AsthmaPhase 3NCT00809757
A Safety, Efficacy and Tolerability Study in Pediatric Subjects With Asthma
A Phase 3 study testing Levalbuterol and Levalbuterol UDV TID in people with Asthma, run by Sumitomo Pharma America, Inc. at 46 sites in United States.
Trial summary
A Safety, Efficacy, and Tolerability Study of Daily Dosing with Levalbuterol Tartrate HFA MDI and Placebo in Subjects Aged Birth to <48 Months with Asthma. Read more about this study
- Who is it for?
- Ages Up to 48 months
- Conditions the study is for
- Asthma
- What is being tested?
- Levalbuterol and Levalbuterol UDV TID
- Could I receive a placebo?
- Yes, some participants may receive a placebo
- How many people
- 197 participants
- Where
- 46 sitesUnited States
- Study dates
- Dec 2008to Jun 2013
- Phase
- Phase 3
- Are there results?
- Yes, posted in the registrySummary in the doctors' view
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages Up to 48 months
- All sexes
- No healthy volunteers
- Child
Who may be able to join
- Subject's parent/legal guardian must give written informed consent, including privacy authorization, prior to study participation. Complete documentation regarding the consent process must be recorded in the case report form (CRF) and source documentation.
- Subject's parent/legal guardian must be willing and able to comply with the study procedures and visit schedules.
- Subject, male or female, must be between the ages of birth and <48 months, exclusive, at the time of consent.
- Subjects 24 to <48 months of age must have a history of physician-diagnosed asthma (defined as at least 3 episodes of respiratory symptoms consistent with asthma symptoms including, but not limited to, cough, wheeze, or dyspnea).
- Subjects 0 to <24 months of age must have a history of 3 episodes of respiratory symptoms that in the judgement of the investigator could be consistent with asthma or reactive airways disease.
- Subject must be in good health and not affected by any other chronic conditions, including respiratory disorders other than asthma.
- In subjects with a chest radiograph (taken 12 months prior to screening visit), no evidence of any chronic cardiopulmonary condition other than asthma should be present as discerned by the Investigator.
- Subject's parent/legal guardian must be able to complete the diary cards and medical event calendars (MEC) reliably on a daily basis and understand dosing instructions and questionnaire completion.
Who cannot join
- Subject who requires or is expected to require any disallowed medications
- Subject who has participated in an investigational drug study within 30 days prior to screening, or who is currently participating in another clinical trial.
- Subject or parent/legal guardian who has daily commitments during the study that would interfere with trial measurements, compliance, or both.
- Subject who has a history of hospitalization for asthma, reactive airways disease, or bronchospasm within 4 weeks prior to screening or who is scheduled for in-patient hospitalization, including elective surgery during the course of the trial.
- Subject who has experienced significant blood loss within 60 days of study drug.
- Subject with a clinical diagnosis of cystic fibrosis.
Show all 18Show fewer
- Subject who was born prematurely, defined as less than 38 weeks gestational age at birth, and is <1 year of age at screening
- Subject whose body weight is less than 7.0 kg at screening. This minimum weight requirement is based upon standard pediatric growth charts [CDC 2000].
- Subject with a known sensitivity to levalbuterol or racemic albuterol, or any of the excipients contained in any of these formulations.
- Subject using any prescription drug with which levalbuterol or racemic albuterol sulfate administration is contraindicated.
- Subject with a history of life-threatening asthma, defined as previous asthma episodes requiring intubation or associated with hypercapnia, respiratory arrest, or hypoxic seizures.
- Subject with clinically significant abnormalities that may interfere with the metabolism or excretion of the study drugs or study participation (eg, abnormalities of renal, hepatic, metabolic, or endocrine function).
- Subject with a history of cancer.
- Subject with any chronic or congenital cardiorespiratory condition other than asthma including, but not limited to, bronchopulmonary dysplasia, congenital heart disease, and cystic fibrosis.
- Subject affected by an upper or lower respiratory tract infection in the 3 weeks prior to screening.
