AsthmaPhase 2NCT00927758
Pilot Study to Examine the Post-Dose Changes in Exhaled Nitric Oxide (eNO) Following Treatment With Fluticasone Propionate (FP)/Salmeterol (SAL) Combination Product Advair
A Phase 2 study testing fluticasone propionate/salmeterol (Flu/Sal) : 100mcg/50mcg, 250mcg/50mcg,500mcg/50 mcg in people with Asthma, run by Sandoz at 3 sites in United States.
Trial summary
To examine the post-dose changes in exhaled Nitric Oxide (eNO) following treatment with inhaled Advair in subjects with chronic but stable asthma as defined in Global Initiative for Asthma (GINA) guidelines. 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/salmeterol (Flu/Sal) : 100mcg/50mcg, 250mcg/50mcg,500mcg/50 mcg
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 105 participants
- Where
- 3 sitesUnited States
- Study dates
- Jun 2009to Dec 2009
- Phase
- Phase 2
- Are there results?
- Yes, posted in the registrySummary in the doctors' view
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
- must be able to speak, read, and understand English
- exhaled Nitrous Oxide levels must be greater than or equal to 60 ppb at screening and greater than or equal to 55 ppb at Visits 2, 9, and 16
- must have history of at least 6 months of chronic, but stable asthma
- except for the presence of asthma, subjects must be in general good health
Who cannot join
- past or present history of experiencing allergic reaction to medications used in this study
- subjects must not be receiving ongoing regular treatment with inhaled corticosteroids
- subjects must not have ragweed allergy
- subjects must have no recent history of respiratory infections for at least 1 month prior to screening and until the end of the study
Trial locations and contacts
3 sites in 1 country.
United States3 sites
University of Florida
Gainesville, Florida, 32610-0486
CompleWare
Iowa City, Iowa, 52244
University of Wisconsin
Madison, Wisconsin, 53792
About this study
To examine the post-dose changes in exhaled Nitric Oxide (eNO) following treatment with inhaled Advair in subjects with chronic but stable asthma as defined in Global Initiative for Asthma (GINA) guidelines.
- Conditions
- Asthma
- Being tested
- fluticasone propionate/salmeterol (Flu/Sal) : 100mcg/50mcg, 250mcg/50mcg,500mcg/50 mcg
- 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/salmeterol (Flu/Sal) : 100mcg/50mcg, 250mcg/50mcg,500mcg/50 mcgDrug
Also called Advair DISKUS
fluticasone propionate/salmeterol diskus
| Study group | Role | What they receive |
|---|---|---|
| Sequence 1: Flu/Sal- 250mcg/50mcg ->100mcg/50mcg->500mcg/50mcg | Active comparator | Treatment cycle 1: Patient randomized to Fluticasone Propionate/Salmeterol (Flu/Sal) received 250mcg/50mcg once daily for 7 days.
Treatement Cycle 2 : Patient randomized to Fluticasone Propionate/Salmeterol (Flu/Sal) received 100mcg/50mcg once daily for 7 days.
Treatment Cycle 3: Patient randomized to Fluticasone Propionate/Salmeterol (Flu/Sal) received 500mcg/50mcg once daily for 7 days.
There were 14 days washout period between cycles. Receives: Drug: fluticasone propionate/salmeterol (Flu/Sal) : 100mcg/50mcg, 250mcg/50mcg,500mcg/50 mcg |
| Sequence 2: Flu/Sal- 500mcg/50mcg ->250mcg/50mcg->100mcg/50mcg | Active comparator | Treatment cycle 1: Patient randomized to Fluticasone Propionate/Salmeterol (Flu/Sal) received 500mcg/50mcg once daily for 7 days.
Treatement Cycle 2 : Patient randomized to Fluticasone Propionate/Salmeterol (Flu/Sal) received 250mcg/50mcg once daily for 7 days.
Treatment Cycle 3: Patient randomized to Fluticasone Propionate/Salmeterol (Flu/Sal) received 100mcg/50mcg once daily for 7 days.
There were 14 days washout period between cycles. Receives: Drug: fluticasone propionate/salmeterol (Flu/Sal) : 100mcg/50mcg, 250mcg/50mcg,500mcg/50 mcg |
| Sequence 3: Flu/Sal- 100mcg/50mcg ->250mcg/50mcg->500mcg/50mcg | Active comparator | Treatment cycle 1: Patient randomized to Fluticasone Propionate/Salmeterol (Flu/Sal) received 100mcg/50mcg once daily for 7 days.
