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Broncho-munal · 1 trial · 1 indication
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 ...
Broncho-munal is an investigational small molecule being studied for the treatment of acute uncomplicated respiratory tract infections. It is currently in Phase 3 clinical development and has not been approved by regulatory authorities. The drug is being evaluated for its efficacy and safety in adult patients with this condition.
Broncho-munal is being developed by Novartis AG, a global pharmaceutical company traded on the New York Stock Exchange under the ticker symbol NVS. The company is conducting clinical trials to evaluate the drug's safety and efficacy for acute uncomplicated respiratory tract infections.
Broncho-munal is in Phase 3 clinical development. It is an investigational drug and has not yet received regulatory approval. The Phase 3 trial has been completed, with results expected to inform potential regulatory submissions for the treatment of acute uncomplicated respiratory tract infections.
Broncho-munal has one completed Phase 3 clinical trial registered as NCT05588804. This randomized, double-blind, placebo-controlled study enrolled 556 adult participants in Russia to evaluate the efficacy and safety of Broncho-munal capsules at a 7 mg dose for acute uncomplicated respiratory tract infections.
Broncho-munal is not FDA approved. It is an investigational drug currently in Phase 3 clinical development for acute uncomplicated respiratory tract infections. The drug has completed a Phase 3 trial, but regulatory approval has not been granted, and it remains under investigation for safety and efficacy.