AsthmaPhase 3NCT00383552

Effects of Mometasone Furoate/Formoterol Combination Versus Mometasone Furoate Alone in Persistent Asthmatics (Study P04073AM1)(COMPLETED)

A Phase 3 study testing Mometasone Furoate/Formoterol Fumarate Combination MDI 100/10 mcg BID, Mometasone Furoate MDI (MF MDI) 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 100/10 mcg BID, Mometasone Furoate MDI (MF MDI) and Formoterol Fumarate 10 mcg
Could I receive a placebo?: Yes, some participants may receive a placebo
How many people: 746 participants
Where: No sites listed yet
Study dates: Sep 2006to Aug 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

>=12 years, either sex, any race, asthma diagnosis >=12 months that is consistent with the following: Diagnosis based on clinical history \& examination, pulmonary function parameters \& response to beta-2-agonists, according to international guidelines.
Been using low daily dose of inhaled corticosteroid (ICS) (either alone or in combination with long-acting beta agonist [LABA]) >=12 weeks \& been on stable asthma regimen for >=2 weeks prior to Screening. Low daily doses of ICS are:
200-500 mcg beclomethasone chlorofluorocarbon (CFC),
100-250 mcg beclomethasone hydrofluoroalkane (HFA),
200-600 mcg budesonide dry powder inhaler (DPI),
500-1000 mcg flunisolide,

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100-250 mcg fluticasone,
200 mcg MF,
400-1000 mcg triamcinolone acetonide,
80 to 160 mcg ciclesonide.
Note: Dose delivery by method/modality other than these must be equivalent.
No harm in changing current asthma therapy to investigator, subject (legal representation, if applicable) must be willing to discontinue his/her ICS or ICS/LABA combination prior to initiating MF MDI run-in medication at Screening Visit, \& transferred to open-label treatment with MF MDI 100 mcg BID for 2-3 weeks prior to Baseline Visit.
To document diagnosis of asthma \& assure responsiveness to bronchodilators before randomization 1 of these can be used at Screening Visit or thereafter, but prior to Baseline Visit:
Demonstrate increase in absolute FEV1 >=12% \& >=200 mL within approximately 15 to 20 minutes after administration of 4 inhalations of albuterol/salbutamol (total dose 360-400 mcg) or nebulized short-acting beta agonist (SABA) (2.5 mg) if confirmed as standard office practice, OR
Demonstrate peak expiratory flow (PEF) variability >20% expressed as percentage of the mean highest \& lowest morning prebronchodilator (before taking albuterol/salbutamol) PEF over >=1 week, OR
Demonstrate diurnal variation in PEF of >20% based on difference between prebronchodilator (before taking albuterol/salbutamol) morning value \& postbronchodilator value (after taking albuterol/salbutamol) from evening before, expressed as percentage of mean daily PEF value.
At Screening Visit, FEV1 must be >=60% \& <=90% predicted.
At Baseline Visit, FEV1 must be >=60% \& <=85% predicted when all restricted drugs have been withheld for appropriate intervals.
Lab tests at Screening Visit must be normal or acceptable to investigator/sponsor and include serum pregnancy for females of child-bearing potential). Electrocardiogram (ECG) at Screening Visit, using centralized trans-telephonic technology must be acceptable to investigator. Chest x-ray performed at Screening Visit or within 12 months prior to Screening Visit must be acceptable to investigator.
Subject (legal representation, if applicable) must be willing to give written informed consent \& able to adhere to schedules.
A non-pregnant woman of childbearing potential must use birth control. Includes: hormonal contraceptives including hormonal vaginal ring, hormonal implant or depot-injectable; Intrauterine device (IUD); medically prescribed topically-applied transdermal contraceptive patch; condom in combination with spermicide; monogamous relationship with male who had vasectomy. Started birth control method >=3 months prior to Screening (exception condom), \& must agree to continue its use. Female of childbearing potential who is not currently sexually active must agree \& consent to using birth control, should she become active. Women who have been surgically sterilized or are >=1 year postmenopausal are not considered to be of childbearing potential. Female must have negative serum pregnancy test at Screening.

