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

This study is currently recruiting participants. (see Contacts and Locations)
Verified April 2014 by Hoffmann-La Roche
Sponsor:
Information provided by (Responsible Party):
Hoffmann-La Roche
ClinicalTrials.gov Identifier:
NCT01948401
First received: September 6, 2013
Last updated: April 7, 2014
Last verified: April 2014
  Purpose

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.


Condition Intervention Phase
Asthma
Drug: corticosteroids
Drug: prednisolone
Drug: LABA
Phase 2

Study Type: Interventional
Study Design: Allocation: Non-Randomized
Intervention Model: Single Group Assignment
Masking: Open Label
Official Title: A STUDY TO MEASURE SERUM PERIOSTIN, ASTHMA-RELATED BIOMARKERS AND RESPONSE TO PREDNISOLONE IN ADULT AND ADOLESCENT PATIENTS WITH SEVERE ORAL CORTICOSTEROID-DEPENDENT ASTHMA

Resource links provided by NLM:


Further study details as provided by Hoffmann-La Roche:

Primary Outcome Measures:
  • Serum periostin levels [ Time Frame: up to 95 days ] [ Designated as safety issue: No ]

Secondary Outcome Measures:
  • Asthma quality of life questionnaire for adults and adolescents aged 12 years and older (AQLQ12+) [ Time Frame: up to 95 days ] [ Designated as safety issue: No ]
  • IL-13 related biomarker levels [ Time Frame: up to 95 days ] [ Designated as safety issue: No ]
  • Lung function: Forced expiratory volume in 1 second/forced vital capacity (FEV1/FVC) [ Time Frame: up to 95 days ] [ Designated as safety issue: No ]
  • Safety: Incidence of adverse events [ Time Frame: up to 95 days ] [ Designated as safety issue: No ]
  • Patient reported outcomes: Asthma Control Questionnaire (ACQ-7) [ Time Frame: up to 95 days ] [ Designated as safety issue: No ]

Estimated Enrollment: 97
Study Start Date: July 2013
Estimated Study Completion Date: April 2014
Estimated Primary Completion Date: April 2014 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
Experimental: Controlled asthma Drug: corticosteroids
chronic treatment with oral corticosteroids, high dose inhaled corticosteroids
Drug: LABA
long-acting beta-agonist treatment
Experimental: Uncontrolled asthma without additional OCS Drug: corticosteroids
chronic treatment with oral corticosteroids, high dose inhaled corticosteroids
Drug: LABA
long-acting beta-agonist treatment
Experimental: Uncontrolled asthma with additional OCS Drug: corticosteroids
chronic treatment with oral corticosteroids, high dose inhaled corticosteroids
Drug: prednisolone
additional 0.5 mg/kg orally for 7 days
Drug: LABA
long-acting beta-agonist treatment

  Eligibility

Ages Eligible for Study:   12 Years to 75 Years
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   No
Criteria

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
  Contacts and Locations
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

Please refer to this study by its ClinicalTrials.gov identifier: NCT01948401

Contacts
Contact: Reference Study ID Number: WB28850 www.roche.com/about_roche/roche_worldwide.htm 888-662-6728 (U.S. Only) global.rochegenentechtrials@roche.com

Locations
United Kingdom
Recruiting
Belfast, United Kingdom, BT9 7AB
Active, not recruiting
Birmingham, United Kingdom, B9 5SS
Recruiting
Glasgow, United Kingdom, G21 3UW
Recruiting
Glasgow, United Kingdom, G12 0XH
Recruiting
Hampshire, United Kingdom, SO16 6YD
Completed
Leicester, United Kingdom, LE3 9QP
Active, not recruiting
London, United Kingdom, SW3 6NP
Recruiting
London, United Kingdom, EC1A 7BE
Active, not recruiting
Manchester, United Kingdom, M23 9LT
Recruiting
Newcastle Upon Tyne, United Kingdom, NE7 7DN
Recruiting
Nottingham, United Kingdom, NG5 1PB
Sponsors and Collaborators
Hoffmann-La Roche
Investigators
Study Director: Clinical Trials Hoffmann-La Roche
  More Information

No publications provided

Responsible Party: Hoffmann-La Roche
ClinicalTrials.gov Identifier: NCT01948401     History of Changes
Other Study ID Numbers: WB28850
Study First Received: September 6, 2013
Last Updated: April 7, 2014
Health Authority: United Kingdom: Medicines and Healthcare Products Regulatory

Additional relevant MeSH terms:
Bronchial Diseases
Asthma
Respiratory Tract Diseases
Lung Diseases, Obstructive
Lung Diseases
Respiratory Hypersensitivity
Hypersensitivity, Immediate
Hypersensitivity
Immune System Diseases
Methylprednisolone acetate
Prednisolone acetate
Prednisolone
Methylprednisolone
Methylprednisolone Hemisuccinate
Prednisolone hemisuccinate
Prednisolone phosphate
Anti-Inflammatory Agents
Therapeutic Uses
Pharmacologic Actions
Glucocorticoids
Hormones
Hormones, Hormone Substitutes, and Hormone Antagonists
Physiological Effects of Drugs
Antineoplastic Agents, Hormonal
Antineoplastic Agents
Antiemetics
Autonomic Agents
Peripheral Nervous System Agents
Central Nervous System Agents
Gastrointestinal Agents

ClinicalTrials.gov processed this record on October 01, 2014