Mild Persistent AsthmaPhase 2NCT02063139

Knemometry Study to Compare the Systemic Safety of Flutiform pMDI, Fluticasone pMDI and Beclometasone Autohaler in Paediatric Subjects Aged 5 to Less Than 12 Years.

A Phase 2 study testing Flutiform 50/5 ug (2 puffs bid) pMDI, Fluticasone 50 ug (2puffs bid) pMDI and Beclometasone Autohaler 50 ug (2 puffs bid) in people with Mild Persistent Asthma, run by Mundipharma Research Limited at 1 site in Denmark.

Completed

Finished. The study has ended and is not enrolling. Results may be posted on the official record.

Official record

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Trial summary

Aim of the study is to investigate the short-term growth in children with asthma aged 5-11 years in treatment with fluticasone propionate / formoterol spray (flutiform®) 200/20 micrograms per day Read more about this study

Who is it for?: Ages 5 to 12 years
Conditions the study is for: Mild Persistent Asthma
What is being tested?: Flutiform 50/5 ug (2 puffs bid) pMDI, Fluticasone 50 ug (2puffs bid) pMDI and Beclometasone Autohaler 50 ug (2 puffs bid)
Could I receive a placebo?: No, everyone receives an active treatment
How many people: 48 participants
Where: 1 siteDenmark
Study dates: Feb 2014to Jan 2015
Phase: Phase 2
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

Subjects to be included in the study are those who meet all of the following criteria:
Male and Female subjects 5 to <12 years old. Female subjects must be pre-menarche to be eligible.
Subjects must be pre-adolescent without any signs of puberty (acc. to Tanner scale).
Subjects are in normal range for their age in height and weight. Weight and height measurements should fall within the percentile range 3-97-% of normal values for age according to Danish growth charts.
Known history of mild intermittent or persistent reversible asthma for ≥ 3 months prior to the screening visit.
Require:

Show all 36Show fewer

only inhaled SABA therapy (e.g. Bricanyl Turbuhaler) on an as required basis, and/or
Regular non-ICS controller medications for asthma (e.g., cromones or leukotriene receptor antagonists) at a stable dose for ≥ 3 months prior to the screening visit.
No ICS for >2 weeks prior to the screening visit.
Demonstrates adequate spirometry technique and able to use a home PEFR meter.
Demonstrated FEV1 of ≥ 80% predicted value at visit 1following appropriate withholding of asthma medications (if applicable) (no SABA use within 6 hours of the PFT).
Demonstrated satisfactory technique in the use of the pMDI plus spacer and Autohaler devices.
Must be continent of urine and willing to perform (with parental/guardian help) overnight urine collections.
Willing and able to complete morning and evening PEFR measures 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 with study medication.
Written informed consent obtained as per national laws.
FEV1 within ≤20% of the visit 1 value following appropriate withholding of rescue medication (no salbutamol Airomir Autohaler use within 6 hours of the PFT).
Rescue medication use on ≤2 days during the last 7 days of the run in period. Exclusion Criteria
Subjects to be excluded from the study are those who meet any of the following criteria:
Require medications other than inhaled SABAs and/or regular non-ICS controller medications (e.g., cromones or leukotriene receptor antagonists) to maintain asthma control.
ICS use within ≤ 2 weeks prior to the screening visit.
Any asthma exacerbation of any severity for at least 3 months prior to the screening visit.
Any fracture in the leg to be measured by knemometry ≤6 months prior to the screening visit.
Any metabolic disorders or other diseases that may impact on normal growth patterns.
Near fatal or life-threatening asthma within the past year.
Hospitalisation or an emergency visit for asthma within the past 6 months.
History of oral or injectable corticosteroid medication ≤3 months prior to the screening visit.
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.
No major surgery requiring general anesthesia for at least 3 months prior to the screening visit.
No febrile illnesses with temperature > 39°C within a week of the screening visit.
In the Investigator's opinion a clinically significant upper or lower respiratory infection within 4 weeks prior to the screening visit.
Significant, non-reversible active pulmonary disease (e.g. cystic fibrosis, bronchiectasis, tuberculosis).
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.
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.

Who cannot join

None listed.

