Measures of Respiratory Health (MRH)

NCT02657837 | Unknown

• 1 other identifier: 1000051399
• Study Type: observational
• Target: 300
• Locations: 1 country
• Sites: 1

Brief Summary

The Lung Clearance Index, measured by multiple breath washout, is a measure of lung function that is considered a research tool in Canada as the device used to measure it is not approved by Health Canada. The study will assess lung function in patients undergoing routine lung function testing for clinical indications (Cystic Fibrosis and Other Respiratory Diseases). In addition, healthy controls of different ages will be asked to perform this lung function test to gain reference data that can be used to interpret LCI in patients with lung disease.

Conditions

Cystic Fibrosis; Asthma; Sickle Cell Anemia; Bronchiolitis Obliterans

Keywords

CF; Multiple Breath Washout; Lung Clearance Index; Pediatrics

Outcome Measures

Primary Outcomes (1)

• Proportion of patients with an abnormal Lung Clearance Index (>7.5).

  Single time point measurements obtained in enrolled subjects

  Day 1

Secondary Outcomes (1)

• . Proportion of patients with an abnormal pulmonary function tests based on spirometry.

  Day 1

Study Arms (3)

Cystic Fibrosis

Children 2.5 to 18 years old with confirmed diagnosis of cystic fibrosis

Children with other respiratory disease

Children 2.5 to 18 years old with confirmed diagnosis of respiratory disease including but not limited to asthma, transplant, and sickle cell anemia.

Healthy Children

Children and adults 2.5 to 30 years old with no history of chronic disease

Eligibility Criteria

• Age: 30 Months - 30 Years
• Sex: all
• Healthy Volunteers: Yes
• Age Groups: Child (0-17), Adult (18-64)
• Sampling Method: Non-Probability Sample

Study Population

Participants who meet all of the inclusion and none of the exclusion criteria will be eligible for participation in this study. Participants will include individuals with CF, individuals with other respiratory disease and healthy individuals.

You may qualify if:

• years of age at enrolment
• Diagnosis of CF as evidenced by one or more clinical feature consistent with the CF phenotype or positive CF newborn screen AND one or more of the following criteria:
• A documented sweat chloride ≥ 60 mEq/L by quantitative pilocarpine iontophoresis (QPIT)
• A documented genotype with two disease-causing mutations in the CFTR gene
• Informed consent by participant, parent, or legal guardian
• Ability to perform technically acceptable MBW measurements

You may not qualify if:

• Physical findings at screening that would compromise the safety of the participant as judged by the patient's most responsible physician
• Requirement of supplementary oxygen to maintain an oxygen saturation above 95%
• Participants with other respiratory disease
• MD diagnosed lung disease and/or attending the Pulmonary Function Laboratory
• years of age at enrollment
• Informed consent by participant, parent, or legal guardian
• Ability to perform technically acceptable MBW measurements
• Physical findings at screening that would compromise the safety of the participant or the quality of the study data.
• Requirement of supplementary oxygen to maintain an oxygen saturation above 95%
• Healthy Participants
• years of age at enrollment
• Informed consent by participant, parent, or legal guardian
• Ability to perform technically acceptable MBW measurements
• Physical findings at screening that would compromise the safety of the participant or the quality of the study data.
• Evidence of a chronic disease process such as lung disease

Sponsors & Collaborators

• The Hospital for Sick Children: lead

Study Sites (1)

The Hospital for Sick Children

Toronto, Ontario, M5G 1X8, Canada

RECRUITING

Related Publications (10)

• Grasemann H, Ratjen F. Early lung disease in cystic fibrosis. Lancet Respir Med. 2013 Apr;1(2):148-57. doi: 10.1016/S2213-2600(13)70026-2. Epub 2013 Mar 12.

  PMID: 24429095 BACKGROUND

• Ranganathan SC, Dezateux C, Bush A, Carr SB, Castle RA, Madge S, Price J, Stroobant J, Wade A, Wallis C, Stocks J; London Collaborative Cystic Fibrosis Group. Airway function in infants newly diagnosed with cystic fibrosis. Lancet. 2001 Dec 8;358(9297):1964-5. doi: 10.1016/s0140-6736(01)06970-7.

  PMID: 11747924 BACKGROUND

• Sly PD, Brennan S, Gangell C, de Klerk N, Murray C, Mott L, Stick SM, Robinson PJ, Robertson CF, Ranganathan SC; Australian Respiratory Early Surveillance Team for Cystic Fibrosis (AREST-CF). Lung disease at diagnosis in infants with cystic fibrosis detected by newborn screening. Am J Respir Crit Care Med. 2009 Jul 15;180(2):146-52. doi: 10.1164/rccm.200901-0069OC. Epub 2009 Apr 16.

