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Step-down of Inhaled Corticosteroids (ICS) in Non-eosinophilic Asthmatics

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ClinicalTrials.gov Identifier: NCT02169323
Recruitment Status : Completed
First Posted : June 23, 2014
Last Update Posted : May 11, 2017
Sponsor:
Information provided by (Responsible Party):
Renaud Louis, University of Liege

Brief Summary:

There is growing evidence that non-eosinophilic asthmatics are less sensitive to inhaled corticosteroids (ICS) than eosinophilic asthmatics.

As non-eosinophilic asthmatic patients are treated by ICS according to international guidelines for asthma, the investigators would like to investigate whether stepping-down of ICS in these patients may be safe. Indeed, the investigators can reasonably expect that a progressive cessation of ICS is possible in some of these patients without any clinical worsening.


Condition or disease Intervention/treatment Phase
Asthma Other: Step-down Phase 4

Detailed Description:

For patients whose asthma is not controlled at the beginning of the study, a step-up of the treatment is planned to the step 4 of Global Initiative for Asthma (GINA). This step-up will last for 3 months and will permit to ensure that these patients achieve the best possible level of asthma control. A progressive step-down of the inhaled corticosteroids (ICS) will then be achieved.

For patients whose asthma is controlled at the beginning of the study, a progressive step-down of the ICS will be directly achieved.

The progressive step-down of the ICS dose will be undertaken every 3 months according to the dose levels defined by GINA guidelines (from high to low daily dose) until a complete cessation of the ICS for 6 months. Other associated asthma treatment of asthma will be kept unchanged.

At each quarterly visit, a clinical composite outcome will be measured, for each patient. This composite outcome includes the score of asthma control questionnaire (ACQ) and the number of exacerbations. This outcome will determine at each visit if patients continue the study (success criterion) or stop the study (failure criterion). The success criterion is defined in the section "Current Primary Outcome"

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Study Type : Interventional  (Clinical Trial)
Actual Enrollment : 43 participants
Allocation: N/A
Intervention Model: Single Group Assignment
Masking: None (Open Label)
Primary Purpose: Treatment
Official Title: Step-down of Inhaled Corticosteroids (ICS) in Non-eosinophilic Asthmatics
Study Start Date : June 2014
Actual Primary Completion Date : February 27, 2017
Actual Study Completion Date : February 27, 2017

Resource links provided by the National Library of Medicine

MedlinePlus related topics: Asthma Steroids

Arm Intervention/treatment
Experimental: Step-down
Step-down of the inhaled corticosteroid (ICS) dose
Other: Step-down
Step-down of the inhaled corticosteroid (ICS) dose until discontinuation for 6 months




Primary Outcome Measures :
  1. Percentage of patients meeting the success criterion at each visit until the end of the study (corresponding to a discontinuation of the treatment by inhaled corticosteroids (ICS) for 6 months) [ Time Frame: Up to 12 months to reach a 6 month stop of ICS ]

    The success criterion is defined at each visit as:

    - An Asthma Control Questionnaire (ACQ) score lower than 1.5 or a variation of the ACQ score from baseline smaller than 0.5

    AND

    - A number of severe exacerbations from the start of the step-down smaller or equal to the number of severe exacerbations in the previous year



