A Comparison of Mometasone Furoate DPI Versus Budesonide DPI in Budesonide DPI in Asthmatics (Study P04880)

• Sponsor: Organon and Co (Industry)
• Overall Status: Completed
• CT.gov ID: NCT00442117
• Collaborator: (none)
• Enrollment: 180
• Arms: 2
• Duration (Months): 25

Study Details

Study Description

Brief Summary

This study will be an open-label, parallel-group comparison of Mometasone Furoate Dry Powder Inhaler (MF-DPI) 200 mcg once daily in the evening with two puffs vs. Budesonide Dry Powder Inhaler (BUD-DPI) 200 mcg twice daily with two puffs each time in patients previously treated with inhaled corticosteroids (ICS) or without ICS with diagnosed mild persistent or moderate persistent asthma (classified as Global Initiative For Asthma, 2005) in the previous 4 weeks. The primary efficacy endpoint is percent change from baseline in FEV1.

Condition or Disease	Intervention/Treatment	Phase
Asthma	Drug: mometasone furoate dry powder inhaler; Drug: Budesonide DPI	Phase 3

Study Design

• Study Type: Interventional
• Actual Enrollment: 180 participants
• Allocation: Randomized
• Intervention Model: Parallel Assignment
• Masking: None (Open Label)
• Primary Purpose: Treatment
• Official Title: A Comparison of Mometasone Furoate DPI Versus Budesonide DPI in Mild Persistent and Moderate Persistent Asthmatic Patients
• Study Start Date: Jun 1, 2007
• Actual Primary Completion Date: Jul 1, 2009
• Actual Study Completion Date: Jul 1, 2009

Arms and Interventions

Arm	Intervention/Treatment
Experimental: MF-DPI MF DPI 200 mcg, two puffs once daily PM (total of 400 mcg/day)	Drug: mometasone furoate dry powder inhaler; MF DPI 200 mcg, two puffs once daily PM (total of 400 mcg/day) for 12 weeks.; Other Names: Asmanex
Active Comparator: BUD-DPI Budesonide (BUD) DPI 200 mcg, two puffs twice daily (total of 800 mcg/day)	Drug: Budesonide DPI; Budesonide (BUD) DPI 200 mcg, two puffs twice daily (total of 800 mcg/day) for 12 weeks.; Other Names: Pulmicort

Outcome Measures

Primary Outcome Measures

1. Mean Percent Change of Forced Expiratory Volume in One Second (FEV1) From Baseline to Week 12. [Baseline and Week 12]

   FEV1 (forced expiratory volume in one second) measurement at the Baseline visit was compared to the FEV1 measurement during the last visit at Week 12. The mean percent change was calculated.

Secondary Outcome Measures

1. Mean Percent Change of FVC (Forced Vital Capacity) From Baseline to Week 12. [Baseline and Week 12]

   The FVC measurement at the baseline was compared to the FVC measurement during the last visit at Week 12. The mean percent change was calculated.

2. Mean Percent Change of Forced Expiratory Flow (FEF) at (25-75% Interval) From Baseline to Week 12. [Baseline and Week 12]

   The FEF (25-75%) measurement at the baseline was compared to the FEF (25-75%) measurement during the last visit at Week 12. The mean percent change was calculated.

3. Mean Percent Change of AM PEFR (Peak Exploratory Flow Rate) From Baseline to Week 12. [Baseline and Week 12]

   The AM PEFR measurement at the Baseline visit was compared to the AM PEFR measurement during the last visit at Week 12. The mean percent change was calculated.

Eligibility Criteria

Criteria

• Ages Eligible for Study: 12 Years and Older
• Sexes Eligible for Study: All
• Accepts Healthy Volunteers: No

Inclusion Criteria:

• Subjects must be 12 years of age or older of either gender, who (and their parent/guardian if the subject is under the age of 20) must demonstrate their willingness to sign and write informed consent.

• Subjects must have had a history of asthma for at least 6 months.

• The subject must be diagnosed mild persistent or moderate persistent asthma and his/her FEV1 must be >= 60% of predicted normal at both the Screening and Baseline visits, when short-acting inhaled beta agonists have been withheld for at least six hours and long-acting inhaled beta agonists have been withheld for at least 12 hours.