- Subject with a history of ventilation for a respiratory condition occurring at or near birth, including those associated with prematurity or bronchopulmonary dysplasia. Ventilatory support for elective non-cardiopulmonary surgery is not exclusionary. - Subject with any clinically significant abnormal laboratory values (hematology, blood chemistry).
- Subject with a clinically significant abnormal 12-lead ECG that would put the subject at risk for experiencing adverse cardiac effects.
- Subject who is a relative of a staff member.
Trial locations and contacts
46 sites in 1 country.
46 sites in 1 country
United States46 sites
Isis Clinical Research, LLC
Austin, Texas, 78731
Sirius Clinical Research, LLC
Austin, Texas, 78759
Bellingham Asthma, Allergy, & Immunology Clinic
Bellingham, Washington, 98225
Hill Country Family Medical Center
Boerne, Texas, 78006
TTS Research
Boerne, Texas, 78006
Craig A. Spiegel MD
Bridgeton, Missouri, 63044
Maimonides Medical Center
Brooklyn, New York, 11219
PI-Coor Clinical Research, LLC
Burke, Virginia, 22015
IMMUNOe International Research Centers
Centennial, Colorado, 80112
National Allergy, Asthma, and Uticaria Centers
Charleston, South Carolina, 29407
AAC Research - PC
Charleston, South Carolina, 29414
The Asthma Institute, PLLC
Chattanooga, Tennessee, 37421
Rush University Medical Center
Chicago, Illinois, 60612
Cincinnati Children's Hospital Medical Center
Cincinnati, Ohio, 45229
Colonial Heights Pediatrics
Colonial Heights, Virginia, 23834
Brookstone Centre Parkway
Columbus, Georgia, 31904
West Coast Clinical Trials, LLC
Cypress, California, 90630
Allergy/Immunology Research Center of North Texas
Dallas, Texas, 75230
Dallas Allergy Immunology Research
Dallas, Texas, 75230
Dayton Clinical Research
Dayton, Ohio, 45406
Northern Illinois Research Associates
DeKalb, Illinois, 60115
Western Sky Medical Research
El Paso, Texas, 79903
All Seasons Allergy and Asthma Center, P.A.
Fort Walton Beach, Florida, 32547
Grand Blanc Medical
Grand Blanc, Michigan, 48439
ADAC Research, PA
Greenville, South Carolina, 29607
Breath of Life Research Institute
Katy, Texas, 77450
Little Rock Allergy & Asthma Clinical Research Center
Little Rock, Arkansas, 72205
Live Oak Allergy and Asthma Clinic
Live Oak, Texas, 78233
Allergy & Asthma Care Center of Southern California
Long Beach, California, 90808
Vanderbilt University Medical Center
Nashville, Tennessee, 37203
Nassim, McMonigle, Mescia & Associates
New Albany, Indiana, 47150
Sneeze, Wheeze & Itch Associates LLC
Normal, Illinois, 61761
Allergy, Asthma and clinical Research Center
Oklahoma City, Oklahoma, 73120
Eminence Research, LLC
Oklahoma City, Oklahoma, 73139
Midwest Allergy and Asthma center
Omaha, Nebraska, 68130
Clinical Trials of Orange County, Inc.
Orange, California, 92868
The Asthma & Allergy Center, P.C.
Papillion, Nebraska, 68046
Allergy and Asthma Consultants
Redwood City, California, 94063
Quality Assurance Research Center, Inc.
San Antonio, Texas, 78205
Southwest Allergy and Asthma, P.A.
San Antonio, Texas, 78229
Sylvana Research Associates
San Antonio, Texas, 78229
Asthma and Allergy Research Associates
Upland, Pennsylvania, 19013
St. Elizabeth Health Center
Utica, New York, 13502
Allergy & Asthma Care of Waco
Waco, Texas, 76712
Allergy and Asthma Research Institute
Waco, Texas, 76712
Palm Beach Research Center
West Palm Beach, Florida, 33409
About this study
Official title: A Safety, Efficacy, and Tolerability Study of Daily Dosing With Levalbuterol Tartrate HFA MDI and Placebo in Subjects Aged Birth to <48 Months With Asthma
A Safety, Efficacy, and Tolerability Study of Daily Dosing with Levalbuterol Tartrate HFA MDI and Placebo in Subjects Aged Birth to <48 Months with Asthma.
