AnalgesiaPhase 1AEROfenNCT06281951
Nebulized Fentanyl in Healthy Volunteers
A Phase 1 study testing Fentanyl - Inhalation by facial nebulization and Fentanyl - Nebulisation in people with Analgesia and Emergencies, run by University Hospital, Rouen at 1 site in France.
Trial summary
Pain constitutes the predominant motive prompting individuals to seek emergency medical attention, accounting for 80% of admissions to emergency departments. Presently, it is imperative to employ expeditious and efficacious analgesia-sedation methodologies, obviating the necessity for intravenous administration, while… Read more about this study
- Who is it for?
- Ages 18 to 68 yearsHealthy volunteers can take part
- Conditions the study is for
- Analgesia, Emergencies
- What is being tested?
- Fentanyl - Inhalation by facial nebulization and Fentanyl - Nebulisation
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 20 participants
- Where
- 1 siteFrance
- Study dates
- 26 Apr 2024to 1 Jun 2027
- Phase
- Phase 1
- Are there results?
- Not yet: the study is under way
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 18 to 68 years
- All sexes
- Healthy volunteers accepted
- Adult, Older adult
Who may be able to join
- Age ≥ 18 years and < 68 years
- BMI between 19 and 29 kg/m²
- Affiliation to a social security scheme
- Adult who has read and understood the information letter and signed the consent form
- Woman capable of procreating (a woman is considered capable of procreating, i.e. fertile, after menarche and until she becomes menopausal, unless she is definitely sterile ) having very effective contraception (combined hormonal contraception (containing estrogens and progestins) associated with inhibition of ovulation, progestin-only hormonal contraception associated with inhibition of ovulation, intrauterine device, hormone-releasing intrauterine system (IUS), bilateral tubal occlusion, vasectomized partner, sexual abstinence) for 1 year and a negative urine pregnancy test at inclusion and during the duration of the study.
- Woman definitely surgically sterile (hysterectomy, bilateral salpingectomy and bilateral oophorectomy). Postmenopausal woman: The postmenopausal state is defined by the absence of periods for 12 months without any other medical cause.
Who cannot join
- Weight < 50 kg
- Taking long-term painkillers or narcotics
- Sharp pain
- Stable chronic pain (>3 months, with or without long-term treatment)
- Known chronic pathology stabilized or decompensated (hypertension, renal, cardiac, hepatic insufficiency, etc.)
- Stable or decompensated chronic respiratory pathology
Show all 27Show fewer
- Chronic neuropsychiatric pathology likely to modify the pain threshold
- Long-term treatment with an action on the nervous system such as respiratory depression: benzodiazepines, neuroleptics, agonist/antagonist of the opioid system
- Treatment or toxicant whose association is not recommended with fentanyl (alcohol, cannabis, etc.)
- Central nervous system modulator treatment
- Pathologies blocking the pupillary response: Claude-Bernard-Horner syndrome, Adie syndrome, Argyll-Robertson pupil, senile miosis, dysautonomic neuropathy (advanced diabetes, systemic amyloidosis), cataract
- Treatment responsible for fluctuation in PUAL measurements: parasympathetic modulators (clonidine, dexmedetomidine, droperidol, metoclopramide)
- No-indication to FENTANYL PIRAMAL 100µg/2mL, solution for injection in ampoule
- No-indication to PROAMP SODIUM CHLORIDE 0.9%, solution for injection
- Ongoing treatment with nasal vasoconstrictors
- Peripheral oxygen saturation less than 93%
- Alteration of cognitive state: comprehension disorder, language disorder, memory disorder, confusion
- Deaf or mute patient
- Usual heart rate such as HR< 40 bpm and/or hypotension with systolic blood pressure SBP< 100 mm Hg
- Atrioventricular block on ECG
- History of cataract surgery
- Confirmed or suspected covid 19 / active flu infection less than 15 days old
- Allergy to plastic
- Pregnant or parturient or breastfeeding woman or proven absence of contraception
- Person deprived of liberty by an administrative or judicial decision or person placed under judicial protection/under guardianship or curatorship
- Person participating in research participating in another trial / having participated in another trial within 2 weeks
- History of illness or psychological or sensory abnormality likely to prevent the subject from fully understanding the conditions required for participation in the protocol or preventing them from giving informed consent
Trial locations and contacts
1 site in 1 country. Contact the study team or a site near you to ask about taking part.
