Efficacy of Fluticasone Propionate Associated With Salmeterol Using Inhalation Chamber Versus Placebo to Improve the Respiratory Function in Children Over Six Years of Age Who Underwent Allogeneic Hematopoietic Stem Cell Transplantation With a Decline of FEV1 ≥10% From Pre Transplantation

PHASE3TerminatedINTERVENTIONAL
Enrollment

35

Participants

Timeline

Start Date

May 21, 2021

Primary Completion Date

September 27, 2023

Study Completion Date

September 27, 2023

Conditions
Stem Cell Transplant ComplicationsRespiratory DiseaseBronchiolitis Obliterans
Interventions
DRUG

Seretide

"For children between 6 to 11 years (\< 12 years): 50 μg inhaled fluticasone propionate and 25 μg salmeterol (SERETIDE® 50/25) :two puffs twice a day from randomisation during 6 months using inhalation chamber~\- For children between 12 to 17 years (\> or = 12 years) : 125 μg inhaled fluticasone propionate and 25 μg salmeterol (SERETIDE® 125/25): two puffs twice a day from randomisation during 6 months using inhalation chamber"

DRUG

Placebo

For children between 6 to 11 years (\< 12 years): placebo of SERETIDE® 50/25 :two puffs twice a day from randomisation during 6 months using inhalation chamber For children between 12 to 17 years (\> or = 12 years) : placebo of SERETIDE® 125/25: two puffs twice a day from randomisation during 6 months using inhalation chamber

Trial Locations (1)

75019

Houdouin véronique, Paris

Sponsors

Collaborators (1)

All Listed Sponsors
collaborator

GlaxoSmithKline

INDUSTRY

lead

Assistance Publique - Hôpitaux de Paris

OTHER

NCT04655508 - Efficacy of Fluticasone Propionate Associated With Salmeterol Using Inhalation Chamber Versus Placebo to Improve the Respiratory Function in Children Over Six Years of Age Who Underwent Allogeneic Hematopoietic Stem Cell Transplantation With a Decline of FEV1 ≥10% From Pre Transplantation | Biotech Hunter | Biotech Hunter