Clinical Trials Logo

Clinical Trial Details — Status: Completed

Administrative data

NCT number NCT00635882
Other study ID # P05122
Secondary ID
Status Completed
Phase Phase 2
First received
Last updated
Start date February 2008
Est. completion date June 2009

Study information

Verified date February 2022
Source Organon and Co
Contact n/a
Is FDA regulated No
Health authority
Study type Interventional

Clinical Trial Summary

This is a 2-week double-blind, placebo-controlled, parallel group study comparing the anti-inflammatory effects of low, medium, and high dose mometasone furoate/formoterol fumarate (MF/F) metered dose inhaler (MDI) formulation and medium dose mometasone furoate (MF) dry powder inhaler (DPI) and MDI formulations in adults and adolescents with persistent allergic asthma.


Description:

This is a 2-week double-blind, placebo-controlled, parallel group study comparing the anti-inflammatory effects of low, medium, and high dose mometasone furoate/formoterol fumarate MDI formulation and medium dose mometasone furoate (MF) DPI and MDI formulations in adults and adolescents with persistent allergic asthma. An open-label run in period is to be followed by a double-blind treatment period. A total of 90 subjects (15 per treatment) will be enrolled to ensure 12 subjects per treatment at the Day 14 evaluation, accounting for a 20% drop-out rate. A sample size of 12 subjects per treatment is required to detect a treatment difference of 28% in percent change of eNO at Day 14, assuming a pooled standard deviation of 20% with a power of 90%. These estimates are based on examination of eNO levels in asthmatic vs healthy subjects in an article written by S.A. Kharitonov et. al, 2003. Subjects will be randomized to one of six treatment groups (MF/F MDI 100/10 mcg BID, MF/F MDI 200/10 mcg BID, MF/F MDI 400/10 mcg BID, MF DPI 200 mcg BID, MF MDI 200 mcg BID, or Placebo MDI BID) according to an Schering-Plough Research Institute (SPRI) computer-generated randomization schedule. Randomization will be performed in appropriately sized blocks using random numbers generated by statistical analysis software (SAS).