Secondary Outcome Measures :
  1. Evolution of the number of severe exacerbations, defined as use of systemic corticosteroids during at least 3 days or hospitalizations or emergency visits due to asthma with use of systemic corticosteroids [ Time Frame: Every 3 months during the study (up to 15 months) ]
  2. Evolution of the frequency of self-reported adverse event of inhaled therapy for asthma [ Time Frame: Every 3 months during the study (up to 15 months) ]
  3. Evolution of treatment compliance measured by the Mediation Adherence Report Scale (MARS) and by pharmacy records [ Time Frame: Every 3 months during the study (up to 15 months) ]
  4. Evolution of the asthma control measured by the Asthma Control Questionnaire (ACQ) [ Time Frame: Every 3 months during the study (up to 15 months) ]
  5. Evolution of the asthma control measured by the Asthma Control Test (ACT) [ Time Frame: Every 3 months during the study (up to 15 months) ]
  6. Evolution of the asthma related quality of life by the mini-Asthma Quality of Life Questionnaire (miniAQLQ) [ Time Frame: Every 3 months during the study (up to 15 months) ]
  7. Evolution of the Fractional Exhaled Nitric Oxide (FeNO) [ Time Frame: Every 3 months during the study (up to 15 months) ]
  8. Evolution of lung function measured by percentage of predicted Forced Expiratory Volume in 1 second (%FEV1) [ Time Frame: Every 3 months during the study (up to 15 months) ]
  9. Evolution of lung function measured by Forced Expiratory Volume in 1 second (FEV1) divided by Forced Vital Capacity (FVC) [ Time Frame: Every 3 months during the study (up to 15 months) ]
  10. Evolution of lung function measured by reversibility to Short Acting Beta2-Agonists (SABA) [ Time Frame: Every 3 months during the study (up to 15 months) ]
  11. Evolution of inflammatory blood markers : blood cell count, fibrinogen, C-Reactive Protein (CRP) [ Time Frame: Every 3 months during the study (up to 15 months) ]
  12. Evolution of sputum markers of inflammation : rates of neutrophils, eosinophils, macrophages, lymphocytes, epithelial cells [ Time Frame: Every 3 months during the study (up to 15 months) ]
  13. Evolution of the number of moderate exacerbations, defined as the number of visits to an emergency room, the number of unscheduled doctor or pneumologist visits, and increases in reliever use [ Time Frame: Every 3 months during the study (up to 15 months) ]
  14. Evolution of the score of ICQ-S ("Inhaled Corticosteroids side-effect Questionnaire") [ Time Frame: Every 3 months during the study (up to 15 months) ]
  15. Check of the inhalation technique [ Time Frame: Every 3 months during the study (up to 15 months) ]


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

Inclusion Criteria:

  • At least 18 years of age
  • Physician-diagnosed asthma based on the presence of typical symptoms (wheezing, breathlessness, chest tightness, cough)
  • Asthma confirmed by:

    • Forced expiratory volume in 1 second (FEV1) increase of at least 12% and 200 mL after inhalation of 400 mcg salbutamol
    • And/or a provocative concentration of methacholine causing a 20% fall in FEV1 (PC20M) less than 16 mg/ml
  • Sputum eosinophils rate less than 3%
  • Absolute blood eosinophils count less than 400 per mm3
  • Treatment with a stable dose of inhaled corticosteroid (ICS) for the previous three months

Exclusion Criteria:

  • High risk of asthma-related death, defined by:

    • Near-fatal asthma history, requiring a stay in an intensive care unit
    • Current using or recent discontinuation (four weeks) of oral corticosteroids (OCS)
  • Treatment with omalizumab
  • Pregnant women

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): NCT02169323


Locations
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Belgium
University Hospital of Liege
Liege, Belgium, 4000
Sponsors and Collaborators
Renaud Louis
Investigators
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Principal Investigator: Renaud Louis, MD-PhD University of Liege
Publications automatically indexed to this study by ClinicalTrials.gov Identifier (NCT Number):
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Responsible Party: Renaud Louis, Head of the Pneumology Department, University of Liege
ClinicalTrials.gov Identifier: NCT02169323    
Other Study ID Numbers: 2014-98
2014-001316-19 ( EudraCT Number )
First Posted: June 23, 2014    Key Record Dates
Last Update Posted: May 11, 2017
Last Verified: May 2017
Keywords provided by Renaud Louis, University of Liege:
Non-eosinophilic Asthma
Inhaled corticosteroids
Step-down
Additional relevant MeSH terms:
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Asthma
Respiratory Aspiration
Bronchial Diseases
Respiratory Tract Diseases
Lung Diseases, Obstructive
Lung Diseases
Respiratory Hypersensitivity
Hypersensitivity, Immediate
Hypersensitivity
Immune System Diseases
Respiration Disorders
Pathologic Processes