Efficacy Safety Study of Arformoterol QD Dosing Versus BID Dosing in COPD
This study has been completed.
Sponsor:
Sunovion
Information provided by (Responsible Party):
Sunovion
ClinicalTrials.gov Identifier:
NCT00571428
First received: December 10, 2007
Last updated: February 21, 2012
Last verified: February 2012
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Purpose
To evaluate the efficacy and safety of arformoterol tartrate inhalation solution 30μg/4mL QD (two 15μg/2mL dosed in combination) over a 24-hour period compared to arformoterol tartrate inhalation solution 15μg/2 mL BID in subjects with COPD.
| Condition | Intervention | Phase |
|---|---|---|
|
Chronic Obstructive Pulmonary Disease |
Drug: Arformoterol Tartrate Inhalation Solution Drug: Placebo |
Phase 4 |
| Study Type: | Interventional |
| Study Design: | Allocation: Randomized Endpoint Classification: Safety/Efficacy Study Intervention Model: Crossover Assignment Masking: Double Blind (Subject, Investigator, Outcomes Assessor) Primary Purpose: Treatment |
| Official Title: | Modified-blind, Randomized, Multicenter, Single Dose, Two-way Crossover Study of Arformoterol Tartrate Inhalation Solution 15 Micrograms Twice A Day Versus 30 Micrograms Once A Day in Subjects With Chronic Obstructive Pulmonary Disease (COPD) |
Resource links provided by NLM:
Further study details as provided by Sunovion:
Primary Outcome Measures:
- Time-Normalized Area Under the Change From Pre-Dose Curve for Forced Expiratory Volume in One Second Measured Over 24 Hours [ Time Frame: 0-24 hours post dose ] [ Designated as safety issue: No ]Forced Expiratory Volume in one second (FEV1) is the volume of air forcibly exhaled in one second as measured by a spirometer. This outcome measures the change from pre-dose for a series of FEV1 readings taken within 24 hours of dosing.
Secondary Outcome Measures:
- Time-Normalized Area Under the Change From Pre-Dose Curve for Forced Expiratory Volume in One Second Measured Over 12 Hours [ Time Frame: 0-12 hours ] [ Designated as safety issue: No ]Forced Expiratory Volume in one second (FEV1) is the volume of air forcibly exhaled in one second as measured by a spirometer. This outcome measures the change from pre-dose for a series of FEV1 readings taken within 12 hours of dosing.
- Time-Normalized Area Under the Change From Pre-Dose Curve for Forced Expiratory Volume in One Second Measured Between 12-24 Hours [ Time Frame: 12-24 hours ] [ Designated as safety issue: No ]Forced Expiratory Volume in one second (FEV1) is the volume of air forcibly exhaled in one second as measured by a spirometer. This outcome measures the change from pre-dose for a series of FEV1 readings taken between 12 and 24 hours of dosing.
- Change in Forced Expiratory Volume in One Second From Pre-dose to the 24 Hour Time Point [ Time Frame: pre-dose and 24 hours post-dose ] [ Designated as safety issue: No ]Forced Expiratory Volume in one second (FEV1) is the volume of air forcibly exhaled in one second as measured by a spirometer. This outcome measures the change in FEV1 from pre-dose to the readings taken 24 hours post-dose, which represents the trough in dose level.
- Forced Expiratory Volume in One Second Measurements Pre-dose and at Each Assessed Time Point Post-dose [ Time Frame: pre-dose, immediately post-dose, 30 min, 1,2,4,6,8,10,12, 12.5,13,14,16,23,24 hours post first dose ] [ Designated as safety issue: No ]Forced Expiratory Volume in one second (FEV1) is the volume of air forcibly exhaled in one second as measured by a spirometer. This outcome offers the FEV1 readings taken pre-dose and at various time points within 24 hours post-dose.
- Change in Forced Expiratory Volume in One Second From Pre-dose To Each Assessed Time Point Post-Dose [ Time Frame: Immediately post first dose, 30 min, 1,2,4,6,8,10,12,12.5,13,14,16,23,24 hours post first dose ] [ Designated as safety issue: No ]Forced Expiratory Volume in one second (FEV1) is the volume of air forcibly exhaled in one second as measured by a spirometer. This outcome offers the change in FEV1 readings between pre-dose and various time points within 24 hours post-dose.