Recruitment information / eligibility

Status Completed
Enrollment 93
Est. completion date June 2009
Est. primary completion date June 2009
Accepts healthy volunteers No
Gender All
Age group 12 Years and older
Eligibility Inclusion Criteria: - To document asthma diagnosis, historical reversibility defined as an increase in absolute forced expiratory volume (in liters) in 1 second (FEV1) of >= 12% and >= 200 mL must have been performed within 12 months of Screening. For subjects without historical reversibility, one of the following methods can be used at the Screening Visit or at any time before the Baseline Visit: - Demonstration of an increase in absolute FEV1 of at least 12% and a volume increase of at least 200 mL within 15-20 minutes after administration of 4 inhalations of albuterol/salbutamol (total dose 360 to 400 mcg) or of nebulized short-acting beta agonist (SABA) (2.5 mg), if confirmed as standard office practice, OR - Demonstration of a peak expiratory flow (PEF) variability of more than 20% expressed as a percentage of the mean highest and lowest morning prebronchodilator PEF over at least 1 week, OR - Demonstration of a diurnal variation PEF of more than 20% based on the difference between the prebronchodilator (before taking albuterol/salbutamol) morning value and the postbronchodilator value (after taking albuterol/salbutamol) from the evening before, expressed as a percentage of the mean daily PEF value on any day during the open-label Run-in Period. {The calculation formula: Diurnal PEF Variation = Absolute [(highest of 3 readings, PM Post-bronchodilator (BD) PEF from prior evening) - (highest of 3 readings, AM Pre-BD from morning value)]/[(highest PM Post-BD + highest AM Pre-BD)/2] * 100} - At Screening and Baseline Visits, a subject must have persistent allergic asthma with an FEV1 >65% predicted. - A subject must be allergic to at least one common allergen (grasses, trees, weeds, house dust mites, molds, dog and cat) as demonstrated by clinical symptoms when exposed to the allergen(s), and by skin prick testing or a radioallergosorbent (RAST) class >1 (excluding modified RAST procedure [mRAST]) within 2 years of inclusion in the study. - If, based upon the medical judgment of the investigator, there is no inherent harm in changing the subject's current asthma therapy, the subject and/or parent/guardian) must agree to discontinue prescribed inhaled corticosteroid (ICS), anticholinergics, leukotriene receptor inhibitors, and long-acting beta-2 agonists at the Screening Visit as per required washouts, and be transferred to treatment with SABA for relief for 2 weeks before the Baseline/Randomization Visit. - Clinical laboratory tests (complete blood count, blood chemistries, and urinalysis) conducted at the Screening Visit must be within normal limits or clinically acceptable to the investigator. - An electrocardiogram (ECG) performed at the Screening Visit or within 30 days prior to Screening Visit must be clinically acceptable to the investigator and have a QTc interval <440 milliseconds for males and <450 msec for females. - At Screening or any time prior to Baseline, a subject must have an eNO level of >30 parts per billion (ppb) at a flow rate of 50 mL/second. - At Screening or any time before Baseline, a subject must have a sputum eosinophil count >3% of total cell count. - Willingness to give written informed consent and ability to adhere to dose and visit schedules. A subject 12 to 17 years of age must also provide written assent. - A nonpregnant female subject of childbearing potential (with a negative serum pregnancy test at Screening) must use a medically acceptable, adequate form of birth control. If not currently sexually active she must agree to use a double-barrier method if she becomes sexually active during the study. Exclusion Criteria: - Use of systemic glucocorticosteroids within 3 months before Screening. - Upper or lower respiratory tract infection within 4 weeks before Screening. - Decrease in absolute FEV1 >20% between Screening and Baseline Visits. - Requirement for > 8 inhalations per day of SABA MDI, or 2 or more nebulized treatments of 2.5 mg SABA, on any 2 consecutive days between the Screening and Baseline Visits. - A decrease in AM or PM PEF below the Run-in Period stability limit on any 2 consecutive days before Baseline. At Visit 1, the Run-in Period stability limit for PEF will be established based on the subject's personal best. If the subject does not have a historical personal best, the historical PEF measurement will be the PEF predicted based on the subject's sex, age, and height. PEF value to be multiplied by 0.70 to determine stability limit. - A clinical asthma exacerbation defined as a clinical deterioration of asthma that results in emergency treatment, hospitalization for asthma, or treatment with additional, excluded asthma medication (including oral or other systemic corticosteroids but allowing SABA), as per investigator, between Screening and Baseline Visits. - Inability to induce sputum after 1 or 2 trys.

Study Design


Related Conditions & MeSH terms


Intervention

Drug:
mometasone furoate/formoterol 100/10 mcg
mometasone furoate/formoterol 100/10 mcg twice daily (BID) (two inhalations of MF/F 50/5 from a metered-dose inhaler) for 14 days
mometasone furoate/formoterol 200/10 mcg
mometasone furoate/formoterol 200/10 mcg twice daily (BID) (two inhalations of MF/F 100/5 from a metered-dose inhaler) for 14 days
mometasone furoate/formoterol 400/10 mcg
mometasone furoate/formoterol 400/10 mcg twice daily (BID) (two inhalations of MF/F 200/5 mcg from a metered-dose inhaler) for 14 days
MF DPI 200 mcg
MF DPI 200 mcg twice daily (BID) (one inhalation of MF DPI 200 mcg) for 14 days
MF MDI 200 mcg
MF MDI 200 mcg twice daily (BID) (two inhalations of MF MDI 100 mcg) for 14 days
Placebo
MF/F MDI placebo twice daily (BID) (2 inhalations)

Locations

Country Name City State
n/a

Sponsors (1)

