Clinical trial NCT01274507: A Study for Disease Profiling of Asthma and Chronic Obstructive Pulmonary Disease
Official title: A Multicenter Longitudinal Study for Disease Profiling of Asthma and Chronic Obstructive Pulmonary Disease
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: EARLY_PHASE1
Conditions: Asthma
Pulmonary Disease, Chronic Obstructive
Keywords: Asthma
Pulmonary Disease, Chronic Obstructive
Healthy
Longitudinal Study
Bronchoscopy
Lead sponsor: Janssen Research & Development, LLC
Sponsor class: INDUSTRY
First posted: 2011-01-11
Enrollment: 328
Sex: ALL
Minimum age (years): 18
Maximum age (years): 70
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: NA
Intervention model: SINGLE_GROUP
Primary purpose: BASIC_SCIENCE

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.

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)

Primary outcomes:
measure: Asthma Quality of Life Questionnaire (AQLQ) score
timeFrame: Baseline (5 to 14 days after screening), Month 3, Month 6, and Month 12 (for Part 1: participants with asthma)
measure: Asthma Control Questionnaire (ACQ) score
timeFrame: Baseline, Month 3, Month 6, and Month 12 (for Part 1: participants with asthma)
measure: Forced Expiratory Volume in 1 second (FEV1) value
timeFrame: Screening, Baseline, 5 to 14 days after baseline (for Part 1: healthy participants); and Month 3, Month 6, and Month 12 (for Part 1: participants with asthma and for all Part 2 participants)
measure: Forced Vital Capacity (FVC) value
timeFrame: Screening, Baseline, 5 to 14 days after baseline (for Part 1: healthy participants); and Month 3, Month 6, and Month 12 (for Part 1: participants with asthma and for all Part 2 participants)
measure: Forced Expiratory Flow (FEF) 25-75 value
timeFrame: Screening, Baseline, 5 to 14 days after baseline (for Part 1: healthy participants); and Month 3, Month 6, and Month 12 (for Part 1: participants with asthma and for all Part 2 participants)
measure: Peak Expiratory Flow Rate (PEFR)
timeFrame: Screening, Baseline, 5 to 14 days after baseline (for Part 1: healthy participants); and Month 3, Month 6, and Month 12 (for Part 1: participants with asthma and for all Part 2 participants)
measure: Methacholine challenge
timeFrame: Screening or Baseline (for Part 1: participants with asthma)
measure: Fractional Exhaled Nitric Oxide (FENO)
timeFrame: Baseline, Month 3, Month 6, and Month 12 (for Part 1: participants with asthma); and 5 to 14 days after baseline (for Part 2: participants with chronic obstructive pulmonary disease)
measure: Induced sputum
timeFrame: Screening, Baseline (for Part 1: healthy participants and for all Part 2 participants); and Month 6 (for Part 1: participants with asthma)
measure: Saint George's Respiratory Questionnaire score for Chronic Obstructive Pulmonary Disease (COPD) participants (SGRQ-C)
timeFrame: Baseline (for Part 2: participants with COPD)
measure: EXACT-Respiratory Symptoms (E-RS)
timeFrame: Baseline (for Part 2: participants with chronic obstructive pulmonary disease)
measure: Number of participants with adverse events
timeFrame: Up to 1 month (for Part 1: healthy participants and for all Part 2 participants); and Up to 1 year (for Part 1: participants with asthma)
Secondary outcomes:
Other outcomes:
Locations:
city: Birmingham
country: United States
state: Alabama
city: New Haven
country: United States
state: Connecticut
city: Chicago
country: United States
state: Illinois
city: Iowa City
country: United States
state: Iowa
city: Baltimore
country: United States
state: Maryland
city: Chapel Hill
country: United States
state: North Carolina
city: Cleveland
country: United States
state: Ohio
city: Philadelphia
country: United States
state: Pennsylvania
city: Galveston
country: United States
state: Texas
city: Calgary
country: Canada
state: Alberta
city: Vancouver
country: Canada
state: British Columbia
city: Montreal
country: Canada
state: Quebec
city: Sainte Foy
country: Canada
state: Quebec
city: Kobenhavn Nv
country: Denmark
city: Bordeaux Pessac N/A
country: France
city: Marseille
country: France
city: Frankfurt
country: Germany
city: Lübeck
country: Germany
city: Rotterdam
country: Netherlands
city: Bucuresti
country: Romania
city: Manchester
country: United Kingdom
Study officials:
affiliation: Janssen Research & Development, LLC
name: Janssen Research & Development, LLC Clinical Trial
role: STUDY_DIRECTOR
References:
citation: 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.
citation: 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.