Leukotrienes Pathway in Chinese Children With Sleep-disordered Breathing

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details. Identifier: NCT01344746
Recruitment Status : Unknown
Verified August 2010 by Beijing Children's Hospital.
Recruitment status was:  Enrolling by invitation
First Posted : April 29, 2011
Last Update Posted : April 29, 2011
Merck Sharp & Dohme Corp.
Information provided by:
Beijing Children's Hospital

Brief Summary:

Our goals are to demonstrate an active leukotrienes (LTs) mediated inflammatory response is involved in pathophysiology of sleep-disordered breathing (SDB), and to provide a theoretical evidence for LTs modify therapy in treating pediatric patients with SDB.

The investigators have hypothesized that the pathophysiology of pediatric SDB involves specific systemic and local upper airway inflammatory response mediated by LTs.

  1. LT concentration assays reveal higher levels in serum for both leukotriene B4 (LTB4) and cysteinyl leukotrienes (CysLTs) and in morning urine for LTE4 of SDB children, in comparison to healthy ones, and LTs productions emerge disease severity-dependent increases.

    There is a positive correlation between LTs production and other systemic markers such as neutrophil counts and high sensitive C-reactive protein (hsCRP).

  2. Children with SDB have higher leukotriene receptor-1 (LT1-R) and leukotriene receptor-2 (LT2-R) expressions in adenotonsillar tissues of SDB children compared to recurrent infectious tonsillitis subjects.
  3. Levels of LTs are positively correlated with body mass index (BMI) z-score, waist height ratio (WHtR), adenotonsillar size and polysomnography (PSG) indices including apnea-hypopnea index (AHI), obstructive apnea index (OAI), oxygen desaturation index (ODI), arousal index, percentage of time spend saturation lower than 90% (SLT90%) and negatively correlated with mean and minimal pulse oximetric saturation (SpO2), which indicates synergistic role of obesity and hypoxia are the determinants of LTs production in SDB.
  4. In adenotonsillar mixed cell culture system, the addition of LTs can increase cellular proliferation rates and exhibit dose-dependent responses, whereas leukotriene receptor antagonists (LTRAs) elicit dose-dependent cellular reductions.

Condition or disease
Sleep-disordered Breathing

  Show Detailed Description

Study Type : Observational
Estimated Enrollment : 225 participants
Observational Model: Case Control
Time Perspective: Prospective
Official Title: Leukotrienes Pathway in Chinese Children With Sleep-disordered Breathing
Study Start Date : December 2010
Estimated Primary Completion Date : November 2011
Estimated Study Completion Date : April 2012

Snoring group
  1. Subjects with snoring and AHI ≥ 20 episodes/h (severe SDB).
  2. Snorers with AHI < 20 episodes/h and ≥ 5 episodes/h (moderate SDB)
  3. Snorers with AHI < 5 episodes/h and ≥ 1 episodes/h (mild SDB)
Non-snoring group
  • When testing serum and urinal samples, healthy children without snoring will be chosen as controls.
  • When testing lymphoid tissue samples, patients with recurrent infectious tonsillitis (at least five tonsillar infections in less than 6 months) but without snoring will be selected as controls before surgery and recruited to the study, because adenotonsillar tissue can't be obtained from normal children for obvious ethical reasons.

Biospecimen Retention:   Samples With DNA
blood and adenotonsillar tissue

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Ages Eligible for Study:   2 Years to 12 Years   (Child)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   Yes
Sampling Method:   Non-Probability Sample
Study Population
Consecutive children referred to the sleep center for PSG due to symptoms of SDB from December 2009 to June 2010 were enrolled in the study. Normal age-, sex-, and weight-matched children without a history of snoring participated as control subjects, who were recruited from a community-based physical check-up activity.

Inclusion Criteria:

  • Subjects who were aged from 2 to 12 years ( 2 years ≤ subjects' age ≤ 12 years).
  • Subjects who were in the presence of habitual snoring (snoring as reported by parents > 3 nights/week) and his/her history of habitual snoring were at least 3 months could be recruited in snoring group.
  • Subjects who didn't have a history of snoring could be recruited as control subjects

Exclusion Criteria:

  • Subjects who have cardiovascular, neuromuscular, craniofacial or genetic disorders; acute or chronic inflammation disease, e.g. asthma, allergic rhinitis or other allergies.
  • Subjects who receive pharmacologic treatment including antibiotics, aspirin, nonsteroidal anti-inflammatory drugs, corticosteroids, and LTRAs within last 1 month.
  • Subjects who already had undergone T&A in the past.
  • Subjects who were receiving oral appliances or CPAP (Continuous Positive Airway Pressure ) treatment.

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 identifier (NCT number): NCT01344746

China, Beijing
Beijing Children's Hospital
Beijing, Beijing, China, 100045
Sponsors and Collaborators
Beijing Children's Hospital
Merck Sharp & Dohme Corp.
Principal Investigator: Kunling Shen, MD Beijing Children's Hospital

Responsible Party: Shen Kunling/President, Beijing Children's Hospital Identifier: NCT01344746     History of Changes
Other Study ID Numbers: MISP 38608
First Posted: April 29, 2011    Key Record Dates
Last Update Posted: April 29, 2011
Last Verified: August 2010

Keywords provided by Beijing Children's Hospital:
sleep-disordered breathing

Additional relevant MeSH terms:
Respiratory Aspiration
Respiration Disorders
Respiratory Tract Diseases
Pathologic Processes