Trial locations and contacts

1 site in 1 country.

Denmark1 site

Asthma and Allergy Children's Clinic
Randers

Other trials in Denmark

About this study

Official title: A Single (Assessor)-Blind, Randomised, Three-period, Cross-over Study to Compare the Safety of Flutiform pMDI, Fluticasone pMDI, and Beclometasone Autohaler in Paediatric Subjects Aged 5 to Less Than 12 Years With Mild Persistent Asthma by Means of Knemometry

Aim of the study is to investigate the short-term growth in children with asthma aged 5-11 years in treatment with fluticasone propionate / formoterol spray (flutiform®) 200/20 micrograms per day

Conditions: Mild Persistent Asthma
Being tested: Flutiform 50/5 ug (2 puffs bid) pMDI, Fluticasone 50 ug (2puffs bid) pMDI, Beclometasone Autohaler 50 ug (2 puffs bid)
Keywords: Knemometry

What participants receive

What participants receive. In a randomised study each person is assigned to one group by chance.

Flutiform 50/5 ug (2 puffs bid) pMDIDrug
Fluticasone 50 ug (2puffs bid) pMDIDrug
Beclometasone Autohaler 50 ug (2 puffs bid)Drug

Study groups in NCT02063139
Study group	Role	What they receive
Flutiform 50/5 ug (2 puffs bid) pMDI	Experimental	Flutiform 50/5 ug (2 puffs bid) pMDI Receives: Drug: Flutiform 50/5 ug (2 puffs bid) pMDI
Fluticasone 50 ug (2puffs bid) pMDI	Active comparator	Fluticasone 50 ug (2puffs bid) pMDI Receives: Drug: Fluticasone 50 ug (2puffs bid) pMDI
Beclometasone Autohaler 50 ug (2 puffs bid)	Other	Active control Receives: Drug: Beclometasone Autohaler 50 ug (2 puffs bid)

What is being measured

The primary outcome is the main question the study is designed to answer.

To show non-inferiority of flutiform pMDI 50/5 µg (2 puffs bid) versus fluticasone pMDI 50 µg (2 puffs bid) based on the mean lower leg growth rates.
Lower leg length will be measured in the afternoon, between 13:00 and 19:00h. Each individual subject will have their knemometry measurements performed at the same time of day (+/- 1 hour).
Measured: Change from baseline in growth rate during the each treatment and washout period which is 2 weeks

Secondary outcomes (1)

To compare the safety of flutiform pMDI 50/5 µg (2 puffs bid) versus fluticasone pMDI 50 µg based on overnight urinary free cortisol (corrected for creatinine).
Subjects will empty their bladder into the toilet before going to bed at night (or no later than at 10pm). This urine will not be collected. This voiding time will be recorded as the start time of the urine collection. Urine passed after this time during the night (if any) and until 8 am in the morning will be collected into a clean container. Subjects will empty their bladders a final time at 8 am in to the container. This voiding time will be recorded as the stop time of the urine collection.
Measured: every two weeks for duration of study which is two months.

Timeline

From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.

Feb 2014Jan 2015

First posted14 Feb 2014 (estimated)
Study startFeb 2014
Primary completionJun 2014
Study completionJan 2015

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 Mild Persistent 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: Single blind
Who is masked: Outcomes assessor
Enrolment: 48 participants (actual)

IDs, dates and publications

ClinicalTrials.gov ID: NCT02063139
Sponsor's protocol ID: FLT2504
Other IDs: 2013-004719-32
Status last verified: Oct 2018
First submitted: 11 Feb 2014
Last updated: 24 Oct 2018
Results posted: No

Publications

Wolthers OD, Mersmann S, Dissanayake S. A Pilot Study of the Normative Range of Overnight Urinary Free Cortisol Corrected for Creatinine in Children. Clin Drug Investig. 2018 Apr;38(4):313-318. doi: 10.1007/s40261-017-0609-x.
PubMed 29256049

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 Single (Assessor)-Blind, Randomised, Three-period, Cross-over Study to Compare the Safety of Flutiform pMDI, Fluticasone pMDI, and Beclometasone Autohaler in Paediatric Subjects Aged 5 to Less Than 12 Years With Mild Persistent Asthma by Means of Knemometry
ClinicalTrials.gov ID: NCT02063139
Acronym / sponsor ID: FLT2504
Conditions: Mild Persistent Asthma
Keywords: Knemometry
Phase: Phase 2
Study type: Interventional
Recruitment status: Completed
Enrolment: 48 participants (actual)
Lead sponsor: Mundipharma Research LimitedIndustry (pharma, biotech, devices)
Study start: Feb 2014
Primary completion: Jun 2014 (actual)
Study completion: Jan 2015 (actual)
First posted: 14 Feb 2014 (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.

