AsthmaPhase 3NCT01511367
Comparison of Flutiform, Fluticasone and Seretide in Treatment of Moderate to Severe Asthma in Paediatric Patients
A Phase 3 study testing Flutiform, Seretide and Flixotide in people with Asthma, run by Mundipharma Research Limited at 8 sites in 8 countries.
Trial summary
This is a comparator study to assess safety and efficacy of Flutiform compared with Fluticasone pMDI and Seretide pMDI in paediatric asthma patients with moderate to severe persistent, reversible asthma. Read more about this study
- Who is it for?
- Ages 5 to 12 years
- Conditions the study is for
- Asthma
- What is being tested?
- Flutiform, Seretide and Flixotide
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 498 participants
- Where
- 8 sitesin 8 countries
- Study dates
- Mar 2012to Nov 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 5 to 12 years
- All sexes
- No healthy volunteers
- Child
Who may be able to join
- Male and Female subjects 5 to <12 years old.
- Known history of moderate to severe persistent reversible asthma1 for ≥ 6 months prior to the screening visit.
- Demonstrated FEV1 of ≥ 60% to ≤ 90% for predicted normal values (Polgar 1971) during the screening period following appropriate withholding of asthma medications (if applicable):
- No LABA use within 12 hours and/or no SABA use within 6 hours of the PFT
- No use of inhaled ICS-LABA asthma therapy within 12 hours of the PFT
- Inhaled corticosteroids are allowed on the day of screening
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- Documented reversibility of ≥ 15% in FEV1 in the screening period
- Current use of an inhaled corticosteroid for asthma at a stable dose for at least 4 weeks prior to the screening visit
- Inadequate asthma control on an ICS alone at a dose of ≤ 500 µg fluticasone equivalents/day, OR controlled asthma on an ICS-LABA combination at a ICS dose of ≤ 200 µg fluticasone equivalents/day
- Demonstrated satisfactory technique in the use of the pMDI and spacer device
- Can perform spirometry adequately
- Willing and able to enter information in the electronic diary with the help of a parent or guardian, if necessary and attend all study visits
- Willing and able to substitute pre-study prescribed inhaled asthma medication for the entire duration of the study
- If a female subject is post menarche a urine pregnancy test may be undertaken at the discretion of the investigator and the subjects' parent(s) /legal representative. This test must be negative.
- Written informed consent and assent obtained as per national law
Who cannot join
- Near fatal or life-threatening (including intubation) asthma within the past year
- Hospitalisation or an emergency visit for asthma within the past 6 months
- History of systemic (injectable or oral) corticosteroid medication within 1 month of the screening visit
- Current or prior non-response or partial response only to an ICS-LABA combination1
- Evidence of a clinically unstable disease, as determined by medical history, clinical laboratory tests, and physical examination that, in the Investigator's opinion, preclude entry into the study. "Clinically significant" is defined as any disease that, in the opinion of the Investigator, would put the subject at risk through study participation, or which would affect the outcome of the study
- In the Investigator's opinion a clinically significant upper or lower respiratory infection within 4 weeks prior to the screening visit
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- Significant, non-reversible active pulmonary disease (e.g. cystic fibrosis, bronchiecstasis, tuberculosis)
- Known Human Immunodeficiency Virus (HIV)-positive status
- Current smoking history within 12 months prior to the screening visit
- Current evidence of alcohol or substance abuse within 12 months prior to the screening visit
- Subjects who have taken β- blocking agents, tricyclic antidepressants, monoamine oxidase inhibitors, astemizole (Hismanal), quinidine type antiarrythmics, or potent CYP 3A4 inhibitors such as ketoconazole within 1 week prior to the screening visit
- Current use of medications, other than those allowed in the protocol, that in the investigator's opinion will have an effect on bronchospasm and/or pulmonary function
- Current evidence of hypersensitivity or idiosyncratic reaction to test medications or components
- Receipt of an Investigational medicinal product within 30 days of the screening visit
- Current participation in a clinical study
Trial locations and contacts
8 sites in 8 countries.