Lead Sponsor Collaborator
Organon and Co

Outcome

Type Measure Description Time frame Safety issue
Other Baseline Exhaled Nitric Oxide (eNO) Parts Per Billion (Ppb) Baseline
Primary Mean Percent Change From Baseline to Day 14 in Exhaled Nitric Oxide (eNO) Parts Per Billion (Ppb) Baseline to Day 14
Secondary Mean Percent Change From Baseline to Day 7 in eNO Ppb Baseline to Day 7
Secondary Mean Percent Change From Baseline to Day 14 in Sputum Eosinophil Count (Percentage) Baseline to Day 14
Secondary Mean Change From Baseline to Day 15 of Mannitol Challenge Mannitol challenge (also referred to as PD15) is the provocative dose of mannitol required to produce a 15% reduction in the forced expiratory volume (in liters) in one second (FEV1). Baseline to Day 15
Secondary Change From Baseline in AM Total Asthma Symptom Score at Days 2-15 Twice daily, participants rated the following asthma symptoms as experienced during the time period since the last evaluation: wheezing, difficulty breathing, and cough on a scale of 0 (none) to 3 (severe, very uncomfortable and interfered with most or all of normal daily activities/sleep). The total asthma symptom score ranged from 0 to 9. The results were recorded in the participant's diary. Baseline and Days 2-15
Secondary Change From Baseline in PM Total Asthma Symptom Score at Days 1-15 Twice daily, participants rated the following asthma symptoms as experienced during the time period since the last evaluation: wheezing, difficulty breathing, and cough on a scale of 0 (none) to 3 (severe, very uncomfortable and interfered with most or all of normal daily activities/sleep). The total asthma symptom score ranged from 0 to 9. The results were recorded in the participant's diary. Baseline and Days 1-15
Secondary Change From Baseline in AM Peak Expiratory Flow (PEF) at Days 2-15 Baseline and Days 2-15
Secondary Change From Baseline in PM PEF at Days 1-15 Baseline and Days 1-15
See also
  Status Clinical Trial Phase
Terminated NCT04410523 - Study of Efficacy and Safety of CSJ117 in Patients With Severe Uncontrolled Asthma Phase 2
Completed NCT04624425 - Additional Effects of Segmental Breathing In Asthma N/A
Active, not recruiting NCT03927820 - A Pharmacist-Led Intervention to Increase Inhaler Access and Reduce Hospital Readmissions (PILLAR) N/A
Completed NCT04617015 - Defining and Treating Depression-related Asthma Early Phase 1
Recruiting NCT03694158 - Investigating Dupilumab's Effect in Asthma by Genotype Phase 4
Terminated NCT04946318 - Study of Safety of CSJ117 in Participants With Moderate to Severe Uncontrolled Asthma Phase 2
Completed NCT04450108 - Vivatmo Pro™ for Fractional Exhaled Nitric Oxide (FeNO) Monitoring in U.S. Asthmatic Patients N/A
Completed NCT03086460 - A Dose Ranging Study With CHF 1531 in Subjects With Asthma (FLASH) Phase 2
Completed NCT01160224 - Oral GW766944 (Oral CCR3 Antagonist) Phase 2
Completed NCT03186209 - Efficacy and Safety Study of Benralizumab in Patients With Uncontrolled Asthma on Medium to High Dose Inhaled Corticosteroid Plus LABA (MIRACLE) Phase 3
Completed NCT02502734 - Effect of Inhaled Fluticasone Furoate on Short-term Growth in Paediatric Subjects With Asthma Phase 3
Completed NCT01715844 - L-Citrulline Supplementation Pilot Study for Overweight Late Onset Asthmatics Phase 1
Terminated NCT04993443 - First-In-Human Study to Evaluate the Safety, Tolerability, Immunogenicity, and Pharmacokinetics of LQ036 Phase 1
Completed NCT02787863 - Clinical and Immunological Efficiency of Bacterial Vaccines at Adult Patients With Bronchopulmonary Pathology Phase 4
Recruiting NCT06033833 - Long-term Safety and Efficacy Evaluation of Subcutaneous Amlitelimab in Adult Participants With Moderate-to-severe Asthma Who Completed Treatment Period of Previous Amlitelimab Asthma Clinical Study Phase 2
Completed NCT03257995 - Pharmacodynamics, Safety, Tolerability, and Pharmacokinetics of Two Orally Inhaled Indacaterol Salts in Adult Subjects With Asthma. Phase 2
Completed NCT02212483 - Clinical Effectiveness and Economical Impact of Medical Indoor Environment Counselors Visiting Homes of Asthma Patients N/A
Recruiting NCT04872309 - MUlti-nuclear MR Imaging Investigation of Respiratory Disease-associated CHanges in Lung Physiology
Withdrawn NCT01468805 - Childhood Asthma Reduction Study N/A
Recruiting NCT05145894 - Differentiation of Asthma/COPD Exacerbation and Stable State Using Automated Lung Sound Analysis With LungPass Device