- ICH GCP
- US Clinical Trials Registry
- Clinical Trial NCT01136382
A 6-week Study in Asthmatic Children Aged 6 to <12 Yrs Comparing Budesonide pMDI 160ug Twice Daily With Placebo (CHASE 1)
July 30, 2014 updated by: AstraZeneca
Phase 2, Double-blind, Randomized, Parallel-group, Placebo-controlled, Multicenter Study, Comparing Budesonide pMDI 160 ug Bid With Placebo: a 6-week Efficacy and Safety Study in Children Aged 6 to <12 Years With Asthma
This purpose of the study is to investigate if budesonide pMDI 160 �g twice a day during 6 weeks is effective and safe in treating asthmatic children aged 6 to <12 years
Study Overview
Detailed Description
Phase 2, double-blind, randomized, parallel-group, placebo-controlled, multicenter study, comparing budesonide pMDI 160 �g bid with placebo: a 6-week efficacy and safety study in children aged 6 to <12 years with asthma
Study Type
Interventional
Enrollment (Actual)
304
Phase
- Phase 2
Contacts and Locations
This section provides the contact details for those conducting the study, and information on where this study is being conducted.
Study Locations
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Plovdiv, Bulgaria
- Research Site
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Ruse, Bulgaria
- Research Site
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Sofia, Bulgaria
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Budapest, Hungary
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Debrecen, Hungary
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Gyor, Hungary
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Kiskunhalas, Hungary
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Marcali, Hungary
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Miskolc, Hungary
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Nyiregyhaza, Hungary
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Sopron, Hungary
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Szeged, Hungary
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Szigetvar, Hungary
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Torokbalint, Hungary
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Zalaegerszeg, Hungary
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Ogre, Latvia
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Rezekne, Latvia
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Riga, Latvia
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Bialystok, Poland
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Czestochowa, Poland
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Karpacz, Poland
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Lodz, Poland
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Pabianice, Poland
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Bratislava, Slovakia
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Lucenec, Slovakia
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Gauteng
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Krugersdorp, Gauteng, South Africa
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Kwa Zulu Natal
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Durban, Kwa Zulu Natal, South Africa
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Pietermariztburg, Kwa Zulu Natal, South Africa
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W Cape
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Claremont, W Cape, South Africa
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Panorama, W Cape, South Africa
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Arizona
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Scottsdale, Arizona, United States
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California
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Fresno, California, United States
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Granada Hills, California, United States
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Huntington Beach, California, United States
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Mission Viejo, California, United States
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Orange, California, United States
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Palmdal, California, United States
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Rolling Hills Estate, California, United States
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San Diego, California, United States
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Stockton, California, United States
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Colorado
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Centennial, Colorado, United States
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Colorado Springs, Colorado, United States
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Denver, Colorado, United States
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Florida
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Coral Gables, Florida, United States
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Orange City, Florida, United States
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Sarasota, Florida, United States
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Georgia
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Albany, Georgia, United States
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Gainesville, Georgia, United States
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Illinois
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Normal, Illinois, United States
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Kansas
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Overland Park, Kansas, United States
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Maryland
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Bethesda, Maryland, United States
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Massachusetts
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North Dartmouth, Massachusetts, United States
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Michigan
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Ypsilanti, Michigan, United States
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Minnesota
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Plymouth, Minnesota, United States
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Missouri
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Columbia, Missouri, United States
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St Louis, Missouri, United States
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Montana
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Boseman, Montana, United States
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Nebraska
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Bellevue, Nebraska, United States
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Omaha, Nebraska, United States
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New Jersey
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Ocean, New Jersey, United States
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Skillman, New Jersey, United States
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Teaneck, New Jersey, United States
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New York
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Rockville Centre, New York, United States
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North Carolina
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High Point, North Carolina, United States
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Ohio
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Canton, Ohio, United States
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Cincinnati, Ohio, United States
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Cleveland, Ohio, United States
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Sylvania, Ohio, United States
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Toledo, Ohio, United States
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Oklahoma
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Oklahoma City, Oklahoma, United States
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Oregon
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Gresham, Oregon, United States
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Lake Oswego, Oregon, United States
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Medford, Oregon, United States
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Portland, Oregon, United States
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Pennsylvania
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Altoona, Pennsylvania, United States
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Pittsburgh, Pennsylvania, United States
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Upland, Pennsylvania, United States
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South Carolina
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Charleston, South Carolina, United States
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Texas
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Dallas, Texas, United States
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El Paso, Texas, United States
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Fort Worth, Texas, United States
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Georgetown, Texas, United States
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San Antonio, Texas, United States
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Waco, Texas, United States
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Virginia
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Richmond, Virginia, United States
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Wisconsin
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Greenfield, Wisconsin, United States
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West Allis, Wisconsin, United States
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Participation Criteria
Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.
