AsthmaPhase 4SPIRONCT01471340
A Serious Asthma Outcome Study With Mometasone Furoate/Formoterol Versus Mometasone Furoate in Asthmatics 12 Years and Over (P06241)
A Phase 4 study testing Mometasone Furoate/Formoterol MDI 100/5 mcg, Mometasone Furoate/Formoterol MDI 200/5 mcg and Mometasone Furoate MDI 100 mcg in people with Asthma, run by Organon and Co.
Trial summary
The purpose of this study is to test the safety of DULERA. DULERA is a pressurized metered-dose inhaler (MDI) that contains two drugs combined, namely mometasone and formoterol in a single inhaler. Mometasone is an inhaled corticosteroid (ICS), which reduces the inflammation in the airways. Read more about this study
- Who is it for?
- Ages 12 years and older
- Conditions the study is for
- Asthma
- What is being tested?
- Mometasone Furoate/Formoterol MDI 100/5 mcg, Mometasone Furoate/Formoterol MDI 200/5 mcg and Mometasone Furoate MDI 100 mcg
- Type of treatment
- Pill or oral medicine
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 11,744 participants
- Where
- No sites listed yet
- Study dates
- 9 Jan 2012to 30 Nov 2016
- Phase
- Phase 4
- Are there results?
- Yes, posted in the registrySummary in the doctors' view
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 12 years and older
- All sexes
- No healthy volunteers
- Child, Adult, Older adult
Who may be able to join
- Persistent asthma for at least 1-year
- Must use a daily asthma controller medication for at least 4 weeks prior to randomization, including an inhaled corticosteroid (ICS) with or without a long-acting beta agonist (LABA) or other adjunctive asthma therapy OR be using a leukotriene receptor antagonist (LTRA), xanthine or short acting beta agonist (SABA) as a monotherapy.
- Must be able to discontinue current asthma medication
- Must have a history of at least one asthma exacerbation in previous 4 to 52 weeks
Who cannot join
- Unstable asthma
- Taking high dose ICS with or without other adjunctive therapy who have an Asthma Control Questionnaire 6 (ACQ6) total score ≥ 1.5
- Taking LTRA, xanthine or SABA monotherapy with an ACQ-6 total score < 1.5 (controlled)
- Chronic obstructive pulmonary disease (COPD), cystic fibrosis (CF), or other significant, non-asthmatic, lung disease
- Clinically significant abnormality, illness or disorder of any body or organ system
- Significant underlying cardiovascular condition which may contraindicate use of a beta-agonist.
Show all 14Show fewer
- History of smoking greater than 10-pack years
- Had an asthma exacerbation within 4 weeks of the Baseline Visit
- Had more than 4 asthma exacerbations or 2 hospitalizations within 52 weeks of the randomization visit
- Known or suspected hypersensitivity or intolerance to corticosteroids, beta-2 agonists, or any of the (inactive ingredients) excipients present in the medications used in this study
- Require the use of chronic systemic steroids, omalizumab, or other monoclonal or polyclonal antibodies
- Requires the use of beta-blockers
- History of life-threatening asthma, including an asthma episode that required intubation and/or was associated with hypercapnia requiring noninvasive ventilatory support
- Lactating, pregnant, or plans to become pregnant during the course of the trial
About this study
Official title: A 26-Week Randomized, Double-Blinded, Active Controlled Study Comparing the Safety of Mometasone Furoate/Formoterol Fumarate MDI Fixed Dose Combination Versus Mometasone Furoate MDI Monotherapy in Adolescents and Adults With Persistent Asthma (Protocol No. P06241 Also Known as P202)
The purpose of this study is to test the safety of DULERA. DULERA is a pressurized metered-dose inhaler (MDI) that contains two drugs combined, namely mometasone and formoterol in a single inhaler. Mometasone is an inhaled corticosteroid (ICS), which reduces the inflammation in the airways. Formoterol is a long-acting beta 2 agonist (LABA), which helps to relax the muscles of the airways in the lungs, making it easier to breathe. In combination, mometasone and formoterol are used for the treatment of asthma. This study will evaluate whether participants taking a LABA in combination with an ICS in a single inhaler have a different risk of having serious asthma events (hospitalization, intubation and death) compared to participants taking an ICS alone. The primary safety hypothesis is that the time-to-first serious asthma outcome (SAO) with mometasone furoate/formoterol (MF/F) MDI twice daily (BID) is non-inferior to that with mometasone furoate (MF) MDI BID in adolescents and adults with persistent asthma. If non-inferiority is achieved, the key secondary safety hypothesis of superiority of MF/F over MF will be assessed.