Read the detailed description
This is a modified-blind, randomized, placebo-controlled, multicenter, parallel-group trial of levalbuterol HFA MDI administered using a facemask and holding chamber in subjects birth to <48 months with asthma. 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.
- Conditions
- Asthma
- Being tested
- Levalbuterol, Levalbuterol UDV TID, Placebo
- Keywords
- Asthma
- Medical subject headings
- Asthma
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
LevalbuterolDrug
Also called Xopenex HFA Inhalation Aerosol
90 ug Levalbuterol (2 actuations)
Levalbuterol UDV TIDDrug
Also called Xopenex Inhalation Solution
0.31 ug Levalbuterol UDV TID
PlaceboDrug
Placebo (2 actuations)
| Study group | Role | What they receive |
|---|---|---|
| 1 | Experimental | 90 ug Levalbuterol (2 actuations) Receives: Drug: Levalbuterol |
| 2 | Active comparator | 0.31 ug Levalbuterol UDV TID Receives: Drug: Levalbuterol UDV TID |
| 3 | Placebo comparator | Placebo Receives: Drug: Placebo |
What is being measured
The primary outcome is the main question the study is designed to answer.
Change From Baseline to Visit 4 in the Mean Daily Composite Score Based on the Pediatric Asthma Caregiver Assessments (PACA)
The daily composite score is the sum of the scores of 5 domains: Nocturnal Awakenings Due to Wheeze and Cough, Daytime Wheeze, Daytime Cough, Shortness of Breath, and Asthma Symptom Score. A possible score of 0 (no symptoms) to 19 (severe symptoms).
The mean daily composite score at Visit 4 is defined as the mean of the daily composite scores in the week prior to Visit 4.
Measured: Baseline, Visit 4 (Week 4)
Secondary outcomes (25)
Change From Baseline to Visit 3 in Mean Daily Composite Score Based on the Pediatric Asthma Caregiver Assessment
The daily composite score is the sum of the scores of 5 domains: Nocturnal Awakenings Due to Wheeze and Cough, Daytime Wheeze, Daytime Cough, Shortness of Breath, and Asthma Symptom Score. A possible score of 0 (no symptoms) to 19 (severe symptoms).
The mean daily composite score at Visit 3 is defined as the mean of the daily composite scores in the 7 days prior to Visit 3.
Measured: Baseline, Visit 3 (Week 3)
Change From Baseline to Visit 2 to Visit 3 in the Mean Daily Composite Score Based on the Pediatric Asthma Caregiver Assessment
The daily composite score is the sum of the scores of 5 domains: Nocturnal Awakenings Due to Wheeze and Cough, Daytime Wheeze, Daytime Cough, Shortness of Breath, and Asthma Symptom Score. A possible score of 0 (no symptoms) to 19 (severe symptoms).
The mean daily composite score from Visit 2 to Visit 3 is defined as the mean of the daily composite scores from Visit 2 (inclusive) to the day prior to Visit 3.
Measured: The days from Visit 2 (inclusive) to the day prior to Visit 3 - approximately 14 days
Change From Baseline to Visit 3 to Visit 4 in the Mean Daily Composite Score Based on the Pediatric Asthma Caregiver Assessment
The daily composite score is the sum of the scores of 5 domains: Nocturnal Awakenings Due to Wheeze and Cough, Daytime Wheeze, Daytime Cough, Shortness of Breath, and Asthma Symptom Score. A possible score of 0 (no symptoms) to 19 (severe symptoms).
The mean daily composite score from Visit 3 to Visit 4 is defined as the mean of the daily composite scores from Visit 3 (inclusive) to the day prior to Visit 4.
