A Study for Disease Profiling of Asthma and Chronic Obstructive Pulmonary Disease

NCT ID: NCT01274507

Last Updated: 2016-12-20

Basic Information

• Recruitment Status: COMPLETED
• Clinical Phase: EARLY_PHASE1
• Total Enrollment: 328 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2010-07-31
• Study Completion Date: 2014-07-31

Brief Summary

The purpose of this study is to characterize the clinical, physiologic, and molecular profiles of healthy participants, participants with mild, moderate, and severe asthma; and participants with moderate to severe Chronic Obstructive Pulmonary Disease (COPD).

Detailed Description

This is a multi-center, longitudinal (participants are followed over long period of time with continuous or repeated observations of health outcomes) exploratory study (biomarkers, clinical and physiological parameters for participants with asthma and COPD are observed for the first time). This study will be conducted in 2 parts. Part 1 will include healthy participants and participants with mild, moderate, and severe asthma. Part 2 will include healthy nonsmokers, healthy asymptomatic smokers, and participants with moderate and or severe COPD. Study participants will undergo medical tests that will include pulmonary function testing, assessment of airway reactivity, bronchoscopy procedure, blood samples for routine laboratory tests, biomarkers and DNA evaluation (for some study participants), induced sputum collection, and exhaled nitric oxide collection. Safety evaluations will includes assessment of adverse events, clinical laboratory tests, 12-lead electrocardiogram, vital signs, and physical examinations.

Conditions

Asthma; Pulmonary Disease, Chronic Obstructive

Keywords

Asthma; Pulmonary Disease, Chronic Obstructive; Healthy; Longitudinal Study; Bronchoscopy

Study Design

• Allocation Method: NA
• Intervention Model: SINGLE_GROUP
• Primary Study Purpose: BASIC_SCIENCE
• Blinding Strategy: NONE

Study Groups

All participants

Group Type: OTHER

Medical tests

Intervention Type: OTHER

All participants will undergo medical tests and will be observed.

Interventions

Medical tests

All participants will undergo medical tests and will be observed.

Intervention Type: OTHER

Eligibility Criteria

Inclusion Criteria

• Age: for Part 1, healthy: 18 and 55 years; for Part 1, asthma: 18 and 70 years; for Part 2, nonsmokers: 40 and 65 years; for Part 2, smokers: 40 and 65 years; for Part 2, chronic obstructive pulmonary disease (COPD): 40 and 65 years
• Having mild, moderate, or severe asthma (for Part 1, asthma)
• Clinically stable asthma and have been on their current asthma controller therapy for at least 6 weeks prior to screening (for Part 1, asthma)
• No history of chronic respiratory disease including asthma (for Part 2, nonsmokers)
• Be a nonsmoker for 1 year or more at initial screening visit and have 10 packs or less per year history of smoking (for all Part 1 and Pat 2, nonsmokers)
• Be a current smoker with a current history of at least 20 pack years (for Part 2, smokers)
• Stable COPD in the 3 months prior to screening (for Part 2, COPD)
• Treating with Beta-adrenergic receptor agonist, anticholinergic bronchodilators, inhaled corticosteroid at stable doses for at least 4 weeks prior to screening (for Part 2, COPD)

Exclusion Criteria

• History of sleep apnea requiring medical intervention and positive urine pregnancy screening result (for all Part 1 and Part 2)
• Positive urine screen for nicotine; positive serology test for human immunodeficiency virus (HIV) antibodies, hepatitis B surface antigen, or hepatitis C virus antibody at screening (for all Part 1 and Part 2)
• Allergic bronchopulmonary aspergillosis, allergic bronchopulmonary mycosis, or occupational asthma (for Part 1, asthma)
• Requires long term oxygen therapy on a daily basis for chronic hypoxemia at screening visit except when used for exercise only (for Part 2, COPD)
• Pneumonia, COPD exacerbation that required systemic steroids, upper or lower respiratory tract infection, lung cancer surgery, lung volume reduction, or a lung transplant (for Part 2, COPD)

• Minimum Eligible Age: 18 Years
• Maximum Eligible Age: 70 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: No

Sponsors

Janssen Research & Development, LLC

INDUSTRY

Sponsor Role: lead

Responsible Party

Responsibility Role: SPONSOR

Principal Investigators

Janssen Research & Development, LLC Clinical Trial

Role: STUDY_DIRECTOR

Janssen Research & Development, LLC

Locations

Birmingham, Alabama, United States

New Haven, Connecticut, United States

Chicago, Illinois, United States

Iowa City, Iowa, United States

Baltimore, Maryland, United States

Chapel Hill, North Carolina, United States

Cleveland, Ohio, United States

Philadelphia, Pennsylvania, United States

Galveston, Texas, United States

Calgary, Alberta, Canada

Vancouver, British Columbia, Canada

Montreal, Quebec, Canada

Sainte-Foy, Quebec, Canada

København NV, , Denmark

Bordeaux Pessac N/A, , France

Marseille, , France

Frankfurt, , Germany

Lübeck, , Germany

Rotterdam, , Netherlands

Bucharest, , Romania

Manchester, , United Kingdom

Countries

United States; Canada; Denmark; France; Germany; Netherlands; Romania; United Kingdom

References

Cass SP, Yang Y, Xiao J, McGrath JJC, Fantauzzi MF, Thayaparan D, Wang F, Liang Z, Long F, Stevenson CS, Chen R, Stampfli MR. Current smoking status is associated with reduced sputum immunoglobulin M and G expression in COPD. Eur Respir J. 2021 Feb 4;57(2):1902338. doi: 10.1183/13993003.02338-2019. Print 2021 Feb. No abstract available.

Reference Type: DERIVED

PMID: 32883677 (View on PubMed)

Loza MJ, Djukanovic R, Chung KF, Horowitz D, Ma K, Branigan P, Barnathan ES, Susulic VS, Silkoff PE, Sterk PJ, Baribaud F; ADEPT (Airways Disease Endotyping for Personalized Therapeutics) and U-BIOPRED (Unbiased Biomarkers for the Prediction of Respiratory Disease Outcome Consortium) investigators. Validated and longitudinally stable asthma phenotypes based on cluster analysis of the ADEPT study. Respir Res. 2016 Dec 15;17(1):165. doi: 10.1186/s12931-016-0482-9.

Reference Type: DERIVED

PMID: 27978840 (View on PubMed)

Other Identifiers

NOCOMPOUNDASH0001

Identifier Type: OTHER

Identifier Source: secondary_id

CR017362

Identifier Type: -

Identifier Source: org_study_id