• Subjects must demonstrate an increase in absolute FEV1 of >= 12%, with an absolute volume increase of at least 200 mL, after reversibility testing at the Screening visit, or historically within the past 12 months; Subjects without documented absolute FEV1 of >= 12% in reversibility test within the past 12 months need to demonstrate a positive result in Methacholine challenge test.

• If Subjects with ICS treatment have been using ICS on a daily basis for at least 4 weeks prior to Screening. For the two weeks prior to Screening, subjects must have been on a stable regimen of ICS. Each ICS dose is shown in following:

• Flunisolide between 1000 to 2000 mcg/day

• Budesonide between 400 to 800 mcg/day

• Triamcinolone acetonide between 600 to 1600 mcg/day

• Beclomethasone Dipropionate between 252 to 840 mcg/day

• Fluticasone propionate between 200 to 500 mcg/day

• Women of childbearing potential must have a negative urine (hCG) pregnancy test on the day of randomization (Baseline visit).

• Women of childbearing potential (includes women who are less than 1 year postmenopausal) must be using or agree to use an acceptable method of birth control (e.g., hormonal contraceptive, medically prescribed IUD, condom in combination with spermicide) or be surgically sterilized (e.g., hysterectomy or tubal ligation) if they become sexually active.

• Subjects must understand and be able to adhere to visit schedules and enter information in a daily diary.

Exclusion Criteria:

• Female subjects who are pregnant, breast-feeding, or are pre-menarcheal.

• Subjects who are heavy smokers (more than 10 pack years) or who smoked within previous 6 months.

• Subjects who have required daily or alternate day oral corticosteroid treatment for more than a total of 14 days during the 3 months immediately prior to the Screening visit, and/or subjects who have required a course of systemic corticosteroids within the previous month.

• Subjects who used Leukotriene modifiers within 2 weeks of screening.

• Subjects who took immunosuppressive agents within the previous 3 months.

• Subjects who use daily nebulized ß2-adrenergic agonists.

• Subjects who have had either an asthma exacerbation or a clinically relevant change in asthma medication within the last 4 weeks.

• Subjects who have been admitted to the hospital for asthma control within the previous 3 months or have needed emergency service for asthma more than once within the previous 6 months.

• Subjects who have required ventilator support for respiratory failure secondary to their asthma within the last 5 years.

• Subjects who have used any investigational drug in the 30 days prior to Baseline, or subjects who have been treated with any investigational antibody for asthma in the 90 days prior to Baseline.

• Subjects who are allergic or have had an idiosyncratic reaction to corticosteroids.

• Subjects with evidence of clinically significant oropharyngeal candidiasis at Screening or Baseline.

• Subjects with any clinically significant disorder of the cardiovascular, neurologic, hematologic, gastrointestinal, cerebrovascular, or immunologic system, or respiratory disease other than asthma (e.g. COPD), or any other disorder which may interfere with the study evaluations or affect subject safety.

Contacts and Locations

Locations

No locations specified.

Sponsors and Collaborators

• Organon and Co

Investigators

None specified.

Study Documents (Full-Text)

None provided.

More Information

Publications

None provided.

• Responsible Party: Organon and Co
• ClinicalTrials.gov Identifier: NCT00442117
• Other Study ID Numbers: P04880
• First Posted: Mar 1, 2007
• Last Update Posted: Feb 16, 2022
• Last Verified: Feb 1, 2022

• Individual Participant Data (IPD) Sharing Statement: Yes
• Plan to Share IPD: Yes
• Additional relevant MeSH terms: Asthma; Mometasone Furoate; Budesonide

Study Results

Participant Flow

Pre-assignment Detail	A total of 180 participants were enrolled and randomized. There were 8 participants who had taken at least one dose of study medication, but were not eligible for the study and therefore were withdrawn, resulting in the Intent-to-Treat (ITT) population of 172 participants.

