AsthmaPhase 3NCT00383240

Effects of Mometasone Furoate/Formoterol Combination Versus Mometasone Furoate Alone in Persistent Asthmatics (Study P04334AM1)(COMPLETED)

A Phase 3 study testing mometasone furoate/formoterol fumarate combination MDI 200/10 mcg BID, Mometasone furoate MDI (MF MDI) 200 mcg and formoterol fumarate 10 mcg in people with Asthma, run by Organon and Co.

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

Who is it for?: Ages 12 years and older
Conditions the study is for: Asthma
What is being tested?: mometasone furoate/formoterol fumarate combination MDI 200/10 mcg BID, Mometasone furoate MDI (MF MDI) 200 mcg and formoterol fumarate 10 mcg
Could I receive a placebo?: Yes, some participants may receive a placebo
How many people: 781 participants
Where: No sites listed yet
Study dates: Sep 2006to Sep 2008
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

A subject must have been using a medium daily dose of inhaled glucocorticosteroid (ICS) (either alone or in combination with a long-acting beta agonist (LABA)) for at least 12 weeks and must have been on a stable regimen (daily dose unchanged) for at least 2 weeks prior to Screening. Medium daily doses of ICS are defined as follows:
>500 to 1000 mcg beclomethasone chlorofluorocarbon (CFC)
>250 to 500 mcg beclomethasone hydrofluoroalkane (HFA)
>600 to 1000 mcg budesonide dry powder inhaler (DPI)
>1000 to 2000 mcg flunisolide
>250 to 500 mcg fluticasone

Show all 18Show fewer

400 mcg MF
>1000 to 2000 mcg triamcinolone acetonide
Note: Dose delivery by method or modality other than those noted above must be equivalent.
If, based upon the medical judgment of the investigator, there is no inherent harm in changing the subject's current asthma therapy, then the subject (and parent/guardian, if applicable) must be willing to discontinue his/her prescribed ICS or ICS/LABA combination at the Screening Visit, and be transferred to open-label treatment with MF MDI 200 mcg BID for 2 to 3 weeks prior to the Baseline/Randomization Visit.
To document the diagnosis of asthma and assure the subject's responsiveness to bronchodilators before randomization one of the following methods can be used at the Screening Visit, Day -14, or thereafter, but prior to the Baseline Visit:
The subject must demonstrate an increase in absolute FEV1 of at least 12% and at least 200 mL within 15 minutes after administration of four inhalations of albuterol/salbutamol (total dose of 360 to 400 mcg) or of nebulized SABA (2.5 mg) if confirmed as standard office practice, OR
The subject must demonstrate a peak expiratory flow (PEF) variability of more than 20% expressed as a percentage of the highest and lowest morning prebronchodilator PEF over at least 1 week, OR
The subject must demonstrate a diurnal variation in PEF of more than 20% based on the difference between the prebronchodilator morning value and the postbronchodilator value from the evening before, expressed as a percentage of the mean daily PEF value.
At the Screening Visit, the subject's FEV1 must be ≥60% and ≤90% predicted.
At the Baseline Visit, the subject's FEV1 must be ≥60% and ≤85% predicted when all restricted medications have been withheld for the appropriate intervals.
Clinical laboratory tests (complete blood counts [CBC], blood chemistries, and urinalysis) conducted at the Screening Visit must be within normal limits or clinically acceptable to the investigator/sponsor. An electrocardiogram (ECG) using a centralized trans-telephonic technology at the Screening Visit must be clinically acceptable to the investigator. A chest x-ray performed at the Screening Visit, or within 12 months prior to the Screening Visit, must be clinically acceptable to the investigator.
A female subject of childbearing potential must have been using a medically acceptable, adequate form of birth control. This includes: 1) hormonal contraceptives as prescribed by a physician (oral combined, hormonal implant); 2) medically prescribed intra-uterine device (IUD); 3) condom in combination with a spermicide (double barrier method); 4) monogamous relationship with a male partner who has had a vasectomy. The subject must have started this birth control method at least 3 months prior to Screening (with the exception of condom in combination with spermicide), and must agree to continue its use for the duration of the study. A female subject of childbearing potential who is not currently sexually active must agree and consent to using a medically acceptable birth control method should she become sexually active during the course of this study. Women who have been surgically sterilized or are at least 1 year postmenopausal are not considered to be of childbearing potential. A female subject of childbearing potential must have a negative serum pregnancy test at Screening in order to be considered eligible for enrollment.

