Lung Obstruction in Adulthood of Prematurely Born (LUNAPRE)

NCT02923648 | Active Not Recruiting DMC

• 1 other identifier: 2012/1872-31/4
• Study Type: observational
• Target: 96
• Locations: 1 country
• Sites: 2

Brief Summary

Obstructive lung disease is an increasing global health problem of pandemic proportions, with COPD alone affecting \>10% of the population. Smoking is the main and most well studies risk factor for developing COPD. However, chronic airway obstruction also in never-smoking populations has recently been recognized as an increasing health problem. Prematurely born children, particularly survivors of bronchopulmonary dysplasia (BPD), defined as the need for oxygen therapy up to the 28th day of life for children born prior to gestational week 32, have an increased incidence of both airway obstruction and hyper-reactivity, both representing major risk factors for developing COPD, or asthma, later in life. The purpose of this study is to perform in-depth clinical and molecular characterizations of of the lungs of survivors of BPD as they enter adulthood, and compare these profiles to relevant control groups (individuals with mild asthma, healthy prematurely born, and healthy individuals born at full term). Specifically, alterations at the epigenetic, mRNA, microRNA, protein and metabolite level as well as associated molecular pathways critical in the pathological mechanisms of obstructive lung disease related to premature birth and BPD will be identified.

Conditions

Premature Birth- and BPD-related Obstructive Lung Disease

Outcome Measures

Primary Outcomes (5)

• Forced expiratory volume in 1 second (FEV1) including reversibilityForced expiratory volume in 1 second (FEV1) including reversibilityForced expiratory volume in 1 second (FEV1) including reversibility

  Measured at baseline

• Forced Vital Capacity (FVC) including reversibility

  Measured at baseline

• Impulse oscillometry

  Measured at baseline

• Airway hyper-reactivity (methacholine test)

  Measured at baseline

• Emphysema and airway wall thickness, as shown on low radiation chest CT scan

  Measured at baseline

Secondary Outcomes (3)

• COPD status (according to GOLD initiative standards as well as LLN)

  Determined at baseline

• Molecular alterations due to BPD and/or premature birth persisting into adulthood

  Determined at baseline

• Molecular gender differences

  Determined at baseline

Study Arms (4)

Very/extremely prematurely born with BPD

Very/extremely prematurely born (gestational age \[GA\]\< 32 weeks) with bronchopulmonary dysplasia (BPD) as defined by Jobe and Bancalari 2001, age 18-23 years

Very/extremely prematurely born without BPD

Very/extremely prematurely born (GA\< 32 weeks) without BPD in the neonatal period, age 18-23 years

Asthma full-term control group

Subjects with mild atopic asthma, born at term (GA\> 37 weeks), age 18-23 years

Healthy full-term control group

Healthy participants, born at term (GA\>37 weeks), age 18-23 years

Eligibility Criteria

• Age: 18 Years - 23 Years
• Sex: all
• Healthy Volunteers: Yes
• Age Groups: Adult (18-64)
• Sampling Method: Non-Probability Sample

Study Population

Participants from the two prematurely born groups are recruited from cohort sfollowed since birth at Sach's Children's Hospital, Stockholm. Participants in the full term born groups are recruited from the general population through advertisements.

You may qualify if:

• Spirometry of postbronchodilator forced expiratory volume in 1 second (FEV1) \>50% of predicted level for premature groups

You may not qualify if:

• Smoking
• Other lung diseases
• Received antibiotics in the 3 months prior to study entry
• Treatment with oral or inhaled glucocorticoids within past 3 months prior to study entry

Sponsors & Collaborators

• Karolinska Institutet: lead
• Swedish Heart Lung Foundation: collaborator
• The Swedish Research Council: collaborator
• Region Stockholm: collaborator
• Stockholm South General Hospital: collaborator
• University of California, San Francisco: collaborator
• Kyoto University: collaborator
• Göteborg University: collaborator
• University of Oulu: collaborator

Study Sites (2)

Karolinska Institutet/Karolinska University Hospital Solna

Stockholm, Sverige, 17176, Sweden

Location

Stockholm Southern General Hospital

Stockholm, Sweden

Location

Related Publications (3)

• Brostrom EB, Thunqvist P, Adenfelt G, Borling E, Katz-Salamon M. Obstructive lung disease in children with mild to severe BPD. Respir Med. 2010 Mar;104(3):362-70. doi: 10.1016/j.rmed.2009.10.008. Epub 2009 Nov 10.

  PMID: 19906521 BACKGROUND

• Um-Bergstrom P, Hallberg J, Pourbazargan M, Berggren-Brostrom E, Ferrara G, Eriksson MJ, Nyren S, Gao J, Lilja G, Linden A, Wheelock AM, Melen E, Skold CM. Pulmonary outcomes in adults with a history of Bronchopulmonary Dysplasia differ from patients with asthma. Respir Res. 2019 May 24;20(1):102. doi: 10.1186/s12931-019-1075-1.

  PMID: 31126291 RESULT

• Um-Bergstrom P, Pourbazargan M, Brundin B, Strom M, Ezerskyte M, Gao J, Berggren Brostrom E, Melen E, Wheelock AM, Linden A, Skold CM. Increased cytotoxic T-cells in the airways of adults with former bronchopulmonary dysplasia. Eur Respir J. 2022 Sep 29;60(3):2102531. doi: 10.1183/13993003.02531-2021. Print 2022 Sep.

  PMID: 35210327 RESULT

Biospecimen

Retention: SAMPLES WITH DNA

Bronchoalveolar lavage (BAL) cells, BAL fluid, bronchial biopsies, airway epithelial brushings, serum, plasma, blood cells, and urine are collected and stored.

MeSH Terms

Conditions

Premature Birth

Condition Hierarchy (Ancestors)

Obstetric Labor, Premature; Obstetric Labor Complications; Pregnancy Complications; Female Urogenital Diseases and Pregnancy Complications; Urogenital Diseases

Study Officials

• Magnus Skold, MD, PhD

  Karolinska Institute, Karolinska University Hospital

  PRINCIPAL INVESTIGATOR

• Asa M Wheelock, PhD

  Karolinska Institutet

  PRINCIPAL INVESTIGATOR

• Erik Melén, MD, PhD

  Karolinska Institute, Stockholm Southern General Hospital

  PRINCIPAL INVESTIGATOR

• Eva Berggren-Brostrom, MD, PhD

  Stockholm Southern General Hospital

  PRINCIPAL INVESTIGATOR

• Anders Lindén, MD, PhD

  Karolinska Institute, Karolinska University Hospital

  PRINCIPAL INVESTIGATOR

• Sven Nyrén, MD, PhD

  Karolinska Institute, Karolinska University Hospital

  PRINCIPAL INVESTIGATOR

• Craig E Wheelock, PhD

  Karolinska Institutet

  PRINCIPAL INVESTIGATOR

• Maria J Eriksson, MD, PhD

  Karolinska Institute, Karolinska University Hospital

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: observational
• Observational Model: COHORT
• Time Perspective: CROSS SECTIONAL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Associate professor

Study Record Dates

• First Submitted: October 3, 2016
• First Posted: October 4, 2016
• Study Start: March 1, 2013
• Primary Completion: September 30, 2016
• Study Completion (Estimated): December 1, 2035
• Last Updated: April 4, 2025

Record last verified: 2025-04

Data Sharing

• IPD Sharing: Will not share

Locations

SE (2)