Working…
ClinicalTrials.gov
ClinicalTrials.gov Menu

MK0476 Study in Adult Patients With Acute Asthma (0476-322)

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details.
 
ClinicalTrials.gov Identifier: NCT00229970
Recruitment Status : Completed
First Posted : September 30, 2005
Results First Posted : July 17, 2009
Last Update Posted : May 21, 2015
Sponsor:
Information provided by (Responsible Party):
Merck Sharp & Dohme Corp.

Study Type Interventional
Study Design Allocation: Randomized;   Intervention Model: Parallel Assignment;   Masking: Double (Participant, Investigator);   Primary Purpose: Treatment
Condition Asthma
Interventions Drug: montelukast sodium
Drug: Comparator: Placebo
Enrollment 225
Recruitment Details

Phase III.

Studied period: September 12, 2005 (date study drug was first administered to first patient) to October 23, 2006 (date study drug was last administered to last patient). Study was conducted at 64 clinical sites.

Pre-assignment Details Patients with acute exacerbation of bronchial asthma received standard treatments of inhaled β-agonist or oxygen inhalation to treat the acute exacerbations during the 60 minutes in the screening period before the study randomization.
Arm/Group Title Montelukast 7 mg Montelukast 14 mg Placebo
Hide Arm/Group Description Montelukast 7 mg Intravenous Administration Montelukast 14 mg Intravenous Administration Placebo Intravenous Administration
Period Title: Overall Study
Started 78 72 75
Completed 78 72 75
Not Completed 0 0 0
Arm/Group Title Montelukast 7 mg Montelukast 14 mg Placebo Total
Hide Arm/Group Description Montelukast 7 mg Intravenous Administration Montelukast 14 mg Intravenous Administration Placebo Intravenous Administration Total of all reporting groups
Overall Number of Baseline Participants 78 72 75 225
Hide Baseline Analysis Population Description
[Not Specified]
Age, Continuous  
Mean (Standard Deviation)
Unit of measure:  Years
Number Analyzed 78 participants 72 participants 75 participants 225 participants
40.5  (12.5) 41.5  (13.1) 42.3  (12.5) 41.4  (12.7)
Sex: Female, Male  
Measure Type: Count of Participants
Unit of measure:  Participants
Number Analyzed 78 participants 72 participants 75 participants 225 participants
Female
41
  52.6%
34
  47.2%
36
  48.0%
111
  49.3%
Male
37
  47.4%
38
  52.8%
39
  52.0%
114
  50.7%
Asthma Attack Severity based on Asthma Prevention and Management Guideline 2003, Japan   [1] 
Measure Type: Number
Unit of measure:  Participants
Number Analyzed 78 participants 72 participants 75 participants 225 participants
Mild 54 44 56 154
Moderate 23 28 19 70
Severe 1 0 0 1
Serious 0 0 0 0
[1]
Measure Description: Mild (Peak Expiratory Flow: 70%-80%), Moderate (Peak Expiratory Flow: 50%-70%), Severe (Peak Expiratory Flow: <=50%) or Serious (Peak Expiratory Flow: incapable measurement, cyanosis, head trip, disturbed consciousness, incontinence or asphyxia)
Baseline Forced Expiratory Volume in One Second (FEV1)  
Mean (Standard Deviation)
Unit of measure:  Liter
Number Analyzed 78 participants 72 participants 75 participants 225 participants
1.67  (0.55) 1.62  (0.59) 1.76  (0.61) 1.68  (0.58)
Duration of Asthma  
Mean (Standard Deviation)
Unit of measure:  Years
Number Analyzed 78 participants 72 participants 75 participants 225 participants
18.7  (11.5) 15.46  (11.6) 17.7  (11.7) 17.3  (11.6)
1.Primary Outcome
Title The Time-weighted Average of Change in Forced Expiratory Volume in One Second (FEV1)
Hide Description The Time Weighed Average Changes in Forced Expiratory Volume in One Second (FEV1) from pre-allocation baseline over the first 60 minutes after study drug administration with time interval between any measurement and the measurement prior to it is used as the weighting factor
Time Frame baseline over the first 60 minutes
Hide Outcome Measure Data
Hide Analysis Population Description
Last observed value during the 60 minutes treatment period was used in the Full Analysis Set (FAS)
Arm/Group Title Montelukast 7 mg Montelukast 14 mg Placebo
Hide Arm/Group Description:
Montelukast 7 mg Intravenous Administration
Montelukast 14 mg Intravenous Administration
Placebo Intravenous Administration
Overall Number of Participants Analyzed 78 72 75
Least Squares Mean (95% Confidence Interval)
Unit of Measure: Liter
0.09
(0.04 to 0.15)
0.17
(0.12 to 0.23)
0.01
(-0.05 to 0.06)
Show Statistical Analysis 1 Hide Statistical Analysis 1
Statistical Analysis Overview Comparison Group Selection Montelukast 7 mg, Placebo
Comments [Not Specified]
Type of Statistical Test Superiority or Other
Comments [Not Specified]
Statistical Test of Hypothesis P-Value 0.022
Comments [Not Specified]
Method ANCOVA
Comments The model included a factor for treatment and using the baseline Forced Expiratory Volume in One Second (FEV1) as a covariate.
Method of Estimation Estimation Parameter Mean Difference (Final Values)
Estimated Value 0.09
Confidence Interval 95%
0.01 to 0.16
Estimation Comments [Not Specified]
Show Statistical Analysis 2 Hide Statistical Analysis 2
Statistical Analysis Overview Comparison Group Selection Montelukast 14 mg, Placebo
Comments [Not Specified]
Type of Statistical Test Superiority or Other
Comments [Not Specified]
Statistical Test of Hypothesis P-Value <0.001
Comments [Not Specified]
Method ANCOVA
Comments The model included a factor for treatment and using the baseline Forced Expiratory Volume in One Second (FEV1) as a covariate.
Method of Estimation Estimation Parameter Mean Difference (Final Values)
Estimated Value 0.17
Confidence Interval 95%
0.09 to 0.24
Estimation Comments [Not Specified]
Time Frame [Not Specified]
Adverse Event Reporting Description [Not Specified]
 
