Randomized, multiCentre, dOuble-blind, double-duMmy, parallel-group clinical study on efficacy and safety of iBuprofen/N-acetylcysteine fixed dose cOmbination vs. its individual components (ibuprofen and N- acetylcysteine monotherapies) in patients with symptomatic uncomplicated upper respiratory tract infections with wet coughCOMBO - 23CT0001

E Pharma Trento S.p.A.0 sites483 target enrollmentStarted: July 21, 2023Last updated: July 22, 2024

Conditions

Trial Snapshot

Phase: Phase 1
Status: Active, not recruiting
Sponsor
Enrollment: 483

Study Overview Eligibility Criteria Investigators Records & Identifiers Similar Trials

Study Overview

Brief Summary

No summary available.

Study Design

Study Type: Interventional

Eligibility Criteria

Ages: 18 to 65+ (—)
Sex: All

Inclusion Criteria

•Male or female, age =18 and = 75 years, Clinical diagnosis of symptomatic uncomplicated URTI, as confirmed by the Investigator, Signs/symptoms of uncomplicated URTI (e.g., fever [i.e., axillary temperature = 37.5 °C], cold symptoms [i.e., runny nose, plugged nose, sneezing, scratchy throat, hoarseness, head congestion, chest congestion, feeling tired], sore throat, shortness of breath and limitation in daily activities) and wet cough for = 3 days prior to screening, Presence of wet cough of at least moderate severity (i.e., a score = 2 on the 5-point Likert scale) and total sum of the 5-point Likert scale (range 0-4) for signs and symptom of uncomplicated URTI (cough, fever, cold symptoms, sore throat, shortness of breath and limitation in daily activities) = 9, Signed written informed consent (to be obtained before any trial procedure is performed), Willingness and capability to fulfil all tasks foreseen by the trial protocol, Negative severe acute respiratory syndrome coronavirus 2 (SARS-CoV-2) rapid antigen test at screening, Females of childbearing potential must have a negative urine pregnancy test (dipstick) prior to the first Investigational Medicinal Product (IMP) administration, and currently use or agree to use consistently and correctly (i.e., perfect use) a highly effective method of contraception for the individual subject and her partner(s) throughout the trial and for at least one full contraceptive cycle (when applicable). Highly effective methods of contraception include the following: a) implantable progestogen-only hormone contraception associated with inhibition of ovulation; b) intrauterine device (IUD); c) intrauterine hormone-releasing system (IUS); d) combined (oestrogen- and progestogen-containing) hormonal contraception associated with inhibition of ovulation (oral; intravaginal; transdermal), provided the patient has been using that hormonal contraceptive for an adequate period of time to ensure effectiveness; e) progestogen-only hormone contraception associated with inhibition of ovulation (oral; injectable), provided the patient has been using that hormonal contraceptive for an adequate period of time to ensure effectiveness; f) vasectomized partner, provided that the partner is the sole patient’s sexual partner and the absence of sperm has been confirmed; g) bilateral tubal occlusion or tubal ligation; h) sexual abstinence, defined as refraining from heterosexual intercourse during the entire period of risk associated with the IMP (i.e., up to 24h after the end of treatment). Barrier contraceptives (i.e., diaphragm or cervical cap with spermicide and/or condoms [male or female] with or without a spermicidal agent) are not considered highly effective methods of contraception, and thus must not be used as sole method of contraception. Of note, females who are either permanently sterilized (hysterectomy, bilateral oophorectomy, or bilateral salpingectomy), or who are postmenopausal (at least 12 months of amenorrhea following cessation of all exogenous hormonal treatment) are not considered of childbearing potential.

Exclusion Criteria

•Patients with asthma or chronic obstructive pulmonary disease (COPD) or other chronic respiratory disorders, Patients with clinical signs or history of coagulation disorders, or requiring anticoagulants., Patients with known (as previously documented) severe heart failure (NYHA class IV), severe renal impairment (eGFR <30 mL/min), or severe hepatic impairment (Child-Pugh class C)., Patients with uncontrolled arterial hypertension (in unstable pharmacological therapy)., History of atrial fibrillation., Clinically significant or unstable concurrent diseases whose sequelae or treatment might contraindicate trial participation or interfere with the trial evaluation parameters, as judged by the Investigator., History of drug abuse or use of illegal drugs., Alcohol abuse, i.e., regular use of more than 2 units of alcohol per day or 10 units per week or a history of alcoholism (one unit of alcohol equals 250 ml beer, 125 ml wine or 25 ml spirits)., History of serious psychiatric disorders., Previous participation in this clinical trial., Participation in other clinical trials at the same time or within 90 days prior to Visit 1 (calculated from the date of the final examination of the previous trial)., Patients with suspected lower respiratory tract infection or other infections requiring treatment with antibiotics., Pregnancy or lactation period throughout the whole trial duration., History of allergy or hypersensitivity or intolerance to IBU and/or NAC and/or any of their excipients., Known hypersensitivity to NSAIDs, Use within 7 days prior to Visit 1 of oral, rectal, parenteral or inhaled NSAIDs and analgesics with a half-life greater than 5 hours (see Appendix I of the trial protocol for a non-exhaustive list of NSAIDs and analgesics with a half-life lower than 5 hours that are allowed up to the day before Visit 1). The use of other analgesics and modified-release NSAIDs and analgesics within 2 weeks prior to Visit 1 is prohibited. Topical NSAIDs and analgesics are allowed., Use of oral, parenteral or inhaled corticosteroids, and leukotriene antagonists within 4 weeks before Visit 1., Use of antibiotics, antivirals, and bronchodilators in the week before Visit 1. Topical antibiotics and antivirals are allowed., Patients with clinical signs of or known or history of peptic ulcer disease.

Investigators

Sponsor

E Pharma Trento S.p.A.

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