Treatement Cycle 2 : Patient randomized to Fluticasone Propionate/Salmeterol (Flu/Sal) received 250mcg/50mcg once daily for 7 days.
Treatment Cycle 3: Patient randomized to Fluticasone Propionate/Salmeterol (Flu/Sal) received 500mcg/50mcg once daily for 7 days.
There were 14 days washout period between cycles. Receives: Drug: fluticasone propionate/salmeterol (Flu/Sal) : 100mcg/50mcg, 250mcg/50mcg,500mcg/50 mcg |
| Sequence 4: Flu/Sal- 250mcg/50mcg ->500mcg/50mcg->100mcg/50mcg | Active comparator | Treatment cycle 1: Patient randomized to Fluticasone Propionate/Salmeterol (Flu/Sal) received 250mcg/50mcg once daily for 7 days.
Treatement Cycle 2 : Patient randomized to Fluticasone Propionate/Salmeterol (Flu/Sal) received 500mcg/50mcg once daily for 7 days.
Treatment Cycle 3: Patient randomized to Fluticasone Propionate/Salmeterol (Flu/Sal) received 100mcg/50mcg once daily for 7 days.
There were 14 days washout period between cycles. Receives: Drug: fluticasone propionate/salmeterol (Flu/Sal) : 100mcg/50mcg, 250mcg/50mcg,500mcg/50 mcg |
| Sequence 5: Flu/Sal- 500mcg/50mcg ->100mcg/50mcg->250mcg/50mcg | Active comparator | Treatment cycle 1: Patient randomized to Fluticasone Propionate/Salmeterol (Flu/Sal) received 500mcg/50mcg once daily for 7 days.
Treatement Cycle 2 : Patient randomized to Fluticasone Propionate/Salmeterol (Flu/Sal) received 100mcg/50mcg once daily for 7 days.
Treatment Cycle 3: Patient randomized to Fluticasone Propionate/Salmeterol (Flu/Sal) received 250mcg/50mcg once daily for 7 days.
There were 14 days washout period between cycles. Receives: Drug: fluticasone propionate/salmeterol (Flu/Sal) : 100mcg/50mcg, 250mcg/50mcg,500mcg/50 mcg |
| Sequence 6: Flu/Sal- 100mcg/50mcg ->500mcg/50mcg->250mcg/50mcg | Active comparator | Treatment cycle 1: Patient randomized to Fluticasone Propionate/Salmeterol (Flu/Sal) received 100mcg/50mcg once daily for 7 days.
Treatement Cycle 2 : Patient randomized to Fluticasone Propionate/Salmeterol (Flu/Sal) received 500mcg/50mcg once daily for 7 days.
Treatment Cycle 3: Patient randomized to Fluticasone Propionate/Salmeterol (Flu/Sal) received 250mcg/50mcg once daily for 7 days.
There were 14 days washout period between cycles. Receives: Drug: fluticasone propionate/salmeterol (Flu/Sal) : 100mcg/50mcg, 250mcg/50mcg,500mcg/50 mcg |
What is being measured
The primary outcome is the main question the study is designed to answer.
Percentage Change From Baseline (for Each Treatment Cycle) in Exhaled Nitric Oxide (eNO)
Percentage change in eNO was reported following treatment with inhaled Advair in subjects with chronic but stable asthma as defined in Global Initiative for Asthma (GINA) guidelines. eNO was calculated 3 times every day in a treatment cycle for 7 days. The maximum value of all 3 collected value were collected for each seven days of the individual treatment cycle. Out of the maximum values, the minimum was taken and used for calculating the percentage change from baseline.
Measured: Baseline to Day 7 of each treatment cycle (total duration about 8 - 10 weeks)
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted25 Jun 2009 (estimated)
- Study startJun 2009
- Primary completionDec 2009
- Study completionDec 2009
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Posted resultsParticipant flow, outcome measures and adverse events reported by the sponsor.