Aim of the study is to investigate the short-term growth in children with asthma aged 5-11 years in treatment with fluticasone propionate / formoterol spray (flutiform®) 200/20 micrograms per day

Study design

Primary purpose: Treatment
Allocation: Randomised
Intervention model: Crossover
Masking: Single blind (outcomes assessor)
Number of arms: 3

Arm	Type	Receives
Flutiform 50/5 ug (2 puffs bid) pMDI	Experimental	Drug: Flutiform 50/5 ug (2 puffs bid) pMDIFlutiform 50/5 ug (2 puffs bid) pMDI
Fluticasone 50 ug (2puffs bid) pMDI	Active comparator	Drug: Fluticasone 50 ug (2puffs bid) pMDIFluticasone 50 ug (2puffs bid) pMDI
Beclometasone Autohaler 50 ug (2 puffs bid)	Other	Drug: Beclometasone Autohaler 50 ug (2 puffs bid)Active control

Who may qualify

Ages: 5 to 12 years
Sex: All
Healthy volunteers: Not accepted
Age groups: Child

Key inclusion criteria (36 listed)

Male and Female subjects 5 to <12 years old. Female subjects must be pre-menarche to be eligible.
Subjects must be pre-adolescent without any signs of puberty (acc. to Tanner scale).
Subjects are in normal range for their age in height and weight. Weight and height measurements should fall within the percentile range 3-97-% of normal values for age according to Danish growth charts.
Known history of mild intermittent or persistent reversible asthma for ≥ 3 months prior to the screening visit.
Require:

Key exclusion criteria (0 listed)

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
Flutiform 50/5 ug (2 puffs bid) pMDI	Drug	Flutiform 50/5 ug (2 puffs bid) pMDI
Fluticasone 50 ug (2puffs bid) pMDI	Drug	Fluticasone 50 ug (2puffs bid) pMDI
Beclometasone Autohaler 50 ug (2 puffs bid)	Drug	Beclometasone Autohaler 50 ug (2 puffs bid)

Primary outcome

To show non-inferiority of flutiform pMDI 50/5 µg (2 puffs bid) versus fluticasone pMDI 50 µg (2 puffs bid) based on the mean lower leg growth rates.
Time frame: Change from baseline in growth rate during the each treatment and washout period which is 2 weeks
Lower leg length will be measured in the afternoon, between 13:00 and 19:00h. Each individual subject will have their knemometry measurements performed at the same time of day (+/- 1 hour).

1 secondary outcome

To compare the safety of flutiform pMDI 50/5 µg (2 puffs bid) versus fluticasone pMDI 50 µg based on overnight urinary free cortisol (corrected for creatinine).
Time frame: every two weeks for duration of study which is two months.

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.
Derived from this study: PubMed 29256049Wolthers OD, Mersmann S, Dissanayake S. A Pilot Study of the Normative Range of Overnight Urinary Free Cortisol Corrected for Creatinine in Children. Clin Drug Investig. 2018 Apr;38(4):313-318. doi: 10.1007/s40261-017-0609-x.
Results available on registerLink provided by the sponsor.

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.

1 site in 1 country: see every site and its status.

Questions about this trial

What is this clinical trial studying?

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 36 inclusion and 0 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 1 site in Denmark. 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?

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 non-inferiority of flutiform pMDI 50/5 µg (2 puffs bid) versus fluticasone pMDI 50 µg (2 puffs bid) based on the mean lower leg growth rates. (time frame: Change from baseline in growth rate during the each treatment and washout period which is 2 weeks). 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 NCT02063139, 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 24 Oct 2018.