Study of Inhaled Glucocorticosteroids/Long-Acting Bronchodilator Drugs in Subjects With Asthma That Have Been Taking Inhaled Glucocorticosteroids (Study P04705AM1)

Condition(s) targeted: Asthma

Intervention: Mometasone furoate/formoterol (MF/F) combination (Drug); Fluticasone propionate and salmeterol (F/SC) DPI (Drug)

Phase: Phase 3

Status: Recruiting

Sponsored by: Schering-Plough

Official(s) and/or principal investigator(s):
Hendrik Nolte, MD, PhD, Study Director, Affiliation: Allergy/Respiratory Diseases/Clinical Immunology, Schering-Plough

Overall contact:
SP Clinical Trial Registry Call Center, Phone: 1-888-772-8734

This study is being conducted to demonstrate the non-inferiority between two inhaled glucocorticosteroids and long-acting bronchodilator combination drugs called mometasone furoate/formoterol fumarate in a metered-dose inhaler (MDI) and fluticasone propionate/salmeterol in a dry powder inhaler (DPI) on lung function. Information on the onset of action, the overall safety, and how the drugs control asthma will also be assessed. The study is approximately 1 year in duration.

Official title: A 52-Week Efficacy and Safety Non-Inferiority Study of Fluticasone Propionate/Salmeterol 250/50mcg BID Delivered by Dry Powder Inhaler (Diskus) Versus Mometasone Furoate/Formoterol Fumarate 200/10mcg BID Delivered by Pressurized Metered-Dose Inhaler in Persistent Asthmatics Previously Treated With Medium Doses of Inhaled Glucocorticosteroids

Study design: Treatment, Randomized, Single Blind (Investigator), Active Control, Parallel Assignment, Safety/Efficacy Study

Primary outcome: The AUC(0-12 hr) of the change from Baseline to Week 12 in FEV1.

Secondary outcome:

Onset-of-action based on change from Baseline FEV1 at the 5 min PFT assessment on Day 1.

Change from Baseline in Asthma Control Questionnaire total score over the 52-week Treatment Period.

Time-to-first asthma exacerbation over the 52-week Treatment Period.

The proportion of symptom-free days and nights (combined) over the 52-week Treatment Period.

Minimum age: 12 Years. Maximum age: N/A. Gender(s): Both.

Criteria:

Inclusion Criteria:

- Subjects must have a diagnosis of asthma for at least 12 months' duration.

- A subject must have been using a medium daily dose of inhaled glucocorticosteroids

(alone or in combination with LABA) for at least 12 weeks and must have been on a stable regimen for at least 2 weeks prior to Screening.

- If there is no inherent harm in changing the subject's current asthma therapy, the

subject must be willing to discontinue his/her prescribed ICS or ICS/LABA prior to initiating MF MDO run-in medication.

- The diagnosis of asthma must be documented by either demonstrating an increase in

absolute forced expiratory volume in 1 second (FEV1) of at least 12% and a volume increase of at least 200 mL within approximately 15 to 20 minutes after administration of 4 inhalations of albuterol/salbutamol or of nebulized SABA OR PEF variability of more than 20% OR a diurnal variation PEF of more than 20% based on the difference between pre-bronchodilator (before taking albuterol/salbutamol) morning value and the post-bronchodilator value (after taking albuterol/salbutamol) from the evening before, expressed as a percentage of the mean daily PEF value on any day during the open-label Run-in Period.

- A subject must have a history of >= 2 asthma-related unscheduled visits to a physician

or to an emergency room within the past year AND >= 3 asthma-related unscheduled visits within the past 2 years.

- Prior to randomization subjects must have used a total of 12 or more inhalations of

SABA rescue medication during the last 10 days of run-in.

- Clinical laboratory tests (complete blood counts [CBC], blood chemistries, including

serum pregnancy for females of child-bearing potential, and urinalysis) conducted at the Screening Visit must be within normal limits or clinically acceptable to the investigator/sponsor before the subject is instructed to start using open-label MF MDI run-in medication.

- An electrocardiogram (ECG) performed at the Screening Visit, using a centralized

trans-telephonic technology, must be clinically acceptable to the investigator.

- A chest x-ray performed at the Screening Visit, or within 12 months prior to the

Screening Visit, must be clinically acceptable to the investigator.

- A non-pregnant female subject of childbearing potential must be using a medically

acceptable, adequate form of birth control. A female subject of childbearing potential must have a negative serum pregnancy test at Screening in order to be considered eligible for enrollment.

Exclusion Criteria:

- A subject who demonstrates a change in absolute FEV1 of > 20% at any time between the

Screening and Baseline Visits on any 2 consecutive days between the Screening and Baseline visits.

