AsthmaPhase 3NCT00604500

A Patient Handling Study of Mometasone Furoate/Formortoral Fumarate (MF/F) Metered Dose Inhaler (MDI) With an Integrated Dose Counter in Adolescent and Adult Subjects With Asthma or Chronic Obstructive Pulmonary Disease (Study P04703AM1)

A Phase 3 study testing SCH No. 418131 (Mometasone Furoate/Formoterol Furoate abbreviated MF/F ) in people with Asthma and COPD, 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, COPD
What is being tested?: SCH No. 418131 (Mometasone Furoate/Formoterol Furoate abbreviated MF/F )
Could I receive a placebo?: No, everyone receives an active treatment
How many people: 272 participants
Where: No sites listed yet
Study dates: 1 Mar 2008to 1 Nov 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

None listed.

Who cannot join

Participants with a serious uncontrolled medical disorder, which in the judgment of the investigator, could have interfered with the study, or required treatment which might interfere with the study.
Participants who in the judgment of the investigator and/or sponsor had a significant recent or current, repetitive strain injury (RSI) that may have impacted their ability to effectively participate in the full duration of the study.

About this study

Official title: An Open-Label, Multi-Center, Patient Handling Study of Mometasone Furoate/Formoterol Fumarate MDI With an Integrated Dose Counter in Adolescent and Adult Subjects and Adult With Asthma or COPD

This was an open-label, multiple-dose, study of mometasone furoate/formoterol fumarate (MF/F) metered dose inhaler (MDI) 100/10 micrograms (mcg) twice daily (BID) (2 puffs of MF/F MDI 50/5 mcg, administered twice a day approximately 12 hours apart) in participants 12 years of age or older, with a diagnosis of persistent asthma or chronic obstructive pulmonary disease (COPD) of at least 12 months. The primary purpose of the study was to evaluate the performance of the MF/F MDI integrated dose counter under normal patient handling conditions.

Conditions: Asthma, COPD
Being tested: SCH No. 418131 (Mometasone Furoate/Formoterol Furoate abbreviated MF/F )
Medical subject headings: Asthma, Pulmonary Disease, Chronic Obstructive

What participants receive

What participants receive. In a randomised study each person is assigned to one group by chance.

SCH No. 418131 (Mometasone Furoate/Formoterol Furoate abbreviated MF/F )Drug
MF/F MDI 100/10 mcg BID with an integrated dose counter (administered as two inhalations of MF/F MDI 50/5 mcg, twice a day) over a 4-week Treatment Period.

Study groups in NCT00604500
Study group	Role	What they receive
MF/F MDI 100/10 mcg BID with dose counter	Experimental	MF/F MDI 100/10 mcg BID with an integrated dose counter (administered as two inhalations of MFF MDI 50/5 mcg, twice a day) over a 4-week Treatment Period. Receives: Drug: SCH No. 418131 (Mometasone Furoate/Formoterol Furoate abbreviated MF/F )

What is being measured

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

Overall Discrepancy Rate
Overall discrepancies refer to the difference between the participant-recorded number of actuations and the participant-recorded dose counter readout across the 4-week Treatment Period. The Overall Discrepancy Rate was calculated as 100 multiplied by the total number of discrepancies across all participants who used at least 90% of the labeled actuations divided by the total number of actuations in the same participant population (Completer Population).
Measured: 4-week Treatment Period
Overall Quartile Discrepancy Rate
Quartile discrepancies refer to the difference between
the participant-recorded number of actuations and the participant-recorded
counter readout at each of the 4 weekly visit intervals [ie, quartiles] to
evaluate whether there was any difference in agreement over the life of
the inhaler. The Quartile Discrepancy Rate was calculated as 100 multiplied by the total number of discrepancies per Quartile across all participant who used at least 90% of the labeled actuations divided by the total number of actuations per Quartile in the same population.
Measured: 4-week Treatment Period
Overall Discrepancy Size
Discrepancy Size refers to the magnitude of the discrepancy between the dose counter readout and the number of recorded actuations (definition of discrepancy). Overall Discrepancy Size was calculated as 100 multiplied by the sum of the absolute values from each Dose Counter Discrepancy Size across all participants who used at least 90% of the labeled actuations divided by the total number of recorded actuations in the same participant population.
Measured: 4-week Treatment Period
End of Use Agreement: Number of Inhalers With an End of Use Agreement of 0 (Completer Population)
The difference in the final MDI dose counter readout and the total number of recorded actuations at the end-of-use. Dose Counter end-of-use agreement was calculated as the sum of the absolute difference between the final dose counter readout and the number of recorded actuations across all participants who used at least 90% of the labeled actuations (excluding participants who used the inhaler beyond the labeled number of actuations) divided by the total number of participants in this population. No participant used more than two inhalers during the treatment period.
Measured: 4-week Treatment Period

