AsthmaPhase 2NCT01615874
Study of the Effect of Mometasone Furoate/Formoterol (MF/F), Montelukast and Beclomethasone Dipropionate (BDP) on Plasma Cortisol Levels of Children 5-11 Years Old With Persistent Asthma (P05574)
A Phase 2 study testing MF/F Metered Dose Inhaler (MDI) 25/5 mcg, MF/F MDI 50/5 mcg and MF/F MDI 100/5 mcg in people with Asthma, run by Organon and Co.
Trial summary
The purpose of this study is to assess the effect of one of five possible study medications used in the treatment of asthma on blood plasma cortisol levels in children aged 5-11 years with persistent asthma. Read more about this study
- Who is it for?
- Ages 5 to 11 years
- Conditions the study is for
- Asthma
- What is being tested?
- MF/F Metered Dose Inhaler (MDI) 25/5 mcg, MF/F MDI 50/5 mcg and MF/F MDI 100/5 mcg
- Type of treatment
- Pill or oral medicine
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 0 participants
- Where
- No sites listed yet
- Study dates
- Jan 2013to Sep 2013
- 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 11 years
- All sexes
- No healthy volunteers
- Child
Who may be able to join
- diagnosis of persistent asthma of ≥6 months duration
- body weight ≥18 kg
- able to discontinue prescribed inhaled corticosteroid (ICS) or ICS combined with long-acting beta-agonist (LABA) before starting study medication
- use of a low or medium daily dose of ICS (either alone or in combination with a LABA) with no use of oral corticosteroids within 3 months prior to Screening Visit
- stable asthma regimen (daily dose unchanged) for ≥2 weeks prior to Screening Visit
- documented positive responsiveness to bronchodilators
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- ability to use a peak flow meter correctly and to perform spirometry and PEF measurements
- ability to use an inhaler correctly
- consent/assent for the trial and for pharmacogenetic testing (Note: If unwilling to consent/assent for pharmacogenetic testing, inclusion in the study is still allowed, but no pharmacogenetic samples will be obtained.)
Who cannot join
- use of a high dose of ICS for ≥30 days within 6 months prior to Screening Visit
- treatment in the emergency room (for a severe asthma exacerbation requiring systemic corticosteroid treatment) or hospitalization for management of airway obstruction within 3 months prior to Screening Visit
- ever required ventilator support for respiratory failure secondary to asthma
- upper or lower respiratory tract infection (viral or bacterial) within 2 weeks prior to Screening Visit
- clinically significant abnormal vital sign
- evidence of oropharyngeal candidiasis
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- history of clinically significant renal, hepatic, cardiovascular, metabolic, neurologic, hematologic, ophthalmologic, respiratory, gastrointestinal, cerebrovascular, or other significant medical illness or disorder that may interfere with study participation. Specific examples include but are not limited to insulin-dependent diabetes, active hepatitis, cardiovascular disease including hypertension, or conditions that may interfere with respiratory function such as, bronchiectasis, and cystic fibrosis
- allergy to or intolerance of corticoids, beta-2 agonists, montelukast or any of the inactive ingredients in the medications used in this study
- participation in this same study at another study site
- previous randomization into this study
- participation in another investigational study for the duration of this study
- use of any investigational drug within one month prior to Screening Visit
- previous participation in a study with MF/F or montelukast
- direct association with or family member of one of the investigators or study staff
- sibling of a participant in this study
About this study
Official title: A Six-week Evaluator-Blind, Randomized, Active-Controlled Evaluation of the Effects of Three Doses of Mometasone Furoate/Formoterol Fumarate (MF/F) Metered Dose Inhaler (MDI), Montelukast, and Beclomethasone Dipropionate (BDP HFA) on the HPA Axis in Asthmatic Children 5 to 11 Years of Age (Protocol No. P05574/PN158)
The purpose of this study is to assess the effect of one of five possible study medications used in the treatment of asthma on blood plasma cortisol levels in children aged 5-11 years with persistent asthma.
