Stem Cell Transplant ComplicationsPhase 3RESPPEDOBSNCT04655508
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
A Phase 3 study testing Seretide in people with Stem Cell Transplant Complications and Respiratory Disease, run by Assistance Publique - Hôpitaux de Paris at 1 site in France.
Trial summary
Bronchiolitis Obliterative Syndrome (BOS) is the primary noninfectious pulmonary complication after hematopoietic stem cell transplantation (HSCT) and usually carries a poor prognosis. It occurs in about 10% of children underwent HSCT. Read more about this study
- Who is it for?
- Ages 6 to 17 years
- Conditions the study is for
- Stem Cell Transplant Complications, Respiratory Disease, Bronchiolitis Obliterans
- What is being tested?
- Seretide
- Could I receive a placebo?
- Yes, some participants may receive a placebo
- How many people
- 35 participants
- Where
- 1 siteFrance
- Study dates
- 21 May 2021to 27 Sep 2023
- Phase
- Phase 3
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 6 to 17 years
- All sexes
- No healthy volunteers
- Child
Who may be able to join
- 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.
Who cannot join
- 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;
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- 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
Trial locations and contacts
1 site in 1 country.
About this study
Bronchiolitis Obliterative Syndrome (BOS) is the primary noninfectious pulmonary complication after hematopoietic stem cell transplantation (HSCT) and usually carries a poor prognosis. It occurs in about 10% of children underwent HSCT. The National Institutes of Health (NIH) published guidelines and criteria for the diagnosis of BOS. BOS defined by spirometric criteria according to modified NIH consensus guidelines: FEV1 < 75% predicted and a greater than 10% decline from pretransplant baseline, and FEV1/FVC <0.7 (FCV: Forced Vital Capacity). Nevertheless Cheng and al. indicate that the magnitude of FEV1 decline before diagnosis exceeded the diagnostic requirement of a greater than 10% decline compared with baseline FEV. Moreover, the decline in FEV1 prior to BOS diagnosis appeared to occur within 6 months for those patients. Recent studies suggest that any intervention should be targeted during the FEV1 decline, and before the diagnosis of BOS. For this, inhalated treatment are used: Bergeron et al. reported improvements in symptoms as well in FEV1 one month followed treatment including formoterol and budesonide in a prospective trial including adults (12% increase of FEV1 for 62% adults). Williams and al. in another prospective adult's cohort, showed that the association between fluticasone, montelukast and azythromycin was associated with stable lung function, reduced systemic corticosteroids, and improved quality of life at 3 months for adults with BOS.
In our national French prospective cohort which include 300 children with HSCT from 2014 to 2017 (RESPPEDHEM Programme Hospitalier de Recherche Clinique 2012), 35% of children presented a decline of FEV1≥ 10% without BOS criteria (FEV1 < 75% and FEV1/FVC <0.7). Among them, some received combination of corticoids and long acting beta agonists for 6 months. Children with this type of inhalated treatment improved their FEV1 to 88.1% predicted while children without any treatment have a FEV1 at 80.7% predicted. Our hypothesis is that association of Fluticasone Propionate and Salmeterol can be used as a treatment of the decline of FEV1 for children and so prevent BOS.
Read the detailed description
It's a prospective randomized double blind, multicentre, parallel-group in a 1:1 ratio, controlled and superiority trial.
The primary objective is to assess the effect of a Fluticasone Propionate associated with Salmeterol using inhalation chamber compared to placebo on respiratory function at 6 months in children over six years of age who underwent allogeneic hematopoietic stem cell transplantation with a decline of FEV1 ≥ 10% from pre transplantation.
The primary criterion will be the difference in the FEV1% predicted value from inclusion to 6 months following the initiation of treatment.
