Actifed

Catarrh, Urticaria, Angioedema + 10 more
Treatment
14 FDA approvals
20 Active Studies for Actifed

What is Actifed

TriprolidineThe Generic name of this drug
Treatment SummaryPseudoephedrine is a drug related to ephedrine, which is found in the ephedra plant. It has been used for centuries in Eastern medicine and first researched in the West in 1889. In 1927, it was discovered that pseudoephedrine has a decongestant effect, which is a weaker effect than that of ephedrine on the nervous system.
Silafedis the brand name
image of different drug pills on a surface
Actifed Overview & Background
Brand Name
Generic Name
First FDA Approval
How many FDA approvals?
Silafed
Triprolidine
1988
3

Approved as Treatment by the FDA

Triprolidine, also called Silafed, is approved by the FDA for 14 uses like Vasomotor Rhinitis and Seasonal Allergic Rhinitis .
Vasomotor Rhinitis
Seasonal Allergic Rhinitis
mild Angioedema
mild urticaria
Perennial Allergic Rhinitis (PAR)
Hay Fever
Catarrh
Used to treat Common Cold in combination with Codeine
upper respiratory discomfort
Used to treat upper respiratory discomfort in combination with Codeine
Rhinitis, Allergic
Rhinitis, Vasomotor
Urticaria
Allergic Conjunctivitis (AC)
Angioedema
Hypersensitivity

Effectiveness

How Actifed Affects PatientsPseudoephedrine acts as a decongestant by narrowing the blood vessels in the nose and sinuses. Its effects can last for a short time unless it is taken as an extended release product. Taking this drug may cause side effects related to stimulation of the central nervous system, so people should be aware of this risk.
How Actifed works in the bodyPseudoephedrine works by activating certain receptors in the body and by inhibiting certain transporters. This triggers an increase in blood pressure, heart rate and muscle tension. It also affects the body's inflammatory response, making it useful in treating conditions involving inflammation. Pseudoephedrine also helps relieve congestion and treat priapism.