- 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 2
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Crossover
- Masking
- Quadruple blind
- Who is masked
- Participant, Care provider, Investigator, Outcomes assessor
- Enrolment
- 105 participants (actual)
Sponsor and investigators
- Lead sponsor
- Sandoz
- Sponsor type
- Industry (pharma, biotech, devices)
- Responsible party
- Sponsor
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT00927758
- Sponsor's protocol ID
- CP-Sandoz-2009-PilotFP
- Status last verified
- Apr 2014
- First submitted
- 23 Jun 2009
- Last updated
- 29 Mar 2017
- Results posted
- Yes, on ClinicalTrials.gov
Study at a glance
From the registry record, last updated by the sponsor on 29 Mar 2017. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Pilot Study to Examine the Post-Dose Changes in Exhaled Nitric Oxide (eNO) Following Treatment With Fluticasone Propionate (FP)/Salmeterol (SAL) Combination Product Advair
- ClinicalTrials.gov ID
- NCT00927758
- Acronym / sponsor ID
- CP-Sandoz-2009-PilotFP
- Conditions
- Asthma
- Phase
- Phase 2
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 105 participants (actual)
- Lead sponsor
- SandozIndustry (pharma, biotech, devices)
- Study start
- Jun 2009
- Primary completion
- Dec 2009 (actual)
- Study completion
- Dec 2009 (actual)
- First posted
- 25 Jun 2009 (estimated)
- Results
- Posted 8 Sep 2014
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
To examine the post-dose changes in exhaled Nitric Oxide (eNO) following treatment with inhaled Advair in subjects with chronic but stable asthma as defined in Global Initiative for Asthma (GINA) guidelines.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Crossover
- Masking
- Quadruple blind (participant, care provider, investigator, outcomes assessor)
- Number of arms
- 6
| Arm | Type | Receives |
|---|---|---|
| Sequence 1: Flu/Sal- 250mcg/50mcg ->100mcg/50mcg->500mcg/50mcg | Active comparator | Drug: fluticasone propionate/salmeterol (Flu/Sal) : 100mcg/50mcg, 250mcg/50mcg,500mcg/50 mcgTreatment cycle 1: Patient randomized to Fluticasone Propionate/Salmeterol (Flu/Sal) received 250mcg/50mcg once daily for 7 days. Treatement Cycle 2 : Patient randomized to Fluticasone Propionate/Salmeterol (Flu/Sal) received 100mcg/50mcg once daily for 7 days. Treatment Cycle 3: Patient randomized to Fluticasone Propionate/Salmeterol (Flu/Sal) received 500mcg/50mcg once daily for 7 days. There were 14 days washout period between cycles. |
| Sequence 2: Flu/Sal- 500mcg/50mcg ->250mcg/50mcg->100mcg/50mcg | Active comparator | Drug: fluticasone propionate/salmeterol (Flu/Sal) : 100mcg/50mcg, 250mcg/50mcg,500mcg/50 mcgTreatment cycle 1: Patient randomized to Fluticasone Propionate/Salmeterol (Flu/Sal) received 500mcg/50mcg once daily for 7 days. Treatement Cycle 2 : Patient randomized to Fluticasone Propionate/Salmeterol (Flu/Sal) received 250mcg/50mcg once daily for 7 days. Treatment Cycle 3: Patient randomized to Fluticasone Propionate/Salmeterol (Flu/Sal) received 100mcg/50mcg once daily for 7 days. There were 14 days washout period between cycles. |
| Sequence 3: Flu/Sal- 100mcg/50mcg ->250mcg/50mcg->500mcg/50mcg | Active comparator | Drug: fluticasone propionate/salmeterol (Flu/Sal) : 100mcg/50mcg, 250mcg/50mcg,500mcg/50 mcgTreatment cycle 1: Patient randomized to Fluticasone Propionate/Salmeterol (Flu/Sal) received 100mcg/50mcg once daily for 7 days. Treatement Cycle 2 : Patient randomized to Fluticasone Propionate/Salmeterol (Flu/Sal) received 250mcg/50mcg once daily for 7 days. Treatment Cycle 3: Patient randomized to Fluticasone Propionate/Salmeterol (Flu/Sal) received 500mcg/50mcg once daily for 7 days. There were 14 days washout period between cycles. |
| Sequence 4: Flu/Sal- 250mcg/50mcg ->500mcg/50mcg->100mcg/50mcg | Active comparator | Drug: fluticasone propionate/salmeterol (Flu/Sal) : 100mcg/50mcg, 250mcg/50mcg,500mcg/50 mcgTreatment cycle 1: Patient randomized to Fluticasone Propionate/Salmeterol (Flu/Sal) received 250mcg/50mcg once daily for 7 days. Treatement Cycle 2 : Patient randomized to Fluticasone Propionate/Salmeterol (Flu/Sal) received 500mcg/50mcg once daily for 7 days. Treatment Cycle 3: Patient randomized to Fluticasone Propionate/Salmeterol (Flu/Sal) received 100mcg/50mcg once daily for 7 days. There were 14 days washout period between cycles. |