France1 site, 1 recruiting
- Recruiting
University Hospital, Rouen
Rouen, France, 76031
About this study
Official title: Nebulized Fentanyl in Healthy Volunteers : Comparison of Facial Versus Intranasal Aerosol Administration by Pharmacometric Modeling
Pain constitutes the predominant motive prompting individuals to seek emergency medical attention, accounting for 80% of admissions to emergency departments. Presently, it is imperative to employ expeditious and efficacious analgesia-sedation methodologies, obviating the necessity for intravenous administration, while ensuring the secure delivery of pharmaceutical agents. The objective of this study is to assess the feasibility and comfort of nebulized intranasal or facial aerosol administration of Fentanyl through the implementation of a pharmacokinetic/pharmacodynamic (PK/PD) study
Read the detailed description
The prompt identification, assessment, and management of pain are imperative in the context of emergency medicine, necessitating rapid and effective interventions. In the realm of pain management, the investigators deemed it crucial to concentrate on non-invasive approaches, such as opioid nebulization, while ensuring the safe and controlled delivery of the pharmaceutical agent. Intranasal analgesia emerges as a particularly suitable option due to its non-invasiveness, painlessness, ease of administration, cost-effectiveness, and lack of stringent aseptic requirements, making it especially convenient for patients in pain. However, the administration of medications in nasal drop form lacks precise control over the quantity of the active drug, potentially resulting in a hepatic first-pass effect and inactivation before systemic absorption, particularly with large quantities and subsequent swallowing.
Facial nebulization of opiates presents an alternative method for analgesic administration. Traditional pneumatic nebulizers, readily available in emergency settings, are economical aerosol generators. However, they pose challenges related to the reproducibility of administration and the potential for infectious contamination due to the dispersion of nebulized particles in the air between inhalations. Palladium vibrating screen aerosols, designed to produce optimal particle sizes for drug delivery to the lungs, show promise due to their more occlusive system, offering enhanced performance. Yet, these devices lack evaluation in the realm of opioids, particularly in terms of objective nociception measurement.
Pupillometry, specifically PUAL (pupillary unrest in ambient light), stands out as an objective technique capable of quantifying nociception or opioid impregnation. PUAL monitors variations in pupil diameter over time, and previous studies have indicated an inverse correlation between the analgesic response to opioid treatment and PUAL amplitude, suggesting it could serve as a marker of central opioid impregnation. However, scientific evidence in alert emergency medicine patients remains lacking. Additionally, standard clinical pharmacodynamic evaluation criteria for opioids are not well-suited to the variability of therapeutic responses in emergency situations.
Pharmacometric models offer a quantitative approach to understanding relationships between administered drugs, clinico-biological covariates, exposure, and responses (biomarkers, efficacy, safety) as they evolve over time in individual patients and populations. This pilot study aims to evaluate the feasibility, safety, effects, and robustness of nebulized fentanyl administration via facial aerosol or intranasal routes in a population of adult healthy volunteers, employing equivalent analgesic doses. PUAL will serve as an objective pharmacodynamic marker of central opioid impregnation, coupled with pharmacokinetic modeling of nebulized fentanyl administered via facial aerosol or intranasally. The development of a pharmacometric model using a population-based approach aims to establish fentanyl titration strategies based on the objective of reducing PUAL while ensuring central opioid impregnation.
- Conditions
- Analgesia, Emergencies
- Being tested
- Fentanyl - Inhalation by facial nebulization, Fentanyl - Nebulisation
- Keywords
- Severe acute pain, Pharmacometry, Fentanyl, Emergency medicine, Pupillometry (PUAL), Non-invasive analgesia (Intranasal, Facial aerosol)
- Medical subject headings
- Agnosia, Emergencies, Acute Pain
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Fentanyl - Inhalation by facial nebulizationDrug
Also called AEROGEN Nebulizer
3 administrations based on a weight-dependent threshold (40 µg per administration for a weight < 70kg and 50 µg per administration for a weight ≥ 70kg).
