A 12-Week Efficacy and Safety Study of Two Doses of Mometasone Furoate/Formoterol Combination Formulation Compared With Mometasone Furoate Monotherapy, in Persistent Asthmatics Previously treated With High-Dose Inhaled Glucocorticosteroids

• Conditions: Asthma; MedDRA version: 8.1Level: LLTClassification code 10003553Term: Asthma

• Registration Number: EUCTR2005-005910-20-DK
• Lead Sponsor: Schering-Plough Research Institute, a division of Schering Corporation

Brief Summary

Not available

Detailed Description

Not available

Study Timeline

• Study Start: 2006-09-06
• Last Update Posted: 19 March 2012

Recruitment & Eligibility

• Status: ot Recruiting
• Sex: All
• Target Recruitment: 621

Inclusion Criteria

•A subject must have been using high dose Inhaled Corticosteroid (ICS) (either alone or in combination with a Long Acting beta-Agonist (LABA)) for at least 12 weeks prior to Screening and have no use of oral corticosteroids within 30 days prior to Screening. A subject must have been on a stable asthma regimen (daily dose unchanged) for at least two weeks prior to Screening. High dose ICS is defined in the protocol.
•A subject must have experienced at least one severe exacerbation requiring a course of oral glucocorticosteroids 2 – 12 months prior to Screening.
•If, in the medical judgement of the Investigator, there is no inherent harm in changing a subject’s current asthma therapy, a subject must be willing to discontinue their prescribed ICS or ICS/LABA combination at the Screening Visit, and be transferred to open-label treatment with MF MDI 400 microgram BID for 2-3 weeks prior to the Baseline/Randomization Visit.
• To document the diagnosis of asthma and assure the subject's responsiveness to bronchodilators before randomization, one of the following methods can be used at the Screening Visit, Day -14, or thereafter, but prior to the Baseline Visit:
* The subject must demonstrate an increase in absolute FEV1 of at least 12% and at least 200 mL within 15 minutes after administration of four inhalations of albuterol/salbutamol (total dose of 360 to 400 micrograms).
* The subject must demonstrate a PEF variability of more that 20% expressed as a percentage of the best and lowest morning pre-bronchodilator PEF over at least one week.
* The subject must demonstrate a diurnal variation in PEF of more than 20% based on the difference between the pre-bronchodilator morning value and the post-bronchodilator value from the evening before, expressed as percentage of the mean daily PEF value.
•At the Screening Visit, the subject's FEV1 must be >=50% predicted when all restricted medications have been withheld for the appropriate intervals.
•Clinical laboratory tests conducted at the Screening Visit must be within norrmal limits or clinically acceptable to the investigator/sponsor. An ECG performed at the Screening Visit using a centralized transtelephonic technology must be clinically acceptable to the investigator. A chest X-ray performed at Screening Visit or within 12 months prior to the Screening Visit must be clinically acceptable to the investigator.
•A subject must meet other specified spirometry and clinical laboratory test criteria, and female subjects of childbearing age must be using medically acceptable and adequate forms of birth control.

Are the trial subjects under 18? yes
Number of subjects for this age range:
F.1.2 Adults (18-64 years) yes
F.1.2.1 Number of subjects for this age range
F.1.3 Elderly (>=65 years) yes
F.1.3.1 Number of subjects for this age range

Exclusion Criteria

•A subject who demonstrates 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 >8 inhalations per day of Short Acting beta-Agonist (SABA) MDI or >2 nebulized treatments per day of 2.5 mg SABA, on any 2 consecutive days from the Screening Visit up to and including the Baseline Visit.
•A subject who experiences a decrease in AM or PM PEF below the Screening Period stability limit (as specified in the protocol) on any 2 consecutive days prior to randomization.
•A subject who experiences an occurence of any clinical deterioration of asthma that results in emergency treatment, hospitalization due to asthma, or treatment with additional, excluded asthma medication (other than SABA) as judged by the clinical investigator at any time from the Screening Visit up to and including the baseline Visit.
•A subject who is a smoker or ex-smoker and has smoked within the previous year or has had a cumulative smoking history of > 10 pack-years.

Study & Design

• Study Type: Interventional clinical trial of medicinal product
• Study Design: Not specified

Primary Outcome Measures

Name	Time	Method
Primary end point(s): The AUC (0-12 hour) of the change from Baseline to Week 12 in FEV1.;Main Objective: To evaluate the efficacy of mometasone furoate/formoterol (MF/F) Metered Dose inhaler (MDI) 400/10 microgram BID compared with mometasone furoate (MF) MDI 400 microgram BID, as measured by mean area under curve (AUC) of the change from Baseline to Week 12 in FEV1.;Secondary Objective: To evaluate the efficacy of MF/F MDI 400/10 microgram BID compared with MF MDI 400 microgram BID as measured by the Asthma Control Questionnaire (ACQ), the Asthma Quality of Life Questionnaire (AQLQ) and proportion of nocturnal awakenings due to asthma which require use of albuterol/salbutamol rescue medication (SABA).