AsthmaNCT05459194
Efficacy and Safety Study of Fluticasone/Salmeterol Administered With Elpenhaler
A study testing RP - TA in people with Asthma, run by Elpen Pharmaceutical Co. Inc..
Trial summary
The aim of this study is to establish the therapeutic equivalence between the test (Fluticasone/Salmeterol administered with Elpenhaler®db, Rolenium®) and the reference formulation (Seretide®, administered with Diskus®), both containing 250/50μg of the Fluticasone/Salmeterol combination. Read more about this study
- Who is it for?
- Ages 18 to 65 years
- Conditions the study is for
- Asthma
- What is being tested?
- RP - TA
- Type of treatment
- Medical device
- Could I receive a placebo?
- Yes, some participants may receive a placebo
- How many people
- 42 participants
- Where
- No sites listed yet
- Study dates
- Oct 2008to Jan 2009
- Phase
- Interventional
- 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 years,
- diagnosis of asthma of 6 months,
- FEV1 ≥ 50% and ≤ 80% predicted, reversibility of at least 12%,
- stable asthma for at least 4 weeks,
- inhaled steroids (ICS) at a stable dose within the previous 30 days,
- PIF 30 - 90 lt/min and
- informed consent.
Who cannot join
- history of other pulmonary disease, asthma exacerbation or respiratory infection within the previous 4 weeks,
- hospitalization for acute asthmatic symptoms requiring parenteral steroids or oral steroid dose increase within the previous 30 days,
- heavy smokers,
- change of asthma medication within the previous 4 weeks, seasonal asthma alone,
- history of severe heart disease,
- pregnancy or lactation,
- use of a β-blocker, of a NSAID or an antiallergic/antihistaminic medication within 2 weeks prior to screening visit.
About this study
Official title: Multicenter, Randomized, Double-blind, Placebo-controlled, 3-way Crossover, Single Dose Study, Comparing the Efficacy and Safety of Fluticasone/Salmeterol Administered With Elpenhaler Versus Seretide Diskus in Patients With Asthma
The aim of this study is to establish the therapeutic equivalence between the test (Fluticasone/Salmeterol administered with Elpenhaler®db, Rolenium®) and the reference formulation (Seretide®, administered with Diskus®), both containing 250/50μg of the Fluticasone/Salmeterol combination.
In case of inhaled products, it is not possible to follow the classic scheme, based on similarity of plasma concentration-time behavior of parent drug in assessing bioequivalence.
Read the detailed description
A pharmacodynamic study was designed in order to assess the therapeutic equivalence of the new formulation of Fluticasone/Salmeterol with the innovative one. The test and reference Fluticasone/Salmeterol formulations will be compared in terms of their bronchodilator effects in lung function. Forced Expiratory Volume in 1 second (FEV1) will be the primary efficacy measure and will be measured in such a way that a similar time-dependent increase in pulmonary function can be demonstrated for both Fluticasone/Salmeterol formulations in patients with asthma. In terms of safety comparison, repeated measurements of adverse events, vital signs, heart rate, blood hematology and biochemistry as well as ECG changes will enable the establishment of the similar safety profile of the test and reference Fluticasone/Salmeterol combinations.
The study will be conducted in a randomized, double-blind, double-dummy, placebo-controlled, 3x3 crossover fashion.
- Conditions
- Asthma
- Being tested
- RP - TA
- Keywords
- respiratory, combination treatment, Elpenhaler, Diskus
- Medical subject headings
- Asthma
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
RP - TADevice
Also called Rolenium, Seretide
randomized, double-blind, double-dummy, placebo-controlled, 3-way crossover, single dose study, comparing the efficacy and safety of the Fluticasone/Salmeterol combination administered with Elpenhaler®db (Rolenium®) versus the innovative one (Seretide Diskus®)
| Study group | Role | What they receive |
|---|---|---|
| Test | Active comparator | Fluticasone/Salmeterol Elpenhaler active vs Fluticasone/Salmeterol Diskus placebo Receives: Device: RP - TA |
| Refere | Placebo comparator | Fluticasone/Salmeterol Elpenhaler placebo vs Fluticasone/Salmeterol Diskus active Receives: Device: RP - TA |
What is being measured
The primary outcome is the main question the study is designed to answer.
FEV1
12-hour average FEV1
Measured: 8 days
Secondary outcomes (1)
Adverse Events
Number of Adverse Events during the study
Measured: 8 days
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted14 Jul 2022
- Study startOct 2008
- Primary completionJan 2009
- Study completionJan 2009
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 N/A
- Primary purpose
- Other
- Allocation
- Randomised
- Intervention model
- Crossover
- Masking
- Double blind
- Who is masked
- Participant, Investigator
- Enrolment
- 42 participants (actual)
Sponsor and investigators
- Lead sponsor
- Elpen Pharmaceutical Co. Inc.
- Sponsor type
- Industry (pharma, biotech, devices)
- Responsible party
- Sponsor
- Investigators
- Katalin Gömöri, Principal investigator, Számítógépes Adatszolgáltató és Kereskedelmi Kft.