Measured: The days from Visit 3 (inclusive) to the day prior to Visit 4 - approximately 14 days
Change From Baseline to Visit 3 in the Mean Daily Composite Score Based on the Daytime and Nighttime Asthma Symptom Scores as Measured by the Pediatric Asthma Questionnaire (PAQ)
The daily composite score is the sum of the scores of 7 items: Difficulty Breathing, Cough, Wheeze, Activity Limitation, Level of Activity Limitation, Overall Symptom Score, and Nighttime Asthma. The range for the PAQ is 0 (no symptoms) to 27 (severe symptoms).
The mean daily composite score at Visit 3 is defined as the mean daily composite scores for 7 days prior to Visit 3.
Measured: Baseline, Visit 3 (Week 3)
Change From Baseline to Visit 4 in the Mean Daily Composite Score Based on the Daytime and Nighttime Asthma Symptom Scores as Measured by Pediatric Asthma Questionnaire
The daily composite score is the sum of the scores of 7 items: Difficulty Breathing, Cough, Wheeze, Activity Limitation, Level of Activity Limitation, Overall Symptom Score, and Nighttime Asthma. The range for the PAQ is 0 (no symptoms) to 27 (severe symptoms).
The mean daily composite score at Visit 4 is defined as the mean daily composite scores in the 7 days prior to Visit 4.
Measured: Baseline, Visit 4 (Week 4)
Change From Baseline to Visit 2 to Visit 3 in the Mean Daily Composite Score Based on the Daytime and Nighttime Asthma Symptom Scores as Measured by the Pediatric Asthma Questionnaire
The daily composite score is the sum of the scores of 7 items: Difficulty Breathing, Cough, Wheeze, Activity Limitation, Level of Activity Limitation, Overall Symptom Score, and Nighttime Asthma. The range for the PAQ is 0 (no symptoms) to 27 (severe symptoms).
The mean daily composite score from Visit 2 to Visit 3 is defined as the mean of the daily composite scores from Visit 2 (inclusive) to the day prior to Visit 3.
Measured: The days from Visit 2 (inclusive) to the day prior to Visit 3 - approximately 14 days
Change From Baseline to Visit 3 to Visit 4 in the Mean Daily Composite Score Based on the Daytime and Nighttime Asthma Symptom Score as Measured by the Pediatric Asthma Questionnaire
The daily composite score is the sum of the scores of 7 items: Difficulty Breathing, Cough, Wheeze, Activity Limitation, Level of Activity Limitation, Overall Symptom Score, and Nighttime Asthma. The range for the PAQ is 0 (no symptoms) to 27 (severe symptoms).
The mean daily composite score from Visit 3 to Visit 4 is defined as the mean of the daily composite scores from Visit 3 (inclusive) to the day prior to Visit 4.
Measured: The days from Visit 3 (inclusive) to the day prior to Visit 4 - approximately 14 days
Change From Baseline in In-Clinic Peak Expiratory Flow to Postdose Timepoints at Visit 2
Peak expiratory flow (PEF) measures how fast a person can breathe out using the greatest effort
Measured: Baseline, Visit 2: 30 minutes post-dose (on the day of randomization), 1 hour post-dose, 4 hours post-dose, 6 hours post-dose
Change From Baseline in In-Clinic Peak Expiratory Flow to Postdose Timepoint at Visit 3
Measured: Baseline, Visit 3, pre-dose (approximately 14 days after randomization)
Change From Baseline in In-Clinic Peak Expiratory Flow to Postdose Timepoint at Visit 4
Measured: Visit 4: pre-dose (approximately 28 days after randomization) , 30 minutes post-dose, 1 hour post-dose, 4 hours post-dose, 6 hours post-dose
Percent Change From Baseline in In-Clinic Peak Expiratory Flow to Postdose Timepoints at Visit 2
Measured: Baseline, Visit 2: , 30 minutes post-dose (on the day of randomization), 1 hour post-dose, 4 hours post-dose, 6 hours post-dose
Percent Change From Baseline in In-Clinic Peak Expiratory Flow to Postdose Timepoints at Visit 3
Measured: Baseline, Visit 3, pre -dose (approximately 14 days after randomization)
Percent Change From Baseline in In-Clinic Peak Expiratory Flow to Postdose Timepoints at Visit 4
Measured: Baseline, Visit 4, pre -dose (approximately 28 days after randomization)
Change From Baseline in the At-Home Mean Daily Peak Expiratory Flow (PEF to Postdose Timepoint at Visit 3 and Visit 4
Mean of the daily pre-dose PEF values in the week prior to visit in those subjects aged 24 to <48 months capable of performing acceptable and reproducible PEF maneuvers.