Read the detailed description
Amendments 2 and 3 are specific to Brazil; all other countries will enroll patients under Amendment 1.
- Conditions
- Asthma
- Being tested
- Mometasone Furoate/Formoterol MDI 100/5 mcg, Mometasone Furoate/Formoterol MDI 200/5 mcg, Mometasone Furoate MDI 100 mcg, Mometasone Furoate MDI 200 mcg, Albuterol 90 mcg /salbutamol 100 mcg HFA MDI
- Medical subject headings
- Asthma
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Mometasone Furoate/Formoterol MDI 100/5 mcgDrug
Also called MK-0887A; Dulera/Zenhale
two inhalations BID
Mometasone Furoate/Formoterol MDI 200/5 mcgDrug
Also called MK-0887A; Dulera/Zenhale
two inhalations BID
Mometasone Furoate MDI 100 mcgDrug
Also called Asmanex
two inhalations BID
Mometasone Furoate MDI 200 mcgDrug
Also called Asmanex
two inhalations BID
Albuterol 90 mcg /salbutamol 100 mcg HFA MDIDrug
use as needed for asthma symptoms
Prednisone/prednisoloneDrug
Oral prednisone/prednisolone used only as an emergency rescue medication at the discretion of the investigator
| Study group | Role | What they receive |
|---|---|---|
| Mometasone Furoate/Formoterol MDI BID | Experimental | MF/F MDI BID (pooled MF/F MDI 200/10 mcg BID and MF/F MDI 400/10 mcg BID treatments) Receives: Drug: Mometasone Furoate/Formoterol MDI 100/5 mcg; Drug: Mometasone Furoate/Formoterol MDI 200/5 mcg; Drug: Albuterol 90 mcg /salbutamol 100 mcg HFA MDI; Drug: Prednisone/prednisolone |
| Mometasone Furoate MDI BID | Active comparator | MF MDI BID (pooled from MF MDI 200 mcg BID and MF MDI 400 mcg BID treatments) Receives: Drug: Mometasone Furoate MDI 100 mcg; Drug: Mometasone Furoate MDI 200 mcg; Drug: Albuterol 90 mcg /salbutamol 100 mcg HFA MDI; Drug: Prednisone/prednisolone |
What is being measured
The primary outcome is the main question the study is designed to answer.
Time-to-First Serious Asthma Outcomes (SAO): Number of First SAO in the MF/F vs MF Arms
The primary safety outcome was the time-to-first SAO (a composite endpoint of adjudicated asthma-related hospitalizations, adjudicated asthma-related intubations, and adjudicated asthma-related deaths). To accomplish this, the number of participants experiencing a first SAO was collected for 26 weeks following initiation of study treatment (or 7 days after the last treatment dose, whichever occurred later). Data generated by this methodology were used to compute a hazard ratio (HR) and 95% confidence interval (CI), modeling the likelihood of a first SAO occurring at any given time in the MF/F arm relative to the MF arm. Although data were sufficient to generate a HR and 95% CI, time-to-first SAO in the overall population could not be accurately reported due to insufficient SAO occurrence. Therefore, the number of first SAO in either arm is reported as a descriptive measure. For each participant, first SAO denotes first event per participant.