When to interrupt dosage

The suggested measure of Actifed is contingent upon the recognized condition, including Upper Respiratory Tract Infection, Airway secretion clearance therapy and Coughing. The dosage amount is contingent upon the delivery technique (e.g. Tablet, extended release or Oral), which is enumerated in the table beneath.
Condition
Dosage
Administration
Hay Fever
2.5 mg, , 2.5 mg/mL, 0.938 mg/mL, 1.25 mg/mL, 0.625 mg/mL, 1.25 mg, 4.0 mg, 0.313 mg/mL, 30.0 mg/mL, 0.025 mg/mg, 0.66 mg, 0.25 mg/mL, 12.5 mg/mL, 0.125 mg/mL, 2.0 mg/mL
, Oral, Tablet, coated - Oral, Tablet, coated, Tablet, film coated, Tablet, film coated - Oral, Syrup, Syrup - Oral, Liquid, Liquid - Oral, Tablet, Tablet - Oral, Tablet, chewable, Tablet, chewable - Oral, Solution - Oral, Capsule - Oral, Solution, Suspension - Oral, Capsule
Urticaria
2.5 mg, , 2.5 mg/mL, 0.938 mg/mL, 1.25 mg/mL, 0.625 mg/mL, 1.25 mg, 4.0 mg, 0.313 mg/mL, 30.0 mg/mL, 0.025 mg/mg, 0.66 mg, 0.25 mg/mL, 12.5 mg/mL, 0.125 mg/mL, 2.0 mg/mL
, Oral, Tablet, coated - Oral, Tablet, coated, Tablet, film coated, Tablet, film coated - Oral, Syrup, Syrup - Oral, Liquid, Liquid - Oral, Tablet, Tablet - Oral, Tablet, chewable, Tablet, chewable - Oral, Solution - Oral, Capsule - Oral, Solution, Suspension - Oral, Capsule
Influenza
2.5 mg, , 2.5 mg/mL, 0.938 mg/mL, 1.25 mg/mL, 0.625 mg/mL, 1.25 mg, 4.0 mg, 0.313 mg/mL, 30.0 mg/mL, 0.025 mg/mg, 0.66 mg, 0.25 mg/mL, 12.5 mg/mL, 0.125 mg/mL, 2.0 mg/mL
, Oral, Tablet, coated - Oral, Tablet, coated, Tablet, film coated, Tablet, film coated - Oral, Syrup, Syrup - Oral, Liquid, Liquid - Oral, Tablet, Tablet - Oral, Tablet, chewable, Tablet, chewable - Oral, Solution - Oral, Capsule - Oral, Solution, Suspension - Oral, Capsule
Rhinitis, Vasomotor
2.5 mg, , 2.5 mg/mL, 0.938 mg/mL, 1.25 mg/mL, 0.625 mg/mL, 1.25 mg, 4.0 mg, 0.313 mg/mL, 30.0 mg/mL, 0.025 mg/mg, 0.66 mg, 0.25 mg/mL, 12.5 mg/mL, 0.125 mg/mL, 2.0 mg/mL
, Oral, Tablet, coated - Oral, Tablet, coated, Tablet, film coated, Tablet, film coated - Oral, Syrup, Syrup - Oral, Liquid, Liquid - Oral, Tablet, Tablet - Oral, Tablet, chewable, Tablet, chewable - Oral, Solution - Oral, Capsule - Oral, Solution, Suspension - Oral, Capsule
Nasal Congestion
2.5 mg, , 2.5 mg/mL, 0.938 mg/mL, 1.25 mg/mL, 0.625 mg/mL, 1.25 mg, 4.0 mg, 0.313 mg/mL, 30.0 mg/mL, 0.025 mg/mg, 0.66 mg, 0.25 mg/mL, 12.5 mg/mL, 0.125 mg/mL, 2.0 mg/mL
, Oral, Tablet, coated - Oral, Tablet, coated, Tablet, film coated, Tablet, film coated - Oral, Syrup, Syrup - Oral, Liquid, Liquid - Oral, Tablet, Tablet - Oral, Tablet, chewable, Tablet, chewable - Oral, Solution - Oral, Capsule - Oral, Solution, Suspension - Oral, Capsule
Hypersensitivity
2.5 mg, , 2.5 mg/mL, 0.938 mg/mL, 1.25 mg/mL, 0.625 mg/mL, 1.25 mg, 4.0 mg, 0.313 mg/mL, 30.0 mg/mL, 0.025 mg/mg, 0.66 mg, 0.25 mg/mL, 12.5 mg/mL, 0.125 mg/mL, 2.0 mg/mL
, Oral, Tablet, coated - Oral, Tablet, coated, Tablet, film coated, Tablet, film coated - Oral, Syrup, Syrup - Oral, Liquid, Liquid - Oral, Tablet, Tablet - Oral, Tablet, chewable, Tablet, chewable - Oral, Solution - Oral, Capsule - Oral, Solution, Suspension - Oral, Capsule
Catarrh
