Two Investigational Drugs in the Prevention of Airway Constriction Brought on by Exercise in Participants With Asthma (0476-911)

This study has been completed.
Sponsor:
Information provided by (Responsible Party):
Merck Sharp & Dohme Corp.
ClinicalTrials.gov Identifier:
NCT00127166
First received: June 30, 2005
Last updated: August 24, 2015
Last verified: August 2015
Results First Received: June 16, 2009  
Study Type: Interventional
Study Design: Allocation: Randomized;   Endpoint Classification: Efficacy Study;   Intervention Model: Crossover Assignment;   Masking: Double Blind (Subject, Investigator);   Primary Purpose: Treatment
Condition: Exercise Induced Asthma
Interventions: Drug: Montelukast sodium
Drug: Salmeterol xinafoate
Drug: Fluticasone propionate
Drug: Montelukast matching placebo
Drug: Salmeterol matching placebo

  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
Multicenter Study (30 Ex-US sites) Study Initiation Date: December 22, 2005 Study Completion Date: November 14, 2008

Pre-Assignment Details
Significant events and approaches for the overall study following participant enrollment, but prior to group assignment

For randomization, patients fulfilled the following criteria:

  1. Forced Expiratory Volume in one second (FEV1) ≥70% predicted while withholding beta (β)-agonist for at least 6 hours
  2. Exercise-induced bronchoconstriction (EIB) showing FEV1 ≥15% reduction from baseline while on inhaled corticosteroids demonstrated twice during the run-in period.

Reporting Groups
  Description
Montelukast / Salmeterol Period I- Montelukast 5 milligrams (mg) oral tablet once daily and Salmeterol matching placebo dry powder inhaler (DPI) twice daily for 4 weeks followed by a 2-week washout period (salmeterol matching placebo + montelukast matching placebo). Period II- Montelukast matching placebo oral tablet once daily and Salmeterol DPI 50 micrograms (mcg) twice daily for 4 weeks. Inhaled Fluticasone 100 mcg twice daily throughout the study.
Salmeterol / Montelukast Period I- Montelukast matching placebo oral tablet once daily and Salmeterol DPI 50 mcg twice daily for 4 weeks followed by a 2-week washout period (salmeterol matching placebo + montelukast matching placebo). Period II- Montelukast 5 mg oral tablet once daily and Salmeterol matching placebo DPI twice daily for 4 weeks. Inhaled Fluticasone 100 mcg twice daily throughout the study.

Participant Flow for 3 periods

Period 1:   Period I
    Montelukast / Salmeterol     Salmeterol / Montelukast  
STARTED     78     76  
COMPLETED     75     74  
NOT COMPLETED     3     2  
Protocol Violation                 0                 2  
Withdrawal by Subject                 2                 0  
Patient did not meet inclusion criteria                 1                 0  

Period 2:   Washout Period
    Montelukast / Salmeterol     Salmeterol / Montelukast  
STARTED     75     74  
COMPLETED     75     73  
NOT COMPLETED     0     1  
Patient did not meet inclusion criteria                 0                 1  

Period 3:   Period II
    Montelukast / Salmeterol     Salmeterol / Montelukast  
STARTED     75     73  
COMPLETED     72     73  
NOT COMPLETED     3     0  
Withdrawal by Subject                 2                 0  
Patient did not perform Visit 6 exercise                 1                 0  



  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
Montelukast / Salmeterol Period I- Montelukast 5 milligrams (mg) oral tablet once daily and Salmeterol matching placebo dry powder inhaler (DPI) twice daily for 4 weeks followed by a 2-week washout period (salmeterol matching placebo + montelukast matching placebo). Period II- Montelukast matching placebo oral tablet once daily and Salmeterol DPI 50 micrograms (mcg) twice daily for 4 weeks. Inhaled Fluticasone 100 mcg twice daily throughout the study.
Salmeterol / Montelukast Period I- Montelukast matching placebo oral tablet once daily and Salmeterol DPI 50 mcg twice daily for 4 weeks followed by a 2-week washout period (salmeterol matching placebo + montelukast matching placebo). Period II- Montelukast 5 mg oral tablet once daily and Salmeterol matching placebo DPI twice daily for 4 weeks. Inhaled Fluticasone 100 mcg twice daily throughout the study.
Total Total of all reporting groups