| Sequence 5: Flu/Sal- 500mcg/50mcg ->100mcg/50mcg->250mcg/50mcg | Active comparator | Drug: fluticasone propionate/salmeterol (Flu/Sal) : 100mcg/50mcg, 250mcg/50mcg,500mcg/50 mcgTreatment cycle 1: Patient randomized to Fluticasone Propionate/Salmeterol (Flu/Sal) received 500mcg/50mcg once daily for 7 days. Treatement Cycle 2 : Patient randomized to Fluticasone Propionate/Salmeterol (Flu/Sal) received 100mcg/50mcg once daily for 7 days. Treatment Cycle 3: Patient randomized to Fluticasone Propionate/Salmeterol (Flu/Sal) received 250mcg/50mcg once daily for 7 days. There were 14 days washout period between cycles. |
| Sequence 6: Flu/Sal- 100mcg/50mcg ->500mcg/50mcg->250mcg/50mcg | Active comparator | Drug: fluticasone propionate/salmeterol (Flu/Sal) : 100mcg/50mcg, 250mcg/50mcg,500mcg/50 mcgTreatment cycle 1: Patient randomized to Fluticasone Propionate/Salmeterol (Flu/Sal) received 100mcg/50mcg once daily for 7 days. Treatement Cycle 2 : Patient randomized to Fluticasone Propionate/Salmeterol (Flu/Sal) received 500mcg/50mcg once daily for 7 days. Treatment Cycle 3: Patient randomized to Fluticasone Propionate/Salmeterol (Flu/Sal) received 250mcg/50mcg once daily for 7 days. There were 14 days washout period between cycles. |
Who may qualify
- Ages
- 18 to 65 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (4 listed)
- must be able to speak, read, and understand English
- exhaled Nitrous Oxide levels must be greater than or equal to 60 ppb at screening and greater than or equal to 55 ppb at Visits 2, 9, and 16
- must have history of at least 6 months of chronic, but stable asthma
- except for the presence of asthma, subjects must be in general good health
Key exclusion criteria (4 listed)
- past or present history of experiencing allergic reaction to medications used in this study
- subjects must not be receiving ongoing regular treatment with inhaled corticosteroids
- subjects must not have ragweed allergy
- subjects must have no recent history of respiratory infections for at least 1 month prior to screening and until the end of the study
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/salmeterol (Flu/Sal) : 100mcg/50mcg, 250mcg/50mcg,500mcg/50 mcgAlso: Advair DISKUSfluticasone propionate/salmeterol diskus | Drug | Sequence 1: Flu/Sal- 250mcg/50mcg ->100mcg/50mcg->500mcg/50mcg, Sequence 2: Flu/Sal- 500mcg/50mcg ->250mcg/50mcg->100mcg/50mcg, Sequence 3: Flu/Sal- 100mcg/50mcg ->250mcg/50mcg->500mcg/50mcg, Sequence 4: Flu/Sal- 250mcg/50mcg ->500mcg/50mcg->100mcg/50mcg, Sequence 5: Flu/Sal- 500mcg/50mcg ->100mcg/50mcg->250mcg/50mcg, Sequence 6: Flu/Sal- 100mcg/50mcg ->500mcg/50mcg->250mcg/50mcg |
Primary outcome
Percentage Change From Baseline (for Each Treatment Cycle) in Exhaled Nitric Oxide (eNO)
Time frame: Baseline to Day 7 of each treatment cycle (total duration about 8 - 10 weeks)
Percentage change in eNO was reported following treatment with inhaled Advair in subjects with chronic but stable asthma as defined in Global Initiative for Asthma (GINA) guidelines. eNO was calculated 3 times every day in a treatment cycle for 7 days. The maximum value of all 3 collected value were collected for each seven days of the individual treatment cycle. Out of the maximum values, the minimum was taken and used for calculating the percentage change from baseline.
Results and safety
Loading the posted results from ClinicalTrials.gov…
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 29 Mar 2017.
- Posted resultsParticipant flow, baseline, all outcome measures and adverse events.
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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.
3 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/salmeterol (Flu/Sal) : 100mcg/50mcg, 250mcg/50mcg,500mcg/50 mcg in people with Asthma, run by Sandoz at 3 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 4 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 29 Mar 2017. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 3 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. 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?
Yes. Results are posted in the registry (first posted 8 Sep 2014). A summary is in the For doctors view, and the full results are on ClinicalTrials.gov.
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?
Percentage Change From Baseline (for Each Treatment Cycle) in Exhaled Nitric Oxide (eNO) (time frame: Baseline to Day 7 of each treatment cycle (total duration about 8 - 10 weeks)). 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 29 Mar 2017.