2.5 mg, , 2.5 mg/mL, 0.938 mg/mL, 1.25 mg/mL, 0.625 mg/mL, 1.25 mg, 4.0 mg, 0.313 mg/mL, 30.0 mg/mL, 0.025 mg/mg, 0.66 mg, 0.25 mg/mL, 12.5 mg/mL, 0.125 mg/mL, 2.0 mg/mL
, Oral, Tablet, coated - Oral, Tablet, coated, Tablet, film coated, Tablet, film coated - Oral, Syrup, Syrup - Oral, Liquid, Liquid - Oral, Tablet, Tablet - Oral, Tablet, chewable, Tablet, chewable - Oral, Solution - Oral, Capsule - Oral, Solution, Suspension - Oral, Capsule
Angioedema
2.5 mg, , 2.5 mg/mL, 0.938 mg/mL, 1.25 mg/mL, 0.625 mg/mL, 1.25 mg, 4.0 mg, 0.313 mg/mL, 30.0 mg/mL, 0.025 mg/mg, 0.66 mg, 0.25 mg/mL, 12.5 mg/mL, 0.125 mg/mL, 2.0 mg/mL
, Oral, Tablet, coated - Oral, Tablet, coated, Tablet, film coated, Tablet, film coated - Oral, Syrup, Syrup - Oral, Liquid, Liquid - Oral, Tablet, Tablet - Oral, Tablet, chewable, Tablet, chewable - Oral, Solution - Oral, Capsule - Oral, Solution, Suspension - Oral, Capsule
Upper respiratory tract signs and symptoms
2.5 mg, , 2.5 mg/mL, 0.938 mg/mL, 1.25 mg/mL, 0.625 mg/mL, 1.25 mg, 4.0 mg, 0.313 mg/mL, 30.0 mg/mL, 0.025 mg/mg, 0.66 mg, 0.25 mg/mL, 12.5 mg/mL, 0.125 mg/mL, 2.0 mg/mL
, Oral, Tablet, coated - Oral, Tablet, coated, Tablet, film coated, Tablet, film coated - Oral, Syrup, Syrup - Oral, Liquid, Liquid - Oral, Tablet, Tablet - Oral, Tablet, chewable, Tablet, chewable - Oral, Solution - Oral, Capsule - Oral, Solution, Suspension - Oral, Capsule
Rhinitis, Allergic
2.5 mg, , 2.5 mg/mL, 0.938 mg/mL, 1.25 mg/mL, 0.625 mg/mL, 1.25 mg, 4.0 mg, 0.313 mg/mL, 30.0 mg/mL, 0.025 mg/mg, 0.66 mg, 0.25 mg/mL, 12.5 mg/mL, 0.125 mg/mL, 2.0 mg/mL
, Oral, Tablet, coated - Oral, Tablet, coated, Tablet, film coated, Tablet, film coated - Oral, Syrup, Syrup - Oral, Liquid, Liquid - Oral, Tablet, Tablet - Oral, Tablet, chewable, Tablet, chewable - Oral, Solution - Oral, Capsule - Oral, Solution, Suspension - Oral, Capsule
Allergic Conjunctivitis (AC)
2.5 mg, , 2.5 mg/mL, 0.938 mg/mL, 1.25 mg/mL, 0.625 mg/mL, 1.25 mg, 4.0 mg, 0.313 mg/mL, 30.0 mg/mL, 0.025 mg/mg, 0.66 mg, 0.25 mg/mL, 12.5 mg/mL, 0.125 mg/mL, 2.0 mg/mL
, Oral, Tablet, coated - Oral, Tablet, coated, Tablet, film coated, Tablet, film coated - Oral, Syrup, Syrup - Oral, Liquid, Liquid - Oral, Tablet, Tablet - Oral, Tablet, chewable, Tablet, chewable - Oral, Solution - Oral, Capsule - Oral, Solution, Suspension - Oral, Capsule
Allergy to Tree Pollen
2.5 mg, , 2.5 mg/mL, 0.938 mg/mL, 1.25 mg/mL, 0.625 mg/mL, 1.25 mg, 4.0 mg, 0.313 mg/mL, 30.0 mg/mL, 0.025 mg/mg, 0.66 mg, 0.25 mg/mL, 12.5 mg/mL, 0.125 mg/mL, 2.0 mg/mL
, Oral, Tablet, coated - Oral, Tablet, coated, Tablet, film coated, Tablet, film coated - Oral, Syrup, Syrup - Oral, Liquid, Liquid - Oral, Tablet, Tablet - Oral, Tablet, chewable, Tablet, chewable - Oral, Solution - Oral, Capsule - Oral, Solution, Suspension - Oral, Capsule
upper respiratory discomfort
2.5 mg, , 2.5 mg/mL, 0.938 mg/mL, 1.25 mg/mL, 0.625 mg/mL, 1.25 mg, 4.0 mg, 0.313 mg/mL, 30.0 mg/mL, 0.025 mg/mg, 0.66 mg, 0.25 mg/mL, 12.5 mg/mL, 0.125 mg/mL, 2.0 mg/mL
, Oral, Tablet, coated - Oral, Tablet, coated, Tablet, film coated, Tablet, film coated - Oral, Syrup, Syrup - Oral, Liquid, Liquid - Oral, Tablet, Tablet - Oral, Tablet, chewable, Tablet, chewable - Oral, Solution - Oral, Capsule - Oral, Solution, Suspension - Oral, Capsule