Who cannot join

A subject who demonstrates a change (increase or decrease) in absolute FEV1 of >20% at any time from the Screening Visit up to and including the Baseline Visit.
A subject who requires the use of greater than eight inhalations per day of SABA MDI, or two or more nebulized treatments per day of 2.5 mg SABA, on any 2 consecutive days from the Screening Visit up to and including the Baseline Visit.
A subject who experiences a decrease in AM or PM PEF below the Screening Period stability limit on any 2 consecutive days prior to Randomization.
A subject who experiences an occurrence of any clinical deterioration of asthma that results in emergency treatment, hospitalization due to asthma, or treatment with additional, excluded asthma medication (other than SABA) as judged by the clinical investigator at any time from the Screening Visit up to and including the Baseline Visit.
A subject who is a smoker or ex-smoker and has smoked within the previous year or has had a cumulative smoking history >10 pack-years

About this study

Official title: A 26-Week Placebo-Controlled Efficacy and Safety Study of Mometasone Furoate/Formoterol Fumarate Combination Formulation Compared With Mometasone Furoate and Formoterol Monotherapy in Subjects With Persistent Asthma Previously Treated With Medium-Dose Inhaled Glucocorticosteroids

This is a randomized, multi-center, double-blind, double-dummy, placebo-controlled, parallel-group study, evaluating the efficacy of mometasone furoate (MF) /formoterol fumarate (F)[MF/F] metered dose inhaler (MDI) versus MF for 26 weeks. Prior to the 26-week double-blind Treatment Period, subjects will receive open-label MF MDI 200 mcg twice daily (BID) for 2 to 3 weeks during the Run-in Period. Efficacy will be measured by The Area Under the Curve From 0 to 12 Hours [AUC](0-12 hours) of the Change From Baseline to the Week 12 Endpoint

in Forced Expiratory Volume in One Second (FEV1) [Time Frame: Baseline to Week 12] and Time-to-First Severe Asthma Exacerbation across the 26-week treatment period.

Conditions: Asthma
Being tested: mometasone furoate/formoterol fumarate combination MDI 200/10 mcg BID, Mometasone furoate MDI (MF MDI) 200 mcg, formoterol fumarate 10 mcg, Placebo
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 combination MDI 200/10 mcg BIDDrug
Also called SCH 418131
MF/F 200/10 mcg via a metered dose inhaler (MDI) twice daily for 26 weeks
Mometasone furoate MDI (MF MDI) 200 mcgDrug
Also called SCH 32088
MF 200 mcg via metered dose inhaler twice daily for 26 weeks
formoterol fumarate 10 mcgDrug
Also called Foradil
F via metered dose inhaler 10 mcg twice a day for 26 weeks
PlaceboDrug
Placebo metered dose inhaler twice a day for 26 weeks

Study groups in NCT00383240
Study group	Role	What they receive
MF/F MDI 200/10 mcg BID	Experimental	Not described Receives: Drug: mometasone furoate/formoterol fumarate combination MDI 200/10 mcg BID
MF MDI 200 mcg BID	Experimental	Not described Receives: Drug: Mometasone furoate MDI (MF MDI) 200 mcg
F MDI 10 mcg BID	Experimental	Not described Receives: Drug: formoterol fumarate 10 mcg
Placebo BID	Placebo comparator	Not described Receives: Drug: Placebo

What is being measured

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

Mean Area Under the Time Curve From 0 to 12 Hours (AUC(0-12 Hours)) of Change From Baseline to Week 12 in Forced Expiratory Volume (Liters) in 1 Second (FEV1) for MF/F Versus MF
Measured: Baseline to Endpoint (12 weeks)
Time-to-first Asthma Exacerbation Over the 26-week Treatment Period for the Comparison of MF/F Versus F
This endpoint was to measure the time it took for 50% of subjects in a treatment arm to experience a severe asthma exacerbation (also see the posted Other Pre-specified Outcome: Number of Participants With at Least One Severe Asthma Exacerbation)
Measured: 26-week Treatment Period

