Can a single inhaled dose shorten the flu?

NCT ID NCT07791251

What the study statuses mean

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Recruitment status, easiest to join first

Recruiting now
This trial is taking on new participants right now.
Not yet recruiting This study
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 Results may not be published yet.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
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This status has not been confirmed recently, so it may be out of date.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 Aug 27, 2026 · Last updated Sep 01, 2026 · Updated 3 times

Summary

This trial tests whether a single inhaled dose of peramivir can help adults with uncomplicated influenza feel better faster. About 600 adults aged 18 to 64 with lab-confirmed flu and symptoms starting within 48 hours will receive either the drug or a placebo. Researchers will measure how long it takes for seven flu symptoms to ease, along with viral levels and safety. The goal is to see if this inhaled antiviral offers a practical treatment option for the flu.

What this could mean

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

Active substance
peramivir inhalation solution
What this could lead to
If it works, this could offer a faster, more convenient way to treat the flu with a single inhaled dose, potentially reducing symptom duration and viral spread.
What could go wrong
This is a Phase 3 trial, but success is not guaranteed. The treatment may not shorten symptoms more than placebo, and side effects are possible. Results will need confirmation before any new flu treatment becomes available.

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

About 600 people

The number the study aims to enrol. It can still change while the study runs.

Expected to start

Oct 2026

An estimate. Start dates often move.

Expected to finish

May 2028

An estimate. End dates often move.

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

18 to 64 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: * Participants must meet all of the following criteria: The participant or the participant's legally authorized representative understands the study and voluntarily signs the informed consent form. The participant must be 18 to 64 years of age, inclusive, at the time of informed consent. At screening, the participant meets all of the following criteria: Positive result from a rapid influenza diagnostic test (antigen test) or polymerase chain reaction (PCR) test. Axillary temperature of at least 37.3°C at screening. If an antipyretic has been taken, the axillary temperature must be at least 37.3°C at least 4 hours after administration. At least one influenza-related systemic symptom of moderate or greater severity: muscle or joint pain, fatigue, headache, or feverishness/chills. At least one influenza-related respiratory symptom of moderate or greater severity: nasal congestion, sore throat, or cough. The interval between the onset of the first influenza symptom and initiation of study treatment is no more than 48 hours. Symptom onset is defined as either: The first occurrence of a temperature of at least 37.3°C measured axillary, 37.5°C measured orally, or 38.0°C measured rectally or tympanically; or The onset of at least one systemic or respiratory symptom: nasal congestion, sore throat, cough, muscle or joint pain, fatigue, headache, or feverishness/chills. The participant is able to comply with all study procedures and complete the participant diary as required. A female participant must meet either of the following criteria: Not of childbearing potential, defined as having undergone hysterectomy or bilateral oophorectomy, having medically documented ovarian failure, or being postmenopausal. Postmenopausal status is defined as age greater than 50 years with amenorrhea for at least 12 months; or Of childbearing potential, with a negative pregnancy test at screening, and not pregnant, in the peripartum period, or breastfeeding. The participant and the participant's partner agree to remain completely abstinent or use effective contraception from screening through 3 months after completion of study treatment. Acceptable methods include: For a female participant or the female partner of a male participant, one of the following methods together with correct condom use by the male partner: an intrauterine device with an annual failure rate of less than 1%, a female barrier method consisting of a cervical cap or diaphragm with spermicide, or tubal sterilization; or Prior vasectomy of the male participant or the male partner of a female participant. Male participants agree not to donate sperm from screening through 3 months after completion of study treatment. Exclusion Criteria: * Participants meeting any of the following criteria will be excluded: * Influenza requiring hospitalization, as indicated by any of the following: * Severe influenza characterized by one or more of the following: * Persistent fever accompanied by severe cough, purulent sputum, bloody sputum, or chest pain. * Tachypnea, difficulty breathing, or cyanosis of the lips. * Altered mental status, including reduced responsiveness, somnolence, or agitation, or the occurrence of seizures. * Severe vomiting or diarrhea with evidence of dehydration. * Pneumonia. * Marked exacerbation of a pre-existing underlying disease. * Any other clinical condition requiring hospitalization. * Critical influenza characterized by one or more of the following: * Respiratory failure. * Acute necrotizing encephalopathy. * Shock. * Multiple organ dysfunction. * Any other serious clinical condition requiring intensive monitoring or care. * High risk of severe influenza, as indicated by any of the following: * A serious or poorly controlled underlying condition, such as chronic pulmonary disease, liver disease, chronic kidney disease, severe hematologic disease, chronic congestive heart failure classified as New York Heart Association functional class III or IV, neurologic or neuromuscular disease, or metabolic disease. * Clinically significant QT interval abnormality on electrocardiography, defined as a Fridericia-corrected QT interval (QTcF) greater than 450 milliseconds for males or greater than 470 milliseconds for females. * Immunodeficiency, including malignancy, organ or bone marrow transplantation, human immunodeficiency virus infection, or use of immunosuppressive therapy within the previous 3 months. * A concomitant condition requiring treatment with aspirin- or salicylate-containing medication. * Bronchitis, pneumonia, pleural effusion, or interstitial lung abnormality that is clinically suspected or confirmed by chest imaging (posteroanterior or posteroanterior and lateral chest radiography, or computed tomography) at screening and considered clinically significant by the investigator. * Previous diagnosis of chronic obstructive pulmonary disease, severe allergic rhinitis, or asthma. * Acute respiratory tract infection, otitis media, or sinusitis within 2 weeks before screening. * A concomitant infection requiring systemic anti-infective treatment, or a white blood cell count greater than 10.0 × 10\^9/L at screening. * Purulent sputum or suppurative tonsillitis at screening. * Suspected hypersensitivity to any active ingredient or excipient of the investigational product or acetaminophen. * Use of any anti-influenza antiviral medication within 7 days before screening, including but not limited to neuraminidase inhibitors, hemagglutinin inhibitors, M2 ion-channel blockers, or RNA polymerase inhibitors, such as oseltamivir, zanamivir, peramivir, umifenovir (Arbidol), favipiravir, rimantadine, amantadine, baloxavir marboxil, onradivir, suraxavir marboxil, seloxavir marboxil, or pixavir marboxil. * Receipt of an influenza vaccine within 6 months before screening. * Suspected or confirmed history of alcohol or drug abuse. * Participation in another interventional drug or medical device clinical trial within 28 days before screening. * Positive test for SARS-CoV-2 at screening. * Any other condition that, in the investigator's judgment, makes the participant unsuitable for participation in the study

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Conditions

The condition(s) this trial relates to.

As listed by the trial registrant

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

How to take part

Only the study team decides who joins. These are the ways to reach them.

  1. The places running it

    1 site. The list below names each one and where it is.

  2. The official record

    ClinicalTrials.gov lists the study team's own contact details, including names and phone numbers. We don't republish those.

    Open the record ↗

  3. A doctor treating you

    A doctor who knows your case can contact a study site on your behalf, and can tell you whether this study is worth pursuing at all.

Contacts and locations

Locations

  • China-Japan Friendship Hospital

    Beijing, Beijing Municipality, 100, China

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