A Randomized, Double-blind, Active-controlled, Parallel Group, Stratified, Multi-center, 12-Week Study Comparing the Safety and Efficacy of Fluticasone and Formoterol Combination (FlutiForm™ 250/10mcg twice daily) in a Single Inhaler (SkyePharma HFA pMDI) with the Administration of Fluticasone (250mcg twice daily) Alone in SkyePharma HFA pMDI and Flovent® HFA pMDI in Adolescent and Adult Patients with Moderate to Severe Asthma.
- Conditions
- Moderate to severe asthma.MedDRA version: 9.1Level: LLTClassification code 10003553Term: Asthma
- Registration Number
- EUCTR2007-005653-37-CZ
- Lead Sponsor
- SkyePharma AG
- Brief Summary
Not available
- Detailed Description
Not available
Recruitment & Eligibility
- Status
- ot Recruiting
- Sex
- All
- Target Recruitment
- 375
1.Age = 12 years at the Screening Visit.
2.History of asthma for = 12 months prior to the Screening Visit. For the purposes of this study, ‘asthma’ is defined by NAEPP.
3.Documented use of an inhaled corticosteroid for at least 4 weeks prior to the Screening Visit and at a dose not greater than 500ug/day Fluticasone propionate inhalation (or equivalent dose for other inhaled corticosteroids).
4.Demonstrate a FEV1 of 40% to 80% (inclusive) of predicted normal values during the Screening Visit and at the Baseline Visit (Week 0) following appropriate withholding of bronchodilator medication. (rounding FEV1% predicted is permissible)
5.Documented reversibility within 12 months of the Screening Visit or at the Screening Visit. Reversibility is defined as a =15% (or =14.5%) increase from pre- dose FEV1 levels 15–30 minutes following Salbutamol (Albuterol) inhalation (pMDI or nebulizer, 2.5mg/unit dose vial).
6.Meet the following criteria during any 7 consecutive days of the Run-In Period:
a)Use of two or more inhalations per day of rescue Salbutamol (Albuterol) pMDI for at least 3 days, AND
b)One of the following asthma symptoms:
oAt least one night with sleep disturbance, OR
oAt least 3 days with asthma symptoms.
7.Females of childbearing potential must have a negative urine beta human chorionic gonadotropin (beta-HCG) pregnancy test at the Screening and Baseline Visits. Females are eligible only if they are not pregnant or lactating, and are either:
a)2 years postmenopausal, or
b)surgically sterile (tubal ligation or hysterectomy), or
c)using acceptable methods of contraception. For purposes of this study, acceptable methods of birth control include:
?Birth control pills (= 1 month prior to the Screening Visit, and patient agrees to continue taking them for 1 month after the completion of the study);
?Regulatory approved implantable contraceptive (e.g., Mirena®, Norplant®) (= 1 month prior to the Screening Visit, and patient agrees to continue to use it for 1 month after the completion of the study);
?Regulatory approved injectable contraceptive (e.g., Depo-Provera®) (= 1 month prior to the Screening Visit, and patient agrees to continue to use it for 1 month after the completion of the study);
?Double barrier methods (e.g., condoms with spermicide);
?Intrauterine contraceptive devices (IUDs or coil);
?Lifestyle with a personal choice of abstinence;
?Non-heterosexual lifestyle;
?Vasectomy of sexual partner.
8.Must otherwise be healthy as judged by medical history, physical examination, and clinical laboratory tests.
9.Demonstrate satisfactory technique in the use of pMDI.
10.Willing and able to enter information into the telephone diary system.
11.Willing and able to substitute study medication for their prescribed asthma medication for the duration of the study.
12.Willing and able to attend scheduled visits and complete the entire study.
13.Provide written informed consent. The wishes of minors must be respected.
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
1.Life-threatening asthma within the past year or during the Run-In Period. This category includes those patients with a history of near-fatal asthma, a hospitalization or prior intubation for asthma within the past year. Patients may not have an emergency room visit due to asthma in the past 3 months prior to screening visit.
2.History of systemic (oral or injectable) corticosteroid medication within 3 months before the Screening Visit.
3.History of monoclonal antibody (e.g. omalizub) use within the past 6 months.
4.History of leukotriene receptor antagonist use, e.g. montelukast, within the past week.
5.Current evidence or history of any clinically significant disease or abnormality including uncontrolled hypertension, uncontrolled coronary artery disease, congestive heart failure, myocardial infarction, or cardiac dysrhythmia. ‘Clinically significant’ is defined as any disease that, in the opinion of the Investigator, would put the patient at risk through study participation, or which would affect the outcome of the study.
6.An upper or lower respiratory infection within 4 weeks prior to the Screening Visit or during the Run-In Period.
7.Significant, non-reversible, pulmonary disease (e.g., chronic obstructive pulmonary disease [COPD], cystic fibrosis, bronchiectasis).
8.Known Human Immunodeficiency Virus (HIV)-positive status.
9.A smoking history equivalent to 10 pack years” (i.e., at least 1 pack of 20 cigarettes /day for 10 years or 10 packs/day for 1 year, etc.).
10.Current smoking history within 12 months prior to the Screening Visit.
11.Current evidence or history of alcohol and/or substance abuse within 12 months prior to the Screening Visit.
12.Patients who have taken beta-blocking agents, tricyclic antidepressants, monoamine oxidase inhibitors, quinidine type antiarrhythmics, or potent CYP 3A4 inhibitors such as ketoconazole within the past week.
13.Current evidence or history of hypersensitivity or idiosyncratic reaction to test medications or components.
14.Receipt of an investigational drug within 30 days of the Screening Visit (12 weeks if an oral or injectable steroid).
15.Patients who are confined in an institution.
16.Previous exposure to FlutiForm.
17.Patients under the age of 18 years at the time of the screening visit with a history of combination therapy treatment with ICS / LABA within 4 weeks prior Screening Visit. The investigator should not change the asthma treatment of the subject prior screening so that the subject meets the criteria for inclusion into the study.
Study & Design
- Study Type
- Interventional clinical trial of medicinal product
- Study Design
- Not specified
- Primary Outcome Measures
Name Time Method
- Secondary Outcome Measures
Name Time Method