Secondary outcomes (3)

Change From Baseline to Week 26 in Asthma Quality of Life Questionnaire With Standardized Activities (AQLQ[S]) Total Score
AQLQ(S) consists of 32 questions each scaled from 1 (worst case) to 7 (best case). Standard deviations are pooled.
Measured: Baseline to Week 26
Change From Baseline to Week 26 in the Asthma Control Questionnaire (ACQ) Score
ACQ consists of seven questions each scaled from 0 (best case) to 6 (worst case).
Measured: Baseline to week 26
Change From Baseline in Proportion of Nights Across the Treatment Period With Nocturnal Awakenings Due to Asthma Which Require Use of Short-acting Beta 2-agonist (SABA)
Baseline is the proportion of nights of last week (Days -7 to 1) prior to first dose with nocturnal awakenings. Scale is measured as 0 to 1 with 0=no awakenings to 1=awakenings every night. Standard deviation is pooled.
Measured: Baseline to Endpoint

Timeline

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

Sep 2006Sep 2008

First posted3 Oct 2006 (estimated)
Study startSep 2006
Primary completionSep 2008
Study completionSep 2008

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 (1)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 3
Primary purpose: Treatment
Allocation: Randomised
Intervention model: Parallel groups
Masking: Double blind
Who is masked: Participant, Investigator
Enrolment: 781 participants (actual)

IDs, dates and publications

ClinicalTrials.gov ID: NCT00383240
Sponsor's protocol ID: P04334
Other IDs: EUDRACT No.: 2006-001578-25;
Status last verified: Feb 2022
First submitted: 29 Sep 2006
Last updated: 20 May 2024
Results posted: Yes, on ClinicalTrials.gov
Data monitoring committee: No
Individual data sharing: No

Publications

Nathan RA, Nolte H, Pearlman DS; P04334 Study Investigators. Twenty-six-week efficacy and safety study of mometasone furoate/formoterol 200/10 microg combination treatment in patients with persistent asthma previously receiving medium-dose inhaled corticosteroids. Allergy Asthma Proc. 2010 Jul-Aug;31(4):269-79. doi: 10.2500/aap.2010.31.3364. Epub 2010 Jul 30.
PubMed 20678306

Want to know more?

The sponsor has not listed a contact. The official record may have more details.

Talk to your doctor first and take this page with you. Only the study team can confirm whether you can join.

Questions to ask the study team

What is the study trying to find out?
What would I need to do, and how often would I visit?
Could I receive a placebo instead of the treatment?
What are the possible risks and benefits for me?
Will it cost me anything? Are travel or time paid for?
Can I keep seeing my own doctor during the study?
What happens when the study ends?

Official record

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Study at a glance

From the registry record, last updated by the sponsor on 20 May 2024. Recruitment status is as the sponsor reported it: confirm with the study team.

Official title: A 26-Week Placebo-Controlled Efficacy and Safety Study of Mometasone Furoate/Formoterol Fumarate Combination Formulation Compared With Mometasone Furoate and Formoterol Monotherapy in Subjects With Persistent Asthma Previously Treated With Medium-Dose Inhaled Glucocorticosteroids
ClinicalTrials.gov ID: NCT00383240
Acronym / sponsor ID: P04334
Conditions: Asthma
Phase: Phase 3
Study type: Interventional
Recruitment status: Completed
Enrolment: 781 participants (actual)
Lead sponsor: Organon and CoIndustry (pharma, biotech, devices)
Collaborators: Novartis
Study start: Sep 2006
Primary completion: Sep 2008 (actual)
Study completion: Sep 2008 (actual)
First posted: 3 Oct 2006 (estimated)
Results: Posted 7 Mar 2011

Clinical summary

The research question as the sponsor registered it. This describes what the study plans to test, not what it found.

in Forced Expiratory Volume in One Second (FEV1) [Time Frame: Baseline to Week 12] and Time-to-First Severe Asthma Exacerbation across the 26-week treatment period.