Baseline Measures
    Montelukast / Salmeterol     Salmeterol / Montelukast     Total  
Number of Participants  
[units: participants]
  78     76     154  
Age  
[units: years]
Mean (Standard Deviation)
  10.2  (2.0)     9.8  (2.0)     10.0  (2.0)  
Gender  
[units: participants]
     
Female     35     30     65  
Male     43     46     89  
Race/Ethnicity, Customized  
[units: participants]
     
Asian     1     0     1  
Black     11     7     18  
White     38     41     79  
Other     28     28     56  
Area Under the Curve from 0 to 20 minutes (AUC0-20) [1]
[units: Percent times Minutes]
Mean (Standard Deviation)
  320.08  (208.62)     317.74  (165.71)     318.93  (188.06)  
Avg %-change from pre-exercise baseline FEV1 after 1st β-agonist use & prior to 2nd β-agonist use  
[units: Percent change from baseline]
Mean (Standard Deviation)
  1.36  (10.99)     4.78  (10.92)     3.05  (11.05)  
Maximum FEV1 percent predicted  
[units: Percent of predicted value]
Mean (Standard Deviation)
  99.88  (32.45)     100.54  (15.61)     100.21  (25.49)  
Maximum percent fall in FEV1 after exercise  
[units: Percent change from baseline]
Mean (Standard Deviation)
  24.77  (10.25)     25.42  (9.04)     25.09  (9.65)  
Time to recovery [2]
[units: Minutes]
Mean (Standard Deviation)
  23.53  (10.53)     21.51  (8.30)     22.53  (9.51)  
[1] Area Under the Curve for percent-change from pre-exercise baseline FEV1 in liters, from 0 to 20 minutes (AUC0-20)
[2] Montelukast / Salmeterol, n=71; Salmeterol / Montelukast, n=70



  Outcome Measures
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1.  Primary:   Maximum Post-exercise Percent (%) Fall in FEV1   [ Time Frame: 4 weeks (Weeks 0 to 4 or Weeks 6 to 10) ]

2.  Secondary:   Area Under the Curve for %-Change From Pre-exercise Baseline FEV1 in Liters (L), From 0 to 20 Minutes (AUC(0-20))   [ Time Frame: 4 weeks (Weeks 0 to 4 or Weeks 6 to 10) ]

3.  Secondary:   Maximum FEV1 % Predicted Following First Beta-agonist Use   [ Time Frame: 4 weeks (Weeks 0 to 4 or Weeks 6 to 10) ]

4.  Secondary:   Time to Recovery to Within 5% of Baseline FEV1   [ Time Frame: 4 weeks (Weeks 0 to 4 or Weeks 6 to 10) ]

5.  Secondary:   Average (Avg) %-Change in FEV1 After First Beta (β)-Agonist Use and Prior to Second β-agonist Use   [ Time Frame: 4 weeks (Weeks 0 to 4 or Weeks 6 to 10) ]


  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
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  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: Senior Vice President, Global Clinical Development
Organization: Merck Sharp & Dohme Corp.
phone: 1-800-672-6372
e-mail: ClinicalTrialsDisclosure@merck.com


Publications automatically indexed to this study by ClinicalTrials.gov Identifier (NCT Number):

Responsible Party: Merck Sharp & Dohme Corp.
ClinicalTrials.gov Identifier: NCT00127166     History of Changes
Other Study ID Numbers: 0476-911
2004_006 ( Other Identifier: Merck Registration Number )
Study First Received: June 30, 2005
Results First Received: June 16, 2009
Last Updated: August 24, 2015
Health Authority: Italy: Ministry of Health