AzTrials
AzTrials

Chronic Obstructive Pulmonary Disease (COPD)Phase 3NCT00383435

Effects of Mometasone Furoate/Formoterol Combination Versus Formoterol and Mometasone Furoate Alone in COPD (Study P04229AM4)(COMPLETED)

A Phase 3 study testing Mometasone furoate/formoterol (MF/F) combination, Mometasone furoate MDI (MF MDI) and Formoterol MDI in people with Chronic Obstructive Pulmonary Disease (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
Search all trials

Trial summary

This is a randomized, placebo-controlled, parallel-group, multi-site, double-blind study evaluating the efficacy of mometasone furoate/formoterol fumarate (MF/F) metered dose inhaler (MDI) 400/10 mcg twice daily (BID) and MF/F MDI 200/10 mcg BID compared with MF 400 mcg BID and F 10 mcg BID in adults at least 40 years… Read more about this study

Who is it for?
Ages 40 years and older
What is being tested?
Mometasone furoate/formoterol (MF/F) combination, Mometasone furoate MDI (MF MDI) and Formoterol MDI
Could I receive a placebo?
Yes, some participants may receive a placebo
How many people
1,055 participants
Where
No sites listed yet
Study dates
Oct 2006to Jul 2010
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 40 years and older
  • All sexes
  • No healthy volunteers
  • Adult, Older adult

Who may be able to join

  • Moderate to severe COPD based on prebronchodilator FEV1/forced vital capacity (FVC) ratio of <=70%.
  • At Screening, postbronchodilator FEV1 must be <=60% predicted normal \& >=25% predicted normal.
  • COPD symptoms for >=24 months.
  • Ex- or current smoker with smoking history >=10 pack years.
  • Only albuterol/salbutamol for relief for at least 2 weeks prior to randomization.
  • Withdraw from parenteral \& oral steroids, anticholinergics, \& antibiotics at least 4 weeks prior to Screening.
Show all 13Show fewer
  • No harm in changing current COPD therapy, willing to discontinue his/her anticholinergics, inhaled corticosteroids (ICS) or ICS/long-acting beta agonists (LABA) at Screening, \& transferred to albuterol/salbutamol for relief for 2 weeks prior to randomization.
  • Lab tests conducted at Screening must be acceptable to investigator. Electrocardiogram (ECG) performed at Screening Visit or within 30 days prior to Screening must be acceptable to investigator. Chest x-ray performed at Screening or within 12 months prior to Screening must be acceptable to investigator.
  • 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. Female of childbearing potential must use birth control. Includes: hormonal contraceptives, intra-uterine device (IUD), condom in combination with spermicide, monogamous relationship with male partner who had vasectomy. Started birth control at least 3 months prior to Screening (exception condom), \& agree to continue. Female who is not currently sexually active must agree/consent to use a method should she become sexually active. Women surgically sterilized or are at least 1 year postmenopausal are not considered to be of childbearing potential. Female must have negative serum pregnancy test at Screening.

Who cannot join

  • Evidence (upon visual inspection) of oropharyngeal candidiasis at Baseline with or without treatment. If there is evidence at Screening, may be treated as appropriate \& visit can be scheduled upon resolution. If there is evidence at Baseline Visit, may be treated as appropriate \& visit can be rescheduled upon resolution.
  • History of renal, hepatic, cardiovascular, metabolic, neurologic, hematologic, ophthalmological, respiratory, gastrointestinal, cerebrovascular, or other which could interfere with study or require treatment which might interfere with study. Examples include (but are not limited to) 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 milliseconds (msecs)]), stroke, severe rheumatoid arthritis, chronic open-angle glaucoma or posterior subcapsular cataracts, acquired immune deficiency syndrome (AIDS), or conditions that may interfere with respiratory function such as asthma, bronchiectasis, cystic fibrosis. Others which are well-controlled \& stable (eg hypertension not requiring beta-blockers) will not prohibit participation if deemed appropriate per investigator.
  • Allergy/sensitivity to glucocorticosteroids, beta-2 agonists, study drug/excipients.
  • Female who is breast-feeding, pregnant, or intends to become pregnant.
  • Illicit drug user.
  • Human immunodeficiency virus (HIV) positive (testing not conducted).
Show all 30Show fewer
  • Unable to correctly use oral MDI.
  • Taking any restricted medications prior to Screening without meeting washout.
  • Cannot adhere to permitted concomitant \& prohibited medications.
  • May not participate in this same study at another investigational site. Cannot participate in different investigational study at any site, during same time of study.
  • Not be randomized into study more than once.
  • No person directly associated with administration of study may participate.
  • Previously participated in MF/F trial.
  • Increase in absolute volume of >=400 milliliters (mL) at Screening or prior to Baseline within 30 minutes after administration of 4 inhalations of albuterol/salbutamol (total dose of 360 to 400 mcg), or nebulized 2.5 mg albuterol/salbutamol.
  • Asthma.
  • Blood eosinophil count greater than 0.57 x 10^3/microliter (uL).
  • Lobectomy, pneumonectomy or lung volume reduction surgery.
  • Lung cancer.
  • Requires long-term administration of oxygen (>15 hours per day).
  • A subject who experiences an exacerbation of COPD requiring medical
  • intervention within 4 weeks prior to randomization, beta-blocking agents, or
  • treatment with additional excluded medication (other than short-acting beta agonists (SABA)/short-acting
  • anticholinergic to be used as rescue medication).
  • alpha-1-antitrypsin deficiency.
  • Cataract extractions on both eyes.
  • A history and/or presence of intraocular pressure in either eye >=22 millimeters of mercury (mm Hg), glaucoma, and/or posterior subcapsular cataracts. A subject who has undergone incisional or intraocular surgery in which the natural lens is still present in the eye. A subject with a history of penetrating trauma to both eyes. A subject with one or more of the following Lens Opacities Classification System (LOCS) III grades at screening:
  • nuclear opalescence (NO): >=3.0,
  • nuclear color (NC): >=3.0,
  • cortical cataract (C): >=2.0,
  • posterior subcapsular (P): >=0.5.