Study design

Primary purpose: Treatment
Allocation: Randomised
Intervention model: Parallel groups
Masking: Double blind (participant, investigator)
Number of arms: 4

Arm	Type	Receives
MF/F MDI 200/10 mcg BID	Experimental	Drug: mometasone furoate/formoterol fumarate combination MDI 200/10 mcg BID
MF MDI 200 mcg BID	Experimental	Drug: Mometasone furoate MDI (MF MDI) 200 mcg
F MDI 10 mcg BID	Experimental	Drug: formoterol fumarate 10 mcg
Placebo BID	Placebo comparator	Drug: Placebo

Who may qualify

Ages: 12 years and older
Sex: All
Healthy volunteers: Not accepted
Age groups: Child, Adult, Older adult

Key inclusion criteria (18 listed)

A subject must have been using a medium daily dose of inhaled glucocorticosteroid (ICS) (either alone or in combination with a long-acting beta agonist (LABA)) for at least 12 weeks and must have been on a stable regimen (daily dose unchanged) for at least 2 weeks prior to Screening. Medium daily doses of ICS are defined as follows:
>500 to 1000 mcg beclomethasone chlorofluorocarbon (CFC)
>250 to 500 mcg beclomethasone hydrofluoroalkane (HFA)
>600 to 1000 mcg budesonide dry powder inhaler (DPI)
>1000 to 2000 mcg flunisolide

Key exclusion criteria (5 listed)

A subject who demonstrates a change (increase or decrease) in absolute FEV1 of >20% at any time from the Screening Visit up to and including the Baseline Visit.
A subject who requires the use of greater than eight inhalations per day of SABA MDI, or two or more nebulized treatments per day of 2.5 mg SABA, on any 2 consecutive days from the Screening Visit up to and including the Baseline Visit.
A subject who experiences a decrease in AM or PM PEF below the Screening Period stability limit on any 2 consecutive days prior to Randomization.
A subject who experiences an occurrence of any clinical deterioration of asthma that results in emergency treatment, hospitalization due to asthma, or treatment with additional, excluded asthma medication (other than SABA) as judged by the clinical investigator at any time from the Screening Visit up to and including the Baseline Visit.
A subject who is a smoker or ex-smoker and has smoked within the previous year or has had a cumulative smoking history >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 combination MDI 200/10 mcg BIDAlso: SCH 418131MF/F 200/10 mcg via a metered dose inhaler (MDI) twice daily for 26 weeks	Drug	MF/F MDI 200/10 mcg BID
Mometasone furoate MDI (MF MDI) 200 mcgAlso: SCH 32088MF 200 mcg via metered dose inhaler twice daily for 26 weeks	Drug	MF MDI 200 mcg BID
formoterol fumarate 10 mcgAlso: ForadilF via metered dose inhaler 10 mcg twice a day for 26 weeks	Drug	F MDI 10 mcg BID
PlaceboPlacebo metered dose inhaler twice a day for 26 weeks	Drug	Placebo BID

Primary outcome

Mean Area Under the Time Curve From 0 to 12 Hours (AUC(0-12 Hours)) of Change From Baseline to Week 12 in Forced Expiratory Volume (Liters) in 1 Second (FEV1) for MF/F Versus MF
Time frame: Baseline to Endpoint (12 weeks)
Time-to-first Asthma Exacerbation Over the 26-week Treatment Period for the Comparison of MF/F Versus F
Time frame: 26-week Treatment Period
This endpoint was to measure the time it took for 50% of subjects in a treatment arm to experience a severe asthma exacerbation (also see the posted Other Pre-specified Outcome: Number of Participants With at Least One Severe Asthma Exacerbation)

3 secondary outcomes

Change From Baseline to Week 26 in Asthma Quality of Life Questionnaire With Standardized Activities (AQLQ[S]) Total Score
Time frame: Baseline to Week 26
Change From Baseline to Week 26 in the Asthma Control Questionnaire (ACQ) Score
Time frame: Baseline to week 26
Change From Baseline in Proportion of Nights Across the Treatment Period With Nocturnal Awakenings Due to Asthma Which Require Use of Short-acting Beta 2-agonist (SABA)
Time frame: Baseline to Endpoint

Results and safety

Results posted to the registry on 7 Mar 2011, as reported by the sponsor. Figures are copied from the record, not re-analysed. Full results on ClinicalTrials.gov.

