COPSAC2010 cohort

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The COPSAC₂₀₁₀ cohort

The COPSAC₂₀₁₀ mother-child cohort is a population based longitudinal clinical study of 736 pregnant women and their 700 children. It is the overriding objective to reduce the burden of disease from asthma and other wheezy disorders, eczema and allergy in young children and the long term impact to humans and society. The COPSAC₂₀₁₀ study builds on the comprehensive experience and knowledge gained from the COPSAC₂₀₀₀ mother-child cohort, which has been monitored closely since 1998. Building the novel COPSAC₂₀₁₀ mother-child cohort, we utilized the same standard operating procedures, infrastructure and skilled personnel, assuring the clinical aspects of the study goals will be achieved. The families are monitored closely from week 24 of mothers pregnancy. A major effort is the detailed clinical phenotyping and assessments of genetics, immunology and microbiology.

See available data on the cohort

Cohort Recruitment

Recruitment of 736 pregnant women was initiated late 2008 and ended July 2010 with 700 children enrolled after the last birth in March 2011.

Recruitment was conducted at two collaborating sites and was split 3:1 between the COPSAC research centre at Gentofte Hospital and a COPSAC satellite unit at Naestved Hospital.

The personnel exchange regularly between these two clinics to assure consistency of procedures.

The study is conducted in accordance with the Declaration of Helsinki and was approved by the Danish Ethics Committee (H-B-2008-093) and the Danish Data Protection Agency (2008-41-2599).

The study is conducted and monitored in accordance with the requirements of Good Clinical Practice (GCP) as defined in Guidelines, EU Clinical Trials Directive (2001/20/EC), and EU GCP Directive (2005/28/EC).

All study participants must sign approved informed consent forms prior to any study-related procedures. The confidentiality of all study participants will be protected in accordance with GCP Guidelines.

Randomized Trial

A main hypothesis of the COPSAC₂₀₁₀ mother-child cohort study is that protective factors in maternal diet during pregnancy influence maturation and regulation of neonatal immune responses directly or through modification of the mucosal microbiota and provide an opportunity for preventive supplementation in pregnancy.

Nested within the COPSAC₂₀₁₀ mother-child cohort, we conduct a randomized clinical intervention trial to study the influence of maternal supplementation with marine n-3 long chain polyunsaturated fatty acids (n-3 LCPUFA) and/or vitamin D in third trimester of pregnancy to evaluate effects on disease development in the children.

n-3 LCPUFA

Dietary changes in the westernized world has caused insufficient intake of n-3 Long Chain PolyUnsaturated Fatty Acids (n-3 LCPUFA). n-3 LCPUFA is key in early life maturation of the immune system and low levels of n-3 LCPUFA has been associated with increased risk of asthma. In addition, a randomized controlled trial of supplementation of n-3 LCPUFA to the pregnant mother has recently been associated with a significant reduction in adolescent asthma.

Marine n-3 LCPUFA (2.4 g daily) was administered vs. olive oil from week 24 of gestation in a controlled randomized trial with a factorial design. The children are prospectively followed with extensive monitoring of symptoms and objective assessments.

Vitamin D

Lifestyle changes in industrialized countries has caused insufficient intake of vitamin D due to dietary changes, an increased use of sun blockers, and decreased outdoor activities. Diminished serum vitamin D levels has been associated with an increased risk of asthma and wheezy disorders, which is supported by results from the COPSAC₂₀₀₀ mother-child cohort. Sixty µg vitamin D (2400 IU) per day or matching placebo were administered from week 24 of gestation till delivery. CP-unit.

Azithromycin treatment of acute severe episodes of troublesome lung symptoms

Children aged 12 –36 months with recurrent episodes of troublesome lung symptoms lasting at least 3 days were offered participation in another double-blinded, randomized, placebo-controlled treatment with azithromycin or placebo at acute episodes of troublesome lung symptoms. Children were recruited from the main cohort study if they had recurrent ’wheezy episodes’ (five episodes of three consecutive days of troublesome lung symptoms within a period of 6 months or 4 weeks of continuous troublesome lung symptoms or acute severe asthma).

Influenza A H1N1v vaccination

During the H1N1v pandemic winter 2009–2010, the women were invited from gestational week 20 until 8 months after birth to a phase IV randomized, participant-blinded comparison of monovalent influenza A/California/2009 (H1N1v) surface antigen vaccine in both MF59-adjuvanted and non-adjuvanted forms to compare and evaluate the dose-related immune protection conferred by vaccine and adjuvant (Novartis vaccine, Focteria) in pregnant and non-pregnant women. In addition, the passive immunity conferred to the newborn from these vaccine regimes is assessed.