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 (RESPPEDOBS)
Stem Cell Transplant Complications, Respiratory Disease, Bronchiolitis Obliterans
About this trial
This is an interventional treatment trial for Stem Cell Transplant Complications
Eligibility Criteria
Inclusion Criteria:
- Children and adolescent aged 6 to 17 years
- Getting an Allo Hematopoietic cell stem transplantation
- Provide written informed consent from legal guardian
- Covered by medical insurance (social security ou CMU).
Randomisation criteria:
- Decline of FEV1 ≥ 10% from pre transplantation between M3 and M12 after the transplantation, confirmed over two functional test performed one week apart, without Bronchiolitis Obliterative Syndrome international criteria, neither initiation of inhaled treatment from transplantation to randomization visit.
Exclusion Criteria:
- Patients with no affiliation to a social security scheme (beneficiary or legal)
- Pregnancy
- Asthma defined by reversibility with salbutamol (FEV1 > 12% or FEV1> 200ml) under inhaled corticosteroids or long acting beta agonists during the last three months
- Patients with hypersensitivity to the active substances: salmeterol, fluticasone propionate, or to the excipients: norflurane.
Non-Randomisation criteria :
- Viral respiratory infection (fever ≥ 38°C, tachypnea according to age, positive viral PCR (Polymerase Chain Reaction) pharyngeal aspiration) during the last month;
- Lower respiratory tract infection (fever ≥ 38°C, tachypnea, radiologically or echography confirmed pneumonia, sputum) during the last month;
- Invasive fungal disease (as defined by European Organisation for Research and Treatment of Cancer/Mycoses Study Group consensus group) during the last month.
- Potent cytochrome P450 3A4 inhibitors, such as ritonavir, ketoconazole, itraconazole, troleandomycin, clarithromycin, nelfinavir and nefazodone.
- Corticosteroids or bronchodilatators inhaled treatment after transplantation
- Bronchiolitis Obliterative Syndrome
Sites / Locations
- Houdouin véroniqueRecruiting
Arms of the Study
Arm 1
Arm 2
Experimental
Placebo Comparator
Seretide
placebo
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
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