Efficacy of Fluticasone Propionate associated With Salmeterol underwent allogeneic hematopoietic stem cell transplantatio

Phase 1

• Conditions: Bronchiolitis Obliterative Syndrome after hematopoietic stem cell transplantation (HSCT)..; Therapeutic area: Diseases [C] - Respiratory Tract Diseases [C08]

• Registration Number: EUCTR2020-003010-12-FR
• Lead Sponsor: ASSISTANCE PUBLIQUE - HOPITAUX DE PARIS (AP-HP)

Brief Summary

Not available

Detailed Description

Not available

Study Timeline

• Results First Posted: 1900-01-01
• Study Start: 2020-10-16
• Last Update Posted: 19 October 2020

Recruitment & Eligibility

• Status: A
• Sex: All
• Target Recruitment: 243

Inclusion Criteria

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

Exclusion Criteria

Non-Inclusion criteria before HSCT :
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
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
- BOS

Study & Design

• Study Type: Interventional clinical trial of medicinal product
• Study Design: Not specified