- Conditions
- Asthma
- Being tested
- MF/F Metered Dose Inhaler (MDI) 25/5 mcg, MF/F MDI 50/5 mcg, MF/F MDI 100/5 mcg, BDP hydrofluoroalkane (HFA) 80 mcg, Montelukast tablets 5 mg (4 mg for children 5 years of age)
- Medical subject headings
- Asthma
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
MF/F Metered Dose Inhaler (MDI) 25/5 mcgDrug
Also called SCH 418131, MK-0887A, DULERA®
MF/F MDI 25/5 mcg, 2 inhalations twice a day (BID)
MF/F MDI 50/5 mcgDrug
Also called SCH 418131, MK-0887A, DULERA®
MF/F MDI 50/5 mcg, 2 inhalations BID
MF/F MDI 100/5 mcgDrug
Also called SCH 418131, MK-0887A, DULERA®
MF/F MDI 100/5 mcg, 2 inhalations BID
BDP hydrofluoroalkane (HFA) 80 mcgDrug
Also called BECONASE AQ®, QVAR®
BDP HFA 80 mcg, 2 inhalations BID
Montelukast tablets 5 mg (4 mg for children 5 years of age)Drug
Also called MK-0476, SINGULAIR®
Montelukast chewable tablets 5 mg once daily (QD) for children 6-11 years of age
OR
Montelukast chewable tablets 4 mg QD for children 5 years of age
Rescue medication: short-acting beta-2 agonist (SABA) MDIDrug
albuterol MDI 90 mcg OR or salbutamol HFA MDI 100 mcg for rescue medication, taken as directed
Rescue medication: Prednisone/PrednisoloneDrug
Prednisone/Prednisolone for rescue medication, taken as directed
| Study group | Role | What they receive |
|---|---|---|
| MF/F MDI 50/10 mcg BID | Experimental | Not described Receives: Drug: MF/F Metered Dose Inhaler (MDI) 25/5 mcg; Drug: Rescue medication: short-acting beta-2 agonist (SABA) MDI; Drug: Rescue medication: Prednisone/Prednisolone |
| MF/F MDI 100/10 mcg BID | Experimental | Not described Receives: Drug: MF/F MDI 50/5 mcg; Drug: Rescue medication: short-acting beta-2 agonist (SABA) MDI; Drug: Rescue medication: Prednisone/Prednisolone |
| MF/F MDI 200/10 mcg BID | Experimental | Not described Receives: Drug: MF/F MDI 100/5 mcg; Drug: Rescue medication: short-acting beta-2 agonist (SABA) MDI; Drug: Rescue medication: Prednisone/Prednisolone |
| BDP HFA 160 mcg BID | Active comparator | Not described Receives: Drug: BDP hydrofluoroalkane (HFA) 80 mcg; Drug: Rescue medication: short-acting beta-2 agonist (SABA) MDI; Drug: Rescue medication: Prednisone/Prednisolone |
| Montelukast 5 mg QD (4 mg QD for 5-year-olds) | Active comparator | Not described Receives: Drug: Montelukast tablets 5 mg (4 mg for children 5 years of age); Drug: Rescue medication: short-acting beta-2 agonist (SABA) MDI; Drug: Rescue medication: Prednisone/Prednisolone |
What is being measured
The primary outcome is the main question the study is designed to answer.
Change from Baseline in Plasma Cortisol Area Under the Curve (AUC) 0-24 hrs
Measured: Baseline (Day 1) and Day 42
Secondary outcomes (1)
Change from Baseline in Plasma Cortisol Trough Concentration (Ctrough)
Measured: Baseline (Day 1) and Day 42
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted11 Jun 2012 (estimated)
- Study startJan 2013
- Primary completionSep 2013 (estimated)
- Study completionSep 2013 (estimated)
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 2
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Single blind
- Who is masked
- Investigator
- Enrolment
- 0 participants (actual)
Sponsor and investigators
- Lead sponsor
- Organon and Co
- Sponsor type
- Industry (pharma, biotech, devices)
- Responsible party
- Sponsor
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT01615874
- Sponsor's protocol ID
- P05574
- Other IDs
- 2009-010108-27, 2009
- Status last verified
- Feb 2022
- First submitted
- 7 Jun 2012
- Last updated
- 16 Feb 2022
- Results posted
- No
- Data monitoring committee
- No
Study at a glance
From the registry record, last updated by the sponsor on 16 Feb 2022. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- A Six-week Evaluator-Blind, Randomized, Active-Controlled Evaluation of the Effects of Three Doses of Mometasone Furoate/Formoterol Fumarate (MF/F) Metered Dose Inhaler (MDI), Montelukast, and Beclomethasone Dipropionate (BDP HFA) on the HPA Axis in Asthmatic Children 5 to 11 Years of Age (Protocol No. P05574/PN158)
- ClinicalTrials.gov ID
- NCT01615874
- Acronym / sponsor ID
- P05574
- Conditions
- Asthma
- Phase
- Phase 2
- Study type
- Interventional
- Recruitment status
- Withdrawn
- Enrolment
- 0 participants (actual)
- Lead sponsor
- Organon and CoIndustry (pharma, biotech, devices)
- Study start
- Jan 2013
- Primary completion
- Sep 2013 (estimated)
- Study completion
- Sep 2013 (estimated)
- First posted
- 11 Jun 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.
