Approval Probability 71%
TA Base Rate26%
Adjusted LOA41%
ML RiskLOW_RISK
| NCT ID | Title | Phase | Status | Enrollment | Velocity | Design | Start | Completion | Last Updated | Sites | Countries |
|---|---|---|---|---|---|---|---|---|---|---|---|
| NCT05588804 | Study of the Efficacy and Safety of Broncho-munal®, Capsules, 7 mg for the Treatment of Acute Uncomplicated Respiratory Tract Infections | PHASE3 | COMPLETED | 556 | — | — | Nov 7, 2022 | Dec 18, 2022 | Aug 4, 2023 | 13 | Russia |
Dynamics of symptoms severity according to the WURSS-21 is assessed using the Area under the curve (AUC) for the score for 3, 5, 7 and 10 days of the treatment. WURSS-21 consists of 21 items (2 questions and 2 domains. Symptoms domain consists of 10 items: Runny nose, Plugged nose, Sneezing, Sore throat, Scratchy throat, Cough, Hoarseness, Head congestion, Chest congestion, Feeling tired. Ability domain consists of 9 items: Think clearly, Sleep well, Breathe easily, Walk, climb stairs, exercise, Accomplish daily activities, Work outside the home, Work inside the home, Interact with others, Live your personal life. The first 20 items are scored according to the 8-point scale (from 0 to 7). The last item is scored according to the 7-point scale: (from 0 to 6). Higher scores mean a worse outcome.
| Arm | Type | Description |
|---|---|---|
| Group 1: Broncho-munal® | EXPERIMENTAL | Participants will receive the study drug Broncho-munal®, capsules, 7 mg (Sandoz dd, Slovenia), 1 capsule per day in the morning on an empty stomach, 30 minutes before meals, for 10 consecutive days |
| Group 2: Placebo | PLACEBO_COMPARATOR | Participants will receive a placebo, 1 capsule per day in the morning on an empty stomach, 30 minutes before meals, for 10 consecutive days |
| Name | Type | Description |
|---|---|---|
| Broncho-munal® | DRUG | 1 capsule daily in the morning on an empty stomach, 30 minutes before meals, for 10 consecutive days |
| Placebo | DRUG | 1 capsule daily in the morning on an empty stomach, 30 minutes before meals, for 10 consecutive days |
Inclusion Criteria: * Patient signing and dating of the Patient Information Sheet Informed Consent Form. * Men and women between the ages of 18 and 60 inclusive at the time of signing the Patient Information Sheet Informed Consent Form. * Symptoms of acute uncomplicated respiratory tract infection ...