Phase 2
N=311
Effects of Pleconaril Nasal Spray on Common Cold Symptoms and Asthma Exacerbations Following Rhinovirus Exposure (Study P04295)
Asthma · Common Cold · Picornavirus Infection · Rhinovirus
Bottom Line
View on ClinicalTrials.gov: NCT00394914 ↗Enrolled (actual)
311
Serious AEs
0.0%
Results posted
Oct 2013
Primary outcome: Primary: Percentage of Participants With Rhinovirus PCR-Positive Colds — 2.6; 2.5 percentage of participants — p=0.973
Study Design & Population
- Study type
- Interventional
- Phase
- Phase 2
- Interventions
- Pleconaril (Drug); Placebo to Pleconaril (Drug)
- Age
- Pediatric, Adult, Older Adult · 6+ yrs
- Sex
- All
- Sponsor
- Merck Sharp & Dohme LLC
- Primary completion
- Apr 2007
Outcome Measures
| Outcome | Result | p-value |
|---|---|---|
| PRIMARY Percentage of Participants With Rhinovirus PCR-Positive Colds |
2.6; 2.5 | 0.973 |
| PRIMARY Percentage of Participants With Asthma Exacerbations Together With Rhinovirus-Positive PCR |
1.3; 2.5 | 0.425 |
| SECONDARY LS Mean Change From Baseline in the Asthma Control Questionnaire (ACQ) |
0.86; 0.87; -0.11; -0.06; -0.09; -0.15 | — |
| SECONDARY LS Mean Change From Baseline in Forced Expiratory Volume in 1 Second (FEV1) |
2.335; 2.214; -0.091; -0.100; -0.059; -0.141 | — |
| SECONDARY LS Mean Change From Baseline in Peak Expiratory Flow (PEF) in AM |
306.2; 284.0; -0.1; -1.9; 9.9; 6.1 | — |
| SECONDARY LS Mean Change From Baseline in Peak Expiratory Flow (PEF) in PM |
310.9; 293.4; 0.4; 1.0; 2.0; 0.4 | — |
| SECONDARY LS Mean Change From Baseline in Total Cold Symptom Score |
1.09; 0.99; 0.03; 0.12; 0.21; 0.26 | — |
| SECONDARY LS Mean Change From Baseline in Total Asthma Symptom Score |
0.67; 0.56; 0.02; 0.08; 0.05; 0.07 | — |
| SECONDARY LS Mean Change From Baseline in Short-acting Beta-Agonist (SABA) Rescue Medication Usage |
0.99; 0.81; 0.15; -0.15; 0.19; -0.16 | — |
| SECONDARY LS Mean Change From Baseline in Asthma-Related Sleep Interference |
0.12; 0.07; 0.06; 0.01; 0.02; 0.04 | — |
Summary
This is a randomized, multi-center, double-blind, placebo-controlled study evaluating the efficacy of pleconaril nasal spray in preventing asthma exacerbation and common cold symptoms in asthmatic participants exposed to picornavirus respiratory infections. Participants will be assigned treatment with pleconaril or placebo nasal spray for 7 days (14 doses). Participants will be followed for an additional 14 days.
Eligibility Criteria
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 6 to 17 years of age, exacerbations for the purpose of the inclusion criteria, will be defined as:
- An increase of four or more puffs of a short-acting beta-agonist (SABA) per day for at least 3 consecutive days, or
- An increase of two or more nebulizations of a SABA per day for at least 3 consecutive days, or
- Documentation of morning (AM) peak flow drops >20% per day for at least 2 consecutive days, or
- Documentation of AM peak flow drops of ≥50% for at least 1 day.
- Must have been on a stable dose of any asthma medication (including immunotherapy) for at least 1 month prior to the Screening Visit.
- Must have a pre-bronchodilator FEV1 ≥50% predicted at the Screening Visit, when all prohibited medications have been withheld for the specified interval.
- If a reversibility test has not been performed within the previous 24 months, a participant, ≥17 years of age, must demonstrate an increase in absolute FEV1 of ≥12%, with an absolute volume increase of at least 200 mL. A participant 10 pack years.
- Allergy/sensitivity to the study drug or its excipients.
- Female who is breast-feeding, pregnant, or intends to become pregnant.
- Used any investigational drugs within 30 days of Screening.
- Participating in any other clinical study.
- Part of the staff personnel directly involved with this study.
- Family member of the investigational study staff.
Data sourced from ClinicalTrials.gov (NCT00394914). Outcome figures and adverse-event rates are extracted automatically from the registry's posted results and are provided for clinician reference, not as a substitute for the primary publication.