A Randomized Double-Blind Placebo Controlled Trial Evaluating the Safety and Efficacy of Etanercept 25 mg Twice Weekly in Subjects with Moderate to Severe Persistent Asthma

• Register: EUCTR
• Last refreshed on: 1 May 2012
• Main ID: EUCTR2004-003778-27-FI
• Date of registration: 22/02/2005
• Prospective Registration: Yes
• Primary sponsor: Wyeth Research Division of Wyeth Pharmaceuticals Inc. Clinical resaearch and Development
• Public title: A Randomized Double-Blind Placebo Controlled Trial Evaluating the Safety and Efficacy of Etanercept 25 mg Twice Weekly in Subjects with Moderate to Severe Persistent Asthma
• Scientific title: A Randomized Double-Blind Placebo Controlled Trial Evaluating the Safety and Efficacy of Etanercept 25 mg Twice Weekly in Subjects with Moderate to Severe Persistent Asthma
• Date of first enrolment: 02/05/2005
• Target sample size: 120
• Recruitment status: Not Recruiting
• URL: https://www.clinicaltrialsregister.eu/ctr-search/search?query=eudract_number:2004-003778-27
• Study type: Interventional clinical trial of medicinal product
• Study design: Controlled: yes Randomised: yes Open: no Single blind: no Double blind: yes Parallel group: yes Cross over: no Other: no If controlled, specify comparator, Other Medicinial Product: no Placebo: yes Other: no

Countries of recruitment

Finland, Sweden, United Kingdom

Key inclusion & exclusion criteria

Inclusion criteria:
1. 18 to 70 years of age.
2. Asthma diagnosed at least 1 year prior to randomization.
3. Moderate to severe persistent asthma as defined by National Heart, Lung and Blood Institute (NHLBI) expert panel report.
4. Demonstrated reversibility of at least 12% (actual) with inhaled salbutamol/albuterol during the screening period. But permit the inclusion of subjects with = 9% but < 12% reversibility who have a documented history of achieving = 12% reversibility within 1 year prior to randomisation.
5. Forced expiratory volume in 1 second (FEV1) 45 – 80% predicted demonstrable at least 6 hrs after short-acting ß2 agonist or 12 hrs after long-acting ß2 agonist at screening or baseline. Pulmonary function tests performed at both screening and baseline visits.
6. Minimum total average per item score >= 2 based on the asthma control questionnaire during the screening period.
7. Subjects must be on a high-dose inhaled corticosteroid (ICS) (at least 1000 micro g/day of beclomethasone CFC, 500 micro g/day beclomethasone HFA, 500 micro g/day fluticasone, 1000 micro g/day budesonide, or equivalent).
8. Subjects must be on stable doses of their current medications for asthma for at least 4 weeks before randomization. Subjects must not be on methotrexate or azathioprine within 6 weeks of baseline and cyclophosphamide within 6 months of baseline.
9. Sexually active women of childbearing potential and sexually active men participating in the study must use a medically acceptable form of contraception. A woman of childbearing potential is one who is biologically capable of becoming pregnant. This includes women who are using contraceptives or whose sexual partners are either sterile or using contraceptives. Medically acceptable forms of contraception include oral contraceptives, injectable or implantable methods, intrauterine devices, or properly used barrier contraception. Additionally, the use of condoms is suggested as an adjunct to the methods previously addressed to protect against sexually transmitted diseases and to provide additional protection against accidental pregnancy.
10. Negative result of serum ß-human chorionic gonadotropin (ß –HCG) pregnancy test taken at screening for all women except those surgically sterile or at least 1 year postmenopausal.
11. Subject or designee must have the ability to inject test article subcutaneously.
12. Subjects must be capable of understanding and be willing to provide signed and dated written voluntary informed consent before any protocol-specific screening procedures are performed.
13. Ability to store injectable test article at 2°C to 8°C
Are the trial subjects under 18? no
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:
1. Previous treatment with etanercept, antibody to TNFa, or other TNFa inhibitors.
2. Received any investigational agents or other biologic agents within 3 months of randomization.
3. Received any live (attenuated) vaccine within 4 weeks prior to randomization.
4. Current use of cigarettes or cigars, or smoking history of > 10 pack years.
5. Abnormality in blood chemistry or hematology profiles: hemoglobin <= 85 g/L; hematocrit <= 27%; platelet count <= 125 x 10 to the power 9/L; white blood cell count <= 3.5 x 10 to the power 9/L; serum creatinine >= 175 micro mol/L; aspartate aminotransferase (AST) (serum glutamic-oxaloacetic transaminase [SGOT]) and alanine aminotransferase (ALT) (serum glutamic pyruvic transaminase [SGPT]) >= 2 times the laboratory’s upper limit of normal; or other clinically important laboratory abnormalities.
6. Respiratory tract infection within 4 weeks of baseline.
7. Significant concurrent medical conditions at the time of screening, including: Concurrent chronic obstructive pulmonary disease (COPD), or any significant respiratory diseases. Presence of active infection or any underlying diseases that could predispose subjects to infections. Tuberculosis (follow your contry's guidelines for appropriate screening and treatment of tuberculosis in the setting of anti-TNF treatment. Uncontrolled hypertension (defined as screening systolic blood pressure measurement of greater than 180 mm Hg or screening diastolic blood pressure of greater than 110 mm Hg). Myocardial infarction within 12 months of the screening visit. Unstable angina pectoris. Class III or IV congestive heart failure as defined by the NYHA. Diagnosis of multiple sclerosis or other central demyelinating diseases. Presence or history of confirmed blood dyscrasias. Uncontrolled insulin-dependent diabetes mellitus. Any rheumatologic disease such as rheumatoid arthritis, systemic lupus erythematous, systemic vasculitis, scleroderma, polymyositis, or associated syndrome. Open cutaneous ulcers. Cancer or history of cancer (other than resected cutaneous basal cell or squamous cell carcinoma). Known human immunodeficiency virus (HIV) infection. Presence of hepatitis B surface antigen (HBsAg) or hepatitis C virus (HCV) at screening. Any condition that, in the judgment of the investigator, might cause this study to be detrimental to the subject.
8.Pregnant or breast-feeding women.
9. History of poor compliance.
10. History of/or current psychiatric illness that would interfere with ability to comply with protocol requirements or give informed consent.
11. History of alcohol or drug abuse that would interfere with ability to comply with protocol requirements.
12. Employment by the investigator or reporting directly or indirectly to the investigator


Age minimum:
Age maximum:
Gender:
Female: yes
Male: yes

Health Condition(s) or Problem(s) studied

Moderate to severe asthmatics

Intervention(s)

Product Name: Enbrel (etanercept)
Product Code: 0881
Pharmaceutical Form: Powder and solvent for solution for injection
INN or Proposed INN: etanercept
Current Sponsor code: 0881
Other descriptive name: TNR-001; TNFR:Fc
Concentration unit: mg milligram(s)
Concentration type: equal
Concentration number: 25-
Pharmaceutical form of the placebo: Powder and solvent for solution for injection
Route of administration of the placebo: Subcutaneous use

Primary Outcome(s)

Main Objective: To assess the efficacy and safety of etanercept 25 mg twice weekly in subjects with moderate to severe persistent asthma

Primary end point(s): Change in FEV 1 % predicted from baseline to week 12 (before bronchodilator administration).

Secondary Objective: To assess patient reported outcomes and pharmacodynamics.

Secondary ID(s)

0881A8-205

2004-003778-27-SE