8 sites in 8 countries
About this study
Official title: A Double-blind, Double Dummy, Randomised, Parallel Group, Multicentre Study to Compare the Efficacy and Safety of Flutiform pMDI With Fluticasone pMDI and With Seretide pMDI in Paediatric Subjects Aged 5 to Less Than 12 Years With Moderate to Severe Persistent Reversible Asthma
This is a comparator study to assess safety and efficacy of Flutiform compared with Fluticasone pMDI and Seretide pMDI in paediatric asthma patients with moderate to severe persistent, reversible asthma.
Read the detailed description
This is a study involving a 2-4 week run-in phase followed by a 12 week double blind treatment phase. During the run-in phase, all subjects receive Flixotide. In the treatment phase subjects will be randomised to one of the 3 treatment groups and will receive active Flutiform and placebo Flixotide or Active Seretide and placebo Flixotide or active Flixotide and either placebo seretide or placebo Flutiform. Efficacy will be assessed by lung function tests, asthma symptoms, sleep disturbance due to asthma and rescue medication use. Safety will be assessed by adverse events, lab tests, urinary cortisol and vital signs.
- Conditions
- Asthma
- Being tested
- Flutiform, Seretide, Flixotide
- Keywords
- moderate to severe persistent reversible asthma
- Medical subject headings
- Asthma
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
FlutiformDrug
50/5ug (fluticasone/formoterol) 2 puffs twice daily
SeretideDrug
50/25 ug (fluticasone/salmeterol) 2 puffs twice daily
FlixotideDrug
50ug 2 puffs twice daily
| Study group | Role | What they receive |
|---|---|---|
| Flutiform | Active comparator | Not described Receives: Drug: Flutiform |
| Seretide | Active comparator | Not described Receives: Drug: Seretide |
| Flixotide | Active comparator | Not described Receives: Drug: Flixotide |
What is being measured
The primary outcome is the main question the study is designed to answer.
To show superiority in the efficacy of Flutiform pMDI 50/5μg (2 puffs bid) versus fluticasone pMDI 50 μg (2 puffs bid).
Change from pre-dose Forced Expiratory Volume in one second (FEV1) in litres at baseline to 2 hours post-dose FEV1 at the end of the 12 week treatment period.
Measured: 12 weeks
Secondary outcomes (1)
Show non-inferiority in the efficacy of Flutiform to Seretide
Change from pre-dose FEV1 at baseline to 2 hours post-dose FEV1 at Day 1 and FEV1 AUC0-4 at Day 1 and Week 12 (Flutiform vs Seretide)
Measured: 12 weeks
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted18 Jan 2012 (estimated)
- Study startMar 2012
- Primary completionSep 2013
- Study completionNov 2013
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
- Randomised
- Intervention model
- Parallel groups
- Masking
- Quadruple blind
- Who is masked
- Participant, Care provider, Investigator, Outcomes assessor
- Enrolment
- 498 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Mundipharma Research Limited
- Sponsor type
- Industry (pharma, biotech, devices)
- Responsible party
- Sponsor
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT01511367
- Sponsor's protocol ID
- FLT3506
- Other IDs
- 2010-024635-16
- Status last verified
- Oct 2018
- First submitted
- 7 Dec 2011
- Last updated
- 24 Oct 2018
- Results posted
- No
Study at a glance
From the registry record, last updated by the sponsor on 24 Oct 2018. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- A Double-blind, Double Dummy, Randomised, Parallel Group, Multicentre Study to Compare the Efficacy and Safety of Flutiform pMDI With Fluticasone pMDI and With Seretide pMDI in Paediatric Subjects Aged 5 to Less Than 12 Years With Moderate to Severe Persistent Reversible Asthma
- ClinicalTrials.gov ID
- NCT01511367
- Acronym / sponsor ID
- FLT3506
- Conditions
- Asthma
- Keywords
- moderate to severe persistent reversible asthma
- Phase
- Phase 3
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 498 participants (estimated)
- Lead sponsor
- Mundipharma Research LimitedIndustry (pharma, biotech, devices)
- Study start
- Mar 2012
- Primary completion
- Sep 2013 (actual)
- Study completion
- Nov 2013 (actual)
- First posted
- 18 Jan 2012 (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 is a comparator study to assess safety and efficacy of Flutiform compared with Fluticasone pMDI and Seretide pMDI in paediatric asthma patients with moderate to severe persistent, reversible asthma.
