Can a single inhaled dose shorten the flu?
NCT ID NCT07791251
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 Hide 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
Get updates
Get notified about this study
Sign up to get updates when this study changes or when new studies for Influenza infection are added.
By submitting, you agree to our Terms of use
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.
-
The places running it
1 site. The list below names each one and where it is.
-
The official record
ClinicalTrials.gov lists the study team's own contact details, including names and phone numbers. We don't republish those.
-
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
More trials for these conditions
Other studies related to the condition(s) this trial covers.