Approval Probability
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Pleconaril · 1 trial · 4 indications
The common cold was defined as moderate or severe rhinorrhea and at least one other cold symptom of moderate to severe intensity for at least 1 day, together with rhinovirus-positive polymerase chain reaction (PCR), after a participant had temporal exposure to an index case. PCR+ was defined as positive or equivocal outcome of the picornavirus test any time after randomization.
Asthma exacerbation was defined as a participant having one of the following: 1. 0.5 point or more increase in the Asthma Control Questionnaire (ACQ) from Baseline at Day 7. The ACQ is a validated instrument containing 7 questions to assess asthma control which incorporates symptoms, beta-agonist use, and spirometry. Participants recall their experiences during the previous 7 days and respond to each question using a 7-point scale. The items are equally weighted and the ACQ score is the mean of the 7 items and therefore ranges between 0 (well controlled) and 6 (extremely poorly controlled). The ACQ completed on the day of exposure was the Baseline ACQ. 2. Any change to asthma treatment as prescribed by a physician, unscheduled contact (either office visit or phone contact where medication was changed for asthma symptoms), emergency room visit, or hospitalization. PCR+ was defined as positive or equivocal outcome of the picornavirus test any time after randomization.
| Arm | Type | Description |
|---|---|---|
| Pleconaril | EXPERIMENTAL | Participants will receive Pleconaril nasal spray 4 sprays per nostril twice daily (BID), 24 mg/day for 1 week during the Treatment Period for a total of 14 doses. |
| Placebo | PLACEBO_COMPARATOR | Participants will receive placebo nasal spray 4 sprays per nostril BID for 1 week during the Treatment Period for a total of 14 doses. |
| Name | Type | Description |
|---|---|---|
| Pleconaril | DRUG | Pleconaril nasal suspension is supplied in a bottle containing 120 actuations. Each actuation contains 1.5 mg of pleconaril. |
| Placebo to Pleconaril | DRUG | Placebo nasal suspension |
Inclusion Criteria: * Must be ≥6 to ≤65 years of age, of either sex, and of any race, with a diagnosis of asthma at least 2 years prior to the Screening Visit. * Must have a history of two or more upper respiratory infection-induced asthma exacerbations in the past 24 months. * For participants ...
Pleconaril is an investigational small molecule being studied for use in asthma. It is being evaluated for its effects on common cold symptoms and asthma exacerbations following rhinovirus exposure. The drug is in Phase 2 clinical development and is not approved by the FDA.
Pleconaril is being developed by Merck & Company, Inc., which trades under the ticker MRK. The company is conducting clinical trials to evaluate the drug's safety and efficacy in patients with asthma.
Pleconaril is in Phase 2 clinical development. It is an investigational drug and has not been approved by the FDA. One Phase 2 trial has been completed, and the drug is not currently in any active clinical trials.
Pleconaril has been studied in one completed Phase 2 clinical trial, NCT00394914. This trial evaluated the effects of Pleconaril nasal spray on common cold symptoms and asthma exacerbations following rhinovirus exposure. The trial enrolled 311 participants.
Pleconaril is not known by any alternative names. It is a distinct investigational small molecule being developed by Merck & Company, Inc. for the treatment of asthma.