Eligibility Criteria
Ages Eligible for Study
6 years to 11 years (Child)
Accepts Healthy Volunteers
No
Genders Eligible for Study
All
Description
Inclusion Criteria:
- Has a documented clinical diagnosis of asthma for at least 6 months prior to Visit 2 that has required daily inhaled corticosteroid in the low dose range OR LTRA as monotherapy for at least 30 days prior to Visit 2.
- Has a morning clinic pre-bronchodilator FEV1 measured at least 6 hours after the last dose of inhaled short acting beta agonist of greater than or equal to 70% and less than or equal to 95% of predicted normal
- Demonstrated reversibility of FEV1 of ≥12% from pre short acting beta agonist level within 15 to 30 minutes after administration of a standard dose of short acting beta agonist OR has a documented reversibility of ≥ 12 % within 12 months prior to Visit 2.
Exclusion Criteria:
- Has been hospitalized at least once or required emergency treatment (was seen in the emergency room or had an urgent care visit) more than once for an asthma-related condition during the 6 months prior to Visit 2
- Has required treatment with systemic corticosteroids (eg, oral, parenteral, or rectal) for any reason within the 12 weeks prior to Visit 2
Study Plan
This section provides details of the study plan, including how the study is designed and what the study is measuring.
How is the study designed?
Design Details
- Primary Purpose: Treatment
- Allocation: Randomized
- Interventional Model: Parallel Assignment
- Masking: Quadruple
Arms and Interventions
Participant Group / Arm |
Intervention / Treatment |
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Experimental: 1
Budesonide pMDI 160 ug bid (80 ug x 2 inhalations bid)
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pMDI, inhalation, bid, 6 weeks
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Placebo Comparator: 2
Placebo pMDI 2 inhalations bid
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pMDI, inhalation, bid, 6 weeks
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What is the study measuring?
Primary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
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Change in Morning Peak Expiratory Flow (PEF) From Baseline to the Treatment Period Average
Time Frame: Baseline to 6 weeks
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The peak expiratory flow rate is the maximal rate that a person can exhale during a short maximal expiratory effort after a full inspiration.
Baseline was calculated using the mean of the data recorded during the last 7 days of the run-in period, and the treatment period average was calculated as the mean of all available data recorded during the entire treatment period.
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Baseline to 6 weeks
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Secondary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
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Change in Forced Expiratory Volume in 1 Second (FEV1) From Baseline to Treatment Period Average
Time Frame: Baseline to 6 weeks
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FEV1 is the volume exhaled during the first second of a forced expiratory maneuver started from the level of total lung capacity.
Baseline was defined as the pre-dose assessment value measured at randomization (Visit 3), and the treatment period average was calculated as the mean of all available data recorded during the entire treatment period.
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Baseline to 6 weeks
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Change in Evening PEF From Baseline to the Treatment Period Average
Time Frame: Baseline to 6 weeks
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The peak expiratory flow rate is the maximal rate that a person can exhale during a short maximal expiratory effort after a full inspiration.
Baseline was calculated using the mean of the data recorded during the last 7 days of the run-in period, and the treatment period average was calculated as the mean of all available data recorded during the entire treatment period.
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Baseline to 6 weeks
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Change in Forced Vital Capacity (FVC) From Baseline to Treatment Period Average
Time Frame: Baseline to 6 weeks
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FVC is the total volume of air expired after a full inspiration.
Baseline was defined as the pre-dose assessment value measured at randomization (Visit 3), and the treatment period average was calculated as the mean of all available data recorded during the entire treatment period.
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Baseline to 6 weeks
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Change in Forced Mid-expiratory Flow Between 25% and 75% of the FVC (FEF25-75) From Baseline to Treatment Period Average
Time Frame: Baseline to 6 weeks
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FEF25-75 is the average rate of airflow during the midportion of the forced vital capacity.
Baseline was defined as the pre-dose assessment value measured at randomization (Visit 3), and the treatment period average was calculated as the mean of all available data recorded during the entire treatment period.
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Baseline to 6 weeks
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Change in Total Daily and Daytime Asthma Symptom Scores From Baseline to Treatment Period Average
Time Frame: Baseline to 6 weeks
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Patients, with the help of their caregiver, were required to rate and document their asthma symptoms twice daily as an overall symptom score for the time period since their previous recording.
The following rating scales were used: 0 = None; no symptoms of asthma; 1 = Mild symptoms; awareness of asthma symptoms and/or signs that are easily tolerated; 2 = Moderate symptoms, asthma symptoms with some discomfort, causing some interference with daily activities or sleep; 3 = Severe symptoms; incapacitating asthma symptoms and/or signs, with inability to perform daily activities or to sleep.
