AsthmaPhase 2CHASE 1NCT01136382
A 6-week Study in Asthmatic Children Aged 6 to <12 Yrs Comparing Budesonide pMDI 160ug Twice Daily With Placebo
A Phase 2 study testing budesonide in people with Asthma, run by AstraZeneca at 87 sites in 7 countries.
Trial summary
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 Read more about this study
- Who is it for?
- Ages 6 to 11 years
- Conditions the study is for
- Asthma
- What is being tested?
- budesonide
- Could I receive a placebo?
- Yes, some participants may receive a placebo
- How many people
- 304 participants
- Where
- 87 sitesin 7 countries
- Study dates
- Jul 2010to Apr 2013
- Phase
- Phase 2
- 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 6 to 11 years
- All sexes
- No healthy volunteers
- Child
Who may be able to join
- 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.
Who cannot join
- 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
Trial locations and contacts
87 sites in 7 countries.
87 sites in 7 countries
United States57 sites
Research Site
Albany, Georgia
Research Site
Altoona, Pennsylvania
Research Site
Bellevue, Nebraska
Research Site
Bethesda, Maryland
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Bozeman, Montana
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Canton, Ohio
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Centennial, Colorado
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Charleston, South Carolina
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Cincinnati, Ohio
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Cleveland, Ohio
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Colorado Springs, Colorado
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Columbia, Missouri
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Coral Gables, Florida
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Dallas, Texas
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Denver, Colorado
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El Paso, Texas
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Fort Worth, Texas
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Fresno, California
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Gainesville, Georgia
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Georgetown, Texas
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Granada Hills, California
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Greenfield, Wisconsin
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Gresham, Oregon
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High Point, North Carolina
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Huntington Beach, California
Research Site
Lake Oswego, Oregon
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Medford, Oregon
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Mission Viejo, California
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Normal, Illinois
Research Site
North Dartmouth, Massachusetts
Research Site
Ocean City, New Jersey
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Oklahoma City, Oklahoma
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Omaha, Nebraska
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Orange, California
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Orange City, Florida
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Overland Park, Kansas
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Palmdal, California
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Pittsburgh, Pennsylvania
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Plymouth, Minnesota
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Portland, Oregon
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Richmond, Virginia
Research Site
Rockville Centre, New York
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Rolling Hills Estate, California
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San Antonio, Texas
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San Diego, California
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Sarasota, Florida
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Scottsdale, Arizona
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Skillman, New Jersey
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St Louis, Missouri
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Stockton, California
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Sylvania, Ohio
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Teaneck, New Jersey
Research Site
Toledo, Ohio
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Upland, Pennsylvania
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Waco, Texas
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West Allis, Wisconsin
Research Site
Ypsilanti, Michigan
Hungary12 sites
Research Site
Budapest
Research Site
Debrecen
Research Site
Győr
Research Site
Kiskunhalas
Research Site
Marcali
Research Site
Miskolc
Research Site
Nyíregyháza
Research Site
Sopron
Research Site
Szeged
Research Site
Szigetvár
Research Site
Törökbálint
Research Site
Zalaegerszeg
Poland5 sites
Research Site
Bialystok
Research Site
Częstochowa
Research Site
Karpacz
Research Site
Lodz
Research Site
Pabianice
South Africa5 sites
Research Site
Claremont, W Cape
Research Site
Durban, KwaZulu-Natal
Research Site
Krugersdorp, Gauteng
Research Site
Panorama, W Cape
Research Site
Pietermariztburg, KwaZulu-Natal
About this study
Official title: 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
Read the 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
- Conditions
- Asthma
- Being tested
- budesonide, placebo
- Keywords
- asthma, children, budesonide pMDI
- Medical subject headings
- Asthma
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
budesonideDrug
pMDI, inhalation, bid, 6 weeks
placeboDrug
pMDI, inhalation, bid, 6 weeks
| Study group | Role | What they receive |
|---|---|---|
| 1 | Experimental | Budesonide pMDI 160 ug bid (80 ug x 2 inhalations bid) Receives: Drug: budesonide |
| 2 | Placebo comparator | Placebo pMDI 2 inhalations bid Receives: Drug: placebo |
What is being measured
The primary outcome is the main question the study is designed to answer.
Change in Morning Peak Expiratory Flow (PEF) From Baseline to the Treatment Period Average
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.
Measured: Baseline to 6 weeks
Secondary outcomes (10)
Change in Forced Expiratory Volume in 1 Second (FEV1) From Baseline to Treatment Period Average
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.
Measured: Baseline to 6 weeks
Change in Evening PEF From Baseline to the Treatment Period Average
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.
Measured: Baseline to 6 weeks
Change in Forced Vital Capacity (FVC) From Baseline to Treatment Period Average
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.
Measured: Baseline to 6 weeks
Change in Forced Mid-expiratory Flow Between 25% and 75% of the FVC (FEF25-75) From Baseline to Treatment Period Average
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.
Measured: Baseline to 6 weeks
Change in Total Daily and Daytime Asthma Symptom Scores From Baseline to Treatment Period Average
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.
Measured: Baseline to 6 weeks
Change in Nighttime Asthma Symptom Score From Baseline to Treatment Period Average
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.
Measured: Baseline to 6 weeks
Change in Nighttime Awakenings and Nighttime Awakenings With Reliever Medication Use From Baseline to Treatment Period Average
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.
Measured: Baseline to 6 weeks
Change in Total Daily and Daytime Reliever Medication Use From Baseline to Treatment Period Average
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?"
