AsthmaPhase 3NCT00442117

A Comparison of Mometasone Furoate DPI Versus Budesonide DPI in Budesonide DPI in Asthmatics (Study P04880)

A Phase 3 study testing mometasone furoate dry powder inhaler and Budesonide DPI 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 dry powder inhaler and Budesonide DPI
Could I receive a placebo?: No, everyone receives an active treatment
How many people: 180 participants
Where: No sites listed yet
Study dates: Jun 2007to Jul 2009
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 must be 12 years of age or older of either gender, who (and their parent/guardian if the subject is under the age of 20) must demonstrate their willingness to sign and write informed consent.
Subjects must have had a history of asthma for at least 6 months.
The subject must be diagnosed mild persistent or moderate persistent asthma and his/her FEV1 must be >= 60% of predicted normal at both the Screening and Baseline visits, when short-acting inhaled beta agonists have been withheld for at least six hours and long-acting inhaled beta agonists have been withheld for at least 12 hours.
Subjects must demonstrate an increase in absolute FEV1 of >= 12%, with an absolute volume increase of at least 200 mL, after reversibility testing at the Screening visit, or historically within the past 12 months; Subjects without documented absolute FEV1 of >= 12% in reversibility test within the past 12 months need to demonstrate a positive result in Methacholine challenge test.
If Subjects with ICS treatment have been using ICS on a daily basis for at least 4 weeks prior to Screening. For the two weeks prior to Screening, subjects must have been on a stable regimen of ICS. Each ICS dose is shown in following:
Flunisolide between 1000 to 2000 mcg/day

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Budesonide between 400 to 800 mcg/day
Triamcinolone acetonide between 600 to 1600 mcg/day
Beclomethasone Dipropionate between 252 to 840 mcg/day
Fluticasone propionate between 200 to 500 mcg/day
Women of childbearing potential must have a negative urine (hCG) pregnancy test on the day of randomization (Baseline visit).
Women of childbearing potential (includes women who are less than 1 year postmenopausal) must be using or agree to use an acceptable method of birth control (e.g., hormonal contraceptive, medically prescribed IUD, condom in combination with spermicide) or be surgically sterilized (e.g., hysterectomy or tubal ligation) if they become sexually active.
Subjects must understand and be able to adhere to visit schedules and enter information in a daily diary.

Who cannot join

Female subjects who are pregnant, breast-feeding, or are pre-menarcheal.
Subjects who are heavy smokers (more than 10 pack years) or who smoked within previous 6 months.
Subjects who have required daily or alternate day oral corticosteroid treatment for more than a total of 14 days during the 3 months immediately prior to the Screening visit, and/or subjects who have required a course of systemic corticosteroids within the previous month.
Subjects who used Leukotriene modifiers within 2 weeks of screening.
Subjects who took immunosuppressive agents within the previous 3 months.
Subjects who use daily nebulized ß2-adrenergic agonists.

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Subjects who have had either an asthma exacerbation or a clinically relevant change in asthma medication within the last 4 weeks.
Subjects who have been admitted to the hospital for asthma control within the previous 3 months or have needed emergency service for asthma more than once within the previous 6 months.
Subjects who have required ventilator support for respiratory failure secondary to their asthma within the last 5 years.
Subjects who have used any investigational drug in the 30 days prior to Baseline, or subjects who have been treated with any investigational antibody for asthma in the 90 days prior to Baseline.
Subjects who are allergic or have had an idiosyncratic reaction to corticosteroids.
Subjects with evidence of clinically significant oropharyngeal candidiasis at Screening or Baseline.
Subjects with any clinically significant disorder of the cardiovascular, neurologic, hematologic, gastrointestinal, cerebrovascular, or immunologic system, or respiratory disease other than asthma (e.g. COPD), or any other disorder which may interfere with the study evaluations or affect subject safety.

