Working…
COVID-19 is an emerging, rapidly evolving situation.
Get the latest public health information from CDC: https://www.coronavirus.gov.

Get the latest research information from NIH: https://www.nih.gov/coronavirus.
ClinicalTrials.gov
ClinicalTrials.gov Menu

A Study to Measure Serum Periostin, Asthma-Related Biomarkers and Response to Prednisolone in Adult and Adolescent Patients With Severe Oral Corticosteroid-Dependent Asthma

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details.
 
ClinicalTrials.gov Identifier: NCT01948401
Recruitment Status : Completed
First Posted : September 23, 2013
Last Update Posted : November 2, 2016
Sponsor:
Information provided by (Responsible Party):
Hoffmann-La Roche

Tracking Information
First Submitted Date  ICMJE September 6, 2013
First Posted Date  ICMJE September 23, 2013
Last Update Posted Date November 2, 2016
Study Start Date  ICMJE July 2013
Actual Primary Completion Date April 2014   (Final data collection date for primary outcome measure)
Current Primary Outcome Measures  ICMJE
 (submitted: September 18, 2013)
Serum periostin levels [ Time Frame: up to 95 days ]
Original Primary Outcome Measures  ICMJE Same as current
Change History
Current Secondary Outcome Measures  ICMJE
 (submitted: January 20, 2014)
  • Asthma quality of life questionnaire for adults and adolescents aged 12 years and older (AQLQ12+) [ Time Frame: up to 95 days ]
  • IL-13 related biomarker levels [ Time Frame: up to 95 days ]
  • Lung function: Forced expiratory volume in 1 second/forced vital capacity (FEV1/FVC) [ Time Frame: up to 95 days ]
  • Safety: Incidence of adverse events [ Time Frame: up to 95 days ]
  • Patient reported outcomes: Asthma Control Questionnaire (ACQ-7) [ Time Frame: up to 95 days ]
Original Secondary Outcome Measures  ICMJE
 (submitted: September 18, 2013)
  • IL-13 related biomarker levels [ Time Frame: up to 95 days ]
  • Lung function: Forced expiratory volume in 1 second/forced vital capacity (FEV1/FVC) [ Time Frame: up to 95 days ]
  • Safety: Incidence of adverse events [ Time Frame: up to 95 days ]
  • Patient reported outcomes: Asthma Control Questionnaire (ACQ-7) [ Time Frame: up to 95 days ]
  • Asthma quality of life questionnaire for adults and adolescents aged 12 years and older (AQLQ12+) [ Time Frame: up to 95 days ]
Current Other Pre-specified Outcome Measures Not Provided
Original Other Pre-specified Outcome Measures Not Provided
 
Descriptive Information
Brief Title  ICMJE A Study to Measure Serum Periostin, Asthma-Related Biomarkers and Response to Prednisolone in Adult and Adolescent Patients With Severe Oral Corticosteroid-Dependent Asthma
Official Title  ICMJE A STUDY TO MEASURE SERUM PERIOSTIN, ASTHMA-RELATED BIOMARKERS AND RESPONSE TO PREDNISOLONE IN ADULT AND ADOLESCENT PATIENTS WITH SEVERE ORAL CORTICOSTEROID-DEPENDENT ASTHMA
Brief Summary This interventional, open study will evaluate clinical data in relation to biomarkers in patients 12 to 75 years of age with severe oral corticosteroid (OCS) - dependent asthma. Patients with uncontrolled asthma will be offered an additional escalation of OCS at a dose of 0.5 mg/kg for 7 days. Patients enrolled in this study would be eligible to be enrolled in a future placebo-controlled intervention study designed to measure the steroid-sparing effect of lebrikizumab.
Detailed Description Not Provided
Study Type  ICMJE Interventional
Study Phase  ICMJE Phase 2
Study Design  ICMJE Allocation: N/A
Intervention Model: Single Group Assignment
Masking: None (Open Label)
Condition  ICMJE Asthma
Intervention  ICMJE
  • Drug: LABA
    long-acting beta-agonist treatment
  • Drug: corticosteroids
    chronic treatment with oral corticosteroids, high dose inhaled corticosteroids
  • Drug: prednisolone
    additional 0.5 mg/kg orally for 7 days
Study Arms  ICMJE
  • Experimental: Controlled asthma
    Interventions:
    • Drug: LABA
    • Drug: corticosteroids
  • Experimental: Uncontrolled asthma with additional OCS
    Interventions:
    • Drug: LABA
    • Drug: corticosteroids
    • Drug: prednisolone
  • Experimental: Uncontrolled asthma without additional OCS
    Interventions:
    • Drug: LABA
    • Drug: corticosteroids
Publications * Busby J, Holweg CTJ, Chai A, Bradding P, Cai F, Chaudhuri R, Mansur AH, Lordan JL, Matthews JG, Menzies-Gow A, Niven R, Staton T, Heaney LG. Change in type-2 biomarkers and related cytokines with prednisolone in uncontrolled severe oral corticosteroid dependent asthmatics: an interventional open-label study. Thorax. 2019 Aug;74(8):806-809. doi: 10.1136/thoraxjnl-2018-212709. Epub 2019 Apr 2.