Arm/Group Title	MF-DPI	BUD-DPI
Arm/Group Description	Mometasone Furoate Dry Powder Inhaler (MF DPI) 200 mcg, two puffs once daily in the evening (PM) (total of 400 mcg/day)	Budesonide Dry Powder Inhaler (BUD DPI) 200 mcg, two puffs twice daily (total of 800 mcg/day)
Period Title: Overall Study
STARTED	85	87
COMPLETED	47	49
NOT COMPLETED	38	38

Baseline Characteristics

Arm/Group Title	MF-DPI	BUD-DPI	Total
Arm/Group Description	Mometasone Furoate Dry Powder Inhaler (MF DPI) 200 mcg, two puffs once daily in the evening (PM) (total of 400 mcg/day)	Budesonide Dry Powder Inhaler (BUD DPI) 200 mcg, two puffs twice daily (total of 800 mcg/day)	Total of all reporting groups
Overall Participants	91	89	180
Age, Customized (participants) [Number]
Number [participants]	91 100%	89 100%	180 100%
Sex: Female, Male (Count of Participants)
Female	48 52.7%	40 44.9%	88 48.9%
Male	43 47.3%	49 55.1%	92 51.1%

Outcome Measures

1. Primary Outcome

Title	Mean Percent Change of Forced Expiratory Volume in One Second (FEV1) From Baseline to Week 12.
Description	FEV1 (forced expiratory volume in one second) measurement at the Baseline visit was compared to the FEV1 measurement during the last visit at Week 12. The mean percent change was calculated.
Time Frame	Baseline and Week 12

Outcome Measure Data

Analysis Population Description

Intent-to treat (ITT) population: All randomized patients who have taken at least one dose of study medication and have at least one post-baseline efficacy information.

Arm/Group Title	MF-DPI	BUD-DPI
Arm/Group Description	Mometasone Furoate Dry Powder Inhaler (MF DPI) 200 mcg, two puffs once daily in the evening (PM) (total of 400 mcg/day)	Budesonide Dry Powder Inhaler (BUD DPI) 200 mcg, two puffs twice daily (total of 800 mcg/day)
Measure Participants	85	87
Mean (Standard Deviation) [Percent Change of FEV1]	-1.09 (10.57)	-0.02 (10.17)

Statistical Analysis 1

Statistical Analysis Overview	Comparison Group Selection	MF-DPI, BUD-DPI
	Comments
	Type of Statistical Test	Superiority or Other (legacy)
	Comments
Statistical Test of Hypothesis	p-Value	0.4982
	Comments
	Method	ANOVA
	Comments
Method of Estimation	Estimation Parameter	Mean Difference (Final Values)
	Estimated Value	-1.074
	Confidence Interval	(2-Sided) 95%; -4.196 to 2.049
	Parameter Dispersion	Type: Value:
	Estimation Comments

2. Secondary Outcome

Title	Mean Percent Change of FVC (Forced Vital Capacity) From Baseline to Week 12.
Description	The FVC measurement at the baseline was compared to the FVC measurement during the last visit at Week 12. The mean percent change was calculated.
Time Frame	Baseline and Week 12

Outcome Measure Data

Analysis Population Description

Intent-to treat (ITT) population: All randomized patients who have taken at least one dose of study medication and have at least one post-baseline efficacy information.

Arm/Group Title	MF-DPI	BUD-DPI
Arm/Group Description	Mometasone Furoate Dry Powder Inhaler (MF DPI) 200 mcg, two puffs once daily in the evening (PM) (total of 400 mcg/day)	Budesonide Dry Powder Inhaler (BUD DPI) 200 mcg, two puffs twice daily (total of 800 mcg/day)
Measure Participants	85	87
Mean (Standard Deviation) [Percent Change of FVC]	-0.11 (10.91)	-0.88 (11.50)

Statistical Analysis 1

Statistical Analysis Overview	Comparison Group Selection	MF-DPI, BUD-DPI
	Comments
	Type of Statistical Test	Superiority or Other (legacy)
	Comments
Statistical Test of Hypothesis	p-Value	0.6544
	Comments
	Method	ANOVA
	Comments
Method of Estimation	Estimation Parameter	Mean Difference (Final Values)
	Estimated Value	0.7601
	Confidence Interval	(2-Sided) 95%; -2.585 to 4.106
	Parameter Dispersion	Type: Value:
	Estimation Comments

3. Secondary Outcome

Title	Mean Percent Change of Forced Expiratory Flow (FEF) at (25-75% Interval) From Baseline to Week 12.
Description	The FEF (25-75%) measurement at the baseline was compared to the FEF (25-75%) measurement during the last visit at Week 12. The mean percent change was calculated.
Time Frame	Baseline and Week 12

Outcome Measure Data

Analysis Population Description

Intent-to treat (ITT) population: All randomized patients who have taken at least one dose of study medication and have at least one post-baseline efficacy information.

