AsthmaPhase 3NCT01795664
Compare the Effects of Seretide® Evohaler and a Generic Salmeterol/Fluticasone Hydrofluoroalkane (HFA) Pressurized Metered-dose Inhaler (pMDI) on Functional Respiratory Imaging Parameters in Asthmatic Patients
A Phase 3 study testing Functional Respiratory Imaging, Salmeterol xinafoate and Fluticasone propionate HFA pMDI and Seretide Evohaler in people with Asthma, run by FLUIDDA nv at 1 site in Belgium.
Trial summary
This study will be conducted as a randomized, double blind, double dummy two period crossover study in stable asthma patients. A total of 16 stable asthma patients treated in accordance with the Global Initiative for Asthma (GINA) guidelines, will be included. Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Asthma
- What is being tested?
- Functional Respiratory Imaging, Salmeterol xinafoate and Fluticasone propionate HFA pMDI and Seretide Evohaler
- Type of treatment
- Surgery or procedure
- Could I receive a placebo?
- Yes, some participants may receive a placebo
- How many people
- 16 participants
- Where
- 1 siteBelgium
- Study dates
- Mar 2013to Aug 2013
- 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
- Male or female patient ≥ 18 years old
- Written informed consent obtained
- Patient with a documented diagnosis of asthma according to the GINA guidelines
- Patient with a co-operative attitude and ability to be trained to correctly use the pMDI
- Female patient of childbearing potential who confirm that a contraception method was used at least 14 days before visit 1 and will continue to use a contraception method during the study
- Patient must be stable and treated in accordance with the GINA guidelines
- Patient must be a non-smoker or ex-smoker who have stopped smoking at least 1 year prior to visit 1 and has a smoking history of < 10 pack years
- Patient must be able to understand and complete the protocol requirements, instructions, questionnaires and protocol-stated restrictions
Who cannot join
- Pregnant or lactating female
- Unstable patient who developed an exacerbation during the last 8 weeks
- Patient with upper or lower airways infection
- Patient unable to carry out pulmonary function testing
- Patient with an uncontrolled disease or any condition that might, in the judgement of the investigator, place the patient at undue risk or potentially compromise the results or interpretation of the study
- Patient with cancer or any other chronic disease with poor prognosis and /or affecting patient status
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- Patient with allergy, sensitivity or intolerance to study drugs and/or study drug formulation ingredients
- Patient unlikely to comply with the protocol or unable to understand the nature, scope and possible consequences of the study
- Patient who received oral corticosteroids within the last 4 weeks prior to visit 1
- Patient who received any investigational new drug within the last 4 weeks prior to visit 1 or twice the duration of the biological effect of any drug (whichever is longer)
- Patient with a history of alcohol or substance abuse that in the opinion of the investigator may be of clinical significance
- Patient who has undergone major surgery in the last 12 weeks before the visit 1 or has planned to undergo a major surgery before the end of the trial
- Patient with diagnosis of chronic obstructive pulmonary disease (COPD)
Trial locations and contacts
1 site in 1 country.
About this study
Official title: A Double Blind, Double Dummy, Randomized, Two Way Cross-over Study to Compare the Effects of Seretide® Evohaler (Supplied by Allen & Hanburys, UK) and a Generic Salmeterol/Fluticasone HFA pMDI (Manufactured by Cipla Ltd, India) on Functional Respiratory Imaging Parameters in Asthmatic Patients.
This study will be conducted as a randomized, double blind, double dummy two period crossover study in stable asthma patients. A total of 16 stable asthma patients treated in accordance with the Global Initiative for Asthma (GINA) guidelines, will be included.
Objectives:
- The primary objective of this study is to evaluate the effect of both the study drugs under investigation on Functional Respiratory Imaging (FRI) parameters and to evaluate the particle deposition in the lungs using Computational Fluid Dynamic (CFD)
- The secondary objectives are to assess the effect of both the study drugs on lung function (spirometry and body plethysmography), on exercise capacity (6 Minutes Walking Test = 6MWT) and on dyspnea (Borg Category (C) Ratio (R) 10 Scale and Visual Analog Scale (VAS) dyspnea). Furthermore the safety of the 2 products under investigation will be evaluated through monitoring of adverse events (AEs) throughout the study.
