A Double-Blind, Randomized, Placebo-Controlled, Parallel Group Exploratory Study of the Safety and Efficacy of JNJ-39758979 in the Treatment of Adults with Persistent Asthma
- Conditions
- JNJ-39756979 is being developed for the treatment of asthma.MedDRA version: 9.1Level: LLTClassification code 10003553Term: Asthma
- Registration Number
- EUCTR2009-012444-16-LV
- Lead Sponsor
- Janssen-Cilag International NV
- Brief Summary
Not available
- Detailed Description
Not available
Recruitment & Eligibility
- Status
- ot Recruiting
- Sex
- All
- Target Recruitment
- 100
1. Subjects must have signed an informed consent document indicating that they understand the purpose of and procedures required for the study and are willing to participate in the study.
2. To participate in the optional pharmacogenomic component of this study, subjects (or their legally acceptable representative) must have signed the informed consent form for pharmacogenomic research indicating willingness to participate in the pharmacogenomic component of the study (where local regulations permit). Refusal to consent for this component does not exclude a subject from participation in the clinical study.
3. Man or woman between 18 and 65 years of age, inclusive
4. Healthy on the basis of physical examination, medical history, vital signs, and 12-lead ECG performed at screening.
5. Chest x-ray performed within the past 6 months without clinically significant abnormalities.
6. Healthy on the basis of clinical laboratory tests performed at screening. If the results of the serum chemistry panel, hematology, coagulation tests, or urinalysis are outside the normal reference ranges, the subject may be included only if the investigator judges the abnormalities or deviations from normal as not clinically significant or as appropriate and reasonable for the population under study. This determination must be recorded in the subject's source documents and initialed by the investigator.
7. Medically confirmed diagnosis of persistent asthma according to EPR-3 and GINA guidelines for at least six months. (See Attachment 3.)
8. FEV1 of 55-85% predicted measured >6 hours after the most recent use of a bronchodilator at screening.
9. Evidence of FEV1 reversibility at screening as demonstrated by an increase in FEV1 of at least 12% and 200 ml 15 to 30 minutes after administration of 4 puffs (360 mcg) of albuterol/salbutamol via a metered-dose inhaler (MDI) or 2.5 mg albuterol/salbutamol nebulized solution. Subjects suspected of being reversible but not meeting this criterion at Screening may have one repeat reversibility assessment within 7 days of the initial assessment. If a subject does not meet this reversibility criterion either at screening or at repeat assessment but has FEV1 reversibility documented within 12 months of screening, they may be included following discussion with the sponsor.
10. Score of 1.5 or greater on the Asthma Control Questionnaire (ACQ) at screening.
11. Short-acting beta-agonist (SABA) use ³5 times in the 2 weeks prior to screening.
12. Based on investigator's assessment, an adequate supply of albuterol/salbutamol in a MDI for use as a quick-relief medication as needed throughout the Run-in and Treatment Periods (other SABAs are not permitted).
13. Women must be one of the following:
a.postmenopausal,
b.surgically sterile.
c.abstinent
d.or if sexually active, be practicing an effective method of birth control which must be used consistently for 3 months prior to run-in as local regulations permit, before entry, and must agree to continue to use the same method of contraception throughout the study and for 6 months after the last dose of study drug.
14. Male subjects must consent to utilize a medically acceptable method of contraception throughout the study and for six months after the last dose of study drug and to not donate sperm during the study and for 6 months after receiving the last dose of study drug. Medically acceptable methods of contraception that may be used by the subject and/or the partner include diap
1. History of life-threatening asthma attack requiring intubation or ICU admission, hospitalization for asthma within 5 years of screening, or emergency department (ED) treatment of asthma within one (1) month of screening.
2. Have current signs or symptoms of liver insufficiency or cardiac, vascular, pulmonary, gastrointestinal, endocrine, neurologic, hematologic, psychiatric, or metabolic disturbances that are severe, progressive or uncontrolled in the investigator’s discretion.
3. History of drug/alcohol abuse within 5 years
4. Moderate or severe renal insufficiency as measured by creatinine clearance less than 50 mL/min as calculated by Cockcroft-Gault formula.
5. Positive anti-HCV, anti-HIV test, or evidence of HBV infection (positive HBsAg and/or HBcAb test) at screening
6. Cigarette smoking within 12 months prior to Screening or a greater than 10 pack year smoking history, as determined by medical history or subject’s verbal report.
7. Known allergies, hypersensitivity, or intolerance to JNJ-39758979 or its excipients (refer to Section 15.1 Physical Description of Study Drug(s)
8. Have received, or are expected to receive, any live virus, including FluMistâ, or bacterial vaccination within 1 month prior to the first administration of study agent, during the trial, or within 3 months after the last dose of study drug
9. Use of disallowed therapies:
a. Systemic corticosteroids within 4 weeks of Week –2 (start of run-in period)
b. Inhaled corticosteroids (ICS) within 2 weeks of Week -2
c. Long-acting beta agonists (LABA) within 1 week of Week –2
d. Oral beta agonists within 1 week of Week –2
e. Cromolyns, leukotriene inhibitors (zileuton, zafirlukast, montelukast), theophylline or inhaled anti-cholinergic agents within 1 week of Week -2
f. Omalizumab within 130 days (5 half-lives) of Week –2
10. Initiation or discontinuation of allergen immunotherapy within 3 months of Randomization (Stable doses of allergen immunotherapy are allowed).
11. History of upper respiratory infection (URI) [rhinitis or sinusitis] within 2 weeks of Week –2 (Start of Run-in Period). Subjects developing a URI between Week -2 and Randomization may repeat the Run-in Period after discussion with the medical monitor.
12. Screening or baseline (randomization) QTc (Fridericia) interval >450 msec (men) or >470 msec (women), or a history of additional risk factors for torsades de pointe (eg, heart failure, hypokalemia, family history of Long QT Syndrome)
13. Received an investigational drug or used an investigational medical device within 30 days before the planned start of treatment or are currently enrolled in an investigational study.
14. Pregnant or breast-feeding
15. Any condition that, in the opinion of the investigator, would compromise the well-being of the subject or the study or prevent the subject from meeting or performing study requirements
16. Employees of the investigator or study center, with direct involvement in the proposed study or other studies under the direction of that investigator or study center, as well as family members of the employees or the investigator.
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