The purpose of this study is to assess the effect of one of five possible study medications used in the treatment of asthma on blood plasma cortisol levels in children aged 5-11 years with persistent asthma.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Single blind (investigator)
- Number of arms
- 5
| Arm | Type | Receives |
|---|---|---|
| MF/F MDI 50/10 mcg BID | Experimental | Drug: MF/F Metered Dose Inhaler (MDI) 25/5 mcg, Drug: Rescue medication: short-acting beta-2 agonist (SABA) MDI, Drug: Rescue medication: Prednisone/Prednisolone |
| MF/F MDI 100/10 mcg BID | Experimental | Drug: MF/F MDI 50/5 mcg, Drug: Rescue medication: short-acting beta-2 agonist (SABA) MDI, Drug: Rescue medication: Prednisone/Prednisolone |
| MF/F MDI 200/10 mcg BID | Experimental | Drug: MF/F MDI 100/5 mcg, Drug: Rescue medication: short-acting beta-2 agonist (SABA) MDI, Drug: Rescue medication: Prednisone/Prednisolone |
| BDP HFA 160 mcg BID | Active comparator | Drug: BDP hydrofluoroalkane (HFA) 80 mcg, Drug: Rescue medication: short-acting beta-2 agonist (SABA) MDI, Drug: Rescue medication: Prednisone/Prednisolone |
| Montelukast 5 mg QD (4 mg QD for 5-year-olds) | Active comparator | Drug: Montelukast tablets 5 mg (4 mg for children 5 years of age), Drug: Rescue medication: short-acting beta-2 agonist (SABA) MDI, Drug: Rescue medication: Prednisone/Prednisolone |
Who may qualify
- Ages
- 5 to 11 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Child
Key inclusion criteria (9 listed)
- diagnosis of persistent asthma of ≥6 months duration
- body weight ≥18 kg
- able to discontinue prescribed inhaled corticosteroid (ICS) or ICS combined with long-acting beta-agonist (LABA) before starting study medication
- use of a low or medium daily dose of ICS (either alone or in combination with a LABA) with no use of oral corticosteroids within 3 months prior to Screening Visit
- stable asthma regimen (daily dose unchanged) for ≥2 weeks prior to Screening Visit
Key exclusion criteria (15 listed)
- use of a high dose of ICS for ≥30 days within 6 months prior to Screening Visit
- treatment in the emergency room (for a severe asthma exacerbation requiring systemic corticosteroid treatment) or hospitalization for management of airway obstruction within 3 months prior to Screening Visit
- ever required ventilator support for respiratory failure secondary to asthma
- upper or lower respiratory tract infection (viral or bacterial) within 2 weeks prior to Screening Visit
- clinically significant abnormal vital sign
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 |
|---|---|---|
| MF/F Metered Dose Inhaler (MDI) 25/5 mcgAlso: SCH 418131, MK-0887A, DULERA®MF/F MDI 25/5 mcg, 2 inhalations twice a day (BID) | Drug | MF/F MDI 50/10 mcg BID |
| MF/F MDI 50/5 mcgAlso: SCH 418131, MK-0887A, DULERA®MF/F MDI 50/5 mcg, 2 inhalations BID | Drug | MF/F MDI 100/10 mcg BID |
| MF/F MDI 100/5 mcgAlso: SCH 418131, MK-0887A, DULERA®MF/F MDI 100/5 mcg, 2 inhalations BID | Drug | MF/F MDI 200/10 mcg BID |
| BDP hydrofluoroalkane (HFA) 80 mcgAlso: BECONASE AQ®, QVAR®BDP HFA 80 mcg, 2 inhalations BID | Drug | BDP HFA 160 mcg BID |
| Montelukast tablets 5 mg (4 mg for children 5 years of age)Also: MK-0476, SINGULAIR®Montelukast chewable tablets 5 mg once daily (QD) for children 6-11 years of age OR Montelukast chewable tablets 4 mg QD for children 5 years of age | Drug | Montelukast 5 mg QD (4 mg QD for 5-year-olds) |
| Rescue medication: short-acting beta-2 agonist (SABA) MDIalbuterol MDI 90 mcg OR or salbutamol HFA MDI 100 mcg for rescue medication, taken as directed | Drug | BDP HFA 160 mcg BID, MF/F MDI 100/10 mcg BID, MF/F MDI 200/10 mcg BID, MF/F MDI 50/10 mcg BID, Montelukast 5 mg QD (4 mg QD for 5-year-olds) |
| Rescue medication: Prednisone/PrednisolonePrednisone/Prednisolone for rescue medication, taken as directed | Drug | BDP HFA 160 mcg BID, MF/F MDI 100/10 mcg BID, MF/F MDI 200/10 mcg BID, MF/F MDI 50/10 mcg BID, Montelukast 5 mg QD (4 mg QD for 5-year-olds) |
Primary outcome
Change from Baseline in Plasma Cortisol Area Under the Curve (AUC) 0-24 hrs
Time frame: Baseline (Day 1) and Day 42
1 secondary outcome
Change from Baseline in Plasma Cortisol Trough Concentration (Ctrough)
Time frame: Baseline (Day 1) and Day 42
Results and safety
The study was withdrawn before enrolling participants, so there are no results.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 16 Feb 2022.
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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.
Questions about this trial
What is this clinical trial studying?
A Phase 2 study testing MF/F Metered Dose Inhaler (MDI) 25/5 mcg, MF/F MDI 50/5 mcg and MF/F MDI 100/5 mcg in people with Asthma, run by Organon and Co.
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 9 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: withdrawn, as of the sponsor's last update on 16 Feb 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. 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 was withdrawn before enrolling participants, so there are no results.
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?
Change from Baseline in Plasma Cortisol Area Under the Curve (AUC) 0-24 hrs (time frame: Baseline (Day 1) and Day 42). 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 16 Feb 2022.