To assess the effect of a Fluticasone Propionate associated with Salmeterol using inhalation chamber compared to placebo in children over six years old underwent allogeneic hematopoietic stem cell transplantation with a decline of FEV1 ≥ 10% from pre transplantation baseline to 6 months following the initiation of treatment, and 6 months after the end of treatment, on pulmonary function, respiratory symptoms, Bronchiolitis Obliterative Syndrome (BOS) rate, oral steroid exposure and occurrence of infections;
To assess potential confounding factors associated to the 6-months inhaled treatment efficacy from baseline to 12 months, especially:
- GVHD (Graft Versus Host Disease) occurrence, severity and treatment (steroid dose exposure, calcineurins inhibitors dose, second line of GVHD treatment); To assess the safety and tolerability of the treatment at baseline, M1, M3 and M6 following the initiation of treatment
All endpoints were collected at baseline, randomization, 1, 3, 6 months during the treatment period, and then 3, 6 months after the end of the treatment.
- Endpoints relative to respiratory symptoms :
- dyspnea will be evaluate at the NYHA (New York Heart Association) scoring;
- step test (patient climb up and down step during three minutes at the frequency of 30/mn) : Respiratory rate, dyspnea Heart rate, SaO2 (oxygen saturation) during the exercise.
- Endpoints relative to pulmonary function :
- FEV1 (Forced expiratory volume) VC (Vital Capacity) , TLC (Total Lung capacity) , RV (Residual volume), FRC (Functional Residual Capacity), sRaw (specific airway resistance) DLCO (diffusing capacity of the lungs) using a similar method of measurement for static lung volumes (plethysmography)
- Number of patients presented with BOS defined as the absence of infection, and FEV1 < 75% predicted, and the FEV1/ FVC < 0.7, and the RV >120% or air trapping or bronchiectasis or small airways thickening on computed tomography
- Endpoints relative to GVHD :
- Acute and Chronic GVHD manifestations defined on NIH consensus with scoring;
- First line of treatment: cumulative dose of corticosteroid systemic exposure and cumulative dose of calcineurins inhibitors.
- Second line of GVHD treatment exposure will be assessed using the other type of treatment.
- Endpoints relative to respiratory infections :
- Number of adverse events.
- Endpoints relative to safety and tolerance:
- Adverse events during the study period such as treatment tolerance, thrush, death.
The investigators will study patients over six years of age who underwent allogeneic hematopoietic stem cell transplantation with a decline of FEV1 ≥10% from pre transplantation.
The choice of this range of age is motivated by the fact that PFTs (Pulmonary Function Test) requires a degree of cooperation that is age dependent, only children who are 6 years of age or older are able to realize reproducible PFTs.
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
- Being tested
- Seretide, Placebo
- Medical subject headings
- Respiration Disorders, Bronchiolitis Obliterans
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
SeretideDrug
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
PlaceboDrug
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
| Study group | Role | What they receive |
|---|---|---|
| Seretide | Experimental | 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 Receives: Drug: Seretide |
| placebo | Placebo comparator | 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 Receives: Drug: Placebo |
What is being measured
The primary outcome is the main question the study is designed to answer.
FEV: Forced Expiratory Volume in 1 second
The primary criterion will be the change in the FEV1% predicted value from inclusion to 6 months following the initiation of treatment
Measured: The primary criterion will be measured at months 0, 1, 3, 6, 9 and 12.
Secondary outcomes (12)
Graft Versus Host Disease
GVHD occurrence (Acute and Chronic GVHD manifestations defined on NIH consensus with scoring), First line of treatment: cumulative dose of corticosteroid systemic exposure and cumulative dose of calcineurins inhibitors and Second line of GVHD treatment exposure will be assessed using the other type of treatment
Measured: The criterion will be measured at months 0, 1, 3, 6, 9 and 12.
Dyspnea
dyspnea will be evaluate at the NYHA scoring from I to IV (I: none, IV: symptomatic at rest)
Measured: The criterion will be measured at months 0, 1, 3, 6, 9 and 12.
Step Test
step test: Respiratory rate, dyspnea Heart rate, SaO2 during the exercise.
Measured: The criterion will be measured at months 0, 1, 3, 6, 9 and 12.
