Effects of Pleconaril Nasal Spray on Common Cold Symptoms and Asthma Exacerbations Following Rhinovirus Exposure (Study P04295)(COMPLETED)

This study has been completed.
Sponsor:
Information provided by (Responsible Party):
Merck Sharp & Dohme Corp.
ClinicalTrials.gov Identifier:
NCT00394914
First received: October 31, 2006
Last updated: February 24, 2014
Last verified: February 2014
Results First Received: August 27, 2013  
Study Type: Interventional
Study Design: Allocation: Randomized;   Endpoint Classification: Safety/Efficacy Study;   Intervention Model: Parallel Assignment;   Masking: Double Blind (Subject, Investigator);   Primary Purpose: Prevention
Conditions: Asthma
Common Cold
Picornavirus Infection
Rhinovirus
Interventions: Drug: Pleconaril
Drug: Placebo to Pleconaril

  Participant Flow
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Recruitment Details
Key information relevant to the recruitment process for the overall study, such as dates of the recruitment period and locations
No text entered.

Pre-Assignment Details
Significant events and approaches for the overall study following participant enrollment, but prior to group assignment
All enrolled participants were screened. After the screening visit and before randomization, participants received weekly phone calls and revisited the site once per month during a Pre-exposure Period until exposed to a household member with a cold (index case).

Reporting Groups
  Description
All Participants (Pre-randomization) All participants on study prior to randomization.
Pleconaril Participants were randomized to 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 Participants were randomized to receive placebo nasal spray 4 sprays per nostril BID for 1 week during the Treatment Period for a total of 14 doses.

Participant Flow for 3 periods

Period 1:   Screening Period
    All Participants (Pre-randomization)     Pleconaril     Placebo  
STARTED     311     0     0  
COMPLETED     311     0     0  
NOT COMPLETED     0     0     0  

Period 2:   Pre-exposure Period
    All Participants (Pre-randomization)     Pleconaril     Placebo  
STARTED     311     0     0  
COMPLETED     311     0     0  
NOT COMPLETED     0     0     0  

Period 3:   Treatment Period
    All Participants (Pre-randomization)     Pleconaril     Placebo  
STARTED     0     154     157  
COMPLETED     0     144     151  
NOT COMPLETED     0     10     6  
Adverse Event                 0                 3                 1  
Lost to Follow-up                 0                 1                 0  
Withdrawal by Subject                 0                 2                 2  
Noncompliance with protocol                 0                 3                 2  
Did not meet protocol eligibility                 0                 1                 1  



  Baseline Characteristics
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Population Description
Explanation of how the number of participants for analysis was determined. Includes whether analysis was per protocol, intention to treat, or another method. Also provides relevant details such as imputation technique, as appropriate.
No text entered.

Reporting Groups
  Description
Pleconaril Participants received 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 Participants received placebo nasal spray 4 sprays per nostril BID for 1 week during the Treatment Period for a total of 14 doses.
Total Total of all reporting groups

Baseline Measures
    Pleconaril     Placebo     Total  
Number of Participants  
[units: participants]
  154     157     311  
Age  
[units: years]
Mean ± Standard Deviation
  29.4  ± 16.7     28.7  ± 17.3     29.1  ± 17.0  
Gender  
[units: participants]
     
Female     85     97     182  
Male     69     60     129  



  Outcome Measures
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1.  Primary:   Percentage of Participants With Rhinovirus PCR-Positive Colds   [ Time Frame: From time of exposure to index case to end of Follow-up Period (21 days) ]

2.  Primary:   Percentage of Participants With Asthma Exacerbations Together With Rhinovirus-Positive PCR   [ Time Frame: From time of exposure to index case to end of Follow-up Period (21 days) ]

3.  Secondary:   LS Mean Change From Baseline in the Asthma Control Questionnaire (ACQ)   [ Time Frame: Baseline through the Final Visit (Day 21) ]

4.  Secondary:   LS Mean Change From Baseline in Forced Expiratory Volume in 1 Second (FEV1)   [ Time Frame: Baseline through the Final Visit (Day 21) ]

5.  Secondary:   LS Mean Change From Baseline in Peak Expiratory Flow (PEF) in AM   [ Time Frame: Baseline through the Final Visit (Day 21) ]

6.  Secondary:   LS Mean Change From Baseline in Peak Expiratory Flow (PEF) in PM   [ Time Frame: Baseline through the Final Visit (Day 21) ]

7.  Secondary:   LS Mean Change From Baseline in Total Cold Symptom Score   [ Time Frame: Baseline through the Final Visit (Day 21) ]

8.  Secondary:   LS Mean Change From Baseline in Total Asthma Symptom Score   [ Time Frame: Baseline through the Final Visit (Day 21) ]

9.  Secondary:   LS Mean Change From Baseline in Short-acting Beta-Agonist (SABA) Rescue Medication Usage   [ Time Frame: Baseline through the Final Visit (Day 21) ]

10.  Secondary:   LS Mean Change From Baseline in Asthma-Related Sleep Interference   [ Time Frame: Baseline through the Final Visit (Day 21) ]


  Serious Adverse Events


  Other Adverse Events


  More Information
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Certain Agreements:  
Principal Investigators are NOT employed by the organization sponsoring the study.
There IS an agreement between Principal Investigators and the Sponsor (or its agents) that restricts the PI's rights to discuss or publish trial results after the trial is completed.
The agreement is:
unchecked The only disclosure restriction on the PI is that the sponsor can review results communications prior to public release and can embargo communications regarding trial results for a period that is less than or equal to 60 days. The sponsor cannot require changes to the communication and cannot extend the embargo.
unchecked The only disclosure restriction on the PI is that the sponsor can review results communications prior to public release and can embargo communications regarding trial results for a period that is more than 60 days but less than or equal to 180 days. The sponsor cannot require changes to the communication and cannot extend the embargo.


Limitations and Caveats
Limitations of the study, such as early termination leading to small numbers of participants analyzed and technical problems with measurement leading to unreliable or uninterpretable data
No text entered.  


Results Point of Contact:  
Name/Title: Senior Vice President, Global Clinical Development
Organization: Merck Sharp & Dohme Corp
e-mail: ClinicalTrialsDisclosure@merck.com


No publications provided


Responsible Party: Merck Sharp & Dohme Corp.
ClinicalTrials.gov Identifier: NCT00394914     History of Changes
Other Study ID Numbers: P04295, Doc ID: 3303796
Study First Received: October 31, 2006
Results First Received: August 27, 2013
Last Updated: February 24, 2014
Health Authority: United States: Food and Drug Administration