Measured: Baseline, Visit 3 (the week prior to Visit 3) and Visit 4
Percent Change From Baseline in the At-Home Mean Daily Peak Expiratory Flow (PEF to Postdose Timepoint at Visit 3 and Visit 4)
Mean of the daily pre-dose PEF values in the week prior to visit in those subjects aged 24 to <48 months capable of performing acceptable and reproducible PEF maneuvers.
Measured: Visit 3 (the week prior to Visit 3), Visit 4 (the week prior to Visit 4)
Investigator Global Assessment - Question 1
Since the start of the study, how would you evaluate the child's asthma symptoms?
Measured: Visit 4 (End of 28 day treatment period)
Investigator Global Assessment - Question 2
Since the start of the study, how would you evaluate your ability to manage the subject's asthma?
Measured: Visit 4 (End of 28 day treatment period)
Caregiver Global Assessment - Question 1
Since the start of the study, how would you evaluate your child's asthma symptoms?
Measured: Visit 4 (End of 28 day treatment period)
Caregiver Global Assessment - Question 2
Since the start of the study, how would you evaluate your ability to manage your child's asthma?
Measured: Visit 4 (End of 28 day treatment period)
Caregiver Global Assessment - Question 3
Overall I was: Very satisfied with the control of the child's asthma symptoms while enrolled in this study, Moderately satisfied with the control of the child's asthma symptoms while enrolled in this study, Slightly satisfied with the control of the child's asthma symptoms while enrolled in this study, Not satisfied with the control of the child's asthma symptoms while enrolled in this study or answer Missing
Measured: Visit 4 (End of 28 day treatment period)
Rescue Medication Use: Number of Subjects Using Rescue Medication During the Treatment Period
Number of subjects using rescue medication during the treatment period
Measured: Visit 2 to Visit 3 (the first 2 weeks of the study) , Visit 3 to Visit 4 (the second 2 weeks of the study), Visit 2 to Visit 4 (the entire 4 weeks of the study)
Rescue Medication Use - Change From Baseline in Mean Number of Days Used Per Week When Used
Measured: Visit 2 to Visit 3 (the first 2 weeks of the study) , Visit 3 to Visit 4 (the second 2 weeks of the study), Visit 2 to Visit 4 (the entire 4 weeks of the study)
Rescue Medication Use - Change From Baseline in Mean Number of Doses Used Per Week
Measured: Visit 2 to Visit 3 (the first 2 weeks of the study) , Visit 3 to Visit 4 (the second 2 weeks of the study), Visit 2 to Visit 4 (the entire 4 weeks of the study)
Rescue Medication Use - Change From Baseline in Mean Number of Doses Used Per Week During Weeks When Used
Measured: Visit 2 to Visit 3 (the first 2 weeks of the study), Visit 3 to Visit 4 (the second 2 weeks of the study), Visit 2 to Visit 4 (the entire 4 weeks of the study)
Change From Baseline to Visit 3 and Visit 4 in the Pediatric Asthma Caregiver's Quality of Life Questionnaire (PACQLA) Composite Score
The PACQLQ composite score was calculated as the mean of the scores of the 13 individual questions. Composite scores could range from 1 to 7. Lower scores indicated greater impact of disease on quality of life.
Measured: Visit 3 and Visit 4 (End of 28 day treatment period)
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted17 Dec 2008 (estimated)
- Study startDec 2008
- Primary completionJun 2013
- Study completionJun 2013
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Posted resultsParticipant flow, outcome measures and adverse events reported by the sponsor.
- Other trials for AsthmaStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase 3
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Triple blind
- Who is masked
- Participant, Care provider, Investigator
- Enrolment
- 197 participants (actual)
Sponsor and investigators
- Lead sponsor
- Sumitomo Pharma America, Inc.