- Percent of Predicted Forced Expiratory Volume at One Second at Pre-dose and Each Assessed Time Point Post-Dose [ Time Frame: Pre-dose, Immediately post first dose, 30 min, 1,2,4,6,8,10,12,12.5,13,14,16,23,24 hours post first dose ] [ Designated as safety issue: No ]Predicted FEV1 is based on a formula using sex, age and height of a person, and is an estimate of healthy lung capacity. This outcome uses actual FEV1 readings to generate the percent of the estimated healthy lung function at specified time points.
- Change in Percent of Predicted Forced Expiratory Volume at One Second (FEV1) at Each Assessed Time Point Post-Dose Compared to Pre-Dose [ Time Frame: Immediately post first dose, 30 min, 1,2,4,6,8,10,12,12.5,13,14,16,23,24 hours post first dose ] [ Designated as safety issue: No ]Predicted FEV1 is based on a formula using sex, age and height of a person, and is an estimate of healthy lung capacity. This outcome uses actual FEV1 readings to generate the change in percent of the estimated healthy lung function at specified time points compared to the pre-dose value.
- Peak Percent of Predicted Forced Expiratory Volume at One Second (FEV1) Over 12 Hours Post-Dose. [ Time Frame: 12 hours ] [ Designated as safety issue: No ]Predicted FEV1 is based on a formula using sex, age and height of a person, and is an estimate of healthy lung capacity. This outcome uses actual FEV1 readings to generate the percent of the estimated healthy lung function and reports the highest percent found within 12 hours of dosing.
- Peak Change in Forced Expiratory Volume at One Second (FEV1) Within 12 Hours Post Dose Compared to Pre-dose [ Time Frame: 12 hours ] [ Designated as safety issue: No ]Forced Expiratory Volume in one second (FEV1) is the volume of air forcibly exhaled in one second as measured by a spirometer. This outcome measures the change in FEV1 from pre-dose to the readings taken 12 hours post-dose, and reports the largest change during that time.
- Time to Onset of 15 Percent Response Within 12 Hours of Dosing [ Time Frame: 12 hours post first dose ] [ Designated as safety issue: No ]Time to a 15 percent improvement in forced expiratory volume in one second (FEV1) within 12 hours of dosing. Only patients who achieved at least a 15 percent improvement are included.
- Time to Onset of Response of Both a 12 Percent Increase and 200 Milliliter Increase Within 12 Hours of Dosing [ Time Frame: up to 12 hours post dose ] [ Designated as safety issue: No ]Time to a 12 percent improvement in forced expiratory volume in one second (FEV1) AND a 200 milliliter increase in FEV1 within 12 hours of dosing. Only patients who met both conditions are included
- Time to Onset of Response of Both a 12 Percent Increase and 200 Milliliter Increase in Forced Expiratory Volume in One Second Within 12 Hours of Dosing [ Time Frame: pre-dose, immediately post first dose, 30 min, 1,2,4,6,8,10,12, 12.5, 13, 14, 16, 23,24 hours post first dose ] [ Designated as safety issue: No ]Forced vital capacity is the total amount of air that can forcibly be blown out after full inspiration.
- Change in Forced Vital Capacity From Pre-dose to Each Post-Dose Assessed Time Point [ Time Frame: immediately post first dose, 30 min, 1,2,4,6,8,10,12, 12.5, 13, 14, 16, 23,24 hours post first dose ] [ Designated as safety issue: No ]Forced vital capacity is the total amount of air that can forcibly be blown out after full inspiration. The measure compares the change from pre-dose reading to each post-dose time point.
| Enrollment: | 33 |
| Study Start Date: | November 2007 |
| Study Completion Date: | March 2008 |
| Primary Completion Date: | March 2008 (Final data collection date for primary outcome measure) |
| Arms | Assigned Interventions |
|---|---|
|
Experimental: 15 mcg BID / 30 mcg QD
Arformoterol 15 microgram twice a day (BID) taken each morning and evening for one visit followed by Arformoterol 30 microgram once a day (QD) in the morning and placebo in the evening for the next visit.