Bronchiolitis Obliterative Syndrome
The investigators will measure the number of patients presented with Bronchiolitis Obliterative Syndrome
Measured: The criterion will be measured at months 0, 1, 3, 6, 9 and 12.
Adverse events
The investigators will measure the Occurrence of infections
Measured: The criterion will be measured at months 0, 1, 3, 6, 9 and 12.
Pulmonary function
A plethysmography will be performed to measured pulmonary parameters: FEV1 (Forced Expiratory Volume)
Measured: FEV1 will be measured at months 0, 1, 3, 6, 9 and 12
Pulmonary function
A plethysmography will be performed to measured pulmonary parameters: VC (Vital Capacity)
Measured: VC will be measured at months 0, 1, 3, 6, 9 and 12
Pulmonary function
A plethysmography will be performed to measured pulmonary parameters: TLC (Total Lung Capacity)
Measured: TLC will be measured at months 0, 1, 3, 6, 9 and 12
Pulmonary function
A plethysmography will be performed to measured pulmonary parameters: RV (Residual Volume)
Measured: RV will be measured at months 0, 1, 3, 6, 9 and 12
Pulmonary function
A plethysmography will be performed to measured pulmonary parameters: FRC (Functional Residual Capacity)
Measured: FRC will be measured at months 0, 1, 3, 6, 9 and 12
Pulmonary function
A plethysmography will be performed to measured pulmonary parameters: sRaw (Specific airway resistance)
Measured: sRaw will be measured at months 0, 1, 3, 6, 9 and 12
Pulmonary function
A plethysmography will be performed to measured pulmonary parameters: DLCO (Diffusing Capacity of the Lungs)
Measured: DLCO will be measured at months 0, 1, 3, 6, 9 and 12
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted7 Dec 2020
- Study start21 May 2021
- Primary completion27 Sep 2023
- Study completion27 Sep 2023
Why it stopped: insufficient enrollment.
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Stem Cell Transplant ComplicationsStudies of the same condition, open and under way.
- More trials run by Assistance Publique - Hôpitaux de ParisThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase 3
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Triple blind
- Who is masked
- Participant, Care provider, Investigator
- Enrolment
- 35 participants (actual)
Sponsor and investigators
- Lead sponsor
- Assistance Publique - Hôpitaux de Paris
- Sponsor type
- University, hospital or other
- Collaborators
- GlaxoSmithKline
- Responsible party
- Sponsor
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT04655508
- Sponsor's protocol ID
- APHP180600
- Acronym
- RESPPEDOBS
- Status last verified
- Feb 2024
- First submitted
- 10 Nov 2020
- Last updated
- 16 Sep 2025
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- Undecided
Study at a glance
From the registry record, last updated by the sponsor on 16 Sep 2025. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- 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
- ClinicalTrials.gov ID
- NCT04655508
- Acronym / sponsor ID
- RESPPEDOBS / APHP180600
- Phase
- Phase 3
- Study type
- Interventional
- Recruitment status
- TerminatedReason stopped: insufficient enrollment.
- Enrolment
- 35 participants (actual)
- Lead sponsor
- Assistance Publique - Hôpitaux de ParisUniversity, hospital or other
- Collaborators
- GlaxoSmithKline
- Study start
- 21 May 2021 (actual)
- Primary completion
- 27 Sep 2023 (actual)
- Study completion
- 27 Sep 2023 (actual)
- First posted
- 7 Dec 2020 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
Bronchiolitis Obliterative Syndrome (BOS) is the primary noninfectious pulmonary complication after hematopoietic stem cell transplantation (HSCT) and usually carries a poor prognosis. It occurs in about 10% of children underwent HSCT. The National Institutes of Health (NIH) published guidelines and criteria for the diagnosis of BOS. BOS defined by spirometric criteria according to modified NIH consensus guidelines: FEV1 < 75% predicted and a greater than 10% decline from pretransplant baseline, and FEV1/FVC <0.7 (FCV: Forced Vital Capacity). Nevertheless Cheng and al. indicate that the magnitude of FEV1 decline before diagnosis exceeded the diagnostic requirement of a greater than 10% decline compared with baseline FEV. Moreover, the decline in FEV1 prior to BOS diagnosis appeared to occur within 6 months for those patients. Recent studies suggest that any intervention should be targeted during the FEV1 decline, and before the diagnosis of BOS. For this, inhalated treatment are used: Bergeron et al. reported improvements in symptoms as well in FEV1 one month followed treatment including formoterol and budesonide in a prospective trial including adults (12% increase of FEV1 for 62% adults). Williams and al. in another prospective adult's cohort, showed that the association between fluticasone, montelukast and azythromycin was associated with stable lung function, reduced systemic corticosteroids, and improved quality of life at 3 months for adults with BOS.
