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A Study of the Equivalent Effectiveness of 400 mcg Mometasone Furoate Using Two Different Dry Powder Inhalers in Moderate Asthmatics (Study P04828)

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: NCT00521599
Recruitment Status : Completed
First Posted : August 28, 2007
Results First Posted : March 23, 2010
Last Update Posted : February 22, 2022
Sponsor:
Information provided by (Responsible Party):
Organon and Co

Study Type Interventional
Study Design Allocation: Randomized;   Intervention Model: Parallel Assignment;   Masking: Double (Participant, Investigator);   Primary Purpose: Treatment
Condition Asthma
Interventions Drug: Mometasone furoate dry powder inhaler
Drug: Placebo
Enrollment 672
Recruitment Details  
Pre-assignment Details  
Arm/Group Title MF DPI 2 x 100 mcg BID MF DPI 1 x 200 mcg BID Placebo BID
Hide Arm/Group Description 2 inhalations of mometasone furoate dry powder inhaler (MF DPI) 100 mcg plus 1 inhalation of placebo matching MF DPI 200 mcg twice daily (BID) for 8 weeks 1 inhalation of MF DPI 200 mcg plus 2 inhalations of placebo matching MF DPI 100 mcg twice daily for 8 weeks 2 inhalations of placebo matching MF DPI 100 mcg plus 1 inhalation of placebo matching MF DPI 200 mcg twice daily for 8 weeks
Period Title: Overall Study
Started 268 268 136
Completed 243 239 100
Not Completed 25 29 36
Reason Not Completed
Adverse Event             5             7             6
Treatment Failure             8             9             22
Lost to Follow-up             2             1             2
Withdrawal by Subject             3             5             1
Withdrawal by subject treatment related             3             1             2
Protocol Violation             2             4             2
Did not meet protocol eligibility             2             2             1
Arm/Group Title MF DPI 2 x 100 mcg BID MF DPI 1 x 200 mcg BID Placebo BID Total
Hide Arm/Group Description 2 inhalations of mometasone furoate dry powder inhaler (MF DPI) 100 mcg plus 1 inhalation of placebo matching MF DPI 200 mcg twice daily (BID) for 8 weeks 1 inhalation of MF DPI 200 mcg plus 2 inhalations of placebo matching MF DPI 100 mcg twice daily for 8 weeks 2 inhalations of placebo matching MF DPI 100 mcg plus 1 inhalation of placebo matching MF DPI 200 mcg twice daily for 8 weeks Total of all reporting groups
Overall Number of Baseline Participants 268 268 136 672
Hide Baseline Analysis Population Description
[Not Specified]
Age, Categorical  
Measure Type: Count of Participants
Unit of measure:  Participants
Number Analyzed 268 participants 268 participants 136 participants 672 participants
<=18 years
0
   0.0%
0
   0.0%
0
   0.0%
0
   0.0%
Between 18 and 65 years
259
  96.6%
255
  95.1%
131
  96.3%
645
  96.0%
>=65 years
9
   3.4%
13
   4.9%
5
   3.7%
27
   4.0%
Sex: Female, Male  
Measure Type: Count of Participants
Unit of measure:  Participants
Number Analyzed 268 participants 268 participants 136 participants 672 participants
Female
182
  67.9%
178
  66.4%
104
  76.5%
464
  69.0%
Male
86
  32.1%
90
  33.6%
32
  23.5%
208
  31.0%
1.Primary Outcome
Title Change From Baseline in the Average AM Peak Expiratory Flow (PEF) Over the 7 Days of Week 8.
Hide Description Week 8 End = The last 7 days of data with the last day within the range of Days 51 to 64.