About this study

Official title: A Randomized, 26-Week, Placebo-Controlled Efficacy and Safety Study With a 26-Week Long-Term Safety Extension, of High- and Medium-Dose Inhaled Mometasone Furoate/Formoterol Fixed-Dose Combination Formulation Compared With Formoterol and High-Dose Inhaled Mometasone Furoate Monotherapy in Subjects With Moderate to Severe COPD

This is a randomized, placebo-controlled, parallel-group, multi-site, double-blind study evaluating the efficacy of mometasone furoate/formoterol fumarate (MF/F) metered dose inhaler (MDI) 400/10 mcg twice daily (BID) and MF/F MDI 200/10 mcg BID compared with MF 400 mcg BID and F 10 mcg BID in adults at least 40 years of age, with moderate to severe chronic obstructive pulmonary disease (COPD). All placebo-treated subjects and active-treated

subjects who will not participate in the safety extension will be discontinued

Read more

and will have their Final Visit at Week 26. Subjects who continue into the

26-week safety extension will have their Final Visit at Week 52. Efficacy will be measured by the mean change from Baseline to Week 13 in area under the forced expiratory volume in one second concentration time curve from 0 to 12 hours (FEV1 AUC[0-12hr]) and change from Baseline to Week 13 in AM predose FEV1.

Being tested
Mometasone furoate/formoterol (MF/F) combination, Mometasone furoate MDI (MF MDI), Formoterol MDI, Placebo
Medical subject headings
Pulmonary Disease, Chronic Obstructive

What participants receive

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

  • Mometasone furoate/formoterol (MF/F) combinationDrug

    Also called SCH 418131

    MF/F 400/10 mcg via a metered dose inhaler (MDI) twice daily for 52 weeks

  • Mometasone furoate/formoterol (MF/F) combinationDrug

    Also called SCH 418131

    MF/F 200/10 mcg via a metered dose inhaler (MDI) twice daily for 52 weeks

  • Mometasone furoate MDI (MF MDI)Drug

    Also called SCH 32088

    MF 400 mcg via metered dose inhaler twice daily for 52 weeks

  • Formoterol MDIDrug

    Also called Foradil

    Formoterol 10 mcg via metered dose inhaler twice a day for 52 weeks

  • PlaceboDrug

    Placebo MDI twice a day for 26 weeks

Study groups in NCT00383435
Study groupRoleWhat they receive
MF/F MDI 400/10 mcg BIDExperimentalNot described
Receives: Drug: Mometasone furoate/formoterol (MF/F) combination
MF/F MDI 200/10 mcg BIDExperimentalNot described
Receives: Drug: Mometasone furoate/formoterol (MF/F) combination
MF MDI 400 mcg BIDExperimentalNot described
Receives: Drug: Mometasone furoate MDI (MF MDI)
Formoterol MDI 10 mcg BIDActive comparatorNot described
Receives: Drug: Formoterol MDI
Placebo MDI BIDPlacebo comparatorNot described
Receives: Drug: Placebo

What is being measured

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

  1. Mean Area Under the Time Curve From 0 to 12 Hours (AUC(0-12 Hours)) of Change From Baseline to Week 13 in Forced Expiratory Volume (Liters) in 1 Second (FEV1)

    FEV1 AUC was standardized to liters. Endpoint was the last post-baseline non-missing result through Week 13 carried forward.