In our national French prospective cohort which include 300 children with HSCT from 2014 to 2017 (RESPPEDHEM Programme Hospitalier de Recherche Clinique 2012), 35% of children presented a decline of FEV1≥ 10% without BOS criteria (FEV1 < 75% and FEV1/FVC <0.7). Among them, some received combination of corticoids and long acting beta agonists for 6 months. Children with this type of inhalated treatment improved their FEV1 to 88.1% predicted while children without any treatment have a FEV1 at 80.7% predicted. Our hypothesis is that association of Fluticasone Propionate and Salmeterol can be used as a treatment of the decline of FEV1 for children and so prevent BOS.
Detailed description
It's a prospective randomized double blind, multicentre, parallel-group in a 1:1 ratio, controlled and superiority trial.
The primary objective is to assess the effect of a Fluticasone Propionate associated with Salmeterol using inhalation chamber compared to placebo on respiratory function at 6 months in children over six years of age who underwent allogeneic hematopoietic stem cell transplantation with a decline of FEV1 ≥ 10% from pre transplantation.
The primary criterion will be the difference in the FEV1% predicted value from inclusion to 6 months following the initiation of treatment.
To assess the effect of a Fluticasone Propionate associated with Salmeterol using inhalation chamber compared to placebo in children over six years old underwent allogeneic hematopoietic stem cell transplantation with a decline of FEV1 ≥ 10% from pre transplantation baseline to 6 months following the initiation of treatment, and 6 months after the end of treatment, on pulmonary function, respiratory symptoms, Bronchiolitis Obliterative Syndrome (BOS) rate, oral steroid exposure and occurrence of infections;
To assess potential confounding factors associated to the 6-months inhaled treatment efficacy from baseline to 12 months, especially:
- GVHD (Graft Versus Host Disease) occurrence, severity and treatment (steroid dose exposure, calcineurins inhibitors dose, second line of GVHD treatment); To assess the safety and tolerability of the treatment at baseline, M1, M3 and M6 following the initiation of treatment
All endpoints were collected at baseline, randomization, 1, 3, 6 months during the treatment period, and then 3, 6 months after the end of the treatment.
- Endpoints relative to respiratory symptoms :
- dyspnea will be evaluate at the NYHA (New York Heart Association) scoring;
- step test (patient climb up and down step during three minutes at the frequency of 30/mn) : Respiratory rate, dyspnea Heart rate, SaO2 (oxygen saturation) during the exercise.
- Endpoints relative to pulmonary function :
- FEV1 (Forced expiratory volume) VC (Vital Capacity) , TLC (Total Lung capacity) , RV (Residual volume), FRC (Functional Residual Capacity), sRaw (specific airway resistance) DLCO (diffusing capacity of the lungs) using a similar method of measurement for static lung volumes (plethysmography)
- Number of patients presented with BOS defined as the absence of infection, and FEV1 < 75% predicted, and the FEV1/ FVC < 0.7, and the RV >120% or air trapping or bronchiectasis or small airways thickening on computed tomography
- Endpoints relative to GVHD :
- Acute and Chronic GVHD manifestations defined on NIH consensus with scoring;
- First line of treatment: cumulative dose of corticosteroid systemic exposure and cumulative dose of calcineurins inhibitors.
