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Periostin-guided Withdrawal of Inhaled Corticosteroids in Patients With Non-eosinophilic Asthma

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ClinicalTrials.gov Identifier: NCT03141424
Recruitment Status : Not yet recruiting
First Posted : May 5, 2017
Last Update Posted : February 25, 2019
Sponsor:
Information provided by (Responsible Party):
Christian Westergaard, Hvidovre University Hospital

Brief Summary:

Background: Asthma is a common chronic condition characterized by respiratory symptoms and hyperresponsive airways. According to treatment guidelines, patients with persistent asthma require daily treatment with inhaled corticosteroids (ICS). However, certain subgroups of asthma patients such as non-eosinophilic asthma patients do not respond well to the ICS treatment. In the present study, asthma patients treated with ICS and exhibiting low levels of eosinophilic biomarkers such as S-periostin, FeNO and blood eosinophils, are randomized 1:1 to either 1) tapering of ICS or 2) usual care. Thus, the aim of the present study is to investigate whether patients with non-eosinophilic asthma can sustain their level of disease control during ICS tapering.

Design: This is a randomized, controlled, one-center, non-inferiority study of ICS tapering in patients with non-eosinophilic asthma.

Inclusion and exclusion criteria: 1) Objectively secured asthma diagnosis, 2) Age 18-65 years, 3) ICS treatment equivalent to Budesonide 800 microgr daily or more with at least 80% adherence, 4) Serum-periostin < 50 ng/ml, 5) FeNO<20 ppb at all prior visits, 6) Blood-eosinophils<0.15 at screening, 7) no allergic asthma history, 8) never daily smoker, 9) no other respiratory diasease, 10) no daily treatment with immunosuppressives, 11) no pregnancy, and 12) no history of drug or alcohol abuse.

Endpoints: Primary: Change in Control Questionnaire (ACQ) from baseline to post-tapered ICS and time from baseline to drop-out. Secondary: Change in FeNO, change in Serum-Periostin, change in FEV1, change in blood-eosinophils.

Methods: Relevant patients will be recruited from Respiratory Outpatient Wards. In total, 110 patients will be required. Visits will be performed at screening, at week 0, 4, 8, 12, 16, 26, 52. In the active arm, ICS dosage will be reduced to 50% at week 0 and removed at week 8. All visits include ACQ, FeNO, spirometry, blood eosinophils. S-periostin will be measured at screening and at week 8 and 16.


Condition or disease Intervention/treatment Phase
Asthma Other: Tapering of ICS treatment Not Applicable

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Study Type : Interventional  (Clinical Trial)
Estimated Enrollment : 110 participants
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: None (Open Label)
Primary Purpose: Prevention
Official Title: Periostin-guided Withdrawal of Inhaled Corticosteroids in Patients With Non-eosinophilic Asthma
Estimated Study Start Date : September 1, 2019
Estimated Primary Completion Date : June 1, 2021
Estimated Study Completion Date : December 1, 2021

Resource links provided by the National Library of Medicine

MedlinePlus related topics: Asthma Steroids

Arm Intervention/treatment
Active Comparator: Group A
Usual care. Unchanged asthma medication during the entire study period.
Other: Tapering of ICS treatment
Tapering of ICS treatment over 8 weeks. Follow-up over 52 weeks in total. Dosis reduction of 50% in ICS treatment for 8 weeks, followed by total ICS removal. Other inhaled asthma medication remains unchanged during the entire study period.

Experimental: Group B
Tapering of ICS over 8 weeks. Dosis reduction of 50% in ICS treatment for 8 weeks, followed by total ICS removal. Other inhaled asthma medication remains unchanged during the entire study period.
Other: Tapering of ICS treatment
Tapering of ICS treatment over 8 weeks. Follow-up over 52 weeks in total. Dosis reduction of 50% in ICS treatment for 8 weeks, followed by total ICS removal. Other inhaled asthma medication remains unchanged during the entire study period.




Primary Outcome Measures :
  1. Change in Control Questionnaire (ACQ) from baseline to post-tapered ICS [ Time Frame: 52 weeks ]
  2. Time from baseline to drop-out [ Time Frame: 52 weeks ]

Secondary Outcome Measures :
  1. Change in FeNO [ Time Frame: 52 weeks ]
  2. Change in FEV1 [ Time Frame: 52 weeks ]
  3. Change in blood eosinophils [ Time Frame: 52 weeks ]
  4. Change in serum periostin [ Time Frame: 52 weeks ]


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Ages Eligible for Study:   18 Years to 65 Years   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
Criteria

Inclusion Criteria:

  • Astmapatients followed in the Respiratory Outpatient Ward, Hvidovre Hospital, Amager Hospital or Glostrup Hospital.
  • At least one of the following test suggestive for asthma, performed at any time during the outpatient course: 1) FEV1-reversibility of at least 12% and 200 ml after administration of bronkodilator or Prednisolon course, 2) positive bronkialprovocation test, such as mannitol, or 3) peakflow (PF)-variation of at least 20% assessed during a 14-day period, measured twice daily and at asthmatic symptoms.
  • Age 18-65 years
  • Treated with ICS daily in doses equivalent to Budesonid 800 microgr daily or more
  • ICS adherence of at least 80% during the last year, assessed from used prescriptions
  • Serum-periostin < 50 ng/ml at screening (8)
  • FeNO < 20 ppb at all prior visits
  • Blood-eosinofils <0,15 at screening
  • Signed informed consent

Exclusion Criteria:

  • History of allergic asthma
  • Doctor-diagnosed pneumonia within 6 weeks prior to screening
  • Daily smoking or former daily smoking
  • Known other respiratory condition such as COPD or pulmonary sarcoidosis
  • Known other chronic conditions that could impact or prevent study participation, including severe heart conditions and conditions requiring treatment with immunosuppressive drugs such as Prednisolon, Methotrexate or biological treatments, assessed by study doctor
  • Pregnancy or planned pregnancy
  • Abuse of alcohol or other recreational drugs

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): NCT03141424


Contacts
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Contact: Christian G Westergaard, MD, PhD +4538621020 christian.grabow.westergaard@regionh.dk
Contact: Charlotte S Ulrik, MD, MDSc +4538621020 csulrik@dadlnet.dk

Sponsors and Collaborators
Hvidovre University Hospital

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Responsible Party: Christian Westergaard, MD, PhD, Hvidovre University Hospital
ClinicalTrials.gov Identifier: NCT03141424     History of Changes
Other Study ID Numbers: Asthmaperiostin
First Posted: May 5, 2017    Key Record Dates
Last Update Posted: February 25, 2019
Last Verified: February 2019
Individual Participant Data (IPD) Sharing Statement:
Plan to Share IPD: No

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Studies a U.S. FDA-regulated Drug Product: No
Studies a U.S. FDA-regulated Device Product: No
Product Manufactured in and Exported from the U.S.: No

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