Arm/Group Title Montelukast 7 mg Montelukast 14 mg Placebo
Hide Arm/Group Description Montelukast 7 mg Intravenous Administration Montelukast 14 mg Intravenous Administration Placebo Intravenous Administration
All-Cause Mortality
Montelukast 7 mg Montelukast 14 mg Placebo
Affected / at Risk (%) Affected / at Risk (%) Affected / at Risk (%)
Total   --/--   --/--   --/-- 
Show Serious Adverse Events Hide Serious Adverse Events
Montelukast 7 mg Montelukast 14 mg Placebo
Affected / at Risk (%) Affected / at Risk (%) Affected / at Risk (%)
Total   2   4   4 
Gastrointestinal disorders       
Abdominal pain *  0/78 (0.00%)  0/72 (0.00%)  1/75 (1.33%) 
Gastritis *  1/78 (1.28%)  0/72 (0.00%)  0/75 (0.00%) 
Infections and infestations       
Acute tonsillitis *  0/78 (0.00%)  0/72 (0.00%)  1/75 (1.33%) 
Respiratory, thoracic and mediastinal disorders       
Asthma *  1/78 (1.28%)  4/72 (5.56%)  2/75 (2.67%) 
*
Indicates events were collected by non-systematic assessment
Show Other (Not Including Serious) Adverse Events Hide Other (Not Including Serious) Adverse Events
Frequency Threshold for Reporting Other Adverse Events 2%
Montelukast 7 mg Montelukast 14 mg Placebo
Affected / at Risk (%) Affected / at Risk (%) Affected / at Risk (%)
Total   23   11   13 
General disorders       
Chest pain *  0/78 (0.00%)  0/72 (0.00%)  2/75 (2.67%) 
Infections and infestations       
Bronchitis acute *  0/78 (0.00%)  2/72 (2.78%)  0/75 (0.00%) 
Nasopharyngitis *  5/78 (6.41%)  2/72 (2.78%)  5/75 (6.67%) 
Investigations       
Blood bilirubin increased *  2/77 (2.60%)  0/72 (0.00%)  0/75 (0.00%) 
Blood potassium decreased *  2/76 (2.63%)  0/72 (0.00%)  1/73 (1.37%) 
Blood urine present *  1/75 (1.33%)  2/70 (2.86%)  1/75 (1.33%) 
Glucose urine present *  4/75 (5.33%)  0/70 (0.00%)  1/75 (1.33%) 
Protein urine present *  2/75 (2.67%)  0/70 (0.00%)  1/75 (1.33%) 
White blood cell count increased *  4/77 (5.19%)  4/70 (5.71%)  2/75 (2.67%) 
Nervous system disorders       
Headache *  1/78 (1.28%)  0/72 (0.00%)  2/75 (2.67%) 
Respiratory, thoracic and mediastinal disorders       
Upper respiratory tract inflammation *  4/78 (5.13%)  1/72 (1.39%)  0/75 (0.00%) 
*
Indicates events were collected by non-systematic assessment
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.
Merck agreements may vary with individual investigators, but will not prohibit any investigator from publishing. Merck supports the publication of results from all centers of a multi-center trial but requests that reports based on single-site data not precede the primary publication of the entire clinical trial.
Results Point of Contact
Layout table for Results Point of Contact information
Name/Title: Senior Vice President, Global Clinical Development
Organization: Merck Sharp & Dohme Corp.
Phone: 1-800-672-6372
EMail: ClinicalTrialsDisclosure@merck.com
Layout table for additonal information
Responsible Party: Merck Sharp & Dohme Corp.
ClinicalTrials.gov Identifier: NCT00229970     History of Changes
Other Study ID Numbers: 0476-322
MK0476-322
2005_084
First Submitted: September 28, 2005
First Posted: September 30, 2005
Results First Submitted: May 22, 2009
Results First Posted: July 17, 2009
Last Update Posted: May 21, 2015