Fentanyl - NebulisationDrug
Also called Teleflex intranasal device
3 administrations based on a weight-dependent threshold (20 µg/administration and for a weight < 70kg and 30 µg/administration for a weight ≥ 70kg). The dose of each bolus will be distributed at equivalent volume in both nasal pits
| Study group | Role | What they receive |
|---|---|---|
| Facial Nebulization | Experimental | Fentanyl's facial nebulization in healthy volunteers. Receives: Drug: Fentanyl - Inhalation by facial nebulization |
| Intranasal | Experimental | Fentanyl's intranasal inhalation in healthy volunteers. Receives: Drug: Fentanyl - Nebulisation |
What is being measured
The primary outcome is the main question the study is designed to answer.
Measurement of [F] bioavailability via facial nebulization and intranasal inhalation.
Bioavailability [F] will be expressed as percent mean +/- standard deviation for each group.
Measured: 6 hours
Secondary outcomes (7)
Measurement of maximum decrease in PUAL (pupillary under ambient light) between facial nebulization and intranasal inhalation.
Maximum decrease in PUAL will be expressed as percent of baseline value +/- standard deviation for each group.
Measured: 6 hours
Measurement of the difference between observed and predicted PUAL values by a PK/PD model.
The difference between observed and predicted values will be expressed as RMSE in percent.
Measured: 6 hours
Time required to achieve >30% decrease in PUAL compared to baseline.
Time required for >30% decrease in PUAL will be expressed in minutes +/- standard deviation for each group.
Measured: 6 hours
To assess respiratory tolerance
Using the respiratory rate and pulse oxygen saturation for respiratory tolerance
Measured: 8 hours
To assess neurological tolerance
Using the Ramsay score for neurological tolerance
Measured: 8 hours
To assess hemodynamic tolerance
Using the heart rate and blood pressure for hemodynamic tolerance
Measured: 8 hours
Measurement of administration comfort score using a visual analog scale ranging from 0 (maximum discomfort) to 10 (optimal comfort) (unitless).
Administration comfort score will be expressed as mean +/- standard deviation for both groups.
Measured: 6 hours
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted28 Feb 2024
- Study start26 Apr 2024
- Primary completion1 Jun 2027 (estimated)
- Study completion1 Jun 2027 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (8)Papers the sponsor has linked to this study.
- Other trials for AnalgesiaStudies of the same condition, open and under way.
- More trials run by University Hospital, RouenThe 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 1
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Crossover
- Masking
- None (open label)
- Enrolment
- 20 participants (estimated)
Sponsor and investigators
- Lead sponsor
- University Hospital, Rouen
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT06281951
- Sponsor's protocol ID
- 2022/0271/HP
- Acronym
- AEROfen
- Status last verified
- May 2026
- First submitted
- 5 Feb 2024
- Last updated
- 11 May 2026
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Publications
Barksdale AN, Hackman JL, Williams K, Gratton MC. ED triage pain protocol reduces time to receiving analgesics in patients with painful conditions. Am J Emerg Med. 2016 Dec;34(12):2362-2366. doi: 10.1016/j.ajem.2016.08.051. Epub 2016 Aug 27.
PubMed 27663766Gueant S, Taleb A, Borel-Kuhner J, Cauterman M, Raphael M, Nathan G, Ricard-Hibon A. Quality of pain management in the emergency department: results of a multicentre prospective study. Eur J Anaesthesiol. 2011 Feb;28(2):97-105. doi: 10.1097/EJA.0b013e3283418fb0.
PubMed 21119516Lvovschi V, Aubrun F, Bonnet P, Bouchara A, Bendahou M, Humbert B, Hausfater P, Riou B. Intravenous morphine titration to treat severe pain in the ED. Am J Emerg Med. 2008 Jul;26(6):676-82. doi: 10.1016/j.ajem.2007.10.025.
PubMed 18606320Galinski M, Robledo JB, Tellier E, Catoire P, De La Riviere C, Lvovschi V, Gil-Jardine C. Are Patients with Chronic Pain Less Satisfied with Their ED Management Than Non-Chronic Pain Patients? Am J Emerg Med. 2022 Jun;56:7-9. doi: 10.1016/j.ajem.2022.03.032. Epub 2022 Mar 19. No abstract available.
