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AsthmaPhase 2NCT01948401

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

A Phase 2 study testing LABA, corticosteroids and prednisolone in people with Asthma, run by Hoffmann-La Roche at 11 sites in United Kingdom.

Completed

Finished. The study has ended and is not enrolling. Results may be posted on the official record.

Official record
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Trial 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. Read more about this study

Who is it for?
Ages 12 to 75 years
Conditions the study is for
Asthma
What is being tested?
LABA, corticosteroids and prednisolone
Type of treatment
Pill or oral medicine
Could I receive a placebo?
No, everyone receives an active treatment
How many people
54 participants
Where
11 sitesUnited Kingdom
Study dates
Jul 2013to Apr 2014
Phase
Phase 2
Are there results?
None posted in the registry

Key requirements

Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.

  • Ages 12 to 75 years
  • All sexes
  • No healthy volunteers
  • Child, Adult, Older adult

Who may be able to join

  • 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

Who cannot join

  • 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
Show all 20Show fewer
  • 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

Trial locations and contacts

11 sites in 1 country.

11 sites in 1 country

United Kingdom11 sites

  • Study site

    Belfast, BT9 7AB

  • Study site

    Birmingham, B9 5SS

  • Study site

    Glasgow, G12 0XH

  • Study site

    Glasgow, G21 3UW

  • Study site

    Hampshire, SO16 6YD

  • Study site

    Leicester, LE3 9QP

  • Study site

    London, EC1A 7BE

  • Study site

    London, SW3 6NP

  • Study site

    Manchester, M23 9LT

  • Study site

    Newcastle upon Tyne, NE7 7DN

  • Study site

    Nottingham, NG5 1PB

Other trials in United Kingdom

About this study

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

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.

Conditions
Asthma
Being tested
LABA, corticosteroids, prednisolone
Medical subject headings
Asthma

What participants receive

What participants receive. In a randomised study each person is assigned to one group by chance.

  • LABADrug

    long-acting beta-agonist treatment

  • corticosteroidsDrug

    chronic treatment with oral corticosteroids, high dose inhaled corticosteroids

  • prednisoloneDrug

    additional 0.5 mg/kg orally for 7 days

Study groups in NCT01948401
Study groupRoleWhat they receive
Controlled asthmaExperimentalNot described
Receives: Drug: LABA; Drug: corticosteroids
Uncontrolled asthma with additional OCSExperimentalNot described
Receives: Drug: LABA; Drug: corticosteroids; Drug: prednisolone
Uncontrolled asthma without additional OCSExperimentalNot described
Receives: Drug: LABA; Drug: corticosteroids

What is being measured

The primary outcome is the main question the study is designed to answer.

  1. Serum periostin levels

    Measured: up to 95 days

Secondary outcomes (5)

  1. Asthma quality of life questionnaire for adults and adolescents aged 12 years and older (AQLQ12+)

    Measured: up to 95 days

  2. IL-13 related biomarker levels

    Measured: up to 95 days

  3. Lung function: Forced expiratory volume in 1 second/forced vital capacity (FEV1/FVC)

    Measured: up to 95 days

  4. Safety: Incidence of adverse events

    Measured: up to 95 days

  5. Patient reported outcomes: Asthma Control Questionnaire (ACQ-7)

    Measured: up to 95 days

Timeline

From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.

  1. First posted23 Sep 2013 (estimated)
  2. Study startJul 2013
  3. Primary completionApr 2014
  4. Study completionApr 2014

Resources

More details

For doctors and researchers: how the study is designed, who runs it, and its registry IDs.

Study design
Study type
Interventional
Phase
Phase 2
Allocation
Not applicable
Intervention model
Single group
Masking
None (open label)
Enrolment
54 participants (actual)
IDs, dates and publications
ClinicalTrials.gov ID
NCT01948401
Sponsor's protocol ID
WB28850
Status last verified
Nov 2016
First submitted
6 Sep 2013
Last updated
2 Nov 2016
Results posted
No

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.

    PubMed 30940770

Questions about this trial

What is this clinical trial studying?

A Phase 2 study testing LABA, corticosteroids and prednisolone in people with Asthma, run by Hoffmann-La Roche at 11 sites in United Kingdom.

The full registered description is in the About this study section and the official record.

Who may be eligible to take part?

The sponsor lists 8 inclusion and 20 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.

Is this clinical trial currently recruiting?

The record says: finished, as of the sponsor's last update on 2 Nov 2016. Status can change between updates, so confirm with the study contact before making plans.

Where is the study taking place?

The record lists 11 sites in United Kingdom. Whether a site is taking part right now should be confirmed with that site. See every site.

What are the possible benefits and risks?

They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.

What does this phase mean?

Phase 2 studies give the treatment to a larger group to see whether it has the intended effect and to keep checking safety.

Not every study follows the same path, and some studies (observational studies, device studies) have no phase.

Are results available for this study?

The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.

How can a doctor refer a patient or contact the research team?

The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.

What does the primary outcome measure?

Serum periostin levels (time frame: up to 95 days). It is what the study was designed to measure, not a finding.

Where can I read the original study information?

On the ClinicalTrials.gov record for NCT01948401, which also lists 1 linked publication.

Does a listing mean the treatment is approved or proven to work?

No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.

How often is this information updated?

AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 2 Nov 2016.

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