Time Frame Baseline and Week 8 End
Hide Outcome Measure Data
Hide Analysis Population Description
All treated subjects included all but one placebo-treated subject from the All Randomized Subjects data set, who was randomized, but never treated in either the open-label or double-blind Treatment Periods due to non-compliance with the protocol
Arm/Group Title MF DPI 2 x 100 mcg BID MF DPI 1 x 200 mcg BID Placebo BID
Hide Arm/Group Description:
2 inhalations of mometasone furoate dry powder inhaler (MF DPI) 100 mcg plus 1 inhalation of placebo matching MF DPI 200 mcg twice daily (BID) for 8 weeks
1 inhalation of MF DPI 200 mcg plus 2 inhalations of placebo matching MF DPI 100 mcg twice daily for 8 weeks
2 inhalations of placebo matching MF DPI 100 mcg plus 1 inhalation of placebo matching MF DPI 200 mcg twice daily for 8 weeks
Overall Number of Participants Analyzed 268 268 136
Least Squares Mean (Standard Deviation)
Unit of Measure: liters/minute
Baseline 361.8  (96.7) 374.3  (96.7) 348.4  (96.7)
Week 8 End 6.03  (37.0) 7.65  (37.0) -7.93  (37.0)
Hide Statistical Analysis 1
Statistical Analysis Overview Comparison Group Selection MF DPI 2 x 100 mcg BID, MF DPI 1 x 200 mcg BID
Comments Week 8 End scores
Type of Statistical Test Non-Inferiority or Equivalence (legacy)
Comments assume n=240 per group and standard deviation (STD) = 45 L/min for AM Peak Flow Rate at Week 8. If the two actives are the same, 95% CI of their mean difference has 90% probability to be completely within +/- 15 L/min.
Statistical Test of Hypothesis P-Value 0.654
Comments [Not Specified]
Method ANOVA
Comments [Not Specified]
Method of Estimation Estimation Parameter Mean Difference (Net)
Estimated Value -1.62
Confidence Interval (2-Sided) 95%
-8.74 to 5.49
Parameter Dispersion
Type: Standard Deviation
Value: 37.0
Estimation Comments [Not Specified]
Hide Statistical Analysis 2
Statistical Analysis Overview Comparison Group Selection MF DPI 2 x 100 mcg BID, Placebo BID
Comments Week 8 End scores
Type of Statistical Test Superiority or Other (legacy)
Comments [Not Specified]
Statistical Test of Hypothesis P-Value 0.003
Comments [Not Specified]
Method ANOVA
Comments [Not Specified]
Hide Statistical Analysis 3
Statistical Analysis Overview Comparison Group Selection MF DPI 1 x 200 mcg BID, Placebo BID
Comments Week 8 End scores
Type of Statistical Test Superiority or Other (legacy)
Comments [Not Specified]
Statistical Test of Hypothesis P-Value 0.001
Comments [Not Specified]
Method ANOVA
Comments [Not Specified]
Time Frame [Not Specified]
Adverse Event Reporting Description [Not Specified]
 
Arm/Group Title OL 1 X 200 mcg BID MF DPI 2 x 100 mcg BID MF DPI 1 x 200 Mcg BID Placebo
Hide Arm/Group Description Open-label MF DPI 200 mcg BID 2 inhalations of MF DPI 100 mcg plus 1 inhalation of placebo matching MF DPI 200 mcg twice daily for 8 weeks 1 inhalation of mometasone furoate dry powder inhaler (MF DPI) 200 mcg plus 2 inhalations of placebo matching MF DPI 100 mcg twice daily (BID) for 8 weeks 2 inhalations of placebo matching MF DPI 100 mcg plus 1 inhalation of placebo matching MF DPI 200 mcg twice daily for 8 weeks
All-Cause Mortality
OL 1 X 200 mcg BID MF DPI 2 x 100 mcg BID MF DPI 1 x 200 Mcg BID Placebo
Affected / at Risk (%) Affected / at Risk (%) Affected / at Risk (%) Affected / at Risk (%)
Total   --/--      --/--      --/--      --/--    