Warnings

Actifed has five counter-indications, and its use should be avoided when encountering any of the circumstances outlined in the following table.There are 20 known major drug interactions with Actifed.
Common Actifed Drug Interactions
Drug Name
Risk Level
Description
Azelastine
Major
Triprolidine may increase the central nervous system depressant (CNS depressant) activities of Azelastine.
Ethanol
Major
Triprolidine may increase the central nervous system depressant (CNS depressant) activities of Ethanol.
Hydroxyzine
Major
The risk or severity of QTc prolongation can be increased when Triprolidine is combined with Hydroxyzine.
Mobocertinib
Major
The risk or severity of QTc prolongation can be increased when Triprolidine is combined with Mobocertinib.
Oliceridine
Major
The risk or severity of hypotension, sedation, death, somnolence, and respiratory depression can be increased when Triprolidine is combined with Oliceridine.
Actifed Toxicity & Overdose RiskThe lowest toxic dose of pseudoephedrine in rats has been found to be 2206mg/kg and 726mg/kg in mice. Symptoms of overdose include dizziness, headaches, nausea, vomiting, increased heart rate, chest pain, difficulty urinating, muscle weakness, anxiety, restlessness, insomnia, mental confusion, irregular heartbeat, fainting, seizures, loss of consciousness, and trouble breathing. Treatments for pseudoephedrine overdose include removing any unabsorbed drug and providing supportive care.
image of a doctor in a lab doing drug, clinical research

Actifed Novel Uses: Which Conditions Have a Clinical Trial Featuring Actifed?

270 active trials are underway to evaluate the potential of Actifed for alleviating Allergies, Migraines and Ocular ailments.
Condition
Clinical Trials
Trial Phases
Urticaria
0 Actively Recruiting
Angioedema
0 Actively Recruiting
Influenza
29 Actively Recruiting
Not Applicable, Phase 4, Phase 2, Phase 1, Phase 3
Allergic Conjunctivitis (AC)
1 Actively Recruiting
Phase 2
Hay Fever
0 Actively Recruiting
Nasal Congestion
0 Actively Recruiting
Catarrh
0 Actively Recruiting
upper respiratory discomfort
0 Actively Recruiting
Rhinitis, Vasomotor
0 Actively Recruiting
Rhinitis, Allergic
0 Actively Recruiting
Upper respiratory tract signs and symptoms
0 Actively Recruiting
Hypersensitivity
1 Actively Recruiting
Phase 4
Allergy to Tree Pollen
0 Actively Recruiting

Actifed Reviews: What are patients saying about Actifed?

5Patient Review
7/15/2012
Actifed for Inflammation of the Nose due to an Allergy
Walact is an effective sinusitis medication that contains the active ingredient triplodene. You can find it at Walgreens.
5Patient Review
10/4/2014
Actifed for Runny Nose
This treatment is effective and I would recommend it to others.
5Patient Review
2/1/2019
Actifed for Cold Symptoms
This drug was recommended to me by a pharmacist when I had flu-like symptoms while traveling in France. It worked quickly and effectively.
3.7Patient Review
2/1/2008
Actifed for Stuffy Nose
I unfortunately had to stop using this medication because it caused me to have severe anxiety attacks.
3.3Patient Review
4/24/2010
Actifed for Cold Symptoms
I felt terrible the next day after taking this medication. I was extremely sleepy and depressed.
image of drug pills surrounding a glass of water symbolizing drug consumption

Patient Q&A Section about actifed

These questions and answers are submitted by anonymous patients, and have not been verified by our internal team.

What is Actifed called now?

"The active ingredients in Wal-Act D are the same as those in the old Actifed formula: Triprolidine HCL and Pseudoehedrine HL. I bought some today at Wallgreens; it's their house brand, and you have to ask the pharmacist for it."

Answered by AI

Does Actifed make you sleep?

"”

Actifed is an effective medication for cold symptoms that cause constant coughing, especially at night. It may cause drowsiness, but this is not a problem for use at night."

Answered by AI

What is the drug Actifed used for?

"Decongestants help to reduce swelling in the nose.

This medication is a combination of an antihistamine and a decongestant and is used to relieve the symptoms of the common cold, flu, allergies, or other breathing illnesses temporarily. The antihistamine component helps relieve watery eyes, itchy eyes, nose, and throat, as well as a runny nose and sneezing. The decongestant component helps to reduce swelling in the nose."

Answered by AI

Clinical Trials for Actifed

Image of National Institutes of Health Clinical Center in Bethesda, United States.