Participant flow

Group	Started	Completed
MF/F MDI 200/10 mcg BID	191	156
MF MDI 200 mcg BID	192	159
F MDI 10 mcg BID	202	117
Placebo BID	196	119

Primary outcome: Mean Area Under the Time Curve From 0 to 12 Hours (AUC(0-12 Hours)) of Change From Baseline to Week 12 in Forced Expiratory Volume (Liters) in 1 Second (FEV1) for MF/F Versus MF

Time frame: Baseline to Endpoint (12 weeks). Least squares mean (Standard Deviation). Unit: liters x hours

Measure	MF/F MDI 200/10 mcg BID n = 190	MF MDI 200 mcg BID n = 190	F MDI 10 mcg BID n = 202	Placebo BID n = 193
Baseline (n=188/189/198/192, respectively)	3.20 (2.96)	1.29 (2.96)	2.73 (2.96)	1.42 (2.96)
Endpoint (Change from Baseline)	3.19 (3.98)	1.31 (3.98)	1.60 (3.98)	0.51 (3.98)

MF/F MDI 200/10 mcg BID vs MF MDI 200 mcg BID: p <.001, ANCOVA
MF/F MDI 200/10 mcg BID vs F MDI 10 mcg BID: p <.001, ANCOVA
MF/F MDI 200/10 mcg BID vs Placebo BID: p <.001, ANCOVA

Population analysed: Intent to Treat (ITT) population

Primary outcome: Time-to-first Asthma Exacerbation Over the 26-week Treatment Period for the Comparison of MF/F Versus F

Time frame: 26-week Treatment Period. Median (Inter-Quartile Range). Unit: days

Measure	MF/F MDI 200/10 mcg BID n = 191	MF MDI 200 mcg BID n = 192	F MDI 10 mcg BID n = 202	Placebo BID n = 196
Value	NA (NA)	NA (NA)	92 (NA)	131 (NA)

Population analysed: All Randomized Subjects

3 secondary outcomes are reported in the full results.

Adverse events

Other adverse events reported at 5% frequency or more

Group	Serious adverse events	Other adverse events	Deaths
OL MF MDI 200 MCG BID	4 of 984 (0.4%)	25 of 984 (2.5%)	Not reported
MF/F MDI 200/10 MCG BID	5 of 191 (2.6%)	31 of 191 (16.2%)	Not reported
MF MDI 200 MCG BID	3 of 192 (1.6%)	35 of 192 (18.2%)	Not reported
F MDI 10 MCG BID	3 of 202 (1.5%)	29 of 202 (14.4%)	Not reported
PLACEBO	3 of 196 (1.5%)	30 of 196 (15.3%)	Not reported

Loading the posted results from ClinicalTrials.gov…

Research links

Official record on ClinicalTrials.govLast updated by the sponsor 20 May 2024.
Posted resultsParticipant flow, baseline, all outcome measures and adverse events.
Derived from this study: PubMed 20678306Nathan RA, Nolte H, Pearlman DS; P04334 Study Investigators. Twenty-six-week efficacy and safety study of mometasone furoate/formoterol 200/10 microg combination treatment in patients with persistent asthma previously receiving medium-dose inhaled corticosteroids. Allergy Asthma Proc. 2010 Jul-Aug;31(4):269-79. doi: 10.2500/aap.2010.31.3364. Epub 2010 Jul 30.
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.

The record lists no contact. Use the official record to reach the sponsor.

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 18 inclusion and 5 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 20 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. Some participants in this study may receive a placebo. 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 7 Mar 2011). 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?

Mean Area Under the Time Curve From 0 to 12 Hours (AUC(0-12 Hours)) of Change From Baseline to Week 12 in Forced Expiratory Volume (Liters) in 1 Second (FEV1) for MF/F Versus MF (time frame: Baseline to Endpoint (12 weeks)). The study lists 2 primary outcomes in all. 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 NCT00383240, 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 20 May 2024.