    Measured: Baseline to Endpoint (13 weeks)

  2. Mean Change From Baseline to Week 13 Endpoint in AM Predose FEV1

    Endpoint was the last post-baseline non-missing result through Week 13 carried

    forward.

    Measured: Baseline to Endpoint (13 weeks)

Secondary outcomes (4)

  1. Change From Baseline to Endpoint in St George's Respiratory Questionaire (SGRQ) Total Score

    SGRQ consisted of 76 items aggregated into 3 component scores: symptoms (frequency/severity), activity (cause or limited by breathlessness), impact (social functioning, psychological disturbances from airway disease), \& total score. Best health scores have a low numeric value. All component scores \& total score range from 0-100, with a higher score indicating greater disease burden. A 4-point increase over placebo (and Baseline) was considered the minimum clinically important difference. Endpoint is the last post-baseline non-missing result through the 26 week evaluation carried forward.

    Measured: Baseline to Endpoint (26 weeks)

  2. Change From Baseline in Proportion of Chronic Obstructive Pulmonary Disease (COPD) Symptom-Free Nights (AM Diary Symptoms)

    Prior to the use of study drug rescue medication (in the morning upon awakening) the participant evaluated the COPD symptoms of wheezing, cough, and difficulty breathing. A symptom-free night was defined as a combined score of 0 (no symptoms) across all three COPD symptoms evaluated the following morning. Proportion for Baseline included data from the last week before the first dose. Proportion for Endpoint included data across the entire 26-week treatment period.

    Measured: Baseline to Endpoint (26 weeks)

  3. Number of Participants With Partly Stable COPD

    Partly stable COPD was a composite measure that included the following COPD

    outcomes: (1) No oral steroid rescue medication; (2) No AM or PM COPD weekly average symptom score greater than 2 during at least 7 of 8 weeks; (3) No moderate or severe exacerbations; (4) No unscheduled visits due to COPD worsenings; (5) No study discontinuation due to treatment failure or

    treatment-related adverse event as determined by the investigator.

    Measured: Endpoint (26 weeks)

  4. Number of Participants With Mild, Moderate, or Severe COPD Exacerbations

    Mild = 12 or more inhalations/day of inhaled rescue medication or 2 or more nebulized treatments/day of inhaled rescue medication. Moderate = treatment with antibiotics or oral steroids. Severe = emergency room treatment or hospitalizations of survival curves. If an event was composed of multiple criteria, the most severe criteria was assigned to the event.

    Measured: Endpoint (26 weeks)

Timeline

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

  1. First posted3 Oct 2006 (estimated)
  2. Study startOct 2006
  3. Primary completionJul 2010
  4. Study completionJul 2010

Resources

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
1,055 participants (actual)
IDs, dates and publications
ClinicalTrials.gov ID
NCT00383435
Sponsor's protocol ID
P04229
Other IDs
Doc ID: 3227334;, Eudract No: 2006-002308-32;
Status last verified
Feb 2022
First submitted
29 Sep 2006
Last updated
20 May 2024
Data monitoring committee
Yes
Individual data sharing
No

Publications

  • 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

  • Tashkin DP, Doherty DE, Kerwin E, Matiz-Bueno CE, Knorr B, Shekar T, Gates D, Staudinger H. Efficacy and safety characteristics of mometasone furoate/formoterol fumarate fixed-dose combination in subjects with moderate to very severe COPD: findings from pooled analysis of two randomized, 52-week placebo-controlled trials. Int J Chron Obstruct Pulmon Dis. 2012;7:73-86. doi: 10.2147/COPD.S29444. Epub 2012 Feb 3.

    PubMed 22334770

  • Tashkin DP, Doherty DE, Kerwin E, Matiz-Bueno CE, Knorr B, Shekar T, Banerjee S, Staudinger H. Efficacy and safety of a fixed-dose combination of mometasone furoate and formoterol fumarate in subjects with moderate to very severe COPD: results from a 52-week Phase III trial. Int J Chron Obstruct Pulmon Dis. 2012;7:43-55. doi: 10.2147/COPD.S27319. Epub 2012 Feb 3.

    PubMed 22334768

Questions about this trial

What is this clinical trial studying?

A Phase 3 study testing Mometasone furoate/formoterol (MF/F) combination, Mometasone furoate MDI (MF MDI) and Formoterol MDI in people with Chronic Obstructive Pulmonary Disease (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 13 inclusion and 30 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 3 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 13 in Forced Expiratory Volume (Liters) in 1 Second (FEV1) (time frame: Baseline to Endpoint (13 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 NCT00383435, 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.

AzTrials uses cookies for analytics and advertising. You can accept or reject them; the site works either way. Privacy Policy.

Free account

Log in to keep searching

You’ve used your 3 free searches. AzTrials is free: log in or create a free account to keep searching clinical trials and save the ones you want to follow.

Create a free accountLog in