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Baseline to 6 weeks
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Change in Nighttime Asthma Symptom Score From Baseline to Treatment Period Average
Time Frame: Baseline to 6 weeks
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Patients, with the help of their caregiver, were required to rate and document their asthma symptoms twice daily as an overall symptom score for the time period since their previous recording.
The following rating scales were used: 0 = None; no symptoms of asthma; 1 = Mild symptoms; awareness of asthma symptoms and/or signs that are easily tolerated; 2 = Moderate symptoms, asthma symptoms with some discomfort, causing some interference with daily activities or sleep; 3 = Severe symptoms; incapacitating asthma symptoms and/or signs, with inability to perform daily activities or to sleep.
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Baseline to 6 weeks
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Change in Nighttime Awakenings and Nighttime Awakenings With Reliever Medication Use From Baseline to Treatment Period Average
Time Frame: Baseline to 6 weeks
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Patients, with the help of their caregiver, were asked to respond to a standard question each morning as they completed their eDiary.
The question to be answered was, "Did your asthma cause you to wake-up last night?"
If yes, patients were asked, "Did you need to use your reliever medication (albuterol/salbutamol inhaler) before you went back to sleep?" Baseline is defined as the percentage of days where patient experienced nighttime awakenings out of all available days where data was collected during the last 7 days of the run-in period.
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Baseline to 6 weeks
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Change in Total Daily and Daytime Reliever Medication Use From Baseline to Treatment Period Average
Time Frame: Baseline to 6 weeks
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The patient, with the help of their caregiver, recorded the number of inhalations of reliever medication used, for relief of asthma symptoms, twice daily in the eDiary.
Patients were asked to respond to a standard question twice daily (morning and evening).
The question to be answered was, "How many albuterol/salbutamol inhalations since last diary entry?"
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Baseline to 6 weeks
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Change in Nighttime Reliever Medication Use From Baseline to Treatment Period Average
Time Frame: Baseline to 6 weeks
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The patient, with the help of their caregiver, recorded the number of inhalations of reliever medication used, for relief of asthma symptoms, twice daily in the eDiary.
Patients were asked to respond to a standard question twice daily (morning and evening).
The question to be answered was, "How many albuterol/salbutamol inhalations since last diary entry?"
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Baseline to 6 weeks
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Number of Withdrawals Due to Pre-defined Asthma Events
Time Frame: Baseline to 6 weeks
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Patients were considered to have experienced a "pre-defined asthma event" if any of the following conditions were met during the study: 1.
At each visit or follow-up visit, a decrease in morning pre-dose FEV1 >=20% from the Visit 3 (randomization visit) morning pre-dose FEV1 or a decrease to <65% of predicted normal value; 2. The use of >=8 actuations of albuterol/salbutamol per day on 3 or more days within any period of 7 consecutive days following randomization; 3. A decrease in morning PEF >=20% from baseline on 3 or more days within any period of 7 consecutive days after randomization; 4. Two or more nights with an awakening due to asthma, which required the use of reliever medication within any period of 7 consecutive days after randomization; 5.
A clinical exacerbation requiring emergency treatment, hospitalization, or use of an asthma medication not allowed by the study protocol.
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Baseline to 6 weeks
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Collaborators and Investigators
This is where you will find people and organizations involved with this study.
Sponsor
Investigators
- Study Director: Göran Eckerwall, MD, AZ R&D Mölndal
Publications and helpful links
The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.
Study record dates
These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.
Study Major Dates
Study Start
July 1, 2010
Primary Completion (Actual)
April 1, 2013
Study Completion (Actual)
April 1, 2013
Study Registration Dates
First Submitted
June 1, 2010
First Submitted That Met QC Criteria
June 1, 2010
First Posted (Estimate)
June 3, 2010
Study Record Updates
Last Update Posted (Estimate)
August 1, 2014
Last Update Submitted That Met QC Criteria
July 30, 2014
Last Verified
July 1, 2014
More Information
Terms related to this study
Keywords
Additional Relevant MeSH Terms
- Respiratory Tract Diseases
- Immune System Diseases
- Lung Diseases
- Hypersensitivity, Immediate
- Bronchial Diseases
- Lung Diseases, Obstructive
- Respiratory Hypersensitivity
- Hypersensitivity
- Asthma
- Physiological Effects of Drugs
- Autonomic Agents
- Peripheral Nervous System Agents
- Anti-Inflammatory Agents
- Glucocorticoids
- Hormones
- Hormones, Hormone Substitutes, and Hormone Antagonists
- Bronchodilator Agents
- Anti-Asthmatic Agents
- Respiratory System Agents
- Budesonide
Other Study ID Numbers
- D589GC00001
This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.
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