Status:
COMPLETED
Study of Mometasone Furoate/Formoterol Combination and Fluticasone/Salmeterol in Persistent Asthmatics Previously Treated With Inhaled Glucocorticosteroids (P04139)
Lead Sponsor:
Organon and Co
Conditions:
Asthma
Eligibility:
All Genders
12+ years
Phase:
PHASE3
Brief Summary
The purpose of this study is to evaluate the long-term safety of mometasone furoate/formoterol (MF/F) metered dose inhaler (MDI) 200/10 mcg twice-a-day (BID) and MF/F MDI 400/10 mcg BID and two doses ...
Eligibility Criteria
Inclusion
- Subjects of either sex and any race, at least 12 years of age, with a diagnosis of asthma of at least 12 months.
- Use of medium or high daily dose of ICS (alone or in combination with long-acting beta-agonist \[LABA\]) for at least 12 weeks prior to Screening and have been on a stable regimen for at least 2 weeks prior to Screening.
- Medium daily doses of ICS:
- \> 500 to 1000 mcg beclomethasone chlorofluorocarbon (CFC)
- \> 250 to 500 mcg beclomethasone hydrofluoroalkane (HFA)
- \> 600 to 1000 mcg budesonide dry powder inhaler (DPI)
- \> 1000 to 2000 mcg flunisolide
- \> 250 to 500 mcg fluticasone
- 400 mcg MF
- \> 1000 to 2000 mcg triamcinolone acetonide
- High daily doses of ICS:
- \> 1000 mcg beclomethasone CFC
- \> 500 mcg beclomethasone HFA
- \> 1000 mcg budesonide DPI
- \> 2000 mcg flunisolide
- \> 500 mcg fluticasone
- \> 400 mcg MF
- \> 2000 mcg triamcinolone acetonide
- If there is no inherent harm in changing the subject's current asthma therapy, the subject must discontinue prescribed ICS or ICS/LABA combination at Baseline.
- Must show evidence of reversibility within the last 12 months or during the Screening Period. Historical reversibility defined as an increase in absolute forced expiratory volume in 1 second (FEV1) of \>= 12% and \>= 200 mL will qualify if performed within 12 months of Screening. If no historical reversibility, subject must demonstrate an absolute FEV1 of \>= 12% and \>= 200 mL within 10 to 15 minutes after four puffs of salbutamol at Visit 1 or anytime prior to Baseline.
- At Screening and Baseline, FEV1 must be \>= 50% predicted, when restricted medications are withheld for the appropriate intervals.
- Complete blood count, blood chemistries, urinalysis, and electrocardiogram (ECG) conducted at Screening must be within normal limits or clinically acceptable to the investigator/sponsor. A chest x-ray performed at Screening or within 12 months prior must be clinically acceptable.
- A female of childbearing potential must be using a medically acceptable, adequate form of birth control:
- prescribed hormonal contraceptives;
- medically prescribed intrauterine device (IUD);
- medically prescribed transdermal contraceptive;
- condom in combination with spermicide;
- monogamous relationship with a male partner who has had a vasectomy.
- Birth control must have started at least 3 months prior to Screening. Subject must agree to continue its use for the duration of the study. A subject of childbearing potential who is not currently sexually active must agree to use a medically acceptable method should she become sexually active during the study. Women who have been surgically sterilized or are at least 1 year postmenopausal are not considered to be of childbearing potential. A subject of childbearing potential must have a negative serum pregnancy test at Screening.
- Key
Exclusion
- A change (increase or decrease) in absolute FEV1 of \> 20% at any time from the Screening Visit up to, and including, the Baseline Visit.
- A subject who requires the use of \> 12 inhalations per day of short-acting beta-agonist (SABA) MDI or \> 2 nebulized treatments per day of 2.5 mg salbutamol, on any 2 consecutive days from the Screening Visit up to, and including, the Baseline Visit.
- A subject who experiences a clinical asthma exacerbation (defined as a deterioration of asthma that results in emergency treatment, hospitalization due to asthma, or treatment with additional, excluded asthma medication \[other than SABA\]) at any time from the Screening Visit up to, and including, the Baseline Visit.
- A subject who has ever required ventilator support for respiratory failure secondary to asthma.
- A subject who is a smoker or ex-smoker and has smoked within the previous year or has had a cumulative smoking history \> 10 pack-years.
Key Trial Info
Start Date :
June 1 2006
Trial Type :
INTERVENTIONAL
Allocation :
ACTUAL
End Date :
November 1 2007
Estimated Enrollment :
404 Patients enrolled
Trial Details
Trial ID
NCT00379288
Start Date
June 1 2006
End Date
November 1 2007
Last Update
May 20 2024
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