About this study

Official title: A Comparison of Mometasone Furoate DPI Versus Budesonide DPI in Mild Persistent and Moderate Persistent Asthmatic Patients

This study will be an open-label, parallel-group comparison of Mometasone Furoate Dry Powder Inhaler (MF-DPI) 200 mcg once daily in the evening with two puffs vs. Budesonide Dry Powder Inhaler (BUD-DPI) 200 mcg twice daily with two puffs each time in patients previously treated with inhaled corticosteroids (ICS) or without ICS with diagnosed mild persistent or moderate persistent asthma (classified as Global Initiative For Asthma, 2005) in the previous 4 weeks. The primary efficacy endpoint is percent change from baseline in FEV1.

Conditions: Asthma
Being tested: mometasone furoate dry powder inhaler, Budesonide DPI
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 dry powder inhalerDrug
Also called Asmanex
MF DPI 200 mcg, two puffs once daily PM (total of 400 mcg/day) for 12 weeks.
Budesonide DPIDrug
Also called Pulmicort
Budesonide (BUD) DPI 200 mcg, two puffs twice daily (total of 800 mcg/day) for 12 weeks.

Study groups in NCT00442117
Study group	Role	What they receive
MF-DPI	Experimental	MF DPI 200 mcg, two puffs once daily PM (total of 400 mcg/day) Receives: Drug: mometasone furoate dry powder inhaler
BUD-DPI	Active comparator	Budesonide (BUD) DPI 200 mcg, two puffs twice daily (total of 800 mcg/day) Receives: Drug: Budesonide DPI

What is being measured

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

Mean Percent Change of Forced Expiratory Volume in One Second (FEV1) From Baseline to Week 12.
FEV1 (forced expiratory volume in one second) measurement at the Baseline visit was compared to the FEV1 measurement during the last visit at Week 12. The mean percent change was calculated.
Measured: Baseline and Week 12

Secondary outcomes (3)

Mean Percent Change of FVC (Forced Vital Capacity) From Baseline to Week 12.
The FVC measurement at the baseline was compared to the FVC measurement during the last visit at Week 12. The mean percent change was calculated.
Measured: Baseline and Week 12
Mean Percent Change of Forced Expiratory Flow (FEF) at (25-75% Interval) From Baseline to Week 12.
The FEF (25-75%) measurement at the baseline was compared to the FEF (25-75%) measurement during the last visit at Week 12. The mean percent change was calculated.
Measured: Baseline and Week 12
Mean Percent Change of AM PEFR (Peak Exploratory Flow Rate) From Baseline to Week 12.
The AM PEFR measurement at the Baseline visit was compared to the AM PEFR measurement during the last visit at Week 12. The mean percent change was calculated.
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.

Jun 2007Jul 2009

First posted1 Mar 2007 (estimated)
Study startJun 2007
Primary completionJul 2009
Study completionJul 2009

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: Randomised
Intervention model: Parallel groups
Masking: None (open label)
Enrolment: 180 participants (actual)

IDs, dates and publications

ClinicalTrials.gov ID: NCT00442117
Sponsor's protocol ID: P04880
Status last verified: Feb 2022
First submitted: 28 Feb 2007
Last updated: 20 May 2024
Results posted: Yes, on ClinicalTrials.gov
Data monitoring committee: No
Individual data sharing: No

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 Comparison of Mometasone Furoate DPI Versus Budesonide DPI in Mild Persistent and Moderate Persistent Asthmatic Patients
ClinicalTrials.gov ID: NCT00442117
Acronym / sponsor ID: P04880
Conditions: Asthma
Phase: Phase 3
Study type: Interventional
Recruitment status: Completed
Enrolment: 180 participants (actual)
Lead sponsor: Organon and CoIndustry (pharma, biotech, devices)
Study start: Jun 2007
Primary completion: Jul 2009 (actual)
Study completion: Jul 2009 (actual)
First posted: 1 Mar 2007 (estimated)
Results: Posted 10 Feb 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: None (open label)
Number of arms: 2

Arm	Type	Receives
MF-DPI	Experimental	Drug: mometasone furoate dry powder inhalerMF DPI 200 mcg, two puffs once daily PM (total of 400 mcg/day)
BUD-DPI	Active comparator	Drug: Budesonide DPIBudesonide (BUD) DPI 200 mcg, two puffs twice daily (total of 800 mcg/day)

Who may qualify

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

Key inclusion criteria (13 listed)