- Conditions
- Asthma
- Being tested
- Functional Respiratory Imaging, Salmeterol xinafoate and Fluticasone propionate HFA pMDI, Seretide Evohaler, Placebo of Test product, Placebo of Reference product
- Keywords
- Asthma, Salmeterol xinafoate and Fluticasone propionate, Seretide Evohaler, Functional Respiratory Imaging, Computational Fluid Dynamic
- Medical subject headings
- Asthma
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Functional Respiratory ImagingRadiation
CT-scan of thorax, at visit 2 pre and postdose and at visit 3 pre and postdose
Salmeterol xinafoate and Fluticasone propionate HFA pMDIDrug
Also called Test product
Strength: 25/250 mcg per actuation; Dose: single dose of 2 puffs; A total dose of 50/500 mcg
At visit 2 or visit 3 (cross-over design)
Seretide EvohalerDrug
Also called Reference product, Salmeterol xinafoate and Fluticasone propionate combination HFA pMDI
Strength: 25/250 mcg per actuation; Dose: single dose of 2 puffs; A total dose of 50/500 mcg
At visit 2 or visit 3 (cross-over design)
Placebo of Test productDrug
Also called Placebo inhaler containing HFA propellant resembling the test active inhaler
Single dose of 2 puffs
To ensure blinding, each patient will receive two inhalers (one active and one placebo) on each dosing day.
Placebo of Reference productDrug
Also called Placebo inhaler containing HFA propellant resembling the reference active inhaler
Single dose of 2 puffs
To ensure blinding, each patient will receive two inhalers (one active and one placebo) on each dosing day.
| Study group | Role | What they receive |
|---|---|---|
| Seretide Evohaler | Active comparator | Salmeterol xinafoate and Fluticasone propionate combination HFA pMDI (Seretide Evohaler, Allen \& Hanburys, UK)
Strength: 25/250 mcg per actuation; Dose: single dose of 2 puffs; a total dose of 50/500 mcg Receives: Radiation: Functional Respiratory Imaging; Drug: Seretide Evohaler; Drug: Placebo of Test product |
| Salmeterol xinafoate and Fluticasone propionate HFA pMDI | Experimental | Salmeterol xinafoate and Fluticasone propionate combination HFA pMDI (Cipla Ltd., India)
Strength: 25/250 mcg per actuation; Dose: single dose of 2 puffs; a total dose of 50/500 mcg Receives: Radiation: Functional Respiratory Imaging; Drug: Salmeterol xinafoate and Fluticasone propionate HFA pMDI; Drug: Placebo of Reference product |
What is being measured
The primary outcome is the main question the study is designed to answer.
Total airway volume
The primary objective of this study is to evaluate the effect of both the study drugs under investigation on Functional Respiratory Imaging (FRI) parameters and to evaluate the particle deposition in the lungs using Computational Fluid Dynamic (CFD)
Measured: At visit 2 (= 7-11 days after visit 1)
The number of deposited particles per pre-defined airway section
The primary objective of this study is to evaluate the effect of both the study drugs under investigation on Functional Respiratory Imaging (FRI) parameters and to evaluate the particle deposition in the lungs using Computational Fluid Dynamic (CFD)
Measured: At visit 2 (= 7-11 days after visit 1)
Total airway resistance
The primary objective of this study is to evaluate the effect of both the study drugs under investigation on Functional Respiratory Imaging (FRI) parameters and to evaluate the particle deposition in the lungs using Computational Fluid Dynamic (CFD)
Measured: At visit 2 (= 7-11 days after visit 1)
Total airway volume
The primary objective of this study is to evaluate the effect of both the study drugs under investigation on Functional Respiratory Imaging (FRI) parameters and to evaluate the particle deposition in the lungs using Computational Fluid Dynamic (CFD)
Measured: At visit 3 (= 3-7 days after visit 2)
The number of deposited particles per pre-defined airway section
The primary objective of this study is to evaluate the effect of both the study drugs under investigation on Functional Respiratory Imaging (FRI) parameters and to evaluate the particle deposition in the lungs using Computational Fluid Dynamic (CFD)
Measured: At visit 3 (= 3-7 days after visit 2)
Total airway resistance
The primary objective of this study is to evaluate the effect of both the study drugs under investigation on Functional Respiratory Imaging (FRI) parameters and to evaluate the particle deposition in the lungs using Computational Fluid Dynamic (CFD)
Measured: At visit 3 (= 3-7 days after visit 2)
Secondary outcomes (7)
Lung function tests (spirometry, body plethysmography)
The secondary objectives are to assess the effect of both the study drugs on lung function (spirometry and body plethysmography), on exercise capacity (6 Minutes Walking Test = 6MWT) and on dyspnea (Borg Category (C) Ratio (R) 10 Scale and Visual Analog Scale (VAS) dyspnea).
