NCT00560261

Brief Summary

Sickle cell disease (SCD) is the most common inherited disease of the world affecting African and Caribbean populations. SCD is caused by the homozygous inheritance of the gene for sickle hemoglobin (HbS). Most patients with SCD develop abnormal pulmonary function characterized by airway obstruction, restrictive lung disease, abnormal diffusing capacity, hypoxemia and pulmonary hypertension In healthy subjects, lung capillary blood volume (Qc) and membrane diffusing capacity (Dm) can be accurately measured by the nitric oxide-carbon monoxide (NO-CO) method. We propose to study, for the first time, lung capillary blood volume and alveolar membrane diffusing capacity, using the NO-CO method, in children with SCD aged of at least 6 years Early determination of lung function and pulmonary circulation in children with SCD is very important, not only for the understanding of physiopathologic mechanisms of the disease but also for a better therapeutic management of these children.

Trial Health

87
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
120

participants targeted

Target at P25-P50 for phase_3

Timeline
Completed

Started Feb 2008

Typical duration for phase_3

Geographic Reach
1 country

1 active site

Status
completed

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

First Submitted

Initial submission to the registry

November 16, 2007

Completed
3 days until next milestone

First Posted

Study publicly available on registry

November 19, 2007

Completed
2 months until next milestone

Study Start

First participant enrolled

February 1, 2008

Completed
4 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

February 1, 2012

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

February 1, 2012

Completed
Last Updated

February 3, 2023

Status Verified

July 1, 2012

Enrollment Period

4 years

First QC Date

November 16, 2007

Last Update Submit

February 1, 2023

Conditions

Sickle Cell Disease

Keywords

Sickle cell disease;Lung capillary blood volume;Children

Outcome Measures

Primary Outcomes (1)

  • Study of lung capillary blood volume and alveolar membrane diffusing capacity using NO-CO method

    The day of the measure

Secondary Outcomes (4)

  • Respiratory physiopathology's study in sickle cell disease

    At the induction of the study

  • Valid alveolar membrane diffusing capacity using NO-CO in children with or without sickle cell disease

    At the induction of the study

  • Purpose respiratory function follow up in sickle cell disease child

    At the induction of the study

  • Find relationship between these vascular abnormalities and NO metabolism

    At the induction of the study

Study Arms (2)

1:Children with sickle cell disease

EXPERIMENTAL

NO-CO inhalation and expiration: Children with sickle cell disease

Other: NO-CO inhalation and expiration

2: Healthy volunteers

ACTIVE COMPARATOR

NO-CO inhalation and expiration: Healthy volunteers

Other: NO-CO inhalation and expiration

Interventions

NO-CO inhalation and expirationOTHER

NO-CO inhalation and expiration

1:Children with sickle cell disease

Eligibility Criteria

Age6 Years - 18 Years
Sexall
Healthy VolunteersYes
Age GroupsChild (0-17), Adult (18-64)

You may qualify if:

  • Children between 6 and 18 years
  • Sickle cell disease( SS,SC, SBETA O, SDpunjab) and control without sickle cell disease
  • Social insurance
  • Signed informed consent

You may not qualify if:

  • Respiratory disease other tha asthma
  • Cardiac disease
  • Encephalopathy
  • G6PD deficiency
  • Consent not signed

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Hopital Robert DEBRE

Paris, 75019, France

Location

Related Publications (1)

  • Bokov P, Boizeau P, Pautrat J, Missud F, Ba A, Haouari Z, Denjean A, Delclaux C, Benkerrou M. Altered pulmonary capillary blood volume in childhood sickle cell disease. Eur Respir J. 2020 Dec 10;56(6):2000379. doi: 10.1183/13993003.00379-2020. Print 2020 Dec. No abstract available.

    PMID: 32616593RESULT

MeSH Terms

Conditions

Anemia, Sickle Cell

Interventions

Exhalation

Condition Hierarchy (Ancestors)

Anemia, Hemolytic, CongenitalAnemia, HemolyticAnemiaHematologic DiseasesHemic and Lymphatic DiseasesHemoglobinopathiesGenetic Diseases, InbornCongenital, Hereditary, and Neonatal Diseases and Abnormalities

Intervention Hierarchy (Ancestors)

Respiratory MechanicsRespirationRespiratory Physiological PhenomenaCirculatory and Respiratory Physiological Phenomena

Study Officials

  • Florence MISSUD, Md

    Assistance Publique - Hôpitaux de Paris

    PRINCIPAL INVESTIGATOR

Study Design

Study Type
interventional
Phase
phase 3
Allocation
NON RANDOMIZED
Masking
NONE
Purpose
DIAGNOSTIC
Intervention Model
PARALLEL
Sponsor Type
OTHER
Responsible Party
SPONSOR

Study Record Dates

First Submitted

November 16, 2007

First Posted

November 19, 2007

Study Start

February 1, 2008

Primary Completion

February 1, 2012

Study Completion

February 1, 2012

Last Updated

February 3, 2023

Record last verified: 2012-07

Locations

FR(1)