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The Effects of Montelukast on Smokers With Asthma

This study has been completed.
Sponsor:
Information provided by (Responsible Party):
Chang-Keun Kim, Dr., Inje University
ClinicalTrials.gov Identifier:
NCT00712335
First received: July 7, 2008
Last updated: April 18, 2012
Last verified: April 2012
Results First Received: November 16, 2011  
Study Type: Interventional
Study Design: Allocation: Randomized;   Endpoint Classification: Pharmacodynamics Study;   Intervention Model: Parallel Assignment;   Masking: Single Blind (Subject);   Primary Purpose: Diagnostic
Conditions: Asthmatic Smokers
Non-asthmatic Smokers
Interventions: Drug: Fluticasone Propionate
Drug: Montelukast
Drug: Salmeterol

  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
Recruitment period: January 2008-April 2011 Recruitment location: Asthma and Allergy Center, Inje University Sanggye Paik Hospital

Pre-Assignment Details
Significant events and approaches for the overall study following participant enrollment, but prior to group assignment
After randomization, a 10-day washout period followed in which subjects were taken off all medications except albuterol metered dose inhaler as needed. After the washout period, baseline induced sputum was obtained in each group along with primary and secondary endpoints. This was followed by a 3-week run in period.

Reporting Groups
  Description
Asthmatic Smokers Treated With Combination Therapy

Asthmatic smokers treated with combination therapy:

Fluticasone propionate dosage - DPI 250 mcg BID for 3 months Salmeterol dosage - DPI 50 mcg BID for 3 months

Asthmatic Smoker Treated With Montelukast Only

Asthmatic smoker treated with Montelukast only:

Montelukast dosage - PO 10 mg QHS for 3 months

Non-smoking Asthmatic Treated With Combination Therapy

Non-smoking asthmatic treated with combination therapy:

Fluticasone propionate dosage - DPI 250 mcg BID for 3 months Salmeterol dosage - DPI 50 mcg BID for 3 months

Non-smoking Asthmatic Treated With Montelukast Only

Non-smoking asthmatic treated with Montelukast only:

Montelukast dosage - PO 10 mg QHS for 3 months

Normal Controls Normal controls did not receive any treatment.

Participant Flow:   Overall Study
    Asthmatic Smokers Treated With Combination Therapy     Asthmatic Smoker Treated With Montelukast Only     Non-smoking Asthmatic Treated With Combination Therapy     Non-smoking Asthmatic Treated With Montelukast Only     Normal Controls  
STARTED     8     32     11     24     30  
COMPLETED     5     15     6     19     30  
NOT COMPLETED     3     17     5     5     0  
Withdrawal by Subject                 0                 7                 2                 3                 0  
Lost to Follow-up                 2                 5                 0                 1                 0  
Protocol Violation                 1                 2                 1                 0                 0  
Lack of Efficacy                 0                 0                 1                 1                 0  
Other Reason                 0                 3                 1                 0                 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
Asthmatic Smokers Treated With Combination Therapy

Asthmatic smokers treated with combination therapy:

Fluticasone propionate dosage - DPI 250 mcg BID for 3 months Salmeterol dosage - DPI 50 mcg BID for 3 months

Asthmatic Smoker Treated With Montelukast Only

Asthmatic smoker treated with Montelukast only:

Montelukast dosage - PO 10 mg QHS for 3 months

Non-smoking Asthmatic Treated With Combination Therapy

Non-smoking asthmatic treated with combination therapy:

Fluticasone propionate dosage - DPI 250 mcg BID for 3 months Salmeterol dosage - DPI 50 mcg BID for 3 months

Non-smoking Asthmatic Treated With Montelukast Only

Non-smoking asthmatic treated with Montelukast only:

Montelukast dosage - PO 10 mg QHS for 3 months

Normal Controls Normal controls did not receive any treatment.
Total Total of all reporting groups

Baseline Measures
    Asthmatic Smokers Treated With Combination Therapy     Asthmatic Smoker Treated With Montelukast Only     Non-smoking Asthmatic Treated With Combination Therapy     Non-smoking Asthmatic Treated With Montelukast Only     Normal Controls     Total  
Number of Participants  
[units: participants]
  8     32     11     24     30     105  
Age  
[units: participants]
           
<=18 years     0     0     0     0     0     0  
Between 18 and 65 years     8     32     11     24     30     105  
>=65 years     0     0     0     0     0     0  
Age  
[units: years]
Mean ± Standard Deviation
  51.38  ± 11.41     36.03  ± 8.52     45.64  ± 17.46     39.00  ± 14.79     40.55  ± 11.35     40.09  ± 4.24  
Gender  
[units: participants]
           
Female     3     5     4     22     22     56  
Male     5     27     7     2     8     49  
Region of Enrollment  
[units: participants]
           
Korea, Republic of     8     32     11     24     30     105  



  Outcome Measures
  Show All Outcome Measures

1.  Primary:   Sputum Neutrophil Percentages   [ Time Frame: 24 weeks ]

2.  Secondary:   Sputum Eosinophil Percentages   [ Time Frame: 24 weeks ]

3.  Secondary:   Sputum IL-8 Levels   [ Time Frame: 24 weeks ]

4.  Secondary:   Sputum GM-CSF Levels   [ Time Frame: 24 weeks ]

5.  Secondary:   Sputum IFN-gamma/IL-5 Ratios   [ Time Frame: 24 weeks ]

6.  Secondary:   Sputum Eotaxin Levels   [ Time Frame: 24 weeks ]

7.  Secondary:   Sputum RANTES Levels   [ Time Frame: 24 weeks ]


  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
It is difficult attaining representative gender ratios (i.e., representative of the general population) when conducting a smoking study in Korea, as smoking by females is still considered culturally taboo.


  More Information
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Certain Agreements:  
Principal Investigators are NOT employed by the organization sponsoring the study.
There is NOT 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.


Results Point of Contact:  
Name/Title: Dr. Chang-Keun Kim
Organization: Inje University
phone: 82-2-950-8832
e-mail: kimck@paik.ac.kr


No publications provided


Responsible Party: Chang-Keun Kim, Dr., Inje University
ClinicalTrials.gov Identifier: NCT00712335     History of Changes
Other Study ID Numbers: MASK2008
Study First Received: July 7, 2008
Results First Received: November 16, 2011
Last Updated: April 18, 2012
Health Authority: South Korea: Institutional Review Board