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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 being studied for the treatment of acute uncomplicated respiratory tract infections. It is an investigational small molecule developed by Novartis AG (ticker NVS) and has reached Phase 3 clinical development. The completed Phase 3 trial enrolled 556 adults aged 18 years and older in Russia.
Broncho-munal is developed by Novartis AG, which trades under the ticker NVS. Novartis is the sponsor of the clinical program evaluating the drug in acute uncomplicated respiratory tract infections. The asset is an investigational small molecule in Phase 3 development.
Broncho-munal is in Phase 3 clinical development. One Phase 3 trial has been completed, and no trials are currently active. The program has enrolled a total of 556 participants. The drug is investigational and has not been established as approved for any indication.
Broncho-munal has been evaluated in one completed Phase 3 trial, NCT05588804, titled Study of the Efficacy and Safety of Broncho-munal, Capsules, 7 mg for the Treatment of Acute Uncomplicated Respiratory Tract Infections. The trial was randomized, double blind, and placebo controlled, enrolling 556 adults in Russia.
Yes, Broncho-munal and Broncho-munal® refer to the same investigational drug. The registered trademark symbol is simply a notation of the brand name. Both names identify the Novartis AG asset being studied in Phase 3 for acute uncomplicated respiratory tract infections.