Measured: 26 weeks, or 7 days after the last treatment dose, whichever occurred later
Secondary outcomes (1)
Time-to-First Severe Asthma Exacerbation (SAEX): Number of First SAEX in the MF/F vs MF Arms
The key secondary efficacy outcome was time-to-first protocol-defined asthma exacerbation (SAEX). The SAEX were deteriorations of asthma requiring: use of systemic corticosteroids (tablets, suspension, or injection) for >= 3 consecutive days, in-patient hospitalization >= 24 hours, or an emergency department (ED) visit < 24 hours that required systemic corticosteroids in the MF/F MDI BID arm versus the MF MDI BID arm. The number of first SAEX occurred from initiation of study treatment to 7 days after the last treatment (modified intention-to-treat). This outcome was measured as the HR and 95% CI for the number of first SAEX in the MF/F MDI BID arm versus the number of first SAEX in the MF MDI BID arm. Given insufficient data for SAEX events, it was not informative to report the time-to-first SAEX in the overall population. Therefore, the number of first SAEXs in either arm is reported as a descriptive measure. For each participant, first SAEX denotes first event per participant.
Measured: 26 weeks, plus 7 days after the last treatment
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted16 Nov 2011 (estimated)
- Study start9 Jan 2012
- Primary completion30 Nov 2016
- Study completion30 Nov 2016
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Posted resultsParticipant flow, outcome measures and adverse events reported by the sponsor.
- Publications (2)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 4
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Double blind
- Who is masked
- Participant, Investigator
- Enrolment
- 11,744 participants (actual)
Sponsor and investigators
- Lead sponsor
- Organon and Co
- Sponsor type
- Industry (pharma, biotech, devices)
- Responsible party
- Sponsor
- Investigators
- Medical Director, Study director, Merck Sharp & Dohme LLC
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT01471340
- Sponsor's protocol ID
- P06241
- Other IDs
- 2011-002142-13, MK-0887A-202
- Acronym
- SPIRO
- Status last verified
- Apr 2024
- First submitted
- 10 Nov 2011
- Last updated
- 23 May 2024
- Results posted
- Yes, on ClinicalTrials.gov
- Data monitoring committee
- Yes
- FDA-regulated drug
- Yes
- FDA-regulated device
- No
- Individual data sharing
- No
Publications
Weinstein CLJ, Ryan N, Shekar T, Gates D, Lane SJ, Agache I, Nathan RA; SPIRO Investigators. Serious asthma events with mometasone furoate plus formoterol compared with mometasone furoate. J Allergy Clin Immunol. 2019 Apr;143(4):1395-1402. doi: 10.1016/j.jaci.2018.10.065. Epub 2018 Dec 8.
PubMed 30537475Oba Y, Anwer S, Maduke T, Patel T, Dias S. Effectiveness and tolerability of dual and triple combination inhaler therapies compared with each other and varying doses of inhaled corticosteroids in adolescents and adults with asthma: a systematic review and network meta-analysis. Cochrane Database Syst Rev. 2022 Dec 6;12(12):CD013799. doi: 10.1002/14651858.CD013799.pub2.
