AsthmaPhase 3NCT01566149
Study of Mometasone Furoate/Formoterol Fumarate (MF/F) Metered Dose Inhaler (MDI) in Adolescents & Adults With Persistent Asthma (P08212)
A Phase 3 study testing Mometasone Furoate/Formoterol Fumarate (MF/F) 100/5 mcg MDI and Mometasone Furoate/Formoterol Fumarate (MF/F) 200/5 mcg MDI in people with Asthma, run by Organon and Co.
Trial summary
The purpose of this study is to assess the safety, tolerability \& effectiveness of 2 strengths of Mometasone Furoate/Formoterol Fumarate (MF/F) Metered Dose Inhaler (MDI) in the treatment of persistent asthma in adults \& adolescents. 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 Fumarate (MF/F) 100/5 mcg MDI and Mometasone Furoate/Formoterol Fumarate (MF/F) 200/5 mcg MDI
- Type of treatment
- Pill or oral medicine
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 49 participants
- Where
- No sites listed yet
- Study dates
- Mar 2012to Sep 2012
- Phase
- Phase 3
- 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
- Diagnosis of asthma of at least 6 months duration
- Current use of a medium or high daily dose of an inhaled corticosteroid (ICS) (alone or in combination with a long-acting beta agonist [LABA]) for at least 6 weeks prior to Screening AND must be on a stable asthma regimen (daily dose unchanged) for at least 2 weeks prior to Screening
- Agrees to change asthma therapy (if changing asthma therapy poses no inherent risk)
- If female of reproductive potential, agrees to remain abstinent or use 2 acceptable methods of birth control during study participation. Acceptable methods of birth control are: intrauterine device (IUD), diaphragm with spermicide, contraceptive sponge, condom, vasectomy, hormonal contraceptive
Who cannot join
- Treatment in the emergency room (for a severe asthma exacerbation), or admitted to the hospital for management of airway obstruction within previous 3 months
- Any prior ventilator support for respiratory failure secondary to asthma,
- Upper or lower respiratory tract infection (viral or bacterial) within previous 2 weeks
- History of a medical condition that, in the investigator's opinion, may interfere with study participation,
- History of smoking within previous year or a cumulative smoking history of more than 10 pack-years
- Known allergy to or intolerance of ICSs, LABAs, or any of the ingredients included in the study medications
Show all 9Show fewer
- History of use of illicit drugs
- Inability to correctly use an oral MDI
- Pregnant, breastfeeding or plans to become pregnant during study
About this study
Official title: An Open-Label Study to Assess the Safety and Tolerability of Zenhale® (a Fixed-Dose Combination of Mometasone Furoate/Formoterol Fumarate Delivered by Metered Dose Inhaler) in 40 Subjects With Persistent Asthma (Protocol No. 206-00 [P08212])
The purpose of this study is to assess the safety, tolerability \& effectiveness of 2 strengths of Mometasone Furoate/Formoterol Fumarate (MF/F) Metered Dose Inhaler (MDI) in the treatment of persistent asthma in adults \& adolescents.
- Conditions
- Asthma
- Being tested
- Mometasone Furoate/Formoterol Fumarate (MF/F) 100/5 mcg MDI, Mometasone Furoate/Formoterol Fumarate (MF/F) 200/5 mcg 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 Fumarate (MF/F) 100/5 mcg MDIDrug
Also called Zenhale®, SCH 418131, MK-0887A
Two oral inhalations per dose
Mometasone Furoate/Formoterol Fumarate (MF/F) 200/5 mcg MDIDrug
Also called Zenhale®, SCH 418131, MK-0887A
Two oral inhalations per dose
| Study group | Role | What they receive |
|---|---|---|
| MF/F 200/10 mcg MDI BID | Active comparator | Participants receiving MF/F 200/10 mcg MDI twice daily (BID) for 12 weeks Receives: Drug: Mometasone Furoate/Formoterol Fumarate (MF/F) 100/5 mcg MDI |
| MF/F 400/10 mcg MDI BID | Active comparator | Participants receiving MF/F 400/10 mcg MDI BID for 12 weeks Receives: Drug: Mometasone Furoate/Formoterol Fumarate (MF/F) 200/5 mcg MDI |
What is being measured
The primary outcome is the main question the study is designed to answer.