Measured: At visit 2 (= 7-11 days after visit 1)
Exercise capacity (6 minutes walking test)
The secondary objectives are to assess the effect of both the study drugs on lung function (spirometry and body plethysmography), on exercise capacity (6 Minutes Walking Test = 6MWT) and on dyspnea (Borg Category (C) Ratio (R) 10 Scale and Visual Analog Scale (VAS) dyspnea).
Measured: At visit 2 (= 7-11 days after visit 1)
Dyspnea (BORG CR 10 scale and VAS dyspnea)
The secondary objectives are to assess the effect of both the study drugs on lung function (spirometry and body plethysmography), on exercise capacity (6 Minutes Walking Test = 6MWT) and on dyspnea (Borg Category (C) Ratio (R) 10 Scale and Visual Analog Scale (VAS) dyspnea).
Measured: At visit 2 (= 7-11 days after visit 1)
Incidence of adverse events
The safety of the 2 products under investigation will be evaluated through monitoring of adverse events (AEs) throughout the study.
Measured: From visit 1 until visit 4 = timeperiod of 3 à 4 weeks
Lung function tests (spirometry, body plethysmography)
The secondary objectives are to assess the effect of both the study drugs on lung function (spirometry and body plethysmography), on exercise capacity (6 Minutes Walking Test = 6MWT) and on dyspnea (Borg Category (C) Ratio (R) 10 Scale and Visual Analog Scale (VAS) dyspnea).
Measured: At visit 3 (= 3-7 days after visit 2)
Exercise capacity (6 minutes walking test)
The secondary objectives are to assess the effect of both the study drugs on lung function (spirometry and body plethysmography), on exercise capacity (6 Minutes Walking Test = 6MWT) and on dyspnea (Borg Category (C) Ratio (R) 10 Scale and Visual Analog Scale (VAS) dyspnea).
Measured: At visit 3 (= 3-7 days after visit 2)
Dyspnea (BORG CR 10 scale and VAS dyspnea)
The secondary objectives are to assess the effect of both the study drugs on lung function (spirometry and body plethysmography), on exercise capacity (6 Minutes Walking Test = 6MWT) and on dyspnea (Borg Category (C) Ratio (R) 10 Scale and Visual Analog Scale (VAS) dyspnea).
Measured: At visit 3 (= 3-7 days after visit 2)
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted21 Feb 2013 (estimated)
- Study startMar 2013
- Primary completionAug 2013
- Study completionAug 2013
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (1)Papers the sponsor has linked to this study.
- 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
- Randomised
- Intervention model
- Crossover
- Masking
- Triple blind
- Who is masked
- Participant, Care provider, Investigator
- Enrolment
- 16 participants (actual)
Sponsor and investigators
- Lead sponsor
- FLUIDDA nv
- Sponsor type
- Industry (pharma, biotech, devices)
- Responsible party
- Sponsor
- Investigators
- Wilfried De Backer, MD, PhD, Principal investigator, University Hospital, Antwerp
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT01795664
- Sponsor's protocol ID
- FLUI-2012-94
- Other IDs
- 2012-005789-36, E-RES/12/12-Q13
- Status last verified
- Sep 2013
- First submitted
- 31 Jan 2013
- Last updated
- 19 Sep 2013
- Results posted
- No
- Data monitoring committee
- No
Publications
De Backer J, Van Holsbeke C, Vos W, Vinchurkar S, Dorinsky P, Rebello J, Mangale M, Hajian B, De Backer W. Assessment of lung deposition and analysis of the effect of fluticasone/salmeterol hydrofluoroalkane (HFA) pressurized metered dose inhaler (pMDI) in stable persistent asthma patients using functional respiratory imaging. Expert Rev Respir Med. 2016 Aug;10(8):927-33. doi: 10.1080/17476348.2016.1192464. Epub 2016 Jun 1.
PubMed 27227384
Study at a glance
From the registry record, last updated by the sponsor on 19 Sep 2013. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- A Double Blind, Double Dummy, Randomized, Two Way Cross-over Study to Compare the Effects of Seretide® Evohaler (Supplied by Allen & Hanburys, UK) and a Generic Salmeterol/Fluticasone HFA pMDI (Manufactured by Cipla Ltd, India) on Functional Respiratory Imaging Parameters in Asthmatic Patients.