- A subject who requires the use of greater than 8 inhalations per day of SABA MDI or 2

or more nebulized treatments per day of 2. 5 mg SABA on any 2 consecutive days between the Screening and Baseline Visits.

- A subject who experiences a decrease in AM or PM PEF below the Run-in Period stability

limit on any 2 consecutive days prior to randomization. The average AM and average PM PEF respective values from the preceding 7 days are added, divided by the number of non-missing values, and multiplied by 0. 70 to determine the stability limit.

- A subject who experiences a clinical asthma exacerbation: defined as a clinical

deterioration of asthma as judged by the clinical investigator between the Screening and Baseline Visits, that results in emergency treatment, hospitalization due to asthma, or treatment with additional, excluded asthma medication (including oral or other systemic corticosteroids, but allowing SABA).

SP Clinical Trial Registry Call Center, Phone: 1-888-772-8734

Investigational Site 65, Mississauga L5A 3V4, Canada; Recruiting

Investigational Site 62, Brampton L6T 3J1, Canada; Recruiting

Investigational Site 63, Kelowna V1Y 9L8, Canada; Recruiting

Investigational Site 69, Quebec G1V 4M6, Canada; Recruiting

Investigational Site 70, Winnipeg R3C 0N2, Canada; Completed

Investigational Site 74, Ottawa K1Y 4G2, Canada; Recruiting

Investigational Site 67, Montreal H3H 2R9, Canada; Recruiting

Investigational Site 71, Trois-Rivieres G8T 7A1, Canada; Recruiting

Investigational Site 75, Bogota, Colombia; Recruiting

Investigational Site 77, Bogota, Colombia; Recruiting

Investigational Site 76, Bogota, Colombia; Recruiting

Investigational Site 80, San Jose, Costa Rica; Recruiting

Investigational Site 79, San Jose, Costa Rica; Recruiting

Investigational Site 82, San Jose, Costa Rica; Recruiting

Investigational Site 89, Jindrichuv Hradec 37701, Czech Republic; Recruiting

Investigational Site 94, Brno 61300, Czech Republic; Recruiting

Investigational Site 95, Ostrava-Poruba 70868, Czech Republic; Recruiting

Investigational Site 96, Ostrava-Hrabuvka, Czech Republic; Recruiting

Investigational Site 187, Jaromer, Czech Republic; Recruiting

Investigational Site 90, Jablonec Nad Ni, Czech Republic; Recruiting

Investigational Site 91, Praha 5 150 06, Czech Republic; Recruiting

Investigational Site 92, Beroun, Czech Republic; Recruiting

Investigational Site 93, Praha 6 16300, Czech Republic; Recruiting

Investigational Site 97, Liberec, Czech Republic; Recruiting

Investigational Site 98, Karlovy Vary 36000, Czech Republic; Recruiting

Investigational Site 86, Quito, Ecuador; Recruiting

Investigational Site 100, Tartu 51014, Estonia; Recruiting

Investigational Site 103, Parnu 80010, Estonia; Recruiting

Investigational Site 102, Tallinn 13419, Estonia; Recruiting

Investigational Site 104, Tallinn 13619, Estonia; Recruiting

Investigational Site 106, Helsinki 00290, Finland; Recruiting

Investigational Site 108, Tampere 33520, Finland; Recruiting

Investigational Site 109, Espoo 02740, Finland; Recruiting

Investigational Site 112, Witten 58452, Germany; Recruiting

Investigational Site 113, Hamburg 22143, Germany; Recruiting

Investigational Site 115, Berlin 14050, Germany; Recruiting

Investigational Site 116, Berlin 10117, Germany; Recruiting

Investigational Site 120, Berlin 13507, Germany; Recruiting

Investigational Site 118, Berlin 10717, Germany; Recruiting

Investigational Site 110, Hamburg 20253, Germany; Recruiting

Investigational Site 123, Riga LV-1038, Latvia; Recruiting

Investigational Site 124, Daugavpils LV5401, Latvia; Recruiting

Investigational Site 126, Riga LV1038, Latvia; Recruiting

Investigational Site 122, Riga LV1038, Latvia; Recruiting

Investigational Site 125, Stopini LV2118, Latvia; Recruiting

Investigational Site 127, Kaunas 44320, Lithuania; Recruiting

Investigational Site 131, Klaipeda 92231, Lithuania; Recruiting

Investigational Site 136, Zilvermeeuw 7609 PP, Netherlands; Recruiting

Investigational Site 133, Eindhoven 5623 EJ, Netherlands; Recruiting

Investigational site 134, Nieuwegein 3435 CM, Netherlands; Recruiting

Investigational site 135, Hoofddorp 2134 TM, Netherlands; Recruiting