Who cannot join

Increase/decrease in absolute FEV1 of >20% at any time from Screening Visit up to \& including Baseline Visit. Pulmonary function tests (PFTs) will be performed in the morning.
>8 inhalations/day of SABA MDI or >=2 nebulized treatments/day of 2.5 mg SABA on 2 consecutive days from Screening Visit up to \& including Baseline Visit.
Decrease in AM/PM PEF below Screening Period stability limit on 2 consecutive days prior to randomization.
Asthma deterioration results in emergency treatment, hospitalization, or treatment with additional, excluded asthma medication (including oral or other systemic corticosteroids, but allowing SABA) as judged by investigator at any time from Screening Visit up to \& including Baseline Visit.
Treated in emergency room (ER) (for severe asthma exacerbation requiring systemic glucocorticosteroid treatment) or admitted to hospital for management of airway obstruction within last 3 months.
Ever required ventilator support for respiratory failure secondary to asthma.

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Upper/lower respiratory tract infection within previous 2 weeks prior to Screening \& Baseline Visits. Visits can be rescheduled 2 weeks after complete resolution.
Smoker or ex-smoker \& has smoked within previous year or has cumulative smoking history >10 pack-years.
Significant abnormal vital sign.
Evidence upon visual inspection of significant oropharyngeal candidiasis at Baseline or earlier with or without treatment. If there is evidence at Screening or Pre-Baseline Visit, may be treated as appropriate \& Baseline Visit can be scheduled upon resolution.
History of significant renal, hepatic, cardiovascular, metabolic, neurologic, hematologic, ophthalmologic, respiratory, gastrointestinal, cerebrovascular, or other which, in judgment of investigator, could interfere with study or require treatment which might interfere with study. Examples include (but are not limited to) insulin-dependent diabetes, hypertension being treated with beta-blockers, active hepatitis, coronary artery disease, arrhythmia, significant QTc prolongation (ie QTcF or QTcB [Fridericia or Bazett corrections, respectively >500 msecs), stroke, severe rheumatoid arthritis, chronic open-angle glaucoma or posterior subcapsular cataracts (including prior cataract surgery), acquired immune deficiency syndrome (AIDS), or conditions that may interfere with respiratory function such as chronic obstructive pulmonary disease (COPD), chronic bronchitis, emphysema, bronchiectasis, cystic fibrosis. Others which are well-controlled \& stable (eg hypertension not requiring beta-blockers) will not prohibit participation if deemed appropriate by investigator.
Allergic/intolerant of glucocorticoids, beta-2-agonists, or any inactive excipients in study drugs.
Female who is breast-feeding, pregnant, or intends to become pregnant while in study.
Illicit drug user.
Human immunodeficiency virus (HIV) positive (testing not done).
Unable to use oral MDI inhaler.
Has been taking any restricted medications prior to Screening without meeting required washout.
Cannot adhere to prohibited \& permitted concomitant medications.
May not participate in same study at another site. Cannot participate in different study at any site, during same time.
Must not be randomized into study more than once.
No person directly associated with administration of study may participate.
Previously participated in trial with MF/F.

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 Low-Dose Inhaled Glucocorticosteroids

This is a randomized, multi-center, double-blind, double-dummy, placebo-controlled, parallel-group study, evaluating the efficacy of mometasone furoate/formoterol fumarate (MF/F) metered dose inhaler (MDI) versus MF for 26 weeks. Prior to the 26-week double-blind Treatment Period, participants will receive open-label (OL) MF MDI 100 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) and by the time-to-first severe asthma exacerbation across the 26-week treatment period.