PubMed 36472162
Study at a glance
From the registry record, last updated by the sponsor on 23 May 2024. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- A 26-Week Randomized, Double-Blinded, Active Controlled Study Comparing the Safety of Mometasone Furoate/Formoterol Fumarate MDI Fixed Dose Combination Versus Mometasone Furoate MDI Monotherapy in Adolescents and Adults With Persistent Asthma (Protocol No. P06241 Also Known as P202)
- ClinicalTrials.gov ID
- NCT01471340
- Acronym / sponsor ID
- SPIRO / P06241
- Conditions
- Asthma
- Phase
- Phase 4
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 11,744 participants (actual)
- Lead sponsor
- Organon and CoIndustry (pharma, biotech, devices)
- Study start
- 9 Jan 2012 (actual)
- Primary completion
- 30 Nov 2016 (actual)
- Study completion
- 30 Nov 2016 (actual)
- First posted
- 16 Nov 2011 (estimated)
- Results
- Posted 5 Jan 2018
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 test the safety of DULERA. DULERA is a pressurized metered-dose inhaler (MDI) that contains two drugs combined, namely mometasone and formoterol in a single inhaler. Mometasone is an inhaled corticosteroid (ICS), which reduces the inflammation in the airways. Formoterol is a long-acting beta 2 agonist (LABA), which helps to relax the muscles of the airways in the lungs, making it easier to breathe. In combination, mometasone and formoterol are used for the treatment of asthma. This study will evaluate whether participants taking a LABA in combination with an ICS in a single inhaler have a different risk of having serious asthma events (hospitalization, intubation and death) compared to participants taking an ICS alone. The primary safety hypothesis is that the time-to-first serious asthma outcome (SAO) with mometasone furoate/formoterol (MF/F) MDI twice daily (BID) is non-inferior to that with mometasone furoate (MF) MDI BID in adolescents and adults with persistent asthma. If non-inferiority is achieved, the key secondary safety hypothesis of superiority of MF/F over MF will be assessed.
Detailed description
Amendments 2 and 3 are specific to Brazil; all other countries will enroll patients under Amendment 1.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Double blind (participant, investigator)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Mometasone Furoate/Formoterol MDI BID | Experimental | Drug: Mometasone Furoate/Formoterol MDI 100/5 mcg, Drug: Mometasone Furoate/Formoterol MDI 200/5 mcg, Drug: Albuterol 90 mcg /salbutamol 100 mcg HFA MDI, Drug: Prednisone/prednisoloneMF/F MDI BID (pooled MF/F MDI 200/10 mcg BID and MF/F MDI 400/10 mcg BID treatments) |
| Mometasone Furoate MDI BID | Active comparator | Drug: Mometasone Furoate MDI 100 mcg, Drug: Mometasone Furoate MDI 200 mcg, Drug: Albuterol 90 mcg /salbutamol 100 mcg HFA MDI, Drug: Prednisone/prednisoloneMF MDI BID (pooled from MF MDI 200 mcg BID and MF MDI 400 mcg BID treatments) |
Who may qualify
- Ages
- 12 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Child, Adult, Older adult
Key inclusion criteria (4 listed)
- Persistent asthma for at least 1-year
- Must use a daily asthma controller medication for at least 4 weeks prior to randomization, including an inhaled corticosteroid (ICS) with or without a long-acting beta agonist (LABA) or other adjunctive asthma therapy OR be using a leukotriene receptor antagonist (LTRA), xanthine or short acting beta agonist (SABA) as a monotherapy.
- Must be able to discontinue current asthma medication
- Must have a history of at least one asthma exacerbation in previous 4 to 52 weeks
Key exclusion criteria (14 listed)
- Unstable asthma
- Taking high dose ICS with or without other adjunctive therapy who have an Asthma Control Questionnaire 6 (ACQ6) total score ≥ 1.5
- Taking LTRA, xanthine or SABA monotherapy with an ACQ-6 total score < 1.5 (controlled)
- Chronic obstructive pulmonary disease (COPD), cystic fibrosis (CF), or other significant, non-asthmatic, lung disease
- Clinically significant abnormality, illness or disorder of any body or organ system
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 |
|---|---|---|
| Mometasone Furoate/Formoterol MDI 100/5 mcgAlso: MK-0887A; Dulera/Zenhaletwo inhalations BID | Drug | Mometasone Furoate/Formoterol MDI BID |
| Mometasone Furoate/Formoterol MDI 200/5 mcgAlso: MK-0887A; Dulera/Zenhaletwo inhalations BID | Drug | Mometasone Furoate/Formoterol MDI BID |