|
Drug: Arformoterol Tartrate Inhalation Solution
Nebulized arformoterol tartrate inhalation solution 15 microgram twice a day (BID)
Other Name: Brovana
Drug: Arformoterol Tartrate Inhalation Solution
Nebulized arformoterol tartrate inhalation solution 30 microgram once a day (QD)
Other Name: Brovana
Drug: Placebo
Placebo inhalation solution (citrate buffered 0.9% saline solution) once a day
|
|
Experimental: 30 mcg QD / 15 mcg BID
Arformoterol 30 microgram once a day (QD) in the morning and placebo in the evening for one visit followed by Arformoterol 15 microgram twice a day (BID) in the morning and evening for the next visit.
|
Drug: Arformoterol Tartrate Inhalation Solution
Nebulized arformoterol tartrate inhalation solution 15 microgram twice a day (BID)
Other Name: Brovana
Drug: Arformoterol Tartrate Inhalation Solution
Nebulized arformoterol tartrate inhalation solution 30 microgram once a day (QD)
Other Name: Brovana
Drug: Placebo
Placebo inhalation solution (citrate buffered 0.9% saline solution) once a day
|
Detailed Description:
This is a modified blind, randomized, multicenter, single dose two-way crossover study to assess the efficacy and safety of arformoterol 15μg BID versus arformoterol 30μg QD in subjects with COPD. Subject participation will last approximately three weeks and will include a screening visit, two 24-hour visits, and a follow up telephone call. This study was previously posted by Sepracor Inc. In October 2009, Sepracor Inc. was acquired by Dainippon Sumitomo Pharma., and in October 2010, Sepracor Inc's name was changed to Sunovion Pharmaceuticals Inc.
Eligibility| Ages Eligible for Study: | 45 Years and older |
| Genders Eligible for Study: | Both |
| Accepts Healthy Volunteers: | No |
Criteria
Inclusion Criteria:
- Male and female subjects must be at least 45 years old at the time of consent.
- Subjects must have a pre-established primary clinical diagnosis of COPD.
- Subjects must have a baseline FEV1 of ≤ 65% of predicted normal value at Visit 1.
- Subjects must have a FEV1 ≥ 0.70L at Visit 1.
- Subjects must have a FEV1/forced vital capacity (FVC) ratio of ≤ 70% at Visit 1.
Exclusion Criteria:
- Subjects who do not have a 15 pack-year smoking history and a baseline breathlessness severity grade of 2 (as measured by the Modified Medical Research Council [MMRC] Dyspnea Scale Score) at Screening.
- Subjects with life-threatening/unstable respiratory status, including upper or lower respiratory tract infection, within the previous 30 days prior to Visit
Contacts and Locations
Please refer to this study by its ClinicalTrials.gov identifier: NCT00571428
Locations
| United States, Oregon | |
| Medford, Oregon, United States, 97504 | |
| Portland, Oregon, United States, 97213 | |
| United States, Pennsylvania | |
| Philadelphia, Pennsylvania, United States, 19104 | |
| United States, South Carolina | |
| Spartanburg, South Carolina, United States, 29303 | |
Sponsors and Collaborators
Sunovion
Investigators
| Study Director: | Pulmonary Medical Director | Sunovion |
More Information
Additional Information:
No publications provided by Sunovion
Additional publications automatically indexed to this study by ClinicalTrials.gov Identifier (NCT Number):
| Responsible Party: | Sunovion |
| ClinicalTrials.gov Identifier: | NCT00571428 History of Changes |
| Other Study ID Numbers: | 091-903 |
| Study First Received: | December 10, 2007 |
| Results First Received: | March 13, 2009 |
| Last Updated: | February 21, 2012 |
| Health Authority: | United States: Food and Drug Administration |
Keywords provided by Sunovion:
|
COPD Chronic Bronchitis Emphysema |
Additional relevant MeSH terms:
|
Lung Diseases Respiration Disorders Pulmonary Disease, Chronic Obstructive Lung Diseases, Obstructive Respiratory Tract Diseases Formoterol Adrenergic beta-2 Receptor Agonists Adrenergic beta-Agonists Adrenergic Agonists Adrenergic Agents |
Neurotransmitter Agents Molecular Mechanisms of Pharmacological Action Pharmacologic Actions Physiological Effects of Drugs Bronchodilator Agents Autonomic Agents Peripheral Nervous System Agents Anti-Asthmatic Agents Respiratory System Agents Therapeutic Uses |
ClinicalTrials.gov processed this record on May 19, 2013