Clinical trial NCT00379288: Study of Mometasone Furoate/Formoterol Combination and Fluticasone/Salmeterol in Persistent Asthmatics Previously Treated With Inhaled Glucocorticosteroids (P04139)
Official title: A 1-Year Safety Study of Medium and High Doses of Mometasone Furoate/Formoterol Combination Formulation and Medium and High Doses of Fluticasone/Salmeterol in Persistent Asthmatics Previously Treated With Medium to High Doses of Inhaled Glucocorticosteroids
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: PHASE3
Conditions: Asthma
Lead sponsor: Organon and Co
Sponsor class: INDUSTRY
First posted: 2006-09-21
Enrollment: 404
Sex: ALL
Minimum age (years): 12
Standard ages: CHILD
ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

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 of fluticasone/salmeterol combination (F/SC) (250/50 mcg BID and 500/50 mcg BID) in subjects with persistent asthma who require maintenance treatment on inhaled glucocorticosteroids (ICS); evaluator-blind.

In addition, the extrapulmonary effects on 24-hour plasma cortisol area under curve (AUC), of MF/F MDI 200/10 mcg BID, MF/F MDI 400/10 mcg BID, F/SC MDI 250/50 mcg BID, and F/SC MDI 500/50 mcg BID will be evaluated.


Eligibility criteria: Inclusion Criteria:

* 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 Criteria:

* 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.

Primary outcomes:
measure: The Number of All Randomized Subjects Reporting Adverse Events (AEs).
timeFrame: 1 year
Secondary outcomes:
Other outcomes:
Locations:
Study officials:
References:
citation: Maspero JF, Nolte H, Cherrez-Ojeda I; P04139 Study Group. Long-term safety of mometasone furoate/formoterol combination for treatment of patients with persistent asthma. J Asthma. 2010 Dec;47(10):1106-15. doi: 10.3109/02770903.2010.514634. Epub 2010 Nov 1.
citation: Maspero J, Cherrez I, Doherty DE, Tashkin DP, Kuna P, Kuo WL, Gates D, Nolte H, Chylack LT Jr. Appraisal of lens opacity with mometasone furoate/formoterol fumarate combination in patients with COPD or asthma. Respir Med. 2014 Sep;108(9):1355-62. doi: 10.1016/j.rmed.2014.04.015. Epub 2014 May 2.