PubMed 35338897Mudd S. Intranasal fentanyl for pain management in children: a systematic review of the literature. J Pediatr Health Care. 2011 Sep-Oct;25(5):316-22. doi: 10.1016/j.pedhc.2010.04.011. Epub 2010 Jun 17.
PubMed 21867860Adelgais KM, Brent A, Wathen J, Tong S, Massanari D, Deakyne S, Sills MR. Intranasal Fentanyl and Quality of Pediatric Acute Care. J Emerg Med. 2017 Nov;53(5):607-615.e2. doi: 10.1016/j.jemermed.2017.05.027. Epub 2017 Sep 28.
PubMed 28967529Hudson RJ, Thomson IR, Henderson BT, Singh K, Harding G, Peterson DJ. Validation of fentanyl pharmacokinetics in patients undergoing coronary artery bypass grafting. Can J Anaesth. 2002 Apr;49(4):388-92. doi: 10.1007/BF03017328.
PubMed 11927479Follet C, Dumont A, Roussel M, Gillibert A, Boedard C, Quillard M, Ruault S, Vallin F, Donnadieu N, Nunes Ferreira D, Pereira T, Joly LM, Lvovschi V, Duflot T. AEROfen: protocol for a phase I, open-label, randomised crossover study evaluating the efficiency of nebulised fentanyl in healthy volunteers - comparing facial versus intranasal administration via pharmacometric modelling. BMJ Open. 2025 Jul 3;15(7):e091125. doi: 10.1136/bmjopen-2024-091125.
PubMed 40615143
Study at a glance
From the registry record, last updated by the sponsor on 11 May 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Nebulized Fentanyl in Healthy Volunteers : Comparison of Facial Versus Intranasal Aerosol Administration by Pharmacometric Modeling
- ClinicalTrials.gov ID
- NCT06281951
- Acronym / sponsor ID
- AEROfen / 2022/0271/HP
- Conditions
- Analgesia, Emergencies
- Keywords
- Severe acute pain, Pharmacometry, Fentanyl, Emergency medicine, Pupillometry (PUAL), Non-invasive analgesia (Intranasal, Facial aerosol)
- Phase
- Phase 1
- Study type
- Interventional
- Recruitment status
- Recruiting
- Enrolment
- 20 participants (estimated)
- Lead sponsor
- University Hospital, RouenUniversity, hospital or other
- Study start
- 26 Apr 2024 (actual)
- Primary completion
- 1 Jun 2027 (estimated)
- Study completion
- 1 Jun 2027 (estimated)
- First posted
- 28 Feb 2024 (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.
Pain constitutes the predominant motive prompting individuals to seek emergency medical attention, accounting for 80% of admissions to emergency departments. Presently, it is imperative to employ expeditious and efficacious analgesia-sedation methodologies, obviating the necessity for intravenous administration, while ensuring the secure delivery of pharmaceutical agents. The objective of this study is to assess the feasibility and comfort of nebulized intranasal or facial aerosol administration of Fentanyl through the implementation of a pharmacokinetic/pharmacodynamic (PK/PD) study
Detailed description
The prompt identification, assessment, and management of pain are imperative in the context of emergency medicine, necessitating rapid and effective interventions. In the realm of pain management, the investigators deemed it crucial to concentrate on non-invasive approaches, such as opioid nebulization, while ensuring the safe and controlled delivery of the pharmaceutical agent. Intranasal analgesia emerges as a particularly suitable option due to its non-invasiveness, painlessness, ease of administration, cost-effectiveness, and lack of stringent aseptic requirements, making it especially convenient for patients in pain. However, the administration of medications in nasal drop form lacks precise control over the quantity of the active drug, potentially resulting in a hepatic first-pass effect and inactivation before systemic absorption, particularly with large quantities and subsequent swallowing.
Facial nebulization of opiates presents an alternative method for analgesic administration. Traditional pneumatic nebulizers, readily available in emergency settings, are economical aerosol generators. However, they pose challenges related to the reproducibility of administration and the potential for infectious contamination due to the dispersion of nebulized particles in the air between inhalations. Palladium vibrating screen aerosols, designed to produce optimal particle sizes for drug delivery to the lungs, show promise due to their more occlusive system, offering enhanced performance. Yet, these devices lack evaluation in the realm of opioids, particularly in terms of objective nociception measurement.
