A multicenter Longitudinal Study for Disease Profiling of Asthma
- Conditions
- niet aanwezig10006436
- Registration Number
- NL-OMON36306
- Lead Sponsor
- Janssen-Cilag
- Brief Summary
Not available
- Detailed Description
Not available
Recruitment & Eligibility
- Status
- Completed
- Sex
- Not specified
- Target Recruitment
- 34
Healthy Subjects
Inclusion Criteria
Subjects must satisfy all of the following criteria to be enrolled in the study:
• Must have signed an informed consent indicating that they understand the purpose of and procedures required for the study and are willing to participate in the study.
• Be willing and able to adhere to the study visit schedule and other protocol requirements.
• Be between 18 and 55 years of age, inclusive, at informed consent.
• Have no clinically significant abnormalities as determined by medical history, physical examination, blood chemistry assessments, hematologic assessments including complete blood count (CBC), urinalysis (see Attachment 2 for clinical laboratory analyses), measurement of vital signs, and ECG.
• Have a body mass index (BMI) of less or equal to 32* kg/m2.
• Must be able to produce an adequate induced sputum sample at screening, defined as a selected plug weight of at least 50 mg and a squamous cell count of < 20% (see Study Reference Manual).
• Must be judged by the Principal Investigator (PI) to be a subject suitable to undergo bronchoscopy.
• Have no history of chronic respiratory disease including asthma.
• Have no history of allergic symptoms eg, allergic rhinitis, eczema.
• Be a non-smoker for >= 1 year at initial screening visit and have <= 10 pack- year history of smoking.
• No other acute illness in the 6 weeks prior to screening.
• No contraindications to the procedures in this study including clinical or research bronchoscopy.
• No bleeding disorder including use of anticoagulants and antiplatelet agents that could place the subjects at risk for bleeding. Able to abstain from aspirin use for 7 days and NSAID use for 3 daysprior to bronchoscopy without risk.
• No contraindications to conscious sedation or medications used in the bronchoscopy procedure.
• To participate in the optional genomic component of this study, subjects must have signed the informed consent for genomic research indicating willingness to participate in the genomic component of the study. Refusal to give consent for this component does not exclude a subject from participation in the study.;Subjects with Asthma
Inclusion Criteria for Asthmatic Subjects
Subjects must satisfy all of the following criteria to be enrolled in the study:
• Must have signed an informed consent indicating that they understand the purpose of and procedures required for the study and are willing to participate in the study.
• Be willing and able to adhere to the study visit schedule and other protocol requirements.
• Be between 18 and 70 years of age, inclusive, at informed consent. Subjects who elect to undergo bronchoscopy must be between 18 and 55 years old, inclusive, at informed consent.
• Have no clinically significant abnormalities as determined by medical history, physical examination, blood chemistry assessments, hematologic assessments including CBC, urinalysis (see Attachment 2 for clinical laboratory analyses), measurement of vital signs, and ECG.
• Have a BMI less then or equal to 32 kg/m2.
• Must be able to produce an adequate induced sputum sample at screening, defined as a selected plug weight of at least 50 mg and a squamous cell count of < 20% (see Study Reference Manual).
• Be a non-smoker for >= 1 year prior to screening and have <= 10 pack- year history of smoking.
• No contraindications to the procedures in this stu
Healthy Subjects
Exclusion Criteria
Subjects who meet any of the following criteria will be excluded from participating in the study:
• Be considered, in the opinion of the investigator, to be an unsuitable candidate for the study.
• History of any clinically significant medical illness or medical disorders including (but not limited to) cardiovascular disease, neuromuscular, hematological disease including bleeding disorders, respiratory disease, hepatic or gastrointestinal (GI) disease, neurological or psychiatric disease, ophthalmological disorders, neoplastic disease, renal or urinary tract diseases, or dermatological disease.
• Diagnosis of chronic obstructive pulmonary disease (COPD), cystic fibrosis, or other significant respiratory disorder including significant occupational or environmental exposures with ongoing respiratory symptoms.
• Have a bronchodilator response of more or equal to 12% and at least 200 mL from baseline or an FEV1 value less than*85% of predicted value at screening.
• A known history of sleep apnea requiring medical intervention.
• Major or traumatic surgery within the 3 months prior to screening.
• Have a positive urine pregnancy screening result.
• Have a recent history (within previous 6 months) of alcohol or drug abuse.
• Positive urine toxicology screen for substances of abuse, including but not limited to cannabinoids, cocaine, and methadone
. Positive urine toxicology screen, including but not limited to amphetamines, barbiturates, benzodiazepines, opiates and tricyclic antidepressants. unless the results can be reliably attributed to a concomitant prescription medication by the PI for a condition identified on medical history, in which case the subject may be enrolled after consultation with and agreement of the spnsors medical monitor
• Have a positive urine screen for nicotine (urine cotinine test).
• Have a positive breath test for alcohol at initial screening visit.
• Have a positive serology test for HIV antibodies, hepatitis B surface antigen (HBsAg), or hepatitis C virus antibody (anti-HCV) at screening.
• Have a positive Phadiatop test.
• Donated blood (volume >= *500 mL) within 56 days prior to screening.
• Received an experimental antibody or biologic therapy within the 6 months prior to screening, or received any other experimental therapy or new investigational agent within 60 days or 5 half-lives (whichever is longer) of study start.
• Be unable or unwilling to undergo multiple venipunctures because of poor tolerability or lack of easy access to veins.
• Is an employee or employee family member of the investigator, study center, or Sponsor.
• Any condition that, in the opinion of the investigator, would complicate or compromise the study, or the well-being of the subject.;Subjects with Asthma
Exclusion Criteria
• Be considered, in the opinion of the investigator, to be an unsuitable candidate for the study.
• History of any clinically significant medical illness or medical disorders that place the subject at risk from participation by the judgment of the PI including (but not limited to) cardiovascular disease, neuromuscular, hematological disease including bleeding disorders, respiratory disease, hepatic or GI disease, neurological or psychiatric disease, ophthalmological disorders, neoplastic disease, renal or urinary tract diseases, or dermatological disease. Subjects with stable, well
Study & Design
- Study Type
- Observational invasive
- Study Design
- Not specified
- Primary Outcome Measures
Name Time Method <p>Biomarker assessments will include the evaluation of biomarkers in serum,<br /><br>urine, and whole blood as well as from endobronchial biopsy, brushings and<br /><br>induced sputum specimens. Potential markers include but are not limited to<br /><br>TNF*, IL-8, eotaxin, myeloperoxidase, MMP2, MMP9, IL-4, IL-13, cysteinyl<br /><br>leukotrienes, 8-isoprostane, mRNA and miRNA differential expression profiles.</p><br>
- Secondary Outcome Measures
Name Time Method <p>genomic evaluation (if sucject consents for this part of the study)<br /><br>asthma questionnaires<br /><br>safety evaluations</p><br>