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Asthma Biomarkers for Predicting Response to Therapy

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ClinicalTrials.gov Identifier: NCT01973751
Recruitment Status : Unknown
Verified May 2016 by Guohua Zhen, MD, Tongji Hospital.
Recruitment status was:  Active, not recruiting
First Posted : October 31, 2013
Last Update Posted : May 16, 2016
Sponsor:
Information provided by (Responsible Party):
Guohua Zhen, MD, Tongji Hospital

Brief Summary:
Novel asthma biomarkers to predict the response to inhaled corticosteroid Brief description: This will be a single center study of asthmatic subjects and healthy controls which will investigate mechanisms underlying different response to inhaled corticosteroid, the mainstay of asthma therapy. Only about half of the asthmatic patients have improved lung function after treatment of inhaled corticosteroid. The investigators hypothesize that there are biomarkers such as epithelial cytokines (IL-25, IL-33, TSLP) in airway tissues or plasma of asthmatic patients which could predict the response of asthmatic patients to inhaled corticosteroid. Finding novel asthma biomarker will help the clinicians to choose the optimal treatment for individual asthmatic patient.

Condition or disease Intervention/treatment Phase
Asthma Drug: Budesonide Not Applicable

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Study Type : Interventional  (Clinical Trial)
Actual Enrollment : 148 participants
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: None (Open Label)
Primary Purpose: Treatment
Official Title: Novel Asthma Biomarkers to Predict the Response to Inhaled Corticosteroid
Study Start Date : November 2013
Estimated Primary Completion Date : July 2016
Estimated Study Completion Date : July 2016

Resource links provided by the National Library of Medicine

MedlinePlus related topics: Asthma
Drug Information available for: Budesonide

Arm Intervention/treatment
No Intervention: Healthy controls
Healthy controls who will be studied at baseline and serve as a control group for the bronchoscopy, induced sputum and peripheral blood collection.
Active Comparator: Asthmatics (treatment)
Steroid-naïve asthma, randomized to inhaled budesonide, 2 puffs (200mcg) twice a day for 8 weeks. These subjects will undergo bronchoscopy and induced sputum collection at baseline, undergo pulmonary function testing and peripheral blood collection at baseline, 4 and 8 weeks after treatment with inhaled corticosteroids.
Drug: Budesonide
Inhaled powder of inhaled corticosteroid, 2 puffs (200mcg) twice a day for 8 weeks
Other Name: Pulmicort

No Intervention: Asthmatics (no treatment)
Steroid-naïve asthmatics randomized to no treatment for 8 weeks. These subjects will undergo bronchoscopy and induced sputum collection at baseline, undergo pulmonary function testing and peripheral blood collection at baseline, 4 and 8 weeks of no treatment.



Primary Outcome Measures :
  1. Change from baseline airway epithelial cytokines expression, FEV1 and methacholine PD20 at 4 and 8 weeks [ Time Frame: 8 weeks ]
    1. The baseline expression of airway epithelial cytokines (IL-25, IL-33, TSLP) and/or Th2 cytokines (IL-4, IL-5, IL-13) in bronchial brushing, bronchial biopsy and peripheral blood in healthy control subjects and asthmatic patients.
    2. Change of forced expiratory volume of the 1st second (FEV1) and accumulated dosage of methacholine provoking a 20% fall of in forced expiratory volume in the first second (FEV1 PD20) of asthmatic patients after treatment with inhaled budesonide or non-intervention for 4 and 8 weeks.



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Ages Eligible for Study:   18 Years to 70 Years   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   Yes
Criteria

Group A:

Inclusion Criteria:

  • Male and female subjects between the ages of 18 and 70 years
  • No respiratory symptoms
  • Normal spirometric value and methacholine PD20 >2.5mg

Group B:

Inclusion Criteria:

  • Male and female subjects between the ages of 18 and 70 years
  • History of asthma
  • No use of oral or inhaled corticosteroids for the treatment of asthma
  • No use of leukotriene antagonist for the treatment of asthma
  • Hyperreactivity to methacholine (PD20 FEV1 Methacholine < 2.5 mg) and/or ≥12% increase in FEV1 following inhalation of 200μg salbutamol
  • Asthma symptoms of episodic cough, wheeze and/or breathlessness

Exclusion Criteria:

  • Current or former smokers
  • Pregnant women
  • Subjects with a history of lung disease other than asthma
  • Subjects with a history of a medical disease, which in the opinion of the investigator may put the subject at extra risk from study-related procedures or because the disease may influence the results of the study

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT01973751


Locations
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China, Hubei
Department of Respiratory and Critical Care Medicine, Tongji Hospital
Wuhan, Hubei, China, 430030
Sponsors and Collaborators
Tongji Hospital

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Responsible Party: Guohua Zhen, MD, Professor, Tongji Hospital
ClinicalTrials.gov Identifier: NCT01973751     History of Changes
Other Study ID Numbers: 81170022
30770941
First Posted: October 31, 2013    Key Record Dates
Last Update Posted: May 16, 2016
Last Verified: May 2016

Additional relevant MeSH terms:
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Asthma
Bronchial Diseases
Respiratory Tract Diseases
Lung Diseases, Obstructive
Lung Diseases
Respiratory Hypersensitivity
Hypersensitivity, Immediate
Hypersensitivity
Immune System Diseases
Budesonide
Anti-Inflammatory Agents
Bronchodilator Agents
Autonomic Agents
Peripheral Nervous System Agents
Physiological Effects of Drugs
Anti-Asthmatic Agents
Respiratory System Agents
Glucocorticoids
Hormones
Hormones, Hormone Substitutes, and Hormone Antagonists