Number of Participants With At Least One Adverse Event (AE)
An AE was defined as any unfavorable and unintended sign, symptom, or disease temporally associated with the use of a medicinal product, whether or not considered related to this medicinal product.
Measured: Up to Week 14
Number of Participants With At Least One Drug-Related AE
A drug-related AE was defined as any AE for which there is reasonable possibility of drug relationship as assessed by the Investigator.
Measured: Up to Week 14
Number of Participants With At Least One Serious AE
A serious AE was defined as any untoward medical occurrence or effect that at
any dose: results in death; is life-threatening; requires hospitalization or prolongation of existing hospitalization; results in persistent or significant disability or incapacity; is a congenital anomaly or birth defect; and/or cancer.
Measured: Up to Week 14
Number of Participants Who Discontinued From the Study Due to an AE
An AE was defined as any unfavorable and unintended sign (including an abnormal laboratory finding, for example), symptom, or disease temporally associated with the use of a medicinal product, whether or not considered related to this medicinal product.
Measured: Up to Week 12
Secondary outcomes (1)
Mean Change From Baseline in Forced Expiratory Volume in 1 Second (FEV1) at Week 12
Baseline was defined as the highest FEV1 value of three assessments prior to first dose of study drug. If two (or all three) spirometry efforts had identical FEV1, the FEV1 from the effort with the highest Forced Vital Capacity (FVC) was to be recorded. Week 12 FEV1 was assessed as the morning FEV1 at the end of the dosing interval (trough FEV1). For participants who discontinued prior to Week 12, the FEV1 measurement from the discontinuation visit was to be be carried forward to Week 12 if (and only if) the participant's study medication compliance rate prior to discontinuation was at least 85%.
Measured: Baseline and Week 12
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted29 Mar 2012 (estimated)
- Study startMar 2012
- Primary completionSep 2012
- Study completionSep 2012
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.
- 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
- Non-randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Enrolment
- 49 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
- NCT01566149
- Sponsor's protocol ID
- P08212
- Other IDs
- MK-0887A-206
- Status last verified
- Feb 2022
- First submitted
- 27 Mar 2012
- Last updated
- 24 May 2024
- Results posted
- Yes, on ClinicalTrials.gov
- Data monitoring committee
- No
- Individual data sharing
- No
Study at a glance
From the registry record, last updated by the sponsor on 24 May 2024. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- An Open-Label Study to Assess the Safety and Tolerability of Zenhale® (a Fixed-Dose Combination of Mometasone Furoate/Formoterol Fumarate Delivered by Metered Dose Inhaler) in 40 Subjects With Persistent Asthma (Protocol No. 206-00 [P08212])
- ClinicalTrials.gov ID
- NCT01566149
- Acronym / sponsor ID
- P08212
- Conditions
- Asthma
- Phase
- Phase 3
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 49 participants (actual)
- Lead sponsor
- Organon and CoIndustry (pharma, biotech, devices)
- Study start
- Mar 2012
- Primary completion
- Sep 2012 (actual)
- Study completion
- Sep 2012 (actual)
- First posted
- 29 Mar 2012 (estimated)
- Results
- Posted 29 Jul 2013
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 safety, tolerability \& effectiveness of 2 strengths of Mometasone Furoate/Formoterol Fumarate (MF/F) Metered Dose Inhaler (MDI) in the treatment of persistent asthma in adults \& adolescents.