Subjects must be 12 years of age or older of either gender, who (and their parent/guardian if the subject is under the age of 20) must demonstrate their willingness to sign and write informed consent.
Subjects must have had a history of asthma for at least 6 months.
The subject must be diagnosed mild persistent or moderate persistent asthma and his/her FEV1 must be >= 60% of predicted normal at both the Screening and Baseline visits, when short-acting inhaled beta agonists have been withheld for at least six hours and long-acting inhaled beta agonists have been withheld for at least 12 hours.
Subjects must demonstrate an increase in absolute FEV1 of >= 12%, with an absolute volume increase of at least 200 mL, after reversibility testing at the Screening visit, or historically within the past 12 months; Subjects without documented absolute FEV1 of >= 12% in reversibility test within the past 12 months need to demonstrate a positive result in Methacholine challenge test.
If Subjects with ICS treatment have been using ICS on a daily basis for at least 4 weeks prior to Screening. For the two weeks prior to Screening, subjects must have been on a stable regimen of ICS. Each ICS dose is shown in following:

Key exclusion criteria (13 listed)

Female subjects who are pregnant, breast-feeding, or are pre-menarcheal.
Subjects who are heavy smokers (more than 10 pack years) or who smoked within previous 6 months.
Subjects who have required daily or alternate day oral corticosteroid treatment for more than a total of 14 days during the 3 months immediately prior to the Screening visit, and/or subjects who have required a course of systemic corticosteroids within the previous month.
Subjects who used Leukotriene modifiers within 2 weeks of screening.
Subjects who took immunosuppressive agents within the previous 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 dry powder inhalerAlso: AsmanexMF DPI 200 mcg, two puffs once daily PM (total of 400 mcg/day) for 12 weeks.	Drug	MF-DPI
Budesonide DPIAlso: PulmicortBudesonide (BUD) DPI 200 mcg, two puffs twice daily (total of 800 mcg/day) for 12 weeks.	Drug	BUD-DPI

Primary outcome

Mean Percent Change of Forced Expiratory Volume in One Second (FEV1) From Baseline to Week 12.
Time frame: Baseline and Week 12
FEV1 (forced expiratory volume in one second) measurement at the Baseline visit was compared to the FEV1 measurement during the last visit at Week 12. The mean percent change was calculated.

3 secondary outcomes

Mean Percent Change of FVC (Forced Vital Capacity) From Baseline to Week 12.
Time frame: Baseline and Week 12
Mean Percent Change of Forced Expiratory Flow (FEF) at (25-75% Interval) From Baseline to Week 12.
Time frame: Baseline and Week 12
Mean Percent Change of AM PEFR (Peak Exploratory Flow Rate) From Baseline to Week 12.
Time frame: Baseline and Week 12

Results and safety

Results posted to the registry on 10 Feb 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-DPI	85	47
BUD-DPI	87	49

Primary outcome: Mean Percent Change of Forced Expiratory Volume in One Second (FEV1) From Baseline to Week 12.

Time frame: Baseline and Week 12. Mean (Standard Deviation). Unit: Percent Change of FEV1

Measure	MF-DPI n = 85	BUD-DPI n = 87
Value	-1.09 (10.57)	-0.02 (10.17)

MF-DPI vs BUD-DPI: Mean Difference (Final Values): -1.074 (95% CI -4.196 to 2.049), p = 0.4982, ANOVA

Population analysed: Intent-to treat (ITT) population: All randomized patients who have taken at least one dose of study medication and have at least one post-baseline efficacy information.

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
MF-DPI	3 of 91 (3.3%)	13 of 91 (14.3%)	Not reported
BUD-DPI	2 of 89 (2.2%)	15 of 89 (16.9%)	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.
Individual participant dataSharing planned: No

Related trials for Asthma

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RecruitingPhase 1
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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?

A Phase 3 study testing mometasone furoate dry powder inhaler and Budesonide DPI 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 13 inclusion and 13 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 10 Feb 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 Percent Change of Forced Expiratory Volume in One Second (FEV1) From Baseline to Week 12. (time frame: Baseline and Week 12). 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 NCT00442117.

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.