | Placebo comparator | Drug: PlaceboPlacebo inhaler and/or placebo tablets |
Who may qualify
- Ages
- 18 to 65 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (5 listed)
- Age 18-65 at the Screening Visit;
- History of asthma for at least 6 months prior to Screening Visit
- Well controlled asthma with rescue short acting beta agonist (albuterol) and or stable doses of other medications for at least 4 weeks prior to Screening Visit
- Female subjects that are not pregnant or lactating
- Otherwise healthy as determined by the Investigator.
Key exclusion criteria (8 listed)
- Life-threatening asthma within the past year or visit to emergency room for asthma in the past 3 months prior to the Screening Visit;
- Significant,nonreversible pulmonary disease (e.g. chronic obstructive pulmonary disease, cystic fibrosis or bronchiectasis)
- Use of any steroid medications, topical or inhaled steroids within 4 weeks or systemic (oral or injectable) steroids within 3 months of dosing
- An upper or lower respiratory tract infection within the last 4 weeks pior to Screening Visit or acute illness or infection within 6 weeks prior to dosing
- Any significant disease or major disorder that may jeopardize subject safety
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 |
|---|---|---|
| FlutiForm 250/10 ugSKP FlutiForm 250/10ug is a HFA pMDI that delivers 125ug of Fluticasone propionate per actuation and 5ug of Formoterol fumarate per actuation. Patients will take 2 actuations BID for 6 weeks. | Drug | 1 |
| FlutiForm 100/10 ugSKP FlutiForm 100/10ug is a HFA pMDI that delivers 50ug of Fluticasone propionate per actuation and 5ug of Formoterol fumarate per actuation. Patients will take 2 actuations BID for 6 weeks. | Drug | 2 |
| Oral Prednisone 10mg2 x 5 mg oral prednisone tablets, over encapsulated, once a day for one week. | Drug | 3 |
| Placebo2 x 5 mg placebo tablets, over encapsulated, once a day for six weeks. SKP FlutiForm placebo HFA pMDI. Two actuations BID for six weeks. | Drug | 4 |
Primary outcome
Investigate effect of SKP FlutiForm 250/10 ug HFA pMDI BID for 6 weeks, FlutiForm 100/10 ug HFA pMDI BID, 10 mg prednisone for 7 days, compared to Placebo on the hypothalamic-pituitary-adrenal (HPA) axis using measurement of 24-hours UFC
Time frame: Baseline and Study days 42-43
1 secondary outcome
To assess the safety profile of SKP FlutiForm HFA pMDI using incidence of adverse events (AEs) and changes in electrocardiograms (ECGs), vital signs and clinical laboratory tests.
Time frame: From Baseline up to 2 weeks after last dosing
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 1 Dec 2008.
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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.
19 sites in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 1 study testing FlutiForm 250/10 ug, FlutiForm 100/10 ug and Oral Prednisone 10mg in people with Asthma, run by SkyePharma AG at 19 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 5 inclusion and 8 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 1 Dec 2008. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 19 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 1 studies test a treatment in a small group of people for the first time or in a new way, mainly to check safety and find the right dose.
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?
Investigate effect of SKP FlutiForm 250/10 ug HFA pMDI BID for 6 weeks, FlutiForm 100/10 ug HFA pMDI BID, 10 mg prednisone for 7 days, compared to Placebo on the hypothalamic-pituitary-adrenal (HPA) axis using measurement of 24-hours UFC (time frame: Baseline and Study days 42-43). 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 1 Dec 2008.