Pupillometry, specifically PUAL (pupillary unrest in ambient light), stands out as an objective technique capable of quantifying nociception or opioid impregnation. PUAL monitors variations in pupil diameter over time, and previous studies have indicated an inverse correlation between the analgesic response to opioid treatment and PUAL amplitude, suggesting it could serve as a marker of central opioid impregnation. However, scientific evidence in alert emergency medicine patients remains lacking. Additionally, standard clinical pharmacodynamic evaluation criteria for opioids are not well-suited to the variability of therapeutic responses in emergency situations.
Pharmacometric models offer a quantitative approach to understanding relationships between administered drugs, clinico-biological covariates, exposure, and responses (biomarkers, efficacy, safety) as they evolve over time in individual patients and populations. This pilot study aims to evaluate the feasibility, safety, effects, and robustness of nebulized fentanyl administration via facial aerosol or intranasal routes in a population of adult healthy volunteers, employing equivalent analgesic doses. PUAL will serve as an objective pharmacodynamic marker of central opioid impregnation, coupled with pharmacokinetic modeling of nebulized fentanyl administered via facial aerosol or intranasally. The development of a pharmacometric model using a population-based approach aims to establish fentanyl titration strategies based on the objective of reducing PUAL while ensuring central opioid impregnation.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Crossover
- Masking
- None (open label)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Facial Nebulization | Experimental | Drug: Fentanyl - Inhalation by facial nebulizationFentanyl's facial nebulization in healthy volunteers. |
| Intranasal | Experimental | Drug: Fentanyl - NebulisationFentanyl's intranasal inhalation in healthy volunteers. |
Who may qualify
- Ages
- 18 to 68 years
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (6 listed)
- Age ≥ 18 years and < 68 years
- BMI between 19 and 29 kg/m²
- Affiliation to a social security scheme
- Adult who has read and understood the information letter and signed the consent form
- Woman capable of procreating (a woman is considered capable of procreating, i.e. fertile, after menarche and until she becomes menopausal, unless she is definitely sterile ) having very effective contraception (combined hormonal contraception (containing estrogens and progestins) associated with inhibition of ovulation, progestin-only hormonal contraception associated with inhibition of ovulation, intrauterine device, hormone-releasing intrauterine system (IUS), bilateral tubal occlusion, vasectomized partner, sexual abstinence) for 1 year and a negative urine pregnancy test at inclusion and during the duration of the study.
Key exclusion criteria (27 listed)
- Weight < 50 kg
- Taking long-term painkillers or narcotics
- Sharp pain
- Stable chronic pain (>3 months, with or without long-term treatment)
- Known chronic pathology stabilized or decompensated (hypertension, renal, cardiac, hepatic insufficiency, etc.)
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 |
|---|---|---|
| Fentanyl - Inhalation by facial nebulizationAlso: AEROGEN Nebulizer3 administrations based on a weight-dependent threshold (40 µg per administration for a weight < 70kg and 50 µg per administration for a weight ≥ 70kg). | Drug | Facial Nebulization |
| Fentanyl - NebulisationAlso: Teleflex intranasal device3 administrations based on a weight-dependent threshold (20 µg/administration and for a weight < 70kg and 30 µg/administration for a weight ≥ 70kg). The dose of each bolus will be distributed at equivalent volume in both nasal pits | Drug | Intranasal |
Primary outcome
Measurement of [F] bioavailability via facial nebulization and intranasal inhalation.
Time frame: 6 hours
Bioavailability [F] will be expressed as percent mean +/- standard deviation for each group.
7 secondary outcomes
Measurement of maximum decrease in PUAL (pupillary under ambient light) between facial nebulization and intranasal inhalation.
Time frame: 6 hours
Measurement of the difference between observed and predicted PUAL values by a PK/PD model.
Time frame: 6 hours
Time required to achieve >30% decrease in PUAL compared to baseline.
Time frame: 6 hours
To assess respiratory tolerance
Time frame: 8 hours
To assess neurological tolerance
Time frame: 8 hours
To assess hemodynamic tolerance
Time frame: 8 hours
Measurement of administration comfort score using a visual analog scale ranging from 0 (maximum discomfort) to 10 (optimal comfort) (unitless).