- Sponsor type
- Industry (pharma, biotech, devices)
- Responsible party
- Sponsor
- Investigators
- Respiratory Medical Director, MD, Study director, Sumitomo Pharma America, Inc.
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT00809757
- Sponsor's protocol ID
- 051-359
- Status last verified
- Jul 2014
- First submitted
- 15 Dec 2008
- Last updated
- 28 Jul 2014
- Results posted
- Yes, on ClinicalTrials.gov
- Data monitoring committee
- No
Study at a glance
From the registry record, last updated by the sponsor on 28 Jul 2014. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- A Safety, Efficacy, and Tolerability Study of Daily Dosing With Levalbuterol Tartrate HFA MDI and Placebo in Subjects Aged Birth to <48 Months With Asthma
- ClinicalTrials.gov ID
- NCT00809757
- Acronym / sponsor ID
- 051-359
- Conditions
- Asthma
- Keywords
- Asthma
- Phase
- Phase 3
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 197 participants (actual)
- Lead sponsor
- Sumitomo Pharma America, Inc.Industry (pharma, biotech, devices)
- Study start
- Dec 2008
- Primary completion
- Jun 2013 (actual)
- Study completion
- Jun 2013 (actual)
- First posted
- 17 Dec 2008 (estimated)
- Results
- Posted 28 Jul 2014
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
A Safety, Efficacy, and Tolerability Study of Daily Dosing with Levalbuterol Tartrate HFA MDI and Placebo in Subjects Aged Birth to <48 Months with Asthma.
Detailed description
This is a modified-blind, randomized, placebo-controlled, multicenter, parallel-group trial of levalbuterol HFA MDI administered using a facemask and holding chamber in subjects birth to <48 months with asthma. 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.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Triple blind (participant, care provider, investigator)
- Number of arms
- 3
| Arm | Type | Receives |
|---|---|---|
| 1 | Experimental | Drug: Levalbuterol90 ug Levalbuterol (2 actuations) |
| 2 | Active comparator | Drug: Levalbuterol UDV TID0.31 ug Levalbuterol UDV TID |
| 3 | Placebo comparator | Drug: PlaceboPlacebo |
Who may qualify
- Ages
- Up to 48 months
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Child
Key inclusion criteria (8 listed)
- Subject's parent/legal guardian must give written informed consent, including privacy authorization, prior to study participation. Complete documentation regarding the consent process must be recorded in the case report form (CRF) and source documentation.
- Subject's parent/legal guardian must be willing and able to comply with the study procedures and visit schedules.
- Subject, male or female, must be between the ages of birth and <48 months, exclusive, at the time of consent.
- Subjects 24 to <48 months of age must have a history of physician-diagnosed asthma (defined as at least 3 episodes of respiratory symptoms consistent with asthma symptoms including, but not limited to, cough, wheeze, or dyspnea).
- Subjects 0 to <24 months of age must have a history of 3 episodes of respiratory symptoms that in the judgement of the investigator could be consistent with asthma or reactive airways disease.
Key exclusion criteria (18 listed)
- Subject who requires or is expected to require any disallowed medications
- Subject who has participated in an investigational drug study within 30 days prior to screening, or who is currently participating in another clinical trial.
- Subject or parent/legal guardian who has daily commitments during the study that would interfere with trial measurements, compliance, or both.
- Subject who has a history of hospitalization for asthma, reactive airways disease, or bronchospasm within 4 weeks prior to screening or who is scheduled for in-patient hospitalization, including elective surgery during the course of the trial.
- Subject who has experienced significant blood loss within 60 days of study drug.
