Asthma Origins and Remission Study

NCT03141814 | Unknown

• 1 other identifier: NL2015001
• Study Type: observational
• Target: 80
• Locations: 1 country
• Sites: 1

Brief Summary

Asthma is characterized by chronic airway inflammation of the large and small airways. Asthma patients often have episodes with symptoms of dyspnea, wheezing and nocturnal awakening. Currently available inhaled anti-inflammatory treatments reduce the airway inflammation and treatment but do not cure the disease. Therefore asthma patients often need life-long treatment to control their asthma. In a small subset of patients, their asthma resolves spontaneously. This phenomenon is called asthma remission. Subjects with asthma remission do not experience symptoms or signs of airway inflammation anymore and do not require inhaled treatments. Some subjects with asthma remission also have a completely normal lung function without signs of bronchial hyperresponsivess: they have complete asthma remission. Unfortunately, asthma remission occurs only in a small subset of 15-25% of asthma patients.Objective: to determine the underlying mechanisms and molecular events leading to remission of asthma.

Conditions

Asthma

Outcome Measures

Primary Outcomes (1)

• Single cell sequencing data

  Single cell mRNA sequencing of lymphocytes in bronchial biopsies and blood eosinophils

  baseline

Secondary Outcomes (6)

• Spirometry

  baseline

• body box

  baseline

• HRCT

  baseline

• Airway inflammation

  baseline

• Small airways disease

  baseline

Study Arms (4)

asthma

20 patients with ongoing ashma

complete asthma remission

20 subjects with complete asthma remission

clinical asthma remission

20 subjects with clinical asthma remission

non-asthmatic healthy controls

20 subjects without respiratory symptoms and normal lung function and no bronchial hyperresponsiveness to methacholine and/or AMP

Eligibility Criteria

• Age: 40 Years - 65 Years
• Sex: all
• Healthy Volunteers: Yes
• Age Groups: Adult (18-64), Older Adult (65+)
• Sampling Method: Non-Probability Sample

Study Population

* 20 patients with a documented history of asthma who have clinical asthma remission. * 20 patients with a documented history of asthma who have complete asthma remission. * 20 patients with current asthma. * 20 healthy subjects.

You may qualify if:

• Age between 40 and 65 years old.
• Smoking history ≤ 10 packyears.
• Development of asthma symptoms before 21 years.
• Group 1. Subjects with clinical asthma remission:
• Documented history of asthma diagnosed according to latest GINA guidelines, i.e. respiratory symptoms and either bronchodilator reversibility (improvement in FEV1 of more than 12% of baseline (and at least 200 mL) after inhalation of 800 µg salbutamol.
• No use of asthma medications such as inhaled or oral corticosteroids, β2-agonists or anticholinergic in the last 3 years.
• No symptoms of wheeze or asthma attacks during the last 3 years.
• Group 2. Subjects with complete asthma remission
• Documented history of asthma diagnosed according to latest GINA guidelines, i.e. respiratory symptoms and either bronchodilator reversibility (improvement in FEV1 of more than 12% of baseline (and at least 200 mL) after inhalation of 800 µg salbutamol.
• No use of asthma medications such as inhaled or oral corticosteroids, β2-agonists or anticholinergics in the last 3 years.
• No symptoms of wheeze or asthma attacks during the last 3 years.
• FEV1 \> 90% predicted.
• Absence of bronchial hyperresponsiveness, i.e. both PC20 methacholine \> 8 mg/ml and PC20 AMP \> 320 mg/ml.
• Group 3. Patients with ongoing asthma
• Documented history of asthma diagnosed according to latest GINA guidelines, i.e. respiratory symptoms and either bronchodilator reversibility (improvement in FEV1 of more than 12% of baseline (and at least 200 mL) after inhalation of 800 µg salbutamol.

Sponsors & Collaborators

• University Medical Center Groningen: lead
• GlaxoSmithKline: collaborator

Study Sites (1)

UMCG

Groningen, 9713, Netherlands

RECRUITING

Biospecimen

Retention: SAMPLES WITH DNA

blood sputum bronchial biopsies bronchial brushes nasal brushes particles in exhaled air

MeSH Terms

Conditions

Asthma

Condition Hierarchy (Ancestors)

Bronchial Diseases; Respiratory Tract Diseases; Lung Diseases, Obstructive; Lung Diseases; Respiratory Hypersensitivity; Hypersensitivity, Immediate; Hypersensitivity; Immune System Diseases

Study Officials

• Maarten van den Berge, MD PhD

  University Medical Center Groningen

  PRINCIPAL INVESTIGATOR

Central Study Contacts

Maarten van den Berge, MD, PhD

CONTACT

+31-50-3615260; m.van.den.berge@umcg.nl

Martijn Nawijn, PhD

CONTACT

+31-50-3610998; m.nawijn@umcg.nl

Study Design

• Study Type: observational
• Observational Model: CASE CONTROL
• Time Perspective: PROSPECTIVE
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: MD PhD

Study Record Dates

• First Submitted: May 3, 2017
• First Posted: May 5, 2017
• Study Start: October 1, 2015
• Primary Completion: October 1, 2018
• Study Completion: October 1, 2018
• Last Updated: July 17, 2017

Record last verified: 2017-07

Locations

NL (1)