Time frame: 6 hours
Results and safety
This study is still under way. Results are not available in the source record yet.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 11 May 2026.
- Background: PubMed 27663766Barksdale AN, Hackman JL, Williams K, Gratton MC. ED triage pain protocol reduces time to receiving analgesics in patients with painful conditions. Am J Emerg Med. 2016 Dec;34(12):2362-2366. doi: 10.1016/j.ajem.2016.08.051. Epub 2016 Aug 27.
- Background: PubMed 21119516Gueant S, Taleb A, Borel-Kuhner J, Cauterman M, Raphael M, Nathan G, Ricard-Hibon A. Quality of pain management in the emergency department: results of a multicentre prospective study. Eur J Anaesthesiol. 2011 Feb;28(2):97-105. doi: 10.1097/EJA.0b013e3283418fb0.
- Background: PubMed 18606320Lvovschi V, Aubrun F, Bonnet P, Bouchara A, Bendahou M, Humbert B, Hausfater P, Riou B. Intravenous morphine titration to treat severe pain in the ED. Am J Emerg Med. 2008 Jul;26(6):676-82. doi: 10.1016/j.ajem.2007.10.025.
- Background: PubMed 35338897Galinski M, Robledo JB, Tellier E, Catoire P, De La Riviere C, Lvovschi V, Gil-Jardine C. Are Patients with Chronic Pain Less Satisfied with Their ED Management Than Non-Chronic Pain Patients? Am J Emerg Med. 2022 Jun;56:7-9. doi: 10.1016/j.ajem.2022.03.032. Epub 2022 Mar 19. No abstract available.
- Background: PubMed 21867860Mudd S. Intranasal fentanyl for pain management in children: a systematic review of the literature. J Pediatr Health Care. 2011 Sep-Oct;25(5):316-22. doi: 10.1016/j.pedhc.2010.04.011. Epub 2010 Jun 17.
- Background: PubMed 28967529Adelgais KM, Brent A, Wathen J, Tong S, Massanari D, Deakyne S, Sills MR. Intranasal Fentanyl and Quality of Pediatric Acute Care. J Emerg Med. 2017 Nov;53(5):607-615.e2. doi: 10.1016/j.jemermed.2017.05.027. Epub 2017 Sep 28.
- Background: PubMed 11927479Hudson RJ, Thomson IR, Henderson BT, Singh K, Harding G, Peterson DJ. Validation of fentanyl pharmacokinetics in patients undergoing coronary artery bypass grafting. Can J Anaesth. 2002 Apr;49(4):388-92. doi: 10.1007/BF03017328.
- Derived from this study: PubMed 40615143Follet C, Dumont A, Roussel M, Gillibert A, Boedard C, Quillard M, Ruault S, Vallin F, Donnadieu N, Nunes Ferreira D, Pereira T, Joly LM, Lvovschi V, Duflot T. AEROfen: protocol for a phase I, open-label, randomised crossover study evaluating the efficiency of nebulised fentanyl in healthy volunteers - comparing facial versus intranasal administration via pharmacometric modelling. BMJ Open. 2025 Jul 3;15(7):e091125. doi: 10.1136/bmjopen-2024-091125.
- Individual participant dataSharing planned: No
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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.
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 1 study testing Fentanyl - Inhalation by facial nebulization and Fentanyl - Nebulisation in people with Analgesia and Emergencies, run by University Hospital, Rouen 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 27 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: looking for participants now, as of the sponsor's last update on 11 May 2026. 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. 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 1 studies test a treatment in a small group of people for the first time or in a new way, mainly to check safety and find the right dose.
Not every study follows the same path, and some studies (observational studies, device studies) have no phase.
Are results available for this study?
This study is still under way. Results are not available in the source record yet.
How can a doctor refer a patient or contact the research team?
Contact Cassandre Follet (+33232888990 ext. 60451, cassandre.follet@chu-rouen.fr), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Measurement of [F] bioavailability via facial nebulization and intranasal inhalation. (time frame: 6 hours). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT06281951, which also lists 8 linked publications.
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 11 May 2026.