Conditions: Asthma
Being tested: Mometasone Furoate/Formoterol Fumarate Combination MDI 100/10 mcg BID, Mometasone Furoate MDI (MF MDI), 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 100/10 mcg BIDDrug
Also called SCH 418131
MF/F 100/10 mcg via a metered dose inhaler (MDI) twice daily for 26 weeks
Mometasone Furoate MDI (MF MDI)Drug
Also called SCH 32088
MF 100 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 NCT00383552
Study group	Role	What they receive
MF/F MDI 100/10 mcg BID	Experimental	Not described Receives: Drug: Mometasone Furoate/Formoterol Fumarate Combination MDI 100/10 mcg BID
MF MDI 100 mcg BID	Experimental	Not described Receives: Drug: Mometasone Furoate MDI (MF MDI)
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)
The average of the two predose FEV1 measurements (30 minutes prior to dosing and 0 hour, immediately prior to dosing) at the Baseline Visit were subtracted from each of the serial measurements over the 12-hour period. The AUC was calculated based on these changes from Baseline evaluations. The comparison was for MF/F vs MF. Standard deviation was pooled.
Measured: Baseline to Week 12
Median Time-to-first Severe Asthma Exacerbation Over the 26-week Treatment Period
Severe asthma exacerbation refers to an occurrence of a decrease below 80% of Baseline in FEV1, a decrease below 70% of Baseline in PEF on 2 consecutive days or a clinical deterioration of asthma resulting in emergency treatment, hospitalization or treatment with asthma medication.
Measured: Across the 26 week treatment period
Number of Participants With at Least One Severe Asthma Exacerbation at Week 26
Severe asthma exacerbation refers to an occurrence of a decrease below 80% of Baseline in FEV1, a decrease below 70% of Baseline in PEF on 2 consecutive days and or a clinical deterioration of asthma resulting in emergency treatment, hospitalization or treatment with asthma medication.
Measured: Week 26

Secondary outcomes (5)

Change From Baseline to Week 26 in the Asthma Control Questionnaire (ACQ) Total Score
ACQ consists of seven questions each scaled from 0 (best case) to 6 (worst case). The comparison was for MF/F vs placebo. Standard deviation was pooled.
Measured: Baseline to Week 26
Change From Baseline to Week 26 in Asthma Quality of Life Questionnaire With Standarized Activities (AQLQ[S]) Total Score
AQLQ(S) consists of 32 questions each scaled from 1 (worst case) to 7 (best case). The comparison was for MF/F vs placebo. Standard deviation was pooled.
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 Agonists (SABA)
Baseline is the proportion of nights of the 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. The comparison was for MF/F vs placebo. Standard deviation was pooled.
Measured: Baseline to Endpoint
Change From Baseline in AM FEV1 Pre-dose Assessment, or Trough FEV1, at Week 12
Trough FEV1 is a measure of the end-of-dosing interval. The comparison was for MF/F vs F. Standard deviation was pooled.
Measured: Baseline to Week 12
AUC(0-12 Hour) of the Change From Baseline to Week 12 in FEV1 for Each Body Mass Index (BMI) Subgroup
The average of the two predose FEV1 measurements (30 minutes prior to dosing and 0 hour, immediately prior to dosing) at the Baseline Visit were subtracted from each of the serial measurements over the 12-hour period. The AUC was calculated based on these changes from Baseline evaluations. BMI is a number calculated from a person's weight and height. The higher the number, the higher the amount of fat. The comparison was for MF/F vs placebo. Standard deviation was pooled.
Measured: Baseline to Week 12

Timeline

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

Sep 2006Aug 2008

First posted3 Oct 2006 (estimated)
Study startSep 2006
Primary completionAug 2008
Study completionAug 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: 746 participants (actual)

IDs, dates and publications

ClinicalTrials.gov ID: NCT00383552
Sponsor's protocol ID: P04073
Other IDs: Doc ID: 3100873;, EUDRACT No: 2006-001577-13;
Status last verified: Feb 2022
First submitted: 29 Sep 2006
Last updated: 17 May 2024
Results posted: Yes, on ClinicalTrials.gov
Data monitoring committee: No
Individual data sharing: No

Publications

Meltzer EO, Kuna P, Nolte H, Nayak AS, Laforce C; P04073 Study Investigators. Mometasone furoate/formoterol reduces asthma deteriorations and improves lung function. Eur Respir J. 2012 Feb;39(2):279-89. doi: 10.1183/09031936.00020310. Epub 2011 Aug 4.
PubMed 21828036

