Clinical Trial to Assess Efficacy, Safety, Treatment Adherence and Quality of Life Impact of Mometasone Furoate in Asthmatic Patients (Study P04879)(TERMINATED) (APEGO)

This study has been terminated.
Sponsor:
Information provided by (Responsible Party):
Merck Sharp & Dohme Corp.
ClinicalTrials.gov Identifier:
NCT00687531
First received: May 27, 2008
Last updated: April 29, 2014
Last verified: April 2014
Results First Received: June 17, 2011  
Study Type: Interventional
Study Design: Allocation: Non-Randomized;   Endpoint Classification: Efficacy Study;   Intervention Model: Single Group Assignment;   Masking: Open Label;   Primary Purpose: Treatment
Condition: Asthma
Intervention: Drug: Mometasone Furoate

  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
No text entered.

Reporting Groups
  Description
Mometasone Furoate Mometasone Furoate 400 mcg once daily in the evening through 12 weeks.

Participant Flow:   Overall Study
    Mometasone Furoate  
STARTED     385 [1]
RECEIVED TREATMENT     281  
COMPLETED     250  
NOT COMPLETED     135  
Did not meet protocol eligibility                 104  
Adverse Event                 5  
Lost to Follow-up                 26  
[1] Completed screening procedures



  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
Mometasone Furoate Mometasone Furoate 400 mcg once daily in the evening through 12 weeks.

Baseline Measures
    Mometasone Furoate  
Number of Participants  
[units: participants]
  281  
Age, Customized  
[units: participants]
 
Between 21 and 30 years     54  
Between 31 and 40 years     40  
Between 41 and 50 years     58  
Between 51 and 60 years     64  
Between 61 and 70 years     39  
Between 71 and 80 years     17  
Between 81 and 90 years     6  
Not Available to Report     3  
Gender, Customized  
[units: participants]
 
Female     199  
Male     81  
Not Available to Report     1  



  Outcome Measures
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1.  Primary:   Forced Expiratory Volume in 1 Second (FEV1)   [ Time Frame: Day 1 and Week 12 ]

2.  Secondary:   Morning (AM) and Evening (PM) Peak Expiratory Flow Rate (PEFR)   [ Time Frame: Day 1 and Week 12 ]

3.  Secondary:   Number of Items in the Asthma Quality of Life (QOL) Questionnaire and the General QOL Questionnaire That Had a Significant (Positive) Change From Baseline to Endpoint   [ Time Frame: Day 1 and Week 12 ]

4.  Secondary:   Morning and Evening Asthma Symptoms Based on a 3 Point Scale (4 Individual Symptoms) and 24 Points (Summed).   [ Time Frame: Day 1 and Week 12 ]

5.  Secondary:   Number of Nocturnal Awakenings   [ Time Frame: Day 1 and Week 12 ]

6.  Secondary:   Number of Puffs of Salbutamol Used Daily   [ Time Frame: Day 1 and Week 12 ]

7.  Secondary:   Investigator’s Assessment of Response to Therapy Based on a 5-point Scale   [ Time Frame: Baseline, Week 12 ]

8.  Secondary:   Patient’s Assessment of Response to Therapy Based on a 5-point Scale   [ Time Frame: Baseline, Week 12 ]

9.  Secondary:   Number of Participants With One or More Mild, Moderate or Severe Asthma Exacerbations   [ Time Frame: Day 1 and Week 12 ]

10.  Secondary:   Number of Participants Who Adhered to Treatment   [ Time Frame: Day 1 to Week 12 ]

11.  Secondary:   Number of Participants With Use of Rescue Medication in Each Episode   [ Time Frame: Day 1 and Week 12 ]


  Serious Adverse Events


  Other Adverse Events


  Limitations and Caveats
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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
Protocol deviations may have occurred that resulted in quality issues associated with reporting of the data.


  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.


Results Point of Contact:  
Name/Title: Vice President, Late Stage Development Group Leader
Organization: Merck Sharp & Dohme Corp
e-mail: ClinicalTrialsDisclosure@merck.com


No publications provided


Responsible Party: Merck Sharp & Dohme Corp.
ClinicalTrials.gov Identifier: NCT00687531     History of Changes
Other Study ID Numbers: P04879
Study First Received: May 27, 2008
Results First Received: June 17, 2011
Last Updated: April 29, 2014
Health Authority: Mexico: Federal Commission for Sanitary Risks Protection