The Addition of Montelukast to Fluticasone in the Treatment of Perennial Allergic Rhinitis

This study has been terminated.
(Difficulty in recruitment)
Sponsor:
Collaborator:
Merck Sharp & Dohme Corp.
Information provided by (Responsible Party):
University of Chicago
ClinicalTrials.gov Identifier:
NCT00119015
First received: July 1, 2005
Last updated: January 27, 2014
Last verified: January 2014
Results First Received: December 20, 2012  
Study Type: Interventional
Study Design: Allocation: Randomized;   Endpoint Classification: Efficacy Study;   Intervention Model: Parallel Assignment;   Masking: Double Blind (Subject, Investigator);   Primary Purpose: Treatment
Condition: Rhinitis, Allergic, Perennial
Interventions: Drug: Placebo
Drug: Montelukast
Drug: Fluticasone propionate

  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
Subjects were seen at the Nasal Physiology Laboratory at the University of Chicago.

Pre-Assignment Details
Significant events and approaches for the overall study following participant enrollment, but prior to group assignment
Those having residual symptoms (total nasal symptom score of 4+) after the open-label phase were randomized to montelukast or placebo for another two weeks in addition to fluticasone propionate. Of the 102 subjects in open-label phase, 54 with residual symptoms were randomized and are listed as "completed" in open-label period of participant flow.

Reporting Groups
  Description
Fluticasone Propionate Only Fluticasone propionate nasal spray - 2 sprays in each nostril once a day (200 micrograms daily)
Fluticasone Propionate+Montelukast

Fluticasone propionate nasal spray - 2 sprays in each nostril once a day (200 micrograms daily)

Montelukast - 10 mg po daily

Fluticasone Propionate+Placebo

Fluticasone propionate nasal spray - 2 sprays in each nostril once a day (200 micrograms daily)

Placebo - 10 mg po daily


Participant Flow for 2 periods

Period 1:   Open-Label Phase (2 Weeks)
    Fluticasone Propionate Only     Fluticasone Propionate+Montelukast     Fluticasone Propionate+Placebo  
STARTED     102     0     0  
COMPLETED     54     0     0  
NOT COMPLETED     48     0     0  
Did not have residual symptoms                 48                 0                 0  

Period 2:   Double-Blind, Randomized Phase (2 Weeks)
    Fluticasone Propionate Only     Fluticasone Propionate+Montelukast     Fluticasone Propionate+Placebo  
STARTED     0     28 [1]   26 [1]
COMPLETED     0     28     26  
NOT COMPLETED     0     0     0  
[1] Baseline Analysis Population



  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
Fluticasone Propionate + Montelukast

Fluticasone propionate nasal spray - 2 sprays in each nostril once a day for 2 weeks (200 micrograms daily)

Montelukast - 10 mg po daily for 2 weeks

Fluticasone Propionate + Placebo

Fluticasone propionate nasal spray - 2 sprays in each nostril once a day for 2 weeks (200 micrograms daily)

Placebo - 10 mg po daily for 2 weeks

Total Total of all reporting groups

Baseline Measures
    Fluticasone Propionate + Montelukast     Fluticasone Propionate + Placebo     Total  
Number of Participants  
[units: participants]
  28     26     54  
Age  
[units: years]
Mean ( Full Range )
  35  
  ( 19 to 56 )  
  32  
  ( 18 to 52 )  
  34  
  ( 18 to 56 )  
Gender  
[units: participants]
     
Female     20     15     35  
Male     8     11     19  
Race/Ethnicity, Customized  
[units: participants]
     
White     11     13     24  
Black or African American     16     11     27  
Hispanic     1     2     3  
Region of Enrollment  
[units: participants]
     
United States     28     26     54  



  Outcome Measures
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1.  Primary:   Change From Baseline in Total Nasal Symptom Score (TNSS) Over 2 Week Randomized Treatment Period   [ Time Frame: Baseline and 2 weeks ]

2.  Secondary:   Change From Baseline in Sneezing Symptom Score Over 2 Week Randomized Treatment Period   [ Time Frame: Baseline and 2 weeks ]

3.  Secondary:   Change From Baseline in Runny Nose Symptom Score Over 2 Week Randomized Treatment Period   [ Time Frame: Baseline and 2 weeks ]

4.  Secondary:   Change From Baseline in Stuffy Nose Symptom Score Over 2 Week Randomized Treatment Period   [ Time Frame: Baseline and 2 weeks ]

5.  Secondary:   Change From Baseline in Other Symptom Score Over 2 Week Randomized Treatment Period   [ Time Frame: Baseline and 2 weeks ]


  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 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.


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
Early termination of study due to difficulty recruiting  


Results Point of Contact:  
Name/Title: Robert Naclerio
Organization: University of Chicago
phone: (773) 702-0080
e-mail: rnacleri@surgery.bsd.uchicago.edu


Publications:

Publications automatically indexed to this study:

Responsible Party: University of Chicago
ClinicalTrials.gov Identifier: NCT00119015     History of Changes
Other Study ID Numbers: 13875B, SING-US-60-04
Study First Received: July 1, 2005
Results First Received: December 20, 2012
Last Updated: January 27, 2014
Health Authority: United States: Institutional Review Board