Hide Serious Adverse Events
OL 1 X 200 mcg BID MF DPI 2 x 100 mcg BID MF DPI 1 x 200 Mcg BID Placebo
Affected / at Risk (%) # Events Affected / at Risk (%) # Events Affected / at Risk (%) # Events Affected / at Risk (%) # Events
Total   1/950 (0.11%)      3/268 (1.12%)      2/268 (0.75%)      2/135 (1.48%)    
Gastrointestinal disorders         
OESOPHAGEAL RUPTURE  1  0/950 (0.00%)  0 1/268 (0.37%)  1 0/268 (0.00%)  0 0/135 (0.00%)  0
SMALL INTESTINAL OBSTRUCTION  1  0/950 (0.00%)  0 0/268 (0.00%)  0 1/268 (0.37%)  1 0/135 (0.00%)  0
General disorders         
CHEST PAIN  1  1/950 (0.11%)  1 0/268 (0.00%)  0 0/268 (0.00%)  0 0/135 (0.00%)  0
Infections and infestations         
DIVERTICULITIS  1  0/950 (0.00%)  0 1/268 (0.37%)  1 0/268 (0.00%)  0 0/135 (0.00%)  0
POST PROCEDURAL INFECTION  1  0/950 (0.00%)  0 0/268 (0.00%)  0 1/268 (0.37%)  1 0/135 (0.00%)  0
Injury, poisoning and procedural complications         
JOINT DISLOCATION  1  0/950 (0.00%)  0 0/268 (0.00%)  0 0/268 (0.00%)  0 1/135 (0.74%)  1
LOWER LIMB FRACTURE  1  0/950 (0.00%)  0 0/268 (0.00%)  0 0/268 (0.00%)  0 1/135 (0.74%)  1
MULTIPLE INJURIES  1  0/950 (0.00%)  0 0/268 (0.00%)  0 0/268 (0.00%)  0 1/135 (0.74%)  1
OPEN FRACTURE  1  0/950 (0.00%)  0 0/268 (0.00%)  0 0/268 (0.00%)  0 1/135 (0.74%)  1
Renal and urinary disorders         
NEPHROLITHIASIS  1  0/950 (0.00%)  0 1/268 (0.37%)  1 0/268 (0.00%)  0 0/135 (0.00%)  0
Respiratory, thoracic and mediastinal disorders         
ASTHMA  1  1/950 (0.11%)  1 0/268 (0.00%)  0 0/268 (0.00%)  0 1/135 (0.74%)  1
Indicates events were collected by systematic assessment
1
Term from vocabulary, MedDRA 12.0
Hide Other (Not Including Serious) Adverse Events
Frequency Threshold for Reporting Other Adverse Events 5%
OL 1 X 200 mcg BID MF DPI 2 x 100 mcg BID MF DPI 1 x 200 Mcg BID Placebo
Affected / at Risk (%) # Events Affected / at Risk (%) # Events Affected / at Risk (%) # Events Affected / at Risk (%) # Events
Total   10/950 (1.05%)      19/268 (7.09%)      30/268 (11.19%)      16/135 (11.85%)    
Infections and infestations         
NASOPHARYNGITIS  1  6/950 (0.63%)  6 10/268 (3.73%)  10 16/268 (5.97%)  16 6/135 (4.44%)  8
UPPER RESPIRATORY TRACT INFECTION  1  4/950 (0.42%)  4 10/268 (3.73%)  11 14/268 (5.22%)  14 10/135 (7.41%)  10
Indicates events were collected by systematic assessment
1
Term from vocabulary, MedDRA 12.0
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 investigator agrees not to publish or publicly present any interim results of the study without the prior written consent of sponsor. The investigator further agrees to provide the sponsor 45 days prior to submission for publication or presentation, review copies of abstracts or manuscripts for publication. The sponsor has the right to review and comment. If the parties disagree, the investigator agrees to meet with the sponsor's representative in order to resolve such issues.
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.
EMail: ClinicalTrialsDisclosure@merck.com
Layout table for additonal information
Responsible Party: Organon and Co
ClinicalTrials.gov Identifier: NCT00521599    
Other Study ID Numbers: P04828
First Submitted: August 27, 2007
First Posted: August 28, 2007
Results First Submitted: February 26, 2010
Results First Posted: March 23, 2010
Last Update Posted: February 22, 2022