Detailed description
This is a study involving a 2-4 week run-in phase followed by a 12 week double blind treatment phase. During the run-in phase, all subjects receive Flixotide. In the treatment phase subjects will be randomised to one of the 3 treatment groups and will receive active Flutiform and placebo Flixotide or Active Seretide and placebo Flixotide or active Flixotide and either placebo seretide or placebo Flutiform. Efficacy will be assessed by lung function tests, asthma symptoms, sleep disturbance due to asthma and rescue medication use. Safety will be assessed by adverse events, lab tests, urinary cortisol and vital signs.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Quadruple blind (participant, care provider, investigator, outcomes assessor)
- Number of arms
- 3
| Arm | Type | Receives |
|---|---|---|
| Flutiform | Active comparator | Drug: Flutiform |
| Seretide | Active comparator | Drug: Seretide |
| Flixotide | Active comparator | Drug: Flixotide |
Who may qualify
- Ages
- 5 to 12 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Child
Key inclusion criteria (15 listed)
- Male and Female subjects 5 to <12 years old.
- Known history of moderate to severe persistent reversible asthma1 for ≥ 6 months prior to the screening visit.
- Demonstrated FEV1 of ≥ 60% to ≤ 90% for predicted normal values (Polgar 1971) during the screening period following appropriate withholding of asthma medications (if applicable):
- Documented reversibility of ≥ 15% in FEV1 in the screening period
- Current use of an inhaled corticosteroid for asthma at a stable dose for at least 4 weeks prior to the screening visit
Key exclusion criteria (15 listed)
- Near fatal or life-threatening (including intubation) asthma within the past year
- Hospitalisation or an emergency visit for asthma within the past 6 months
- History of systemic (injectable or oral) corticosteroid medication within 1 month of the screening visit
- Current or prior non-response or partial response only to an ICS-LABA combination1
- Evidence of a clinically unstable disease, as determined by medical history, clinical laboratory tests, and physical examination that, in the Investigator's opinion, preclude entry into the study. "Clinically significant" is defined as any disease that, in the opinion of the Investigator, would put the subject at risk through study participation, or which would affect the outcome 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 |
|---|---|---|
| Flutiform50/5ug (fluticasone/formoterol) 2 puffs twice daily | Drug | Flutiform |
| Seretide50/25 ug (fluticasone/salmeterol) 2 puffs twice daily | Drug | Seretide |
| Flixotide50ug 2 puffs twice daily | Drug | Flixotide |
Primary outcome
To show superiority in the efficacy of Flutiform pMDI 50/5μg (2 puffs bid) versus fluticasone pMDI 50 μg (2 puffs bid).
Time frame: 12 weeks
Change from pre-dose Forced Expiratory Volume in one second (FEV1) in litres at baseline to 2 hours post-dose FEV1 at the end of the 12 week treatment period.
1 secondary outcome
Show non-inferiority in the efficacy of Flutiform to Seretide
Time frame: 12 weeks
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 24 Oct 2018.
- Link to ResultsLink provided by the sponsor.
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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.
8 sites in 8 countries: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 3 study testing Flutiform, Seretide and Flixotide in people with Asthma, run by Mundipharma Research Limited at 8 sites in 8 countries.
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 15 inclusion and 15 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 24 Oct 2018. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 8 sites in Bulgaria, Czechia, Hungary, India, Poland and 3 more countries. 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?
To show superiority in the efficacy of Flutiform pMDI 50/5μg (2 puffs bid) versus fluticasone pMDI 50 μg (2 puffs bid). (time frame: 12 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 24 Oct 2018.