Study design
- Primary purpose
- Treatment
- Allocation
- Non-randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| MF/F 200/10 mcg MDI BID | Active comparator | Drug: Mometasone Furoate/Formoterol Fumarate (MF/F) 100/5 mcg MDIParticipants receiving MF/F 200/10 mcg MDI twice daily (BID) for 12 weeks |
| MF/F 400/10 mcg MDI BID | Active comparator | Drug: Mometasone Furoate/Formoterol Fumarate (MF/F) 200/5 mcg MDIParticipants receiving MF/F 400/10 mcg MDI BID for 12 weeks |
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)
- Diagnosis of asthma of at least 6 months duration
- Current use of a medium or high daily dose of an inhaled corticosteroid (ICS) (alone or in combination with a long-acting beta agonist [LABA]) for at least 6 weeks prior to Screening AND must be on a stable asthma regimen (daily dose unchanged) for at least 2 weeks prior to Screening
- Agrees to change asthma therapy (if changing asthma therapy poses no inherent risk)
- If female of reproductive potential, agrees to remain abstinent or use 2 acceptable methods of birth control during study participation. Acceptable methods of birth control are: intrauterine device (IUD), diaphragm with spermicide, contraceptive sponge, condom, vasectomy, hormonal contraceptive
Key exclusion criteria (9 listed)
- Treatment in the emergency room (for a severe asthma exacerbation), or admitted to the hospital for management of airway obstruction within previous 3 months
- Any prior ventilator support for respiratory failure secondary to asthma,
- Upper or lower respiratory tract infection (viral or bacterial) within previous 2 weeks
- History of a medical condition that, in the investigator's opinion, may interfere with study participation,
- History of smoking within previous year or a cumulative smoking history of more than 10 pack-years
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 Fumarate (MF/F) 100/5 mcg MDIAlso: Zenhale®, SCH 418131, MK-0887ATwo oral inhalations per dose | Drug | MF/F 200/10 mcg MDI BID |
| Mometasone Furoate/Formoterol Fumarate (MF/F) 200/5 mcg MDIAlso: Zenhale®, SCH 418131, MK-0887ATwo oral inhalations per dose | Drug | MF/F 400/10 mcg MDI BID |
Primary outcome
Number of Participants With At Least One Adverse Event (AE)
Time frame: Up to Week 14
An AE was defined as any unfavorable and unintended sign, symptom, or disease temporally associated with the use of a medicinal product, whether or not considered related to this medicinal product.
Number of Participants With At Least One Drug-Related AE
Time frame: Up to Week 14
A drug-related AE was defined as any AE for which there is reasonable possibility of drug relationship as assessed by the Investigator.
Number of Participants With At Least One Serious AE
Time frame: Up to Week 14
A serious AE was defined as any untoward medical occurrence or effect that at any dose: results in death; is life-threatening; requires hospitalization or prolongation of existing hospitalization; results in persistent or significant disability or incapacity; is a congenital anomaly or birth defect; and/or cancer.
Number of Participants Who Discontinued From the Study Due to an AE
Time frame: Up to Week 12
An AE was defined as any unfavorable and unintended sign (including an abnormal laboratory finding, for example), symptom, or disease temporally associated with the use of a medicinal product, whether or not considered related to this medicinal product.
1 secondary outcome
Mean Change From Baseline in Forced Expiratory Volume in 1 Second (FEV1) at Week 12
Time frame: Baseline and Week 12
Results and safety
Loading the posted results from ClinicalTrials.gov…
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 24 May 2024.
- Posted resultsParticipant flow, baseline, all outcome measures and adverse events.
- Individual participant dataSharing planned: No
Related trials for Asthma
RecruitingPhase 1
Pilot Study to Identify the Mediators and Inflammatory Cell Surface Receptors Involved in Allergic Airway Inflammation
Asthma
RecruitingPhase 1
A Study to Compare the Relative Potency of Salbutamol Administered Via Metered Dose Inhalers (MDI) Containing Propellants HFA-152a to HFA-134a in Mild Asthmatics Aged 18 to 65 Inclusive
Asthma, Mild Asthma
RecruitingPhase 3
A Study Assessing the Effect of Dupilumab on Inducing Clinical Remission in Asthma
Asthma Control
Active, not recruitingPhase 2/3
Local Antibiotic Delivery for Community Acquired Pneumonia
Community Acquired Pneumonia (CAP)
RecruitingPhase 2
A Study to Learn About the Study Medicine Called PF-07275315 in People With Moderate-To-Severe Asthma
Asthma
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 3 study testing Mometasone Furoate/Formoterol Fumarate (MF/F) 100/5 mcg MDI and Mometasone Furoate/Formoterol Fumarate (MF/F) 200/5 mcg MDI 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 9 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 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 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?
Yes. Results are posted in the registry (first posted 29 Jul 2013). 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?
Number of Participants With At Least One Adverse Event (AE) (time frame: Up to Week 14). The study lists 4 primary outcomes in all. 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 May 2024.