| Mometasone Furoate MDI 100 mcgAlso: Asmanextwo inhalations BID | Drug | Mometasone Furoate MDI BID |
| Mometasone Furoate MDI 200 mcgAlso: Asmanextwo inhalations BID | Drug | Mometasone Furoate MDI BID |
| Albuterol 90 mcg /salbutamol 100 mcg HFA MDIuse as needed for asthma symptoms | Drug | Mometasone Furoate MDI BID, Mometasone Furoate/Formoterol MDI BID |
| Prednisone/prednisoloneOral prednisone/prednisolone used only as an emergency rescue medication at the discretion of the investigator | Drug | Mometasone Furoate MDI BID, Mometasone Furoate/Formoterol MDI BID |
Primary outcome
Time-to-First Serious Asthma Outcomes (SAO): Number of First SAO in the MF/F vs MF Arms
Time frame: 26 weeks, or 7 days after the last treatment dose, whichever occurred later
The primary safety outcome was the time-to-first SAO (a composite endpoint of adjudicated asthma-related hospitalizations, adjudicated asthma-related intubations, and adjudicated asthma-related deaths). To accomplish this, the number of participants experiencing a first SAO was collected for 26 weeks following initiation of study treatment (or 7 days after the last treatment dose, whichever occurred later). Data generated by this methodology were used to compute a hazard ratio (HR) and 95% confidence interval (CI), modeling the likelihood of a first SAO occurring at any given time in the MF/F arm relative to the MF arm. Although data were sufficient to generate a HR and 95% CI, time-to-first SAO in the overall population could not be accurately reported due to insufficient SAO occurrence. Therefore, the number of first SAO in either arm is reported as a descriptive measure. For each participant, first SAO denotes first event per participant.
1 secondary outcome
Time-to-First Severe Asthma Exacerbation (SAEX): Number of First SAEX in the MF/F vs MF Arms
Time frame: 26 weeks, plus 7 days after the last treatment
Results and safety
Loading the posted results from ClinicalTrials.gov…
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 23 May 2024.
- Posted resultsParticipant flow, baseline, all outcome measures and adverse events.
- Results publication: PubMed 30537475Weinstein CLJ, Ryan N, Shekar T, Gates D, Lane SJ, Agache I, Nathan RA; SPIRO Investigators. Serious asthma events with mometasone furoate plus formoterol compared with mometasone furoate. J Allergy Clin Immunol. 2019 Apr;143(4):1395-1402. doi: 10.1016/j.jaci.2018.10.065. Epub 2018 Dec 8.
- Derived from this study: PubMed 36472162Oba Y, Anwer S, Maduke T, Patel T, Dias S. Effectiveness and tolerability of dual and triple combination inhaler therapies compared with each other and varying doses of inhaled corticosteroids in adolescents and adults with asthma: a systematic review and network meta-analysis. Cochrane Database Syst Rev. 2022 Dec 6;12(12):CD013799. doi: 10.1002/14651858.CD013799.pub2.
- Individual participant dataSharing planned: No
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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.
Medical Director study director
Merck Sharp & Dohme LLC
Questions about this trial
What is this clinical trial studying?
A Phase 4 study testing Mometasone Furoate/Formoterol MDI 100/5 mcg, Mometasone Furoate/Formoterol MDI 200/5 mcg and Mometasone Furoate MDI 100 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 4 inclusion and 14 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 23 May 2024. 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 4 studies take place after a treatment is approved, to learn more about its long-term benefits and risks in everyday use.
Not every study follows the same path, and some studies (observational studies, device studies) have no phase.
Are results available for this study?
Yes. Results are posted in the registry (first posted 5 Jan 2018). A summary is in the For doctors view, and the full results are on ClinicalTrials.gov.
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?
Time-to-First Serious Asthma Outcomes (SAO): Number of First SAO in the MF/F vs MF Arms (time frame: 26 weeks, or 7 days after the last treatment dose, whichever occurred later). 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 NCT01471340, which also lists 2 linked publications.
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 23 May 2024.