BPL-1357 for Flu

18 - 55
All Sexes
Bethesda, MD
Background: Influenza (flu) infections are a serious global health threat. Each year, between 3 and 5 million people get the flu, and up to 500,000 die from it. Current vaccines protect against seasonal flus, but broader vaccines are needed to protect against potential flu pandemics. Objective: To test an experimental flu vaccine. Eligibility: Healthy people aged 18 to 55 years. Design: The study will last 5 to 8 months and has 2 phases, A and B. The study vaccine will be given either as a shot in the arm or as a nasal spray. Participants will receive 1 of 3 combinations: (1) study vaccine in the nose and placebo in the arm; (2) placebo in the nose and study vaccine in the arm; or (3) placebo in the nose and placebo in the arm. A placebo is just like the real vaccine but contains no active ingredients. Phase A: Participants will have 5 clinic visits over 56 days. They will receive a shot and a nasal spray at 2 of the visits, 28 days apart. At each visit, they will have a physical exam, with tests of their blood, urine, and nasal secretions. They will check their temperature at home and record any symptoms for 7 days after each vaccine. Phase B: Participants will stay in the hospital for at least 9 days. They will be infected with a flu virus. They will provide blood, urine, and nasal fluid samples. They will have tests of their heart function. They will remain in the hospital until they test negative for the flu 2 days in a row. They will have 2 follow-up visits, 4 and 8 weeks after leaving the hospital.
Phase 2
Waitlist Available
National Institutes of Health Clinical Center (+1 Sites)Luca T Giurgea, M.D.
Image of Vanderbilt University Medical Center in Nashville, United States.

High vs. Standard Dose Influenza Vaccines for Flu

18+
All Sexes
Nashville, TN
This will be a follow-up study to the "Comparison of High Dose vs. Standard Dose Influenza Vaccine in Lung Allograft Recipient" study (DMID Protocol Number 22-0014) at Vanderbilt University Medical Center. Lung transplantation is a life-saving therapy for patients with advanced lung disease, and is also associated with an improvement in quality of life. However, due to the need for life-long immunosuppression to prevent acute cellular rejection and chronic lung allograft dysfunction ("chronic rejection"), lung transplant recipients are at risk for developing major infections. In fact, one-year survival is 85%, with infection being the leading cause of death within the first year post-transplant. We will conduct a follow-up phase II, randomized, double-blind trial to assess the impact of subsequent administration of two doses of HD-IIV compared to two doses of SD-IIV among lung recipients during the early post-transplant period. Demonstration of improved immunogenicity from two doses of HD-IIV over consecutive influenza seasons would provide potential broad benefit in reducing influenza disease and its associated complications in lung transplant recipients. Moreover, studying vaccine immunogenicity and safety in the same participants over consecutive years can provide insight into the influence of immunosuppression levels and allograft aging on vaccine-mediated immune modulation. This proposed study design will contribute significantly to influenza vaccination guidance and policy for the highly vulnerable lung transplant population. This proposed study is designed to address several key knowledge gaps in vaccine-mediated protection of lung transplant recipients against influenza: * Is there increased immunogenicity with administration of one or two doses of HD-IIV or SD-IIV in the subsequent season compared to two doses of HD-IIV or SD-IIV in the first season? * What is the durability of the humoral and cellular immune response between influenza seasons and does two doses of HD-IIV or SD-IIV sustain higher HAI titers compared to two doses of HD-IIV or SD-IIV in the first season? * What is the impact of maintenance immunosuppression levels on influenza vaccine immunogenicity within the same participant? * Will the optimal immunogenic vaccination strategy be associated with an acceptable long-term safety profile over successive influenza seasons, including injection-site and systemic reactions, allosensitization, and organ rejection?
Phase 2
Recruiting
Vanderbilt University Medical CenterNatahsa Halasa, MD, MPH
Image of Altasciences Inc - Kansas City in Overland Park, United States.

VNT-101 for Safety and Tolerability Study

18 - 59
All Sexes
Overland Park, KS
A randomized, double-blind, placebo-controlled Phase 1 study conducted at a single center with approximately 78 healthy adults aged 18-59 years. Part 1 Single Ascending Dose (SAD) will enroll 48 participants into six cohorts (S1-S6) to receive single oral doses of VNT-101 (100-1500 mg) or placebo under fasting or fed (S5 only) conditions. Part 2 Multiple Ascending Dose (MAD) will enroll 30 participants into three cohorts (M1-M3) to receive multiple oral doses of VNT-101 (250-750 mg BID Days 1-5, QD Day 6) or placebo under fasting conditions. Dose escalation in both parts will proceed after Protocol Safety Review Team (PSRT) review. The primary objective for Part 1 is to evaluate the safety and tolerability of single ascending oral (SAD) doses of VNT-101 in healthy adult participants under either fasting or fed conditions. The primary objective for part 2 is to evaluate the safety and tolerability of multiple ascending oral (MAD) doses of VNT-101 in healthy adult participants.
Phase 1
Recruiting
Altasciences Inc - Kansas City
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Image of University of Maryland, School of Medicine, Center for Vaccine Development and Global Health in Baltimore, United States.