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT05459194
- Sponsor's protocol ID
- 2007-FLUSAL-EL-01
- Other IDs
- 2008-000193-21, Sponsor ID, 2008
- Status last verified
- Sep 2022
- First submitted
- 12 Oct 2011
- Last updated
- 10 Sep 2022
- Results posted
- No
- Data monitoring committee
- No
- Individual data sharing
- Undecided
Study at a glance
From the registry record, last updated by the sponsor on 10 Sep 2022. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Multicenter, Randomized, Double-blind, Placebo-controlled, 3-way Crossover, Single Dose Study, Comparing the Efficacy and Safety of Fluticasone/Salmeterol Administered With Elpenhaler Versus Seretide Diskus in Patients With Asthma
- ClinicalTrials.gov ID
- NCT05459194
- Acronym / sponsor ID
- 2007-FLUSAL-EL-01
- Conditions
- Asthma
- Keywords
- respiratory, combination treatment, Elpenhaler, Diskus
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 42 participants (actual)
- Lead sponsor
- Elpen Pharmaceutical Co. Inc.Industry (pharma, biotech, devices)
- Study start
- Oct 2008 (actual)
- Primary completion
- Jan 2009 (actual)
- Study completion
- Jan 2009 (actual)
- First posted
- 14 Jul 2022 (actual)
- 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 aim of this study is to establish the therapeutic equivalence between the test (Fluticasone/Salmeterol administered with Elpenhaler®db, Rolenium®) and the reference formulation (Seretide®, administered with Diskus®), both containing 250/50μg of the Fluticasone/Salmeterol combination.
In case of inhaled products, it is not possible to follow the classic scheme, based on similarity of plasma concentration-time behavior of parent drug in assessing bioequivalence.
Detailed description
A pharmacodynamic study was designed in order to assess the therapeutic equivalence of the new formulation of Fluticasone/Salmeterol with the innovative one. The test and reference Fluticasone/Salmeterol formulations will be compared in terms of their bronchodilator effects in lung function. Forced Expiratory Volume in 1 second (FEV1) will be the primary efficacy measure and will be measured in such a way that a similar time-dependent increase in pulmonary function can be demonstrated for both Fluticasone/Salmeterol formulations in patients with asthma. In terms of safety comparison, repeated measurements of adverse events, vital signs, heart rate, blood hematology and biochemistry as well as ECG changes will enable the establishment of the similar safety profile of the test and reference Fluticasone/Salmeterol combinations.
The study will be conducted in a randomized, double-blind, double-dummy, placebo-controlled, 3x3 crossover fashion.
Study design
- Primary purpose
- Other
- Allocation
- Randomised
- Intervention model
- Crossover
- Masking
- Double blind (participant, investigator)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Test | Active comparator | Device: RP - TAFluticasone/Salmeterol Elpenhaler active vs Fluticasone/Salmeterol Diskus placebo |
| Refere | Placebo comparator | Device: RP - TAFluticasone/Salmeterol Elpenhaler placebo vs Fluticasone/Salmeterol Diskus active |
Who may qualify
- Ages
- 18 to 65 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (7 listed)
- age 18-65 years,
- diagnosis of asthma of 6 months,
- FEV1 ≥ 50% and ≤ 80% predicted, reversibility of at least 12%,
- stable asthma for at least 4 weeks,
- inhaled steroids (ICS) at a stable dose within the previous 30 days,
Key exclusion criteria (7 listed)
- history of other pulmonary disease, asthma exacerbation or respiratory infection within the previous 4 weeks,
- hospitalization for acute asthmatic symptoms requiring parenteral steroids or oral steroid dose increase within the previous 30 days,
- heavy smokers,
- change of asthma medication within the previous 4 weeks, seasonal asthma alone,
- history of severe heart disease,
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 |
|---|---|---|
| RP - TAAlso: Rolenium, Seretiderandomized, double-blind, double-dummy, placebo-controlled, 3-way crossover, single dose study, comparing the efficacy and safety of the Fluticasone/Salmeterol combination administered with Elpenhaler®db (Rolenium®) versus the innovative one (Seretide Diskus®) | Device | Refere, Test |
Primary outcome
FEV1
Time frame: 8 days
12-hour average FEV1
1 secondary outcome
Adverse Events
Time frame: 8 days
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 10 Sep 2022.
- PMID: 17523742 DOI: 10.2165/00044011-200525010-00001Link provided by the sponsor.
- Individual participant dataSharing planned: Undecided
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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.
Katalin Gömöri principal investigator
Számítógépes Adatszolgáltató és Kereskedelmi Kft.
Questions about this trial
What is this clinical trial studying?
A study testing RP - TA in people with Asthma, run by Elpen Pharmaceutical Co. Inc..
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 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 10 Sep 2022. Status can change between updates, so confirm with the study contact before making plans.
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.
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?
FEV1 (time frame: 8 days). 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 10 Sep 2022.