Arm/Group Title	MF-DPI	BUD-DPI
Arm/Group Description	Mometasone Furoate Dry Powder Inhaler (MF DPI) 200 mcg, two puffs once daily in the evening (PM) (total of 400 mcg/day)	Budesonide Dry Powder Inhaler (BUD DPI) 200 mcg, two puffs twice daily (total of 800 mcg/day)
Measure Participants	85	87
Mean (Standard Deviation) [Percent Change of FEF]	0.01 (12.68)	1.72 (12.92)

Statistical Analysis 1

Statistical Analysis Overview	Comparison Group Selection	MF-DPI, BUD-DPI
	Comments
	Type of Statistical Test	Superiority or Other (legacy)
	Comments
Statistical Test of Hypothesis	p-Value	0.3796
	Comments
	Method	ANOVA
	Comments
Method of Estimation	Estimation Parameter	Mean Difference (Final Values)
	Estimated Value	-1.704
	Confidence Interval	(2-Sided) 95%; -5.528 to 2.115
	Parameter Dispersion	Type: Value:
	Estimation Comments

4. Secondary Outcome

Title	Mean Percent Change of AM PEFR (Peak Exploratory Flow Rate) From Baseline to Week 12.
Description	The AM PEFR measurement at the Baseline visit was compared to the AM PEFR measurement during the last visit at Week 12. The mean percent change was calculated.
Time Frame	Baseline and Week 12

Outcome Measure Data

Analysis Population Description

Intent-to treat (ITT) population: All randomized patients who have taken at least one dose of study medication and have at least one post-baseline efficacy information. Two participants in the MF-DPI group and three participants in the BUD-DPI group were excluded from the analysis.

Arm/Group Title	MF-DPI	BUD-DPI
Arm/Group Description	Mometasone Furoate Dry Powder Inhaler (MF DPI) 200 mcg, two puffs once daily in the evening (PM) (total of 400 mcg/day)	Budesonide Dry Powder Inhaler (BUD DPI) 200 mcg, two puffs twice daily (total of 800 mcg/day)
Measure Participants	83	84
Mean (Standard Deviation) [Percent Change of AM PEFR]	2.59 (42.36)	1.93 (71.02)

Statistical Analysis 1

Statistical Analysis Overview	Comparison Group Selection	MF-DPI, BUD-DPI
	Comments
	Type of Statistical Test	Superiority or Other (legacy)
	Comments
Statistical Test of Hypothesis	p-Value	0.9622
	Comments
	Method	ANOVA
	Comments
Method of Estimation	Estimation Parameter	Mean Difference (Final Values)
	Estimated Value	0.432
	Confidence Interval	(2-Sided) 95%; -17.560 to 18.240
	Parameter Dispersion	Type: Value:
	Estimation Comments

Adverse Events

Arm/Group Title	MF-DPI		BUD-DPI
Arm/Group Description	Mometasone Furoate Dry Powder Inhaler (MF DPI) 200 mcg, two puffs once daily in the evening (PM) (total of 400 mcg/day)		Budesonide Dry Powder Inhaler (BUD DPI) 200 mcg, two puffs twice daily (total of 800 mcg/day)
All Cause Mortality
	MF-DPI		BUD-DPI
	Affected / at Risk (%)	# Events	Affected / at Risk (%)	# Events
Total	/ (NaN)		/ (NaN)
Serious Adverse Events
	MF-DPI		BUD-DPI
	Affected / at Risk (%)	# Events	Affected / at Risk (%)	# Events
Total	3/91 (3.3%)		2/89 (2.2%)
Infections and infestations
cellulitis	2/91 (2.2%)	2	0/89 (0%)	0
Investigations
pregnancy test positive	0/91 (0%)	0	1/89 (1.1%)	1
Musculoskeletal and connective tissue disorders
spondylolisthesis	0/91 (0%)	0	1/89 (1.1%)	1
Respiratory, thoracic and mediastinal disorders
nasal polyps	1/91 (1.1%)	1	0/89 (0%)	0
Other (Not Including Serious) Adverse Events
	MF-DPI		BUD-DPI
	Affected / at Risk (%)	# Events	Affected / at Risk (%)	# Events
Total	13/91 (14.3%)		15/89 (16.9%)
Infections and infestations
upper respiratory tract infection	13/91 (14.3%)	14	15/89 (16.9%)	15

Limitations/Caveats

[Not Specified]

More Information

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.