pH1N1 Virus for Flu

18 - 55
All Sexes
Baltimore, MD
This protocol describes a clinical trial to develop and validate a Controlled Human Infection Model (CHIM) for influenza A/Arkansas/08/2020 (pH1N1). The study is designed to determine the optimal infectious dose of the pH1N1 challenge strain for use in future clinical trials evaluating influenza countermeasures. The study will enroll and challenge adult volunteers with the pH1N1 influenza virus challenge or sham inoculations. Given the adaptive design of this trial, the potential number of participants can vary. Depending on the pathway recommended by the PSRT and followed in the Trial Schema, the study population can range from around 30 to 120. However, it is anticipated that the final sample size will be around 60 participants receiving pH1N1 challenge product plus approximately 4 persons receiving a sham inoculation. Participants will be pre-screened for health and for serological HAI antibody titers of \</1:40 against the challenge strain. Eligible participants will be enrolled sequentially into challenge cohorts and will be randomly assigned to receive a single dose of either sham inoculation or the interventional study product at a dose between 10\^6 to 10\^7 TCID50 (or 10\^5 TCID50 if needed). Dose titration will be conducted under an adaptive escalation schedule whereby dosing will start at 10\^6 TCID50 and escalate to the next dose if a pre-determined symptomatic influenza attack rate and clinical symptom score thresholds are not met and if the dose is determined to be safe with no pre-defined halting criteria being met. The primary objectives of this study are to determine the optimal infectious dose of a pH1N1 viral challenge to cause laboratory-confirmed clinical influenza and to assess the safety profile of pH1N1 viral challenge.
Phase 1
Recruiting
University of Maryland, School of Medicine, Center for Vaccine Development and Global Health (+1 Sites)
Image of Saint Louis University Center for Vaccine Development in St Louis, United States.

A/Texas for Flu

18 - 45
All Sexes
St Louis, MO
This is a research study to understand what happens when a person is infected with influenza ("flu") and how the body controls the infection. Healthy participants (challenge) will be infected with a strain of flu (H3N2), and followed to see what symptoms occur and when they occur. Blood will be drawn and nasopharyngeal (NP) swabs will be collected before participants are infected to understand if having antibodies can protect participants from flu infection or lead to a milder flu illness. Blood will also be drawn and NP swabs collected after participants are infected to understand how and when the body's immune response to flu occurs. Participants will also breathe through a device for virus collection every other day. Participants will be screened during one or more visits and will stay in the inpatient challenge unit for at least 10 days, maybe longer. Participants will complete a FLU PRO Diary Card daily. Blood will be drawn before the challenge and on Days 2, 4, and 8 while in the inpatient unit. NP samples will be taken every day to check for viruses and on certain days, immune responses such as antibodies. If on Day 8 (7 days after the challenge) the participant still has flu virus, medicine will be offered to treat the flu and the participant will be asked to stay in the challenge unit until NP swabs are negative for 2 consecutive days. Once the participant is discharged from the challenge unit, they will be asked to return to the clinic for 3 more visits. At the end of the study will be a final phone call.
Phase 1
Waitlist Available
Saint Louis University Center for Vaccine DevelopmentDaniel F. Hoft, MD, PhD
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Influenza Virus for Influenza