- Second line of GVHD treatment exposure will be assessed using the other type of treatment.
- Endpoints relative to respiratory infections :
- Number of adverse events.
- Endpoints relative to safety and tolerance:
- Adverse events during the study period such as treatment tolerance, thrush, death.
The investigators will study patients over six years of age who underwent allogeneic hematopoietic stem cell transplantation with a decline of FEV1 ≥10% from pre transplantation.
The choice of this range of age is motivated by the fact that PFTs (Pulmonary Function Test) requires a degree of cooperation that is age dependent, only children who are 6 years of age or older are able to realize reproducible PFTs.
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
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Triple blind (participant, care provider, investigator)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Seretide | Experimental | Drug: SeretideFor 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 |
| placebo | Placebo comparator | Drug: PlaceboFor 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 |
Who may qualify
- Ages
- 6 to 17 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Child
Key inclusion criteria (6 listed)
- 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).
- 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.
Key exclusion criteria (11 listed)
- 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.
- Viral respiratory infection (fever ≥ 38°C, tachypnea according to age, positive viral PCR (Polymerase Chain Reaction) pharyngeal aspiration) during the last month;
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| SeretideFor 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 | Seretide |
| PlaceboFor 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 | Drug | placebo |
Primary outcome
FEV: Forced Expiratory Volume in 1 second
Time frame: The primary criterion will be measured at months 0, 1, 3, 6, 9 and 12.
The primary criterion will be the change in the FEV1% predicted value from inclusion to 6 months following the initiation of treatment
12 secondary outcomes
Graft Versus Host Disease
Time frame: The criterion will be measured at months 0, 1, 3, 6, 9 and 12.
Dyspnea
Time frame: The criterion will be measured at months 0, 1, 3, 6, 9 and 12.
Step Test
Time frame: The criterion will be measured at months 0, 1, 3, 6, 9 and 12.
Bronchiolitis Obliterative Syndrome
Time frame: The criterion will be measured at months 0, 1, 3, 6, 9 and 12.
Adverse events
Time frame: The criterion will be measured at months 0, 1, 3, 6, 9 and 12.
Pulmonary function
Time frame: FEV1 will be measured at months 0, 1, 3, 6, 9 and 12
Pulmonary function
Time frame: VC will be measured at months 0, 1, 3, 6, 9 and 12
Pulmonary function
Time frame: TLC will be measured at months 0, 1, 3, 6, 9 and 12
Pulmonary function
Time frame: RV will be measured at months 0, 1, 3, 6, 9 and 12
Pulmonary function
Time frame: FRC will be measured at months 0, 1, 3, 6, 9 and 12
Pulmonary function
Time frame: sRaw will be measured at months 0, 1, 3, 6, 9 and 12
Pulmonary function
Time frame: DLCO will be measured at months 0, 1, 3, 6, 9 and 12
Results and safety
The study was stopped early (reason given: insufficient enrollment.). Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 16 Sep 2025.
- Individual participant dataSharing planned: Undecided
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
The record lists no contact. Use the official record to reach the sponsor.
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 3 study testing Seretide in people with Stem Cell Transplant Complications and Respiratory Disease, run by Assistance Publique - Hôpitaux de Paris at 1 site in France.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 6 inclusion and 11 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: stopped early, as of the sponsor's last update on 16 Sep 2025. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in France. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. Some participants in this study may receive a placebo. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
What does this phase mean?
Phase 3 studies compare the treatment with the current standard treatment or a placebo in a large group, to confirm how well it works and watch for side effects.
Not every study follows the same path, and some studies (observational studies, device studies) have no phase.
Are results available for this study?
The study was stopped early (reason given: insufficient enrollment.). Results are not available in the source record.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
FEV: Forced Expiratory Volume in 1 second (time frame: The primary criterion will be measured at months 0, 1, 3, 6, 9 and 12.). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 16 Sep 2025.