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 17 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 Low-Dose Inhaled Glucocorticosteroids
ClinicalTrials.gov ID: NCT00383552
Acronym / sponsor ID: P04073
Conditions: Asthma
Phase: Phase 3
Study type: Interventional
Recruitment status: Completed
Enrolment: 746 participants (actual)
Lead sponsor: Organon and CoIndustry (pharma, biotech, devices)
Collaborators: Novartis
Study start: Sep 2006
Primary completion: Aug 2008 (actual)
Study completion: Aug 2008 (actual)
First posted: 3 Oct 2006 (estimated)
Results: Posted 25 Oct 2011

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: Double blind (participant, investigator)
Number of arms: 4

Arm	Type	Receives
MF/F MDI 100/10 mcg BID	Experimental	Drug: Mometasone Furoate/Formoterol Fumarate Combination MDI 100/10 mcg BID
MF MDI 100 mcg BID	Experimental	Drug: Mometasone Furoate MDI (MF MDI)
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 (21 listed)

>=12 years, either sex, any race, asthma diagnosis >=12 months that is consistent with the following: Diagnosis based on clinical history \& examination, pulmonary function parameters \& response to beta-2-agonists, according to international guidelines.
Been using low daily dose of inhaled corticosteroid (ICS) (either alone or in combination with long-acting beta agonist [LABA]) >=12 weeks \& been on stable asthma regimen for >=2 weeks prior to Screening. Low daily doses of ICS are:
200-500 mcg beclomethasone chlorofluorocarbon (CFC),
100-250 mcg beclomethasone hydrofluoroalkane (HFA),
200-600 mcg budesonide dry powder inhaler (DPI),

Key exclusion criteria (22 listed)

Increase/decrease in absolute FEV1 of >20% at any time from Screening Visit up to \& including Baseline Visit. Pulmonary function tests (PFTs) will be performed in the morning.
>8 inhalations/day of SABA MDI or >=2 nebulized treatments/day of 2.5 mg SABA on 2 consecutive days from Screening Visit up to \& including Baseline Visit.
Decrease in AM/PM PEF below Screening Period stability limit on 2 consecutive days prior to randomization.
Asthma deterioration results in emergency treatment, hospitalization, or treatment with additional, excluded asthma medication (including oral or other systemic corticosteroids, but allowing SABA) as judged by investigator at any time from Screening Visit up to \& including Baseline Visit.
Treated in emergency room (ER) (for severe asthma exacerbation requiring systemic glucocorticosteroid treatment) or admitted to hospital for management of airway obstruction within last 3 months.

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 100/10 mcg BIDAlso: SCH 418131MF/F 100/10 mcg via a metered dose inhaler (MDI) twice daily for 26 weeks	Drug	MF/F MDI 100/10 mcg BID
Mometasone Furoate MDI (MF MDI)Also: SCH 32088MF 100 mcg via metered dose inhaler twice daily for 26 weeks	Drug	MF MDI 100 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)
Time frame: Baseline to Week 12
The average of the two predose FEV1 measurements (30 minutes prior to dosing and 0 hour, immediately prior to dosing) at the Baseline Visit were subtracted from each of the serial measurements over the 12-hour period. The AUC was calculated based on these changes from Baseline evaluations. The comparison was for MF/F vs MF. Standard deviation was pooled.
Median Time-to-first Severe Asthma Exacerbation Over the 26-week Treatment Period
Time frame: Across the 26 week treatment period
Severe asthma exacerbation refers to an occurrence of a decrease below 80% of Baseline in FEV1, a decrease below 70% of Baseline in PEF on 2 consecutive days or a clinical deterioration of asthma resulting in emergency treatment, hospitalization or treatment with asthma medication.
Number of Participants With at Least One Severe Asthma Exacerbation at Week 26
Time frame: Week 26
Severe asthma exacerbation refers to an occurrence of a decrease below 80% of Baseline in FEV1, a decrease below 70% of Baseline in PEF on 2 consecutive days and or a clinical deterioration of asthma resulting in emergency treatment, hospitalization or treatment with asthma medication.