- ClinicalTrials.gov ID
- NCT01795664
- Acronym / sponsor ID
- FLUI-2012-94
- Conditions
- Asthma
- Keywords
- Asthma, Salmeterol xinafoate and Fluticasone propionate, Seretide Evohaler, Functional Respiratory Imaging, Computational Fluid Dynamic
- Phase
- Phase 3
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 16 participants (actual)
- Lead sponsor
- FLUIDDA nvIndustry (pharma, biotech, devices)
- Study start
- Mar 2013
- Primary completion
- Aug 2013 (actual)
- Study completion
- Aug 2013 (actual)
- First posted
- 21 Feb 2013 (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.
This study will be conducted as a randomized, double blind, double dummy two period crossover study in stable asthma patients. A total of 16 stable asthma patients treated in accordance with the Global Initiative for Asthma (GINA) guidelines, will be included.
Objectives:
- The primary objective of this study is to evaluate the effect of both the study drugs under investigation on Functional Respiratory Imaging (FRI) parameters and to evaluate the particle deposition in the lungs using Computational Fluid Dynamic (CFD)
- The secondary objectives are to assess the effect of both the study drugs on lung function (spirometry and body plethysmography), on exercise capacity (6 Minutes Walking Test = 6MWT) and on dyspnea (Borg Category (C) Ratio (R) 10 Scale and Visual Analog Scale (VAS) dyspnea). Furthermore the safety of the 2 products under investigation will be evaluated through monitoring of adverse events (AEs) throughout the study.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Crossover
- Masking
- Triple blind (participant, care provider, investigator)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Seretide Evohaler | Active comparator | Radiation: Functional Respiratory Imaging, Drug: Seretide Evohaler, Drug: Placebo of Test productSalmeterol xinafoate and Fluticasone propionate combination HFA pMDI (Seretide Evohaler, Allen \& Hanburys, UK) Strength: 25/250 mcg per actuation; Dose: single dose of 2 puffs; a total dose of 50/500 mcg |
| Salmeterol xinafoate and Fluticasone propionate HFA pMDI | Experimental | Radiation: Functional Respiratory Imaging, Drug: Salmeterol xinafoate and Fluticasone propionate HFA pMDI, Drug: Placebo of Reference productSalmeterol xinafoate and Fluticasone propionate combination HFA pMDI (Cipla Ltd., India) Strength: 25/250 mcg per actuation; Dose: single dose of 2 puffs; a total dose of 50/500 mcg |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (8 listed)
- Male or female patient ≥ 18 years old
- Written informed consent obtained
- Patient with a documented diagnosis of asthma according to the GINA guidelines
- Patient with a co-operative attitude and ability to be trained to correctly use the pMDI
- Female patient of childbearing potential who confirm that a contraception method was used at least 14 days before visit 1 and will continue to use a contraception method during the study
Key exclusion criteria (13 listed)
- Pregnant or lactating female
- Unstable patient who developed an exacerbation during the last 8 weeks
- Patient with upper or lower airways infection
- Patient unable to carry out pulmonary function testing
- Patient with an uncontrolled disease or any condition that might, in the judgement of the investigator, place the patient at undue risk or potentially compromise the results or interpretation 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 |
|---|---|---|
| Functional Respiratory ImagingCT-scan of thorax, at visit 2 pre and postdose and at visit 3 pre and postdose | Radiation | Salmeterol xinafoate and Fluticasone propionate HFA pMDI, Seretide Evohaler |
| Salmeterol xinafoate and Fluticasone propionate HFA pMDIAlso: Test productStrength: 25/250 mcg per actuation; Dose: single dose of 2 puffs; A total dose of 50/500 mcg At visit 2 or visit 3 (cross-over design) | Drug | Salmeterol xinafoate and Fluticasone propionate HFA pMDI |
| Seretide EvohalerAlso: Reference product, Salmeterol xinafoate and Fluticasone propionate combination HFA pMDIStrength: 25/250 mcg per actuation; Dose: single dose of 2 puffs; A total dose of 50/500 mcg At visit 2 or visit 3 (cross-over design) | Drug | Seretide Evohaler |
| Placebo of Test productAlso: Placebo inhaler containing HFA propellant resembling the test active inhalerSingle dose of 2 puffs To ensure blinding, each patient will receive two inhalers (one active and one placebo) on each dosing day. | Drug | Seretide Evohaler |