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| LevalbuterolAlso: Xopenex HFA Inhalation Aerosol90 ug Levalbuterol (2 actuations) | Drug | 1 |
| Levalbuterol UDV TIDAlso: Xopenex Inhalation Solution0.31 ug Levalbuterol UDV TID | Drug | 2 |
| PlaceboPlacebo (2 actuations) | Drug | 3 |
Primary outcome
Change From Baseline to Visit 4 in the Mean Daily Composite Score Based on the Pediatric Asthma Caregiver Assessments (PACA)
Time frame: Baseline, Visit 4 (Week 4)
The daily composite score is the sum of the scores of 5 domains: Nocturnal Awakenings Due to Wheeze and Cough, Daytime Wheeze, Daytime Cough, Shortness of Breath, and Asthma Symptom Score. A possible score of 0 (no symptoms) to 19 (severe symptoms). The mean daily composite score at Visit 4 is defined as the mean of the daily composite scores in the week prior to Visit 4.
25 secondary outcomes
Change From Baseline to Visit 3 in Mean Daily Composite Score Based on the Pediatric Asthma Caregiver Assessment
Time frame: Baseline, Visit 3 (Week 3)
Change From Baseline to Visit 2 to Visit 3 in the Mean Daily Composite Score Based on the Pediatric Asthma Caregiver Assessment
Time frame: The days from Visit 2 (inclusive) to the day prior to Visit 3 - approximately 14 days
Change From Baseline to Visit 3 to Visit 4 in the Mean Daily Composite Score Based on the Pediatric Asthma Caregiver Assessment
Time frame: The days from Visit 3 (inclusive) to the day prior to Visit 4 - approximately 14 days
Change From Baseline to Visit 3 in the Mean Daily Composite Score Based on the Daytime and Nighttime Asthma Symptom Scores as Measured by the Pediatric Asthma Questionnaire (PAQ)
Time frame: Baseline, Visit 3 (Week 3)
Change From Baseline to Visit 4 in the Mean Daily Composite Score Based on the Daytime and Nighttime Asthma Symptom Scores as Measured by Pediatric Asthma Questionnaire
Time frame: Baseline, Visit 4 (Week 4)
Change From Baseline to Visit 2 to Visit 3 in the Mean Daily Composite Score Based on the Daytime and Nighttime Asthma Symptom Scores as Measured by the Pediatric Asthma Questionnaire
Time frame: The days from Visit 2 (inclusive) to the day prior to Visit 3 - approximately 14 days
Change From Baseline to Visit 3 to Visit 4 in the Mean Daily Composite Score Based on the Daytime and Nighttime Asthma Symptom Score as Measured by the Pediatric Asthma Questionnaire
Time frame: The days from Visit 3 (inclusive) to the day prior to Visit 4 - approximately 14 days
Change From Baseline in In-Clinic Peak Expiratory Flow to Postdose Timepoints at Visit 2
Time frame: Baseline, Visit 2: 30 minutes post-dose (on the day of randomization), 1 hour post-dose, 4 hours post-dose, 6 hours post-dose
Change From Baseline in In-Clinic Peak Expiratory Flow to Postdose Timepoint at Visit 3
Time frame: Baseline, Visit 3, pre-dose (approximately 14 days after randomization)
Change From Baseline in In-Clinic Peak Expiratory Flow to Postdose Timepoint at Visit 4
Time frame: Visit 4: pre-dose (approximately 28 days after randomization) , 30 minutes post-dose, 1 hour post-dose, 4 hours post-dose, 6 hours post-dose
Percent Change From Baseline in In-Clinic Peak Expiratory Flow to Postdose Timepoints at Visit 2
Time frame: Baseline, Visit 2: , 30 minutes post-dose (on the day of randomization), 1 hour post-dose, 4 hours post-dose, 6 hours post-dose
Percent Change From Baseline in In-Clinic Peak Expiratory Flow to Postdose Timepoints at Visit 3
Time frame: Baseline, Visit 3, pre -dose (approximately 14 days after randomization)
Percent Change From Baseline in In-Clinic Peak Expiratory Flow to Postdose Timepoints at Visit 4
Time frame: Baseline, Visit 4, pre -dose (approximately 28 days after randomization)
Change From Baseline in the At-Home Mean Daily Peak Expiratory Flow (PEF to Postdose Timepoint at Visit 3 and Visit 4
Time frame: Baseline, Visit 3 (the week prior to Visit 3) and Visit 4
Percent Change From Baseline in the At-Home Mean Daily Peak Expiratory Flow (PEF to Postdose Timepoint at Visit 3 and Visit 4)
Time frame: Visit 3 (the week prior to Visit 3), Visit 4 (the week prior to Visit 4)