Timeline

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

1 Mar 20081 Nov 2008

First posted30 Jan 2008 (estimated)
Study start1 Mar 2008
Primary completion1 Nov 2008
Study completion1 Nov 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: Not applicable
Intervention model: Single group
Masking: None (open label)
Enrolment: 272 participants (actual)

IDs, dates and publications

ClinicalTrials.gov ID: NCT00604500
Sponsor's protocol ID: P04703
Other IDs: 3462123
Status last verified: Feb 2022
First submitted: 21 Jan 2008
Last updated: 20 May 2024
Results posted: Yes, on ClinicalTrials.gov
Data monitoring committee: No
Individual data sharing: No

Publications

Weinstein C, Staudinger H, Scott I, Amar NJ, LaForce C. Dose counter performance of mometasone furoate/formoterol inhalers in subjects with asthma or COPD. Respir Med. 2011 Jul;105(7):979-88. doi: 10.1016/j.rmed.2011.01.013. Epub 2011 Mar 12.
PubMed 21398104

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
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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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Active, not recruitingPhase 2/3
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RecruitingPhase 2
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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: An Open-Label, Multi-Center, Patient Handling Study of Mometasone Furoate/Formoterol Fumarate MDI With an Integrated Dose Counter in Adolescent and Adult Subjects and Adult With Asthma or COPD
ClinicalTrials.gov ID: NCT00604500
Acronym / sponsor ID: P04703
Conditions: Asthma, COPD
Phase: Phase 3
Study type: Interventional
Recruitment status: Completed
Enrolment: 272 participants (actual)
Lead sponsor: Organon and CoIndustry (pharma, biotech, devices)
Collaborators: Novartis
Study start: 1 Mar 2008 (actual)
Primary completion: 1 Nov 2008 (actual)
Study completion: 1 Nov 2008 (actual)
First posted: 30 Jan 2008 (estimated)
Results: Posted 12 Apr 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: Not applicable
Intervention model: Single group
Masking: None (open label)
Number of arms: 1

Arm	Type	Receives
MF/F MDI 100/10 mcg BID with dose counter	Experimental	Drug: SCH No. 418131 (Mometasone Furoate/Formoterol Furoate abbreviated MF/F )MF/F MDI 100/10 mcg BID with an integrated dose counter (administered as two inhalations of MFF MDI 50/5 mcg, twice a day) over a 4-week Treatment Period.

Who may qualify

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

Key inclusion criteria (0 listed)

Key exclusion criteria (2 listed)

Participants with a serious uncontrolled medical disorder, which in the judgment of the investigator, could have interfered with the study, or required treatment which might interfere with the study.
Participants who in the judgment of the investigator and/or sponsor had a significant recent or current, repetitive strain injury (RSI) that may have impacted their ability to effectively participate in the full duration of the study.

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
SCH No. 418131 (Mometasone Furoate/Formoterol Furoate abbreviated MF/F )MF/F MDI 100/10 mcg BID with an integrated dose counter (administered as two inhalations of MF/F MDI 50/5 mcg, twice a day) over a 4-week Treatment Period.	Drug	MF/F MDI 100/10 mcg BID with dose counter