*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Recruitment Information
Recruitment Status  ICMJE Completed
Actual Enrollment  ICMJE
 (submitted: October 1, 2015)
54
Original Estimated Enrollment  ICMJE
 (submitted: September 18, 2013)
97
Actual Study Completion Date  ICMJE April 2014
Actual Primary Completion Date April 2014   (Final data collection date for primary outcome measure)
Eligibility Criteria  ICMJE

Inclusion Criteria:

  • Adult and adolescent patients , >/=12 to </=75 years of age at the time of informed consent
  • Severe asthma (as defined by GINA step 5 classification of asthma severity) after a detailed systematic assessment (the BTS UK Difficult Asthma Network assessment model [Heaney et al 2010] or equivalent) and follow-up by an asthma specialist for at least six months
  • History of asthma treatment with high doses of inhaled corticosteroids (ICS ) (>/=1500 mcg beclomethasone dipropionate daily, or equivalent) and long-acting beta-2 agonists (LABAs), with or without an additional controller, for at least six months before Screening
  • Chronic treatment with maintenance oral corticosteroids (OCS) for at least six months before the time of informed consent ; (baseline OCS dose: adults 10 to 40 mg/day, adolescents 5 to 40 mg/day daily dose equivalent)
  • Compliance with OCS therapy will be based on prior detectable levels of serum prednisolone, cortisol suppression, or observation of Cushingoid appearance consistent with regular systemic steroid use
  • Diagnosis of refractory asthma (Heaney et al 2010) with OCS dependence on minimal effective or maximum tolerated dose
  • Confirmed (by chest x-ray) absence of other significant lung disease
  • Documented history of bronchodilator reversibility response of >/=12% and >/=200 mL within the past 12 months before the time of informed consent

Exclusion Criteria:

  • Baseline FEV1 </=39% of predicted
  • Asthma exacerbation (as defined by protocol) within 28 days before the time of informed consent or during Screening
  • Major episode of infection requiring admission to hospital for >/=24 hours or treatment with intravenous antibiotics within the 28 days before the time of informed consent or during Screening or requiring treatment with oral antibiotics within the 14 days before the time of informed consent or during Screening
  • Active parasitic infection or Listeria monocytogenes infection within the 6 months before the time of informed consent
  • For adults active tuberculosis (TB) requiring treatment within the 12 months before the time of informed consent (patients are also required to have no recurrence of symptoms in the 12 months following completion of TB treatment), or for adolescents history of active TB requiring treatment
  • Known history of severe clinically significant immunodeficiency
  • Evidence of acute or chronic hepatitis or known liver cirrhosis
  • Inadequate liver function
  • Diagnosis or history of malignancy, or current investigation for possible malignancy
  • Other clinically significant medical disease that is uncontrolled despite treatment or that is likely, in the opinion of the investigator, to require a change in therapy or affect the ability to participate in the study
  • Current smoker or former smoker with a smoking history of >15 pack-years
  • Current use of an immunomodulatory/immunosuppressive therapy or past use within three months or five drug half-lives (whichever is longer) before the time of informed consent
  • Use of a biologic therapy (including omalizumab) at any time during the 4 months before the time of informed consent
  • History of anaphylaxis with omalizumab treatment or history of anaphylaxis to any therapeutic biological agent
  • Use of zileuton or roflumilast at any time during the two months before the time of informed consent
  • Initiation of or change in allergen immunotherapy within three months before the time of informed consent
  • Treatment with an investigational agent within 30 days of informed consent or 5 half-lives of the investigational agent, whichever is longer
  • Pregnant or lactating women
  • Body mass index (BMI) >38 kg/m2
  • Body weight <40 kg
Sex/Gender  ICMJE
Sexes Eligible for Study: All
Ages  ICMJE 12 Years to 75 Years   (Child, Adult, Older Adult)
Accepts Healthy Volunteers  ICMJE No
Contacts  ICMJE Contact information is only displayed when the study is recruiting subjects
Listed Location Countries  ICMJE United Kingdom
Removed Location Countries  
 
Administrative Information
NCT Number  ICMJE NCT01948401
Other Study ID Numbers  ICMJE WB28850
Has Data Monitoring Committee Not Provided
U.S. FDA-regulated Product Not Provided
IPD Sharing Statement  ICMJE Not Provided
Responsible Party Hoffmann-La Roche
Study Sponsor  ICMJE Hoffmann-La Roche
Collaborators  ICMJE Not Provided
Investigators  ICMJE
Study Director: Clinical Trials Hoffmann-La Roche
PRS Account Hoffmann-La Roche
Verification Date November 2016

ICMJE     Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP