AsthmaPhase 3NCT00379288

Study of Mometasone Furoate/Formoterol Combination and Fluticasone/Salmeterol in Persistent Asthmatics Previously Treated With Inhaled Glucocorticosteroids (P04139)

A Phase 3 study testing mometasone furoate combination MDI 200/10 mcg BID, mometasone furoate combination MDI 400/10 mcg BID and Fluticasone/Salmeterol 250/50 mcg BID 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

The purpose of this study is to evaluate the long-term safety of mometasone furoate/formoterol (MF/F) metered dose inhaler (MDI) 200/10 mcg twice-a-day (BID) and MF/F MDI 400/10 mcg BID and two doses of fluticasone/salmeterol combination (F/SC) (250/50 mcg BID and 500/50 mcg BID) in subjects with persistent asthma who… 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 combination MDI 200/10 mcg BID, mometasone furoate combination MDI 400/10 mcg BID and Fluticasone/Salmeterol 250/50 mcg BID
Could I receive a placebo?: No, everyone receives an active treatment
How many people: 404 participants
Where: No sites listed yet
Study dates: Jun 2006to Nov 2007
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

Subjects of either sex and any race, at least 12 years of age, with a diagnosis of asthma of at least 12 months.
Use of medium or high daily dose of ICS (alone or in combination with long-acting beta-agonist [LABA]) for at least 12 weeks prior to Screening and have been on a stable regimen for at least 2 weeks prior to Screening.
Medium daily doses of ICS:
> 500 to 1000 mcg beclomethasone chlorofluorocarbon (CFC)
> 250 to 500 mcg beclomethasone hydrofluoroalkane (HFA)
> 600 to 1000 mcg budesonide dry powder inhaler (DPI)

Show all 29Show fewer

> 1000 to 2000 mcg flunisolide
> 250 to 500 mcg fluticasone
400 mcg MF
> 1000 to 2000 mcg triamcinolone acetonide
High daily doses of ICS:
> 1000 mcg beclomethasone CFC
> 500 mcg beclomethasone HFA
> 1000 mcg budesonide DPI
> 2000 mcg flunisolide
> 500 mcg fluticasone
> 400 mcg MF
> 2000 mcg triamcinolone acetonide
If there is no inherent harm in changing the subject's current asthma therapy, the subject must discontinue prescribed ICS or ICS/LABA combination at Baseline.
Must show evidence of reversibility within the last 12 months or during the Screening Period. Historical reversibility defined as an increase in absolute forced expiratory volume in 1 second (FEV1) of >= 12% and >= 200 mL will qualify if performed within 12 months of Screening. If no historical reversibility, subject must demonstrate an absolute FEV1 of >= 12% and >= 200 mL within 10 to 15 minutes after four puffs of salbutamol at Visit 1 or anytime prior to Baseline.
At Screening and Baseline, FEV1 must be >= 50% predicted, when restricted medications are withheld for the appropriate intervals.
Complete blood count, blood chemistries, urinalysis, and electrocardiogram (ECG) conducted at Screening must be within normal limits or clinically acceptable to the investigator/sponsor. A chest x-ray performed at Screening or within 12 months prior must be clinically acceptable.
A female of childbearing potential must be using a medically acceptable, adequate form of birth control:
prescribed hormonal contraceptives;
medically prescribed intrauterine device (IUD);
medically prescribed transdermal contraceptive;
condom in combination with spermicide;
monogamous relationship with a male partner who has had a vasectomy.
Birth control must have started at least 3 months prior to Screening. Subject must agree to continue its use for the duration of the study. A subject of childbearing potential who is not currently sexually active must agree to use a medically acceptable method should she become sexually active during the study. Women who have been surgically sterilized or are at least 1 year postmenopausal are not considered to be of childbearing potential. A subject of childbearing potential must have a negative serum pregnancy test at Screening.

Who cannot join

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 > 12 inhalations per day of short-acting beta-agonist (SABA) MDI or > 2 nebulized treatments per day of 2.5 mg salbutamol, on any 2 consecutive days from the Screening Visit up to, and including, the Baseline Visit.
A subject who experiences a clinical asthma exacerbation (defined as a deterioration of asthma that results in emergency treatment, hospitalization due to asthma, or treatment with additional, excluded asthma medication [other than SABA]) at any time from the Screening Visit up to, and including, the Baseline Visit.
A subject who has ever required ventilator support for respiratory failure secondary to asthma.
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 1-Year Safety Study of Medium and High Doses of Mometasone Furoate/Formoterol Combination Formulation and Medium and High Doses of Fluticasone/Salmeterol in Persistent Asthmatics Previously Treated With Medium to High Doses of Inhaled Glucocorticosteroids

In addition, the extrapulmonary effects on 24-hour plasma cortisol area under curve (AUC), of MF/F MDI 200/10 mcg BID, MF/F MDI 400/10 mcg BID, F/SC MDI 250/50 mcg BID, and F/SC MDI 500/50 mcg BID will be evaluated.

Conditions: Asthma
Being tested: mometasone furoate combination MDI 200/10 mcg BID, mometasone furoate combination MDI 400/10 mcg BID, Fluticasone/Salmeterol 250/50 mcg BID, Fluticasone/Salmeterol 500/50 mcg BID
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 combination MDI 200/10 mcg BIDDrug
Also called SCH 418131
MF/F 200/10 mcg via a metered dose inhaler (MDI) twice daily for 1 year
mometasone furoate combination MDI 400/10 mcg BIDDrug
Also called SCH 418131
MF/F 400/10 mcg via a metered dose inhaler (MDI) twice daily for 1 year
Fluticasone/Salmeterol 250/50 mcg BIDDrug
Also called Seretide
F/SC 250/50 twice daily for 1 year
Fluticasone/Salmeterol 500/50 mcg BIDDrug
Also called Seretide
F/SC 500/50 twice daily for 1 year

Study groups in NCT00379288
Study group	Role	What they receive
MF/F 200/10 mcg BID	Experimental	Not described Receives: Drug: mometasone furoate combination MDI 200/10 mcg BID
MF/F 400/10 mcg BID	Experimental	Not described Receives: Drug: mometasone furoate combination MDI 400/10 mcg BID
F/SC 250/50 mcg BID	Active comparator	Not described Receives: Drug: Fluticasone/Salmeterol 250/50 mcg BID
F/SC 500/50 mcg BID	Active comparator	Not described Receives: Drug: Fluticasone/Salmeterol 500/50 mcg BID

What is being measured

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

The Number of All Randomized Subjects Reporting Adverse Events (AEs).
AEs that are considered Related, Severe, and Serious, as determined by the investigator and using specific criteria defined in the protocol, are included in the primary results.
Measured: 1 year

Timeline

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

Jun 2006Nov 2007

First posted21 Sep 2006 (estimated)
Study startJun 2006
Primary completionNov 2007
Study completionNov 2007

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 (3)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: None (open label)
Enrolment: 404 participants (actual)

IDs, dates and publications

ClinicalTrials.gov ID: NCT00379288
Sponsor's protocol ID: P04139
Status last verified: Feb 2022
First submitted: 19 Sep 2006
Last updated: 20 May 2024
Results posted: Yes, on ClinicalTrials.gov
Data monitoring committee: No
Individual data sharing: No

Publications

Maspero JF, Nolte H, Cherrez-Ojeda I; P04139 Study Group. Long-term safety of mometasone furoate/formoterol combination for treatment of patients with persistent asthma. J Asthma. 2010 Dec;47(10):1106-15. doi: 10.3109/02770903.2010.514634. Epub 2010 Nov 1.
PubMed 20874458
Oba 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
Maspero J, Cherrez I, Doherty DE, Tashkin DP, Kuna P, Kuo WL, Gates D, Nolte H, Chylack LT Jr. Appraisal of lens opacity with mometasone furoate/formoterol fumarate combination in patients with COPD or asthma. Respir Med. 2014 Sep;108(9):1355-62. doi: 10.1016/j.rmed.2014.04.015. Epub 2014 May 2.
PubMed 25044280

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

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

All Asthma trials

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 1-Year Safety Study of Medium and High Doses of Mometasone Furoate/Formoterol Combination Formulation and Medium and High Doses of Fluticasone/Salmeterol in Persistent Asthmatics Previously Treated With Medium to High Doses of Inhaled Glucocorticosteroids
ClinicalTrials.gov ID: NCT00379288
Acronym / sponsor ID: P04139
Conditions: Asthma
Phase: Phase 3
Study type: Interventional
Recruitment status: Completed
Enrolment: 404 participants (actual)
Lead sponsor: Organon and CoIndustry (pharma, biotech, devices)
Study start: Jun 2006
Primary completion: Nov 2007 (actual)
Study completion: Nov 2007 (actual)
First posted: 21 Sep 2006 (estimated)
Results: Posted 12 Aug 2010

Clinical summary

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

Study design

Primary purpose: Treatment
Allocation: Randomised
Intervention model: Parallel groups
Masking: None (open label)
Number of arms: 4

Arm	Type	Receives
MF/F 200/10 mcg BID	Experimental	Drug: mometasone furoate combination MDI 200/10 mcg BID
MF/F 400/10 mcg BID	Experimental	Drug: mometasone furoate combination MDI 400/10 mcg BID
F/SC 250/50 mcg BID	Active comparator	Drug: Fluticasone/Salmeterol 250/50 mcg BID
F/SC 500/50 mcg BID	Active comparator	Drug: Fluticasone/Salmeterol 500/50 mcg BID

Who may qualify

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

Key inclusion criteria (29 listed)

Subjects of either sex and any race, at least 12 years of age, with a diagnosis of asthma of at least 12 months.
Use of medium or high daily dose of ICS (alone or in combination with long-acting beta-agonist [LABA]) for at least 12 weeks prior to Screening and have been on a stable regimen for at least 2 weeks prior to Screening.
If there is no inherent harm in changing the subject's current asthma therapy, the subject must discontinue prescribed ICS or ICS/LABA combination at Baseline.
Must show evidence of reversibility within the last 12 months or during the Screening Period. Historical reversibility defined as an increase in absolute forced expiratory volume in 1 second (FEV1) of >= 12% and >= 200 mL will qualify if performed within 12 months of Screening. If no historical reversibility, subject must demonstrate an absolute FEV1 of >= 12% and >= 200 mL within 10 to 15 minutes after four puffs of salbutamol at Visit 1 or anytime prior to Baseline.
At Screening and Baseline, FEV1 must be >= 50% predicted, when restricted medications are withheld for the appropriate intervals.