Primary outcome

Overall Discrepancy Rate
Time frame: 4-week Treatment Period
Overall discrepancies refer to the difference between the participant-recorded number of actuations and the participant-recorded dose counter readout across the 4-week Treatment Period. The Overall Discrepancy Rate was calculated as 100 multiplied by the total number of discrepancies across all participants who used at least 90% of the labeled actuations divided by the total number of actuations in the same participant population (Completer Population).
Overall Quartile Discrepancy Rate
Time frame: 4-week Treatment Period
Quartile discrepancies refer to the difference between the participant-recorded number of actuations and the participant-recorded counter readout at each of the 4 weekly visit intervals [ie, quartiles] to evaluate whether there was any difference in agreement over the life of the inhaler. The Quartile Discrepancy Rate was calculated as 100 multiplied by the total number of discrepancies per Quartile across all participant who used at least 90% of the labeled actuations divided by the total number of actuations per Quartile in the same population.
Overall Discrepancy Size
Time frame: 4-week Treatment Period
Discrepancy Size refers to the magnitude of the discrepancy between the dose counter readout and the number of recorded actuations (definition of discrepancy). Overall Discrepancy Size was calculated as 100 multiplied by the sum of the absolute values from each Dose Counter Discrepancy Size across all participants who used at least 90% of the labeled actuations divided by the total number of recorded actuations in the same participant population.
End of Use Agreement: Number of Inhalers With an End of Use Agreement of 0 (Completer Population)
Time frame: 4-week Treatment Period
The difference in the final MDI dose counter readout and the total number of recorded actuations at the end-of-use. Dose Counter end-of-use agreement was calculated as the sum of the absolute difference between the final dose counter readout and the number of recorded actuations across all participants who used at least 90% of the labeled actuations (excluding participants who used the inhaler beyond the labeled number of actuations) divided by the total number of participants in this population. No participant used more than two inhalers during the treatment period.

Results and safety

Results posted to the registry on 12 Apr 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 (With Dose Counter)	272	261

Primary outcome: Overall Discrepancy Rate

Time frame: 4-week Treatment Period. Number. Unit: Overall discrepancies per 100 actuations

Measure	MF/F MDI 100/10 mcg BID (With Dose Counter) n = 233
Value	0.13

Population analysed: Completer population, defined as participants who recorded use of at least 90% of the labeled actuations during the 4-week Treatment Period.

Primary outcome: Overall Quartile Discrepancy Rate

Time frame: 4-week Treatment Period. Number. Unit: discrepancies per 100 actuations

Measure	MF/F MDI 100/10 mcg BID (With Dose Counter) n = 233
Value	0.13

Population analysed: Completer Population, defined as participants who had recorded use of at least 90% of the labeled actuations during the 4-week Treatment Period.

Primary outcome: Overall Discrepancy Size

Time frame: 4-week Treatment Period. Number. Unit: Discrepancy Size Per 100 actuations

Measure	MF/F MDI 100/10 mcg BID (With Dose Counter) n = 233
Value	0.14

Population analysed: Completer Population, defined as participants who had recorded use of at least 90% of the labeled actuations during the 4-week Treatment Period.

Primary outcome: End of Use Agreement: Number of Inhalers With an End of Use Agreement of 0 (Completer Population)

Time frame: 4-week Treatment Period. Number. Unit: Number of inhalers

Measure	MF/F MDI 100/10 mcg BID (With Dose Counter) n = 233
Value	175

Population analysed: Completer Population, excluding 2 participants who used more than the labeled number of actuations.

Adverse events

Time frame: 6 weeks. Other adverse events reported at 5% frequency or more

Group	Serious adverse events	Other adverse events	Deaths
MF/F MDI 100/10 mcg BID	1 of 272 (0.4%)	0 of 272 (0%)	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 21398104Weinstein C, Staudinger H, Scott I, Amar NJ, LaForce C. Dose counter performance of mometasone furoate/formoterol inhalers in subjects with asthma or COPD. Respir Med. 2011 Jul;105(7):979-88. doi: 10.1016/j.rmed.2011.01.013. Epub 2011 Mar 12.
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?

A Phase 3 study testing SCH No. 418131 (Mometasone Furoate/Formoterol Furoate abbreviated MF/F ) in people with Asthma and COPD, 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 0 inclusion and 2 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 Apr 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?

Overall Discrepancy Rate (time frame: 4-week Treatment Period). 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?

On the ClinicalTrials.gov record for NCT00604500, 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.