Investigational site 137, Hoorn 1624 NP, Netherlands; Recruiting

Investigational Site 139, Bucuresti 303030, Romania; Recruiting

Investigational Site 141, Deva 330084, Romania; Recruiting

Investigational Site 140, Lasi 700115, Romania; Recruiting

Investigational Site 144, Moscow 105077, Russian Federation; Recruiting

Investigational Site 149, Moscow 115478, Russian Federation; Recruiting

Investigational Site 150, Yaroslav 150010, Russian Federation; Recruiting

Investigational Site 151, Moscow 107014, Russian Federation; Recruiting

Investigational Site 152, Moscow 127299, Russian Federation; Recruiting

Investigational Site 153, Smolensk 214001, Russian Federation; Recruiting

Investigational Site 148, Moscow 123182, Russian Federation; Recruiting

Investigational Site 154, Moscow 11528, Russian Federation; Recruiting

Investigational Site 155, Moscow 125206, Russian Federation; Recruiting

Investigational Site 156, Belgrade 1100, Serbia; Recruiting

Investigational Site 157, Belgrade 1100, Serbia; Recruiting

Investigational Site 158, Belgrade 1100, Serbia; Recruiting

Investigational Site 159, Kragujevac 34000, Serbia; Recruiting

Investigational Site 160, Goirnji Matejevac 18204, Serbia; Recruiting

Investigational Site 164, Poprad 5887, Slovenia; Recruiting

Investigational Site 162, Rimavska Sobota 97901, Slovenia; Recruiting

Investigational Site 167, Banska Bystrica, Slovenia; Recruiting

Investigational Site 163, Trencin 91108, Slovenia; Recruiting

Investigational Site 165, Martin 3601, Slovenia; Recruiting

Investigational Site 168, Kharkiv 61035, Ukraine; Recruiting

Investigational Site 169, Lviv 79010, Ukraine; Recruiting

Investigational Site 170, Dnepropetrovsk 49006, Ukraine; Recruiting

Investigational Site 171, Kyiv 01133, Ukraine; Recruiting

Investigational Site 177, Vinnytsya 21029, Ukraine; Recruiting

Investigational Site 178, Kiev 4201, Ukraine; Recruiting

Investigational Site 179, Kyiv 03680, Ukraine; Recruiting

Investigational Site 180, Kharkiv 61035, Ukraine; Recruiting

Investigational Site 51, Rolling Hills Estates, California 90274, United States; Recruiting

Investigational Site 59, Huntington Beach, California 92647, United States; Recruiting

Investigational Site 61, Vista, California 92083, United States; Recruiting

Investigational Site 182, Huntington Beach, California 92647, United States; Recruiting

Investigational Site 43, Miami, Florida 33173, United States; Recruiting

Investigational Site 31, Tampa, Florida 33613, United States; Recruiting

Investigational Site 17, Savannah, Georgia 31406, United States; Recruiting

Investigational Site 38, Normal, Illinois 61761, United States; Recruiting

Investigational Site 7, Metairie, Louisiana 70006, United States; Recruiting

Investigational Site 42, St. Louis, Missouri 63141, United States; Recruiting

Investigational Site 57, Columbia, Missouri 65203-4481, United States; Recruiting

Investigational Site 36, Omaha, Nebraska 68114, United States; Recruiting

Investigational Site 45, Skillman, New Jersey 08558, United States; Recruiting

Investigational Site 4, Cincinnati, Ohio 45231, United States; Recruiting

Investigational Site 55, Oklahoma City, Oklahoma 73120, United States; Recruiting

Investigational Site 29, Medford, Oregon 97504, United States; Recruiting

Investigational Site 26, Eugene, Oregon 97401, United States; Recruiting

Investigational Site 16, Philadelphia, Pennsylvania 19115, United States; Recruiting

Investigational Site 13, Upland, Pennsylvania 19013, United States; Recruiting

Investigational Site 1, Waco, Texas 76712, United States; Recruiting

Investigational Site 52, Houston, Texas 77054, United States; Recruiting

Investigational Site 58, Houston, Texas 77070, United States; Recruiting

Investigational Site 6, Waco, Texas 76708, United States; Recruiting

Investigational Site 8, San Antonio, Texas 78229, United States; Recruiting

Investigational Site 24, Draper, Utah 84020, United States; Recruiting

Investigational Site 56, Seattle, Washington 98105, United States; Recruiting

Investigational Site 54, Greenfield, Wisconsin 53228, United States; Recruiting

Starting date: April 2007
Ending date: June 2009
Last updated: July 16, 2008