Nasal congestion and pain associated with viral upper respiratory tract infection MedDRA version: 9.1 Level: LLT Classification code 10046308 Term: Upper respiratory tract infection viral NOS
Conditions
Interventions
Trade Name: Aspirin Complex
Pharmaceutical Form: Granules for oral solution
CAS Number: 50782
Other descriptive name: ACETYLSALICYLIC ACID
Sponsors
Bayer Consumer Care AG
Eligibility
Sex/Gender
All
Inclusion criteria
Inclusion criteria: • Male and female subjects of at least 18 years. • Female subjects of child bearing potential must be using a highly effective method of birth control for at least 1 month prior to screening and have a negative pregnancy test at screening, and not be breast-feeding. Female subjects must agree to remain on their established method of contraception during their participation in the trial. • Be in good general health at screening (in the opinion of the Investigator) with no clinically significant and relevant abnormalities of medical history or physical examination. • Subjects with upper respiratory tract infection of no more than 72 hours (3 days) duration. • Subjects with nasal obstruction, i.e. a total nasal air flow resistance (NAR) of >0.25 Pa cm3 sec as determined by posterior rhinomanometry. • Subjects with an overall pain symptom (composite score for sore throat, headache, body aches and pain or other pain) of at least moderate intensity, as recorded on a 4-point verbal rating scale (VRS). • Subjects who understand and are willing and are able to comply with the study procedures and restrictions, and who understand the verbal rating scales. • Written informed consent prior to enrollment into the study. Are the trial subjects under 18? no Number of subjects for this age range: F.1.2 Adults (18-64 years) yes F.1.2.1 Number of subjects for this age range F.1.3 Elderly (>=65 years) yes F.1.3.1 Number of subjects for this age range
Exclusion criteria
Exclusion criteria: • A history of o perennial allergic rhinitis (subjects with a history of seasonal allergic rhinitis who are recruited out of season will be eligible for the study), o chronic respiratory disease (which in the opinion of the Investigator is clinically significant), o hyperthyroidism, o diabetes mellitus, o cardiovascular disease, o prostatic hypertrophy, o hypertension or elevated intra-ocular pressure, o peptic ulcer, or active peptic ulcer, o asthma induced by administration of salicylates or substances with a similar action, notably non steroidal anti-inflammatory drugs (NSAID) • Hereditary problems of fructose intolerance, glucose-galactose malabsorption or sucrose-isomaltase insufficiency • Pregnant or lactating females • Uncontrolled chronic diseases • Severe hepatic or renal disease or damage based on the clinical judgment of the Investigator • Severe not compensated heart insufficiency • Severe hypertension • Severe coronary heart disease • Anatomical nasal obstruction or gross anatomical deformity, including moderately or severely deviated nasal septum or the presence of nasal polyps • Use of methotrexate within the last 30 days • Use of corticoids within the last 30 days • Use of astemizole within the last 30 days • Use of antibiotics within the last 7 days • Use of any antihistamine within the last 7 days • Use of analgesic or antipyretic within the last 24 hours • Use of any nasal decongestant (systemic or topical) within the last 12 hours • Use of any medicated lozenge or throat spray within the last 6 hours • Consumption of alcohol within the last 6 hours • Use of any menthol containing product within the last 6 hours • Taking monoamino-oxidase inhibitors (MAOI) medications within the last 30 days • Undergoing anti-coagulation therapy e.g. warfarin • Known or suspected intolerance or hypersensitivity to ASA, any NSAID or PSE or any of their stated ingredients • Subjects with a recent history (within the last 2 years) of abuse of analgesics (i.e. use analgesics on more than 10 days per month), alcoholism or known drug dependence • Participation in another clinical trial or receipt of an investigational drug within 30 days of the screening visit at the start of the clinical trial • Any significant disease or condition which, in the Investigators opinion, may interfere with the study objectives • Previous participation in this clinical trial • Is a member or relative of the study site staff
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Main Objective: The primary objective is to compare the efficacy of 1000 mg ASA combined with 60 mg PSE for pain and nasal congestion with 1000 mg ASA alone, 60 mg PSE alone and placebo in subjects with symptomatic common cold caused by acute URTI for the initial 4 hours after first dose. Efficacy on nasal congestion is assessed by nasal air flow (area under the nasal airflow conductance curve 0-4 hours post first dose - AUC0-4h) and pain is assessed by using a composite pain relief score (total pain relief score 0-4 hours post first dose - TOTPAR0-4h). ; Secondary Objective: The secondary objectives are to assess • pain intensity difference to baseline (PIDt) at various time points up to 3 days post first dose • total pain relief compared to baseline (TOTPAR0-t) at various time points up to 3 days post first dose • the sum of pain intensity difference (SPID0-t) at various time points up to 3 days post first dose • nasal congestion difference to baseline at various time points up to 3 days post first dose • nasal congestion relief compared to baseline at various time points up to 3 days post first dose • the sum of nasal congestion difference (SNCD) at various time points up to 3 days post first dose • global pain relief • global congestion relief • total dose used over the maximum period of 3 days • safety and tolerability ; Primary end point(s): • Nasal airflow conductance as the area under the nasal airflow conductance curve 0-4 hours post-dose (AUC0-4h) • Total pain relief, measured with a 5-point composite VRS (composite of sore throat, headache, body aches and pains) over 4 hours post-dose (TOTPAR0-4h) | — |
Countries
United Kingdom
Outcome results
None listed