| Placebo of Reference productAlso: Placebo inhaler containing HFA propellant resembling the reference active inhalerSingle dose of 2 puffs To ensure blinding, each patient will receive two inhalers (one active and one placebo) on each dosing day. | Drug | Salmeterol xinafoate and Fluticasone propionate HFA pMDI |
Primary outcome
Total airway volume
Time frame: At visit 2 (= 7-11 days after visit 1)
The primary objective of this study is to evaluate the effect of both the study drugs under investigation on Functional Respiratory Imaging (FRI) parameters and to evaluate the particle deposition in the lungs using Computational Fluid Dynamic (CFD)
The number of deposited particles per pre-defined airway section
Time frame: At visit 2 (= 7-11 days after visit 1)
The primary objective of this study is to evaluate the effect of both the study drugs under investigation on Functional Respiratory Imaging (FRI) parameters and to evaluate the particle deposition in the lungs using Computational Fluid Dynamic (CFD)
Total airway resistance
Time frame: At visit 2 (= 7-11 days after visit 1)
The primary objective of this study is to evaluate the effect of both the study drugs under investigation on Functional Respiratory Imaging (FRI) parameters and to evaluate the particle deposition in the lungs using Computational Fluid Dynamic (CFD)
Total airway volume
Time frame: At visit 3 (= 3-7 days after visit 2)
The primary objective of this study is to evaluate the effect of both the study drugs under investigation on Functional Respiratory Imaging (FRI) parameters and to evaluate the particle deposition in the lungs using Computational Fluid Dynamic (CFD)
The number of deposited particles per pre-defined airway section
Time frame: At visit 3 (= 3-7 days after visit 2)
The primary objective of this study is to evaluate the effect of both the study drugs under investigation on Functional Respiratory Imaging (FRI) parameters and to evaluate the particle deposition in the lungs using Computational Fluid Dynamic (CFD)
Total airway resistance
Time frame: At visit 3 (= 3-7 days after visit 2)
The primary objective of this study is to evaluate the effect of both the study drugs under investigation on Functional Respiratory Imaging (FRI) parameters and to evaluate the particle deposition in the lungs using Computational Fluid Dynamic (CFD)
7 secondary outcomes
Lung function tests (spirometry, body plethysmography)
Time frame: At visit 2 (= 7-11 days after visit 1)
Exercise capacity (6 minutes walking test)
Time frame: At visit 2 (= 7-11 days after visit 1)
Dyspnea (BORG CR 10 scale and VAS dyspnea)
Time frame: At visit 2 (= 7-11 days after visit 1)
Incidence of adverse events
Time frame: From visit 1 until visit 4 = timeperiod of 3 à 4 weeks
Lung function tests (spirometry, body plethysmography)
Time frame: At visit 3 (= 3-7 days after visit 2)
Exercise capacity (6 minutes walking test)
Time frame: At visit 3 (= 3-7 days after visit 2)
Dyspnea (BORG CR 10 scale and VAS dyspnea)
Time frame: At visit 3 (= 3-7 days after visit 2)
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 19 Sep 2013.
- Derived from this study: PubMed 27227384De Backer J, Van Holsbeke C, Vos W, Vinchurkar S, Dorinsky P, Rebello J, Mangale M, Hajian B, De Backer W. Assessment of lung deposition and analysis of the effect of fluticasone/salmeterol hydrofluoroalkane (HFA) pressurized metered dose inhaler (pMDI) in stable persistent asthma patients using functional respiratory imaging. Expert Rev Respir Med. 2016 Aug;10(8):927-33. doi: 10.1080/17476348.2016.1192464. Epub 2016 Jun 1.
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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.
Wilfried De Backer, MD, PhD principal investigator
University Hospital, Antwerp
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 3 study testing Functional Respiratory Imaging, Salmeterol xinafoate and Fluticasone propionate HFA pMDI and Seretide Evohaler in people with Asthma, run by FLUIDDA nv at 1 site in Belgium.
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 13 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 19 Sep 2013. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in Belgium. 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?
Total airway volume (time frame: At visit 2 (= 7-11 days after visit 1)). The study lists 6 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT01795664, which also lists 1 linked publication.
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 19 Sep 2013.