5 secondary outcomes

Change From Baseline to Week 26 in the Asthma Control Questionnaire (ACQ) Total Score
Time frame: Baseline to Week 26
Change From Baseline to Week 26 in Asthma Quality of Life Questionnaire With Standarized Activities (AQLQ[S]) Total 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 Agonists (SABA)
Time frame: Baseline to Endpoint
Change From Baseline in AM FEV1 Pre-dose Assessment, or Trough FEV1, at Week 12
Time frame: Baseline to Week 12
AUC(0-12 Hour) of the Change From Baseline to Week 12 in FEV1 for Each Body Mass Index (BMI) Subgroup
Time frame: Baseline to Week 12

Results and safety

Results posted to the registry on 25 Oct 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 100/10 mcg BID	182	146
MF MDI 100 mcg BID	188	147
F MDI 10 mcg BID	188	127
Placebo BID	188	116

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)

Time frame: Baseline to Week 12. Least squares mean (Standard Deviation). Unit: liters * hours

Measure	MF/F MDI 100/10 mcg BID n = 155	MF MDI 100 mcg BID n = 156	F MDI 10 mcg BID n = 146	Placebo BID n = 129
Baseline	3.94 (3.29)	1.85 (3.29)	4.09 (3.29)	1.64 (3.29)
Change from Baseline	4.00 (3.71)	2.53 (3.71)	3.83 (3.71)	1.11 (3.71)

MF/F MDI 100/10 mcg BID vs MF MDI 100 mcg BID: p = 0.001, ANCOVA

Population analysed: Efficacy analyses were based on randomized participants with Baseline and any post-baseline data (intent-to-treat principle).

Primary outcome: Median Time-to-first Severe Asthma Exacerbation Over the 26-week Treatment Period

Time frame: Across the 26 week treatment period. Median (Inter-Quartile Range). Unit: Days

Measure	MF/F MDI 100/10 Mcg BID n = 30	MF MDI 100 Mcg BID n = 53	F MDI 10 Mcg BID n = 84	Placebo BID n = 86
Value	45.5 (101)	54 (98)	51.5 (125.5)	27.5 (87)

Population analysed: Medians for time-to-event outcomes are estimated for those who had events.

Primary outcome: Number of Participants With at Least One Severe Asthma Exacerbation at Week 26

Time frame: Week 26. Number. Unit: participants

Measure	MF/F MDI 100/10 mcg BID n = 155	MF MDI 100 mcg BID n = 156	F MDI 10 mcg BID n = 146	Placebo BID n = 129
Value	30	53	84	86

5 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 100 MCG BID	2 of 882 (0.2%)	22 of 882 (2.5%)	Not reported
MF/F MDI 100/10 MCG BID	4 of 182 (2.2%)	33 of 182 (18.1%)	Not reported
MF MDI 100 MCG BID	5 of 188 (2.7%)	37 of 188 (19.7%)	Not reported
F MDI 10 MCG BID	1 of 188 (0.5%)	32 of 188 (17%)	Not reported
PLACEBO	1 of 188 (0.5%)	24 of 188 (12.8%)	Not reported

Loading the posted results from ClinicalTrials.gov…

Research links

Official record on ClinicalTrials.govLast updated by the sponsor 17 May 2024.
Posted resultsParticipant flow, baseline, all outcome measures and adverse events.
Results publication: PubMed 21828036Meltzer EO, Kuna P, Nolte H, Nayak AS, Laforce C; P04073 Study Investigators. Mometasone furoate/formoterol reduces asthma deteriorations and improves lung function. Eur Respir J. 2012 Feb;39(2):279-89. doi: 10.1183/09031936.00020310. Epub 2011 Aug 4.
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 21 inclusion and 22 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 17 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 25 Oct 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) (time frame: Baseline to Week 12). The study lists 3 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 NCT00383552, 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 17 May 2024.