«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» - RESPPEDOPS

ASSISTANCE PUBLIQUE - HOPITAUX DE PARIS (AP-HP)0 个研究点目标入组 243 人开始时间: 2020年10月16日最近更新: 2020年10月19日

适应症

试验速览

暂无简介。

•Inclusion criteria before HCST :
•- 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 (sécurité sociale 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 BOS international criteria, neither initiation of inhaled treatment from transplantation to randomization visit.
•Are the trial subjects under 18? yes
•Number of subjects for this age range: 243
•F.1.2 Adults (18-64 years) no
•F.1.2.1 Number of subjects for this age range
•F.1.3 Elderly (>=65 years) no
•F.1.3.1 Number of subjects for this age range

•Non-Inclusion criteria before HSCT :
•Patients with no affiliation to a social security scheme (beneficiary or legal)
•Asthma defined by reversibility with salbutamol (FEV1 > 12% or FEV1> 200ml)
•under inhaled corticosteroids or long acting beta agonists during the last three months
•Non-Randomisation criteria :
•- Viral respiratory infection (fever = 38°C, tachypnea according to age, positive viral PCR pharyngeal aspiration) during the last month;
•- Lower respiratory tract infection (fever = 38°C, tachypnea, radiologicaly or echography confirmed pneumonia, sputum) during the last month;
•- Invasive fungal disease (as defined by EORTC/MSG consensus group) during the last month.
•- Potent cytochrome P450 3A4 inhibitors, such as ritonavir, ketoconazole, itraconazole, troleandomycin, clarithromycin, nelfinavir, nilfinavir and nefazodone.
•- Corticosteroids or bronchodilatators inhaled treatment after transplantation

发起方