18 - 49
All Sexes
Atlanta, GA
This study is designed to help us better understand how the immune system responds to the flu and how flu is transmitted in the environment. The ultimate goal is to develop better vaccines and drugs to protect against or fight the flu. This study will describe how the body's immune system responds to the flu virus during and after infection and how the flu virus is transmitted in the environment. The study will use a flu virus called A/Texas/71/2017 (H3N2), clade 3C3a produced specifically for clinical research in controlled conditions. The study will also assess the safety of the H3N2 influenza challenge in healthy participants. Mild to moderate symptoms are expected based on previous studies with this strain of influenza. Study volunteers will be recruited and screened from the general population of metro Atlanta through advertisements or identified from a database of research participants who have previously agreed to be contacted for future research studies. Participants will provide written consent before study participation. Up to 200 healthy adults, 18-49 years old, will be screened for participation. Eligible participants will take part in the study over 5 months. Enrolled participants will be admitted to Emory University Hospital during which time they will receive the influenza virus in the form of a spray in the nose or exposure to infected participants followed by an 8-12 day inpatient stay for observation. Follow-up outpatient visits will take place at the Hope Clinic of the Emory Vaccine Center. Participants will receive compensation (pro-rated for all visits completed) for their time and effort. There will be no costs to participants as a result of being in the study.
Phase 1
Recruiting
Emory University Hospital Clinical Research Network (+1 Sites)Nadine Rouphael, MD
Image of Loma Linda University Medical Center Troesh Medical Campus in Loma Linda, United States.

Endotracheal Suctioning for Procedural Pain

18+
All Sexes
Loma Linda, CA
The goal of this experimental study is to understand if endotracheal tube (ETT) suctioning increases pain and causes stress on the body in intubated adult ICU patients. These patients are already on ventilators, which means they need suctioning to keep their airways clear, but this procedure may be uncomfortable and cause stress. The main questions this study aims to answer are: Does ETT suctioning raise pain levels as measured by the Critical-Care Pain Observation Tool (CPOT)? Does ETT suctioning increase certain chemicals in the blood (hypoxanthine, xanthine, and uric acid) that show stress and lack of oxygen in the body? Researchers will compare patients who have ETT suctioning (intervention group) with those who do not have suctioning during the study period (control group) to see if there are differences in pain and blood markers of stress. Participants will: Have pain measured before and after suctioning using the CPOT. Have blood samples taken from an existing line at three time points: 5 minutes before, 5 minutes after, and 30 minutes after suctioning. Provide demographic information (like age, gender, and diagnosis) from medical records. This research will help improve how pain is managed for ICU patients who cannot speak for themselves, potentially leading to better pain relief methods in the future.
Recruiting
Has No Placebo
Loma Linda University Medical Center Troesh Medical CampusElizabeth Johnston Taylor, PhD, FAAN
Image of Research Institute of McGill University Health Centre in Montréal, Canada.

COVID-19 Booster + Flu Vaccine for Immunocompromised People

18+
All Sexes
Montréal, Canada
The goal of this pragmatic embedded open-label, 2 x 2 factorial phase II randomized controlled trial is to evaluate strategies to improve COVID-19 booster and influenza vaccine immunogenicity in people living with immunocompromising conditions (PLIC). The main questions it aims to answer are: 1. Is co-administration of seasonal inactivated influenza vaccine (IIV) with the most up-to-date recommended COVID-19 booster dose non-inferior in inducing a 1-month peak protective humoral response against COVID-19, compared to a strategy of sequential administration of COVID-19 booster dose followed by seasonal IIV given one month later? 2. Is the administration of the most up-to-date recommended COVID-19 booster doses at 3-month intervals superior at maintaining a longer term protective humoral immune response, compared to booster doses administered at 6-month intervals? Researchers will compare (1) COVID-19 and Influenza vaccines administered at Day 0 + COVID-19 Booster at a 3-month interval, (2) COVID-19 vaccine administered at Day 0 and Influenza vaccine administered at Day 28 + COVID-19 Booster at a 3-month interval, (3) COVID-19 and Influenza vaccines administered at Day 0 + COVID-19 Booster at a 6-month interval, and (4) COVID-19 vaccine administered at Day 0 and Influenza vaccine administered at Day 28 + COVID-19 Booster at a 6-month interval to see if median neutralization capacity of patient sera is non-inferior in the co- vs. sequential administration arms at 1-month after the initial COVID-19 booster and superior in the 3-month interval arms vs. the 6-month interval arms at 12 months after the initial COVID-19 booster. These outcomes will also be compared at 2-months for question 1 and 6-months for question 2. People living with immunocompromising conditions who take part in the trial will have blood samples drawn to verify immune response, be monitored for changes in clinical events and therapies, and complete questionnaires to verify adverse effects, quality of life and economic impact.
Phase 2
Recruiting
Research Institute of McGill University Health Centre (+1 Sites)
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