Investigator Global Assessment - Question 1
Time frame: Visit 4 (End of 28 day treatment period)
Investigator Global Assessment - Question 2
Time frame: Visit 4 (End of 28 day treatment period)
Caregiver Global Assessment - Question 1
Time frame: Visit 4 (End of 28 day treatment period)
Caregiver Global Assessment - Question 2
Time frame: Visit 4 (End of 28 day treatment period)
Caregiver Global Assessment - Question 3
Time frame: Visit 4 (End of 28 day treatment period)
Rescue Medication Use: Number of Subjects Using Rescue Medication During the Treatment Period
Time frame: Visit 2 to Visit 3 (the first 2 weeks of the study) , Visit 3 to Visit 4 (the second 2 weeks of the study), Visit 2 to Visit 4 (the entire 4 weeks of the study)
Rescue Medication Use - Change From Baseline in Mean Number of Days Used Per Week When Used
Time frame: Visit 2 to Visit 3 (the first 2 weeks of the study) , Visit 3 to Visit 4 (the second 2 weeks of the study), Visit 2 to Visit 4 (the entire 4 weeks of the study)
Rescue Medication Use - Change From Baseline in Mean Number of Doses Used Per Week
Time frame: Visit 2 to Visit 3 (the first 2 weeks of the study) , Visit 3 to Visit 4 (the second 2 weeks of the study), Visit 2 to Visit 4 (the entire 4 weeks of the study)
Rescue Medication Use - Change From Baseline in Mean Number of Doses Used Per Week During Weeks When Used
Time frame: Visit 2 to Visit 3 (the first 2 weeks of the study), Visit 3 to Visit 4 (the second 2 weeks of the study), Visit 2 to Visit 4 (the entire 4 weeks of the study)
Change From Baseline to Visit 3 and Visit 4 in the Pediatric Asthma Caregiver's Quality of Life Questionnaire (PACQLA) Composite Score
Time frame: Visit 3 and Visit 4 (End of 28 day treatment period)
Results and safety
Loading the posted results from ClinicalTrials.gov…
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 28 Jul 2014.
- Posted resultsParticipant flow, baseline, all outcome measures and adverse events.
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Asthma
RecruitingPhase 1
A Study to Compare the Relative Potency of Salbutamol Administered Via Metered Dose Inhalers (MDI) Containing Propellants HFA-152a to HFA-134a in Mild Asthmatics Aged 18 to 65 Inclusive
Asthma, Mild Asthma
RecruitingPhase 3
A Study Assessing the Effect of Dupilumab on Inducing Clinical Remission in Asthma
Asthma Control
Active, not recruitingPhase 2/3
Local Antibiotic Delivery for Community Acquired Pneumonia
Community Acquired Pneumonia (CAP)
RecruitingPhase 2
A Study to Learn About the Study Medicine Called PF-07275315 in People With Moderate-To-Severe Asthma
Asthma
Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Respiratory Medical Director, MD study director
Sumitomo Pharma America, Inc.
46 sites in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 3 study testing Levalbuterol and Levalbuterol UDV TID in people with Asthma, run by Sumitomo Pharma America, Inc. at 46 sites in United States.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 8 inclusion and 18 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 28 Jul 2014. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 46 sites in United States. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. Some participants in this study may receive a placebo. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
What does this phase mean?
Phase 3 studies compare the treatment with the current standard treatment or a placebo in a large group, to confirm how well it works and watch for side effects.
Not every study follows the same path, and some studies (observational studies, device studies) have no phase.
Are results available for this study?
Yes. Results are posted in the registry (first posted 28 Jul 2014). A summary is in the For doctors view, and the full results are on ClinicalTrials.gov.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Change From Baseline to Visit 4 in the Mean Daily Composite Score Based on the Pediatric Asthma Caregiver Assessments (PACA) (time frame: Baseline, Visit 4 (Week 4)). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 28 Jul 2014.