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The RECONSTRUCT Study - Reconstructing Disease Mechanisms in Asthma (RECONSTRUCT)

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ClinicalTrials.gov Identifier: NCT03034005
Recruitment Status : Recruiting
First Posted : January 27, 2017
Last Update Posted : July 13, 2017
Sponsor:
Information provided by (Responsible Party):
Celeste Porsbjerg, Bispebjerg Hospital

Brief Summary:
This study aims to assess the effect of inhaled corticosteroids (ICS) on airway smooth muscle (ASM) Na+, K+ pumps in patients with asthma.We wish to investigate differences in Na+, K+ pump content in healthy versus asthmatic patients, whether a reduction in airway hyper-responsiveness observed in asthmatic patients treated with ICS is attributable to an increase in Na+, K+ pump content in ASM cells and compare this in patients with non-eosinophilic asthma versus eosinophilic asthma.

Condition or disease Intervention/treatment Phase
Asthma Drug: Budesonide Phase 4

  Show Detailed Description

Study Type : Interventional  (Clinical Trial)
Estimated Enrollment : 60 participants
Allocation: Non-Randomized
Intervention Model: Single Group Assignment
Masking: None (Open Label)
Primary Purpose: Treatment
Official Title: The RECONSTRUCT Study - Reconstructing Disease Mechanisms in Asthma
Actual Study Start Date : March 27, 2017
Estimated Primary Completion Date : July 1, 2019
Estimated Study Completion Date : July 1, 2019

Resource links provided by the National Library of Medicine

MedlinePlus related topics: Asthma
Drug Information available for: Budesonide

Arm Intervention/treatment
Experimental: Patients with asthma
6 weeks treatment with 1600 ug budesonide
Drug: Budesonide
1600 ug inhaled daily for 6 weeks
Other Name: Pulmicort

No Intervention: Healthy Controls
Healthy controls to establish baseline level of Na/K pumps.



Primary Outcome Measures :
  1. Change in airway hyperresponsiveness (mannitol challenge) per change in Na+, K+ pumps content in airway smooth muscle. [ Time Frame: 6 weeks ]
    Change in PD15 per chhange in NA/K ATP'ase content


Secondary Outcome Measures :
  1. Change in Na+, K+ pump content in airway smooth muscle and in skeletal muscle (ρmol ouabain per g wet weight) in NEA vs. EA. [ Time Frame: 6 weeks ]
    Change in Na+, K+ pump content in airway smooth muscle and in skeletal muscle (ρmol ouabain per g wet weight) in NEA vs. EA.

  2. Change in airway hyperresponsiveness (PD15 to mannitol) in NEA vs. EA [ Time Frame: 6 weeks ]
    Change in airway hyperresponsiveness (PD15 to mannitol) in NEA vs. EA


Other Outcome Measures:
  1. Change in asthma control score vs in Na+, K+ pumps content in airway smooth muscle. [ Time Frame: 6 weeks ]
    Change in asthma control score vs in Na+, K+ pumps content in airway smooth muscle.

  2. Change in lung function (FEV1) vs in Na+, K+ pumps content in airway smooth muscle [ Time Frame: 6 weeks ]
    Change in lung function (FEV1) vs in Na+, K+ pumps content in airway smooth muscle

  3. Change in asthma control score in NEA vs. EA [ Time Frame: 6 weeks ]
    Change in asthma control score in NEA vs. EA

  4. Change in lung function (FEV1) in NEA vs. EA [ Time Frame: 6 weeks ]
    Change in lung function (FEV1) in NEA vs. EA



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Ages Eligible for Study:   18 Years to 64 Years   (Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   Yes
Criteria

Inclusion Criteria:

  • Asthma as defined by GINA (www.ginasthma.org) Eosinophilic asthma: Fractional exhaled nitric oxide (FeNO) > 25 ppb (marker of eosinophilic airway inflammation) Non-eosinophilic asthma: Fractional exhaled nitric oxide (FeNO) < 25 ppb
  • An FEV1 value of ≥70% of expected
  • Airway hyperresponsiveness to mannitol (PD15 ≤ 315 mg)
  • Not treated with oral or inhaled steroids (past 3 months)

Exclusion Criteria:

  • Smoking (current smokers or a maximum of 10 pack years)
  • Competing respiratory diseases
  • Lower respiratory tract infection within the past 4 weeks
  • Medical history with significant comorbidity (ASA>2)
  • Pregnant or breastfeeding
  • Hypersensitivity to study medication including Spirocort, Osmohale, Midazolam or Fentanyl
  • Uncontrolled hypertension
  • Acute myocardial infarction within past 6 months
  • Aorta- or cerebral aneurism
  • Recent abdominal operation
  • Failure to comply with study protocol

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): NCT03034005


Contacts
Contact: Morten Hvidtfeldt 60770127 morten.hvidtfeldt@regionh.dk

Locations
Denmark
Lungemedicinsk forskningsenhed, Bispebjerg Hospital Recruiting
Kobenhavn, Denmark, 2400
Contact: Morten Hvidtfeldt    21580581    morten.hvidtfeldt@regionh.dk   
Sponsors and Collaborators
Bispebjerg Hospital
Investigators
Principal Investigator: Celeste Porsbjerg Assistant Professor

Responsible Party: Celeste Porsbjerg, Associate Professor, Bispebjerg Hospital
ClinicalTrials.gov Identifier: NCT03034005     History of Changes
Other Study ID Numbers: 2016-003509-33
First Posted: January 27, 2017    Key Record Dates
Last Update Posted: July 13, 2017
Last Verified: July 2017
Individual Participant Data (IPD) Sharing Statement:
Plan to Share IPD: No

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

Keywords provided by Celeste Porsbjerg, Bispebjerg Hospital:
Inhaled corticosteroids
Airway hyper-responsiveness
Airway smooth muscle
sodium-potassium pump

Additional relevant MeSH terms:
Asthma
Bronchial Diseases
Respiratory Tract Diseases
Lung Diseases, Obstructive
Lung Diseases
Respiratory Hypersensitivity
Hypersensitivity, Immediate
Hypersensitivity
Immune System Diseases
Budesonide
Anti-Inflammatory Agents
Bronchodilator Agents
Autonomic Agents
Peripheral Nervous System Agents
Physiological Effects of Drugs
Anti-Asthmatic Agents
Respiratory System Agents
Glucocorticoids
Hormones
Hormones, Hormone Substitutes, and Hormone Antagonists