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Effects of Mometasone Furoate/Formoterol Combination Versus Formoterol and Mometasone Furoate Alone in COPD (Study P04229AM4)
This study is currently recruiting participants.
Verified by Schering-Plough, December 2008
Sponsors and Collaborators: Schering-Plough
Novartis
Information provided by: Schering-Plough
ClinicalTrials.gov Identifier: NCT00383435
  Purpose

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). previously randomized to an active treatment group. All placebo-treated subjects and active-treated subjects who will not participate in the safety extension will be discontinued 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.


Condition Intervention Phase
Chronic Obstructive Pulmonary Disease (COPD)
Drug: Mometasone furoate/formoterol (MF/F) combination
Drug: Mometasone furoate MDI (MF MDI)
Drug: Formoterol MDI
Drug: Placebo
Phase III

MedlinePlus related topics: COPD (Chronic Obstructive Pulmonary Disease)
Drug Information available for: Formoterol Arformoterol Arformoterol Tartrate Formoterol fumarate Mometasone furoate
U.S. FDA Resources
Study Type: Interventional
Study Design: Treatment, Randomized, Double Blind (Subject, Investigator), Active Control, Parallel Assignment, Safety/Efficacy 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

Further study details as provided by Schering-Plough:

Primary Outcome Measures:
  • To assess the contribution of F 10 mcg BID to the combination: The mean AUC (0-12 hr) of the change from baseline to wk 13 Endpoint. [ Time Frame: from Baseline to the Week 13 Endpoint ] [ Designated as safety issue: No ]
  • To assess the contribution of MF to the combination: Mean change from baseline to wk 13 endpoint in AM predose FEV1 [ Time Frame: from Baseline to the Week 13 Endpoint ] [ Designated as safety issue: No ]

Secondary Outcome Measures:
  • Change from BL to endpoint in St George's Respiratory Questionaire total score. [ Time Frame: Change from Baseline to the Week 26 Endpoint ] [ Designated as safety issue: No ]
  • Change from BL in proportion of COPD symptom-free nights over Tx Period. [ Time Frame: Change from Baseline to the Week 26 Endpoint ] [ Designated as safety issue: No ]
  • Proportion of subjects with partly stable COPD at endpoint [ Time Frame: Change from Baseline to the Week 26 Endpoint ] [ Designated as safety issue: No ]
  • Time-to-first COPD exacerbation over the Tx Period. [ Time Frame: Change from Baseline to the Week 26 Endpoint ] [ Designated as safety issue: No ]

Estimated Enrollment: 1000
Study Start Date: October 2006
Estimated Study Completion Date: March 2010
Estimated Primary Completion Date: March 2010 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
MF/F MDI 400/10 mcg BID: Experimental Drug: Mometasone furoate/formoterol (MF/F) combination
MF/F 400/10 mcg via a metered dose inhaler (MDI) twice daily for 52 weeks
MF/F MDI 200/10 mcg BID: Experimental Drug: Mometasone furoate/formoterol (MF/F) combination
MF/F 200/10 mcg via a metered dose inhaler (MDI) twice daily for 52 weeks
MF MDI 400 mcg BID: Experimental Drug: Mometasone furoate MDI (MF MDI)
MF 400 mcg via metered dose inhaler twice daily for 52 weeks
Formoterol MDI 10 mcg BID: Active Comparator Drug: Formoterol MDI
Formoterol 10 mcg via metered dose inhaler twice a day for 52 weeks
Placebo MDI BID: Placebo Comparator Drug: Placebo
Placebo MDI twice a day for 52 weeks

  Eligibility

Ages Eligible for Study:   40 Years and older
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   No
Criteria

Inclusion Criteria:

  • Moderate to severe COPD based on prebronchodilator FEV1/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, ICS or ICS/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. 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, 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 msecs]) stroke, severe rheumatoid arthritis, chronic open-angle glaucoma or posterior subcapsular cataracts, 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.
  • 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 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/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, β-blocking agents, or treatment with additional excluded medication (other than SABA/short-acting anticholinergic to be used as rescue medication).
  • α-1-antitrypsin deficiency.
  • Cataract extractions on both eyes.
  • A history and/or presence of intraocular pressure in either eye >=22 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 LOCS III grades at screening:

NO: >=3.0 NC: >=3.0 C: >=2.0 P: >=0.5

  Contacts and Locations
Please refer to this study by its ClinicalTrials.gov identifier: NCT00383435

Contacts
Contact: SP Clinical Trial Registry Call Center 1-888-772-8734

  Show 78 Study Locations
Sponsors and Collaborators
Schering-Plough
Novartis
Investigators
Study Director: Laurence Flint, MD, MS, MBA Schering-Plough
  More Information

Responsible Party: Schering-Plough ( Head, Clinical Trials Registry & Results Disclosure Group )
Study ID Numbers: P04229, Doc ID: 3227334;, Eudract No: 2006-002308-32;
Study First Received: September 29, 2006
Last Updated: December 14, 2008
ClinicalTrials.gov Identifier: NCT00383435  
Health Authority: United States: Food and Drug Administration

Study placed in the following topic categories:
Lung Diseases, Obstructive
Respiratory Tract Diseases
Mometasone furoate
Lung Diseases
Formoterol
Pulmonary Disease, Chronic Obstructive

Additional relevant MeSH terms:
Anti-Inflammatory Agents
Respiratory System Agents
Neurotransmitter Agents
Adrenergic beta-Agonists
Adrenergic Agents
Molecular Mechanisms of Pharmacological Action
Physiological Effects of Drugs
Anti-Asthmatic Agents
Anti-Allergic Agents
Adrenergic Agonists
Pharmacologic Actions
Autonomic Agents
Therapeutic Uses
Peripheral Nervous System Agents
Bronchodilator Agents

ClinicalTrials.gov processed this record on January 16, 2009