  PMID: 19372250 BACKGROUND

• Horsley A. Lung clearance index in the assessment of airways disease. Respir Med. 2009 Jun;103(6):793-9. doi: 10.1016/j.rmed.2009.01.025. Epub 2009 Feb 25.

  PMID: 19246184 BACKGROUND

• Gustafsson PM, Aurora P, Lindblad A. Evaluation of ventilation maldistribution as an early indicator of lung disease in children with cystic fibrosis. Eur Respir J. 2003 Dec;22(6):972-9. doi: 10.1183/09031936.03.00049502.

  PMID: 14680088 BACKGROUND

• Aurora P, Gustafsson P, Bush A, Lindblad A, Oliver C, Wallis CE, Stocks J. Multiple breath inert gas washout as a measure of ventilation distribution in children with cystic fibrosis. Thorax. 2004 Dec;59(12):1068-73. doi: 10.1136/thx.2004.022590.

  PMID: 15563707 BACKGROUND

• Gustafsson PM, De Jong PA, Tiddens HA, Lindblad A. Multiple-breath inert gas washout and spirometry versus structural lung disease in cystic fibrosis. Thorax. 2008 Feb;63(2):129-34. doi: 10.1136/thx.2007.077784. Epub 2007 Aug 3.

  PMID: 17675316 BACKGROUND

• Owens CM, Aurora P, Stanojevic S, Bush A, Wade A, Oliver C, Calder A, Price J, Carr SB, Shankar A, Stocks J; London Cystic Fibrosis Collaboration. Lung Clearance Index and HRCT are complementary markers of lung abnormalities in young children with CF. Thorax. 2011 Jun;66(6):481-8. doi: 10.1136/thx.2010.150375. Epub 2011 Mar 21.

  PMID: 21422040 BACKGROUND

• Hall GL, Logie KM, Parsons F, Schulzke SM, Nolan G, Murray C, Ranganathan S, Robinson P, Sly PD, Stick SM; AREST CF; Berry L, Garratt L, Massie J, Mott L, Poreddy S, Simpson S. Air trapping on chest CT is associated with worse ventilation distribution in infants with cystic fibrosis diagnosed following newborn screening. PLoS One. 2011;6(8):e23932. doi: 10.1371/journal.pone.0023932. Epub 2011 Aug 19.

  PMID: 21886842 BACKGROUND

• Aurora P, Stanojevic S, Wade A, Oliver C, Kozlowska W, Lum S, Bush A, Price J, Carr SB, Shankar A, Stocks J; London Cystic Fibrosis Collaboration. Lung clearance index at 4 years predicts subsequent lung function in children with cystic fibrosis. Am J Respir Crit Care Med. 2011 Mar 15;183(6):752-8. doi: 10.1164/rccm.200911-1646OC. Epub 2010 Oct 8.

  PMID: 20935113 BACKGROUND

MeSH Terms

Conditions

Cystic Fibrosis; Asthma; Anemia, Sickle Cell; Bronchiolitis Obliterans

Condition Hierarchy (Ancestors)

Pancreatic Diseases; Digestive System Diseases; Lung Diseases; Respiratory Tract Diseases; Genetic Diseases, Inborn; Congenital, Hereditary, and Neonatal Diseases and Abnormalities; Infant, Newborn, Diseases; Bronchial Diseases; Lung Diseases, Obstructive; Respiratory Hypersensitivity; Hypersensitivity, Immediate; Hypersensitivity; Immune System Diseases; Anemia, Hemolytic, Congenital; Anemia, Hemolytic; Anemia; Hematologic Diseases; Hemic and Lymphatic Diseases; Hemoglobinopathies; Bronchiolitis; Bronchitis

Study Officials

• Felix Ratjen, MD PhD

  The Hospital for Sick Children

  PRINCIPAL INVESTIGATOR

Central Study Contacts

Felix Ratjen, MD PhD

CONTACT

416-813-7654; felix.ratjen@sickkids.ca

Sanja Stanojevic, PhD

CONTACT

416-813-7654; sanja.stanojevic@sickkids.ca

Study Design

• Study Type: observational
• Observational Model: COHORT
• Time Perspective: PROSPECTIVE
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Division Head, Respiratory Medicine

Study Record Dates

• First Submitted: January 8, 2016
• First Posted: January 18, 2016
• Study Start: January 1, 2016
• Primary Completion: December 1, 2024
• Study Completion: December 1, 2024
• Last Updated: October 23, 2023

Record last verified: 2023-10

Locations

CA (1)