AsthmaPhase 3NCT01484210
Single Dose Study of the Fluticasone/Salmeterol (500/50 μg) Administered With Elpenhaler® Versus Diskus®
A Phase 3 study of Asthma, run by Elpen Pharmaceutical Co. Inc. at 5 sites in Czechia.
Trial summary
The aim of this study is to establish the therapeutic equivalence between the test (Fluticasone/Salmeterol administered with Elpenhaler®, Rolenium®) and the reference formulation (Seretide®, administered with Diskus®), both containing 500/50μg of the Fluticasone/Salmeterol combination. Read more about this study
- Who is it for?
- Ages 18 to 85 years
- Conditions the study is for
- Asthma
- Could I receive a placebo?
- Yes, some participants may receive a placebo
- How many people
- 28 participants
- Where
- 5 sitesCzechia
- Study dates
- Mar 2008to Oct 2008
- 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 to 85 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,
Show all 9Show fewer
- 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.
Trial locations and contacts
5 sites in 1 country.
5 sites in 1 country
Czechia5 sites
Pneumology surgery Vitezna 201/31
Karlovy Vary, Drahovice, 56001
Pneumology surgery Vojtesska 237
Kutná Hora, Zizkov
Pneumology and allergology surgery Voldusska 750
New Town, 337 01
Pneumology surgery Hostinskeho 1536
Prague, 1536
Pneumology surgery Generala Janouska 902/17
Prague, 19800
About this study
Official title: Phase III Therapeutic Evaluation Study Comparing the Efficacy and Safety of the Fluticasone/Salmeterol (500/50 μg) Combination Administered With Elpenhaler® (Rolenium®) Versus the Innovative One (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®, Rolenium®) and the reference formulation (Seretide®, administered with Diskus®), both containing 500/50μg of the Fluticasone/Salmeterol combination.
The study will be conducted in a randomized, double-blind, double-dummy, 2x2 crossover fashion.
Read the detailed description
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.
For this reason, 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.
- Conditions
- Asthma
- Being tested
- Elpenhaler active - Diskus placebo
- Medical subject headings
- Asthma
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Elpenhaler active - Diskus placeboDrug
randomized, double-blind, double-dummy, 2-way crossover, single dose study, comparing the efficacy and safety of the Fluticasone/Salmeterol (500/50 μg) combination administered with Elpenhaler® (Rolenium®) versus the innovative one (Seretide Diskus®) in patients with asthma.
| Study group | Role | What they receive |
|---|---|---|
| Elpenhaler Active - Diskus Placebo | Experimental | Patients on treatment with both devices, Elpenhaler and Diskus, first active substance, second placebo. Receives: Drug: Elpenhaler active - Diskus placebo |
What is being measured
The primary outcome is the main question the study is designed to answer.
The primary variable will be the 12-hour average FEV1 [area under the FEV1 versus time curve divided by 12 (FEV1 AUC0-12/12)].
To establish the therapeutic equivalence between the Fluticasone/Salmeterol combination administered with Elpenhaler® (Rolenium®) and the innovative one (Seretide Diskus®) in terms of their bronchodilator effect in lung function.
Measured: 0 (baseline), Visit 1 (3-7 days), Visit 2 (3-7 days), Telephone Contact Follow up (3-7 days)
Secondary outcomes (3)
The FEV1 values over time for the 12-hour observation period
To compare the efficacy and safety profile of the two Fluticasone/Salmeterol formulations in patients with asthma.
Measured: 0 (baseline), Visit 1 (3-7 days), Visit 2 (3-7 days), Telephone Contact Follow up (3-7 days)
Time to peak FEV1
To compare the effiacy and safety profile of the two Fluticasone/Salmeterol formulations in patients with asthma
Measured: 0 (baseline), Visit 1 (3-7 days), Visit 2 (3-7 days), Telephone Contact Follow up (3-7 days)
Time to peak FEV1 maximum value
same as FEV1
Measured: same as FEV1
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted2 Dec 2011 (estimated)
- Study startMar 2008
- Primary completionAug 2008
- Study completionOct 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 3
- Primary purpose
- Treatment
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Enrolment
- 28 participants (actual)
Sponsor and investigators
- Lead sponsor
- Elpen Pharmaceutical Co. Inc.