Key exclusion criteria (5 listed)

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 > 12 inhalations per day of short-acting beta-agonist (SABA) MDI or > 2 nebulized treatments per day of 2.5 mg salbutamol, on any 2 consecutive days from the Screening Visit up to, and including, the Baseline Visit.
A subject who experiences a clinical asthma exacerbation (defined as a deterioration of asthma that results in emergency treatment, hospitalization due to asthma, or treatment with additional, excluded asthma medication [other than SABA]) at any time from the Screening Visit up to, and including, the Baseline Visit.
A subject who has ever required ventilator support for respiratory failure secondary to asthma.
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 combination MDI 200/10 mcg BIDAlso: SCH 418131MF/F 200/10 mcg via a metered dose inhaler (MDI) twice daily for 1 year	Drug	MF/F 200/10 mcg BID
mometasone furoate combination MDI 400/10 mcg BIDAlso: SCH 418131MF/F 400/10 mcg via a metered dose inhaler (MDI) twice daily for 1 year	Drug	MF/F 400/10 mcg BID
Fluticasone/Salmeterol 250/50 mcg BIDAlso: SeretideF/SC 250/50 twice daily for 1 year	Drug	F/SC 250/50 mcg BID
Fluticasone/Salmeterol 500/50 mcg BIDAlso: SeretideF/SC 500/50 twice daily for 1 year	Drug	F/SC 500/50 mcg BID

Primary outcome

The Number of All Randomized Subjects Reporting Adverse Events (AEs).
Time frame: 1 year
AEs that are considered Related, Severe, and Serious, as determined by the investigator and using specific criteria defined in the protocol, are included in the primary results.

Results and safety

Results posted to the registry on 12 Aug 2010, 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 200/10 mcg BID	141	122
MF/F 400/10 mcg BID	130	108
F/SC 250/50 mcg BID	68	58
F/SC 500/50 mcg BID	65	57

Primary outcome: The Number of All Randomized Subjects Reporting Adverse Events (AEs).

Time frame: 1 year. Number. Unit: participants

Measure	MF/F 200/10 mcg BID n = 141	MF/F 400/10 mcg BID n = 130	F/SC 250/50 mcg BID n = 68	F/SC 500/50 mcg BID n = 65
Treatment-Emergent Adverse Events (TEAE)	109	103	56	50
Related Adverse Events	40	30	16	13
Severe Adverse Events	8	5	4	4
Serious Adverse Events	7	8	4	2

MF/F 200/10 mcg BID: percentage of subjects with TEAEs: 77.4
MF/F 200/10 mcg BID: percentage of subjects with related AEs: 28.4
MF/F 200/10 mcg BID: percentage of subjects with severe AEs: 5.7

Adverse events

Other adverse events reported at 5% frequency or more

Group	Serious adverse events	Other adverse events	Deaths
MF/F MDI 200/10 mcg BID	7 of 141 (5%)	93 of 141 (66%)	Not reported
MF/F MDI 400/10 mcg BID	8 of 130 (6.2%)	82 of 130 (63.1%)	Not reported
F/SC MDI 250/50 mcg BID	4 of 68 (5.9%)	51 of 68 (75%)	Not reported
F/SC MDI 500/50 mcg BID	2 of 65 (3.1%)	41 of 65 (63.1%)	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.
Results publication: PubMed 20874458Maspero JF, Nolte H, Cherrez-Ojeda I; P04139 Study Group. Long-term safety of mometasone furoate/formoterol combination for treatment of patients with persistent asthma. J Asthma. 2010 Dec;47(10):1106-15. doi: 10.3109/02770903.2010.514634. Epub 2010 Nov 1.
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.
Derived from this study: PubMed 25044280Maspero J, Cherrez I, Doherty DE, Tashkin DP, Kuna P, Kuo WL, Gates D, Nolte H, Chylack LT Jr. Appraisal of lens opacity with mometasone furoate/formoterol fumarate combination in patients with COPD or asthma. Respir Med. 2014 Sep;108(9):1355-62. doi: 10.1016/j.rmed.2014.04.015. Epub 2014 May 2.
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
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RecruitingPhase 3
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Active, not recruitingPhase 2/3
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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 29 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. 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 12 Aug 2010). 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?

The Number of All Randomized Subjects Reporting Adverse Events (AEs). (time frame: 1 year). 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 NCT00379288, which also lists 3 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 20 May 2024.