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

• Register: ClinicalTrials.gov
• Last refreshed on: 21 February 2022
• Main ID: NCT00383435
• Date of registration: 29/09/2006
• Prospective Registration: Yes
• Primary sponsor: Organon and Co
• Public title: Effects of Mometasone Furoate/Formoterol Combination Versus Formoterol and Mometasone Furoate Alone in COPD (Study P04229AM4)(COMPLETED)
• Scientific 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
• Date of first enrolment: October 2006
• Target sample size: 1055
• Recruitment status: Completed
• URL: https://clinicaltrials.gov/show/NCT00383435
• Study type: Interventional
• Study design: Allocation: Randomized. Intervention model: Parallel Assignment. Primary purpose: Treatment. Masking: Double (Participant, Investigator).
• Phase: Phase 3

Countries of recruitment

Colombia, Costa Rica, Croatia, Denmark, Guatemala, Hungary, India, Mexico, Netherlands, Peru, Philippines, Poland, Russian Federation, Serbia, Slovakia, Slovenia, South Africa, Thailand, Ukraine, United States, Uzbekistan, Venezuela

Key inclusion & exclusion criteria

Inclusion Criteria:

- 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.

- 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.

Exclusion Criteria:

- 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).

- 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.



Age minimum: 40 Years
Age maximum: N/A
Gender: All

Health Condition(s) or Problem(s) studied

Chronic Obstructive Pulmonary Disease (COPD)

Intervention(s)

Drug: Mometasone furoate MDI (MF MDI)

Drug: Formoterol MDI

Drug: Placebo

Drug: Mometasone furoate/formoterol (MF/F) combination

Primary Outcome(s)

Mean Change From Baseline to Week 13 Endpoint in AM Predose FEV1 [Time Frame: Baseline to Endpoint (13 weeks)]

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)]

Secondary Outcome(s)

Change From Baseline to Endpoint in St George's Respiratory Questionaire (SGRQ) Total Score [Time Frame: Baseline to Endpoint (26 weeks)]

Change From Baseline in Proportion of Chronic Obstructive Pulmonary Disease (COPD) Symptom-Free Nights (AM Diary Symptoms) [Time Frame: Baseline to Endpoint (26 weeks)]

Number of Participants With Partly Stable COPD [Time Frame: Endpoint (26 weeks)]

Number of Participants With Mild, Moderate, or Severe COPD Exacerbations [Time Frame: Endpoint (26 weeks)]

Secondary ID(s)

Doc ID: 3227334;

Eudract No: 2006-002308-32;

P04229

Source(s) of Monetary Support

Please refer to primary and secondary sponsors

Secondary Sponsor(s)

Novartis

Results

• Results available: Yes
• Date Posted: 03/10/2011
• URL: https://clinicaltrials.gov/ct2/show/results/NCT00383435