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Inhaler trial for Kids' lung decline after transplant ends early

NCT ID NCT04655508

Disease control Sponsor: Assistance Publique - Hôpitaux de Paris Source: ClinicalTrials.gov ↗

What the study statuses mean

This study's is highlighted.

Recruitment status, easiest to join first

Recruiting now
This trial is taking on new participants right now.
Not yet recruiting
Registered, but not yet taking participants.
By invitation only
Not open to general applications. Only people the study team invites can take part.
Paused
Paused for now. It may or may not start again.
Ongoing
Running, but no longer taking on new participants.
Completed
The trial has finished. Results may not be published yet.
Stopped early This study
Stopped early, before it reached the end. That can be for many reasons, including safety.
Cancelled
Cancelled before anyone took part.

Expanded access (not trials)

Expanded access
Not a trial. This treatment can be requested outside a study, case by case, for people who qualify.
Expanded access (paused)
Not a trial. The treatment can normally be requested outside a study, but is unavailable right now.
Expanded access (ended)
Not a trial. The treatment could once be requested outside a study, but no longer can.
Approved
The treatment has been approved, so it is available normally rather than through this programme.

When the status isn't known

Details not published
The full record has not been published yet, so there is little to show here.
Status unknown
This status has not been confirmed recently, so it may be out of date.

First seen Jun 26, 2026 · Last updated Jun 26, 2026

Summary

This phase 3 trial tested whether a combination inhaler (fluticasone and salmeterol) could improve lung function in children aged 6–17 who had a drop in breathing capacity after a stem cell transplant. The study aimed to prevent bronchiolitis obliterans, a serious lung complication. However, the trial was terminated early and enrolled only 35 participants, so firm conclusions cannot be drawn.

What this could mean

Our plain-language read of the trial. This is informational only, not medical advice or a prediction.

Active substance
fluticasone propionate and salmeterol (Seretide inhaler)
What this could lead to
If it worked, this could help prevent a serious lung condition called bronchiolitis obliterans in children after stem cell transplant.
What could go wrong
The trial was terminated early and enrolled only 35 children, so results are limited. The treatment may not improve lung function or prevent disease progression.

This is an AI summary of the original study and may miss details. Read our disclaimer.

Study facts

What this study's own registry entry says, in plain language.

Phase

Phase 3

Large-scale testing in a bigger group. Usually the last step before a treatment can be approved.

Participants

35 people

The number who actually took part.

Started

May 2021

Finished

Sep 2023

Lead sponsor

Other sponsor

The registry's catch-all category, for sponsors it does not file as a company, a government agency, or a research network.

Who can take part

This study's own entry requirements. Only the study team can say for certain whether you qualify.

Ages

6 to 17 years

Sex

Anyone

Healthy volunteers

Not accepted

This study is not open to healthy volunteers. The entry requirements below say who it is open to.

Show the full entry requirements

Copied word for word from the study's registry entry, so the wording is the study team's rather than ours.

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

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Conditions

The condition(s) this trial relates to.

Bronchiolitis Obliterans bronchiolitis obliterans syndrome disease related to hematopoietic stem cell transplant Respiration Disorders respiratory system disorder

As listed by the trial registrant

The condition terms exactly as the trial's registrant entered them.

Bronchiolitis obliterans Respiratory disease Stem cell transplant complications

Contacts and locations

Locations

  • Houdouin véronique

    Paris, 75019, France

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