- Sponsor type
- Industry (pharma, biotech, devices)
- Responsible party
- Sponsor
- Investigators
- A Dindos, MD, Principal investigator, Pneumology Surgery, Kojeticka 1021, 27711 Neratovicae
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT01484210
- Sponsor's protocol ID
- 2007-FLUSAL-EL-02
- Other IDs
- 2007-006670-29, Sponsor ID, Sponsor FLUSAL-02
- Status last verified
- Nov 2011
- First submitted
- 12 Oct 2011
- Last updated
- 1 Nov 2023
- Results posted
- No
- Data monitoring committee
- No
Study at a glance
From the registry record, last updated by the sponsor on 1 Nov 2023. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Phase III Therapeutic Evaluation Study Comparing the Efficacy and Safety of the Fluticasone/Salmeterol (500/50 μg) Combination Administered With Elpenhaler® (Rolenium®) Versus the Innovative One (Seretide Diskus®) in Patients With Asthma.
- ClinicalTrials.gov ID
- NCT01484210
- Acronym / sponsor ID
- 2007-FLUSAL-EL-02
- Conditions
- Asthma
- Phase
- Phase 3
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 28 participants (actual)
- Lead sponsor
- Elpen Pharmaceutical Co. Inc.Industry (pharma, biotech, devices)
- Study start
- Mar 2008
- Primary completion
- Aug 2008 (actual)
- Study completion
- Oct 2008 (actual)
- First posted
- 2 Dec 2011 (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 aim of this study is to establish the therapeutic equivalence between the test (Fluticasone/Salmeterol administered with Elpenhaler®, Rolenium®) and the reference formulation (Seretide®, administered with Diskus®), both containing 500/50μg of the Fluticasone/Salmeterol combination.
The study will be conducted in a randomized, double-blind, double-dummy, 2x2 crossover fashion.
Detailed description
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.
For this reason, 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.
Study design
- Primary purpose
- Treatment
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| Elpenhaler Active - Diskus Placebo | Experimental | Drug: Elpenhaler active - Diskus placeboPatients on treatment with both devices, Elpenhaler and Diskus, first active substance, second placebo. |
Who may qualify
- Ages
- 18 to 85 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (8 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,
Key exclusion criteria (9 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,
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 |
|---|---|---|
| Elpenhaler active - Diskus placeborandomized, double-blind, double-dummy, 2-way crossover, single dose study, comparing the efficacy and safety of the Fluticasone/Salmeterol (500/50 μg) combination administered with Elpenhaler® (Rolenium®) versus the innovative one (Seretide Diskus®) in patients with asthma. | Drug | Elpenhaler Active - Diskus Placebo |
Primary outcome
The primary variable will be the 12-hour average FEV1 [area under the FEV1 versus time curve divided by 12 (FEV1 AUC0-12/12)].
Time frame: 0 (baseline), Visit 1 (3-7 days), Visit 2 (3-7 days), Telephone Contact Follow up (3-7 days)
To establish the therapeutic equivalence between the Fluticasone/Salmeterol combination administered with Elpenhaler® (Rolenium®) and the innovative one (Seretide Diskus®) in terms of their bronchodilator effect in lung function.
3 secondary outcomes
The FEV1 values over time for the 12-hour observation period
Time frame: 0 (baseline), Visit 1 (3-7 days), Visit 2 (3-7 days), Telephone Contact Follow up (3-7 days)
Time to peak FEV1
Time frame: 0 (baseline), Visit 1 (3-7 days), Visit 2 (3-7 days), Telephone Contact Follow up (3-7 days)
Time to peak FEV1 maximum value
Time frame: same as FEV1
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 Nov 2023.
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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.
A Dindos, MD principal investigator
Pneumology Surgery, Kojeticka 1021, 27711 Neratovicae
5 sites in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 3 study of Asthma, run by Elpen Pharmaceutical Co. Inc. at 5 sites in Czechia.
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 8 inclusion and 9 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 Nov 2023. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 5 sites in Czechia. 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?
The primary variable will be the 12-hour average FEV1 [area under the FEV1 versus time curve divided by 12 (FEV1 AUC0-12/12)]. (time frame: 0 (baseline), Visit 1 (3-7 days), Visit 2 (3-7 days), Telephone Contact Follow up (3-7 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 1 Nov 2023.