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Study on the Effectiveness and Safety of Ibuprofen and N-Acetylcysteine for Patients with Upper Respiratory Tract Infections with Wet Cough

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What is this trial about?

A plain-language summary of the goals, design and what participants do

This clinical trial is focused on studying the effectiveness and safety of a new treatment for upper respiratory tract infections, which are common illnesses that can cause symptoms like a wet cough, fever, and cold symptoms. The study will compare a combination treatment called IBU-NAC, which includes two active ingredients: acetylcysteine and ibuprofen sodium dihydrate, against each of these ingredients used separately. The goal is to see if the combination works better than using either ingredient alone.

Participants in the study will be randomly assigned to receive either the combination treatment, one of the individual treatments, or a placebo. The study will last for about seven days, during which participants will take the medication orally. The researchers will monitor the time it takes for symptoms to improve significantly and will also assess the safety of the treatments throughout the trial.

The study aims to provide valuable information on whether the combination of acetylcysteine and ibuprofen sodium dihydrate can offer a more effective treatment option for those suffering from uncomplicated upper respiratory tract infections with a wet cough. Participants' progress will be closely observed to ensure their safety and to gather data on how well the treatments work in relieving symptoms.

The research process

The trial runs in 5 steps – from screening to follow-up. Each step says what happens and what the team monitors.

  1. Step 1

    Joining the study

    Upon joining the study, the participant will be randomly assigned to one of the treatment groups. This process is called randomization and ensures that each participant has an equal chance of receiving any of the treatments being tested.

  2. Step 2

    Treatment administration

    Participants will receive one of the following treatments: IBU/NAC (a combination of ibuprofen and acetylcysteine), ibuprofen alone, or acetylcysteine alone. These medications are administered orally.

    The treatment will last for 7 days. The specific dosage and frequency will be determined by the study protocol and provided to the participant at the start of the treatment.

  3. Step 3

    Monitoring and assessment

    Throughout the trial, participants will be monitored for any changes in their symptoms. This includes tracking the severity of symptoms such as cough, fever, and cold symptoms using a 5-point scale.

    Participants will also be asked to report any side effects or adverse reactions they experience during the trial.

  4. Step 4

    End of treatment visit

    At the end of the 7-day treatment period, participants will have a visit to assess the improvement of their symptoms. This visit may occur on Day 8, with a possible variation of one day.

    The assessment will include a review of symptom severity and any side effects experienced during the treatment.

  5. Step 5

    End of study visit

    A final visit will be conducted approximately 15 days after the start of the study, with a possible variation of two days. This visit will evaluate the overall effectiveness of the treatment and any remaining symptoms.

    Participants will also provide feedback on their experience with the treatment and any side effects they encountered.

Who can join the trial?

8 criteria

  • Must be a male or female aged between 18 and 75 years.
  • Must have a clinical diagnosis of a symptomatic uncomplicated upper respiratory tract infection (URTI), confirmed by the study doctor.
  • Must have signs or symptoms of uncomplicated URTI, such as fever (temperature of 37.5 °C or higher), cold symptoms (like runny nose, plugged nose, sneezing, scratchy throat, hoarseness, head congestion, chest congestion, feeling tired), sore throat, shortness of breath, and wet cough for 3 days or less before the screening.
  • Must have a wet cough that is at least moderately severe, and a total score of 9 or more on a scale that measures symptoms like cough, fever, cold symptoms, sore throat, shortness of breath, and limitation in daily activities.
  • Must sign a written informed consent form before any trial procedures are done.
  • Must be willing and able to complete all tasks required by the trial.
  • Must have a negative test for severe acute respiratory syndrome coronavirus 2 (SARS-CoV-2) at screening.
  • Females who can have children must have a negative pregnancy test before the first trial medication is given and must use a highly effective method of birth control during the trial and for at least one full cycle after the trial. Methods include hormonal implants, intrauterine devices, hormonal birth control pills, injections, or patches, a partner who has had a vasectomy, or complete sexual abstinence. Barrier methods like condoms or diaphragms are not considered highly effective on their own.

Who cannot join the trial?

5 criteria

  • Patients who have a different illness than an upper respiratory tract infection (like a cold or flu affecting the nose, throat, or sinuses).
  • Patients who are not within the specified age range for the study.
  • Patients who are not part of the specific group the study is focusing on.
  • Patients who are not male or female, as the study includes both genders.
  • Patients who are considered part of a vulnerable population, which means they might need special protection or care.
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Investigated drugs

  • Ibuprofen/N-acetylcysteine Fixed Dose Combination (IBU/NAC FDC)

    is a medication being tested to see if it works better than taking each of its components separately. It combines ibuprofen, which is commonly used to reduce pain and inflammation, with N-acetylcysteine, which helps to thin mucus in the airways. This combination is being studied to see if it can more effectively improve symptoms of upper respiratory tract infections with a wet cough.

  • Ibuprofen

    is a medication that is often used to relieve pain, reduce inflammation, and lower fever. In this trial, it is being used alone to see how well it works compared to when it is combined with N-acetylcysteine.

  • N-acetylcysteine

    is a medication that helps to thin and loosen mucus in the airways, making it easier to cough up. It is being tested on its own to compare its effectiveness against the combination with ibuprofen.

What is already known about the treatment

  • Ibuprofen/N-acetylcysteine Fixed Dose Combination

    This medication is administered orally and is currently being studied in clinical trials for its effectiveness and safety in treating upper respiratory tract infections with wet cough. It combines ibuprofen, a non-steroidal anti-inflammatory drug, and N-acetylcysteine, a mucolytic agent, to potentially enhance therapeutic outcomes. The combination aims to reduce inflammation and thin mucus, making it easier to expel. It is classified as a combination drug therapy, and its efficacy is being compared to the individual components in ongoing research.

  • Ibuprofen

    This medication is taken orally and is widely used in medicine as a non-steroidal anti-inflammatory drug (NSAID). It is commonly indicated for reducing pain, inflammation, and fever. At the molecular level, ibuprofen works by inhibiting enzymes called cyclooxygenases, which are involved in the production of inflammatory chemicals in the body. It is classified under NSAIDs and is being studied in clinical trials for its role in treating upper respiratory tract infections with wet cough.

  • N-acetylcysteine

    Administered orally, this medication is well-established in medical literature as a mucolytic agent, primarily used to help clear mucus from the airways. It is indicated for conditions where mucus build-up is a problem, such as in respiratory infections. N-acetylcysteine works by breaking down the structure of mucus, making it less thick and sticky. It is classified as a mucolytic and is being evaluated in clinical trials for its effectiveness in treating upper respiratory tract infections with wet cough.

Investigated diseases

Upper Respiratory Tract Infections – These infections affect the nose, throat, and airways, often caused by viruses. Symptoms typically include a runny or stuffy nose, sore throat, cough, and sometimes fever. The condition usually begins with mild symptoms that can progress to more severe discomfort, such as a persistent cough or increased mucus production. Over time, symptoms may fluctuate in intensity, often peaking within a few days. Most cases resolve on their own, but symptoms can linger for a week or more. The progression and duration can vary depending on the individual's immune response and the specific virus involved.
Trial detailsLast updated 7 Oct 2026
Age18+ yearsPhasePhase IIITrial ID2023-505809-17-00Protocol code23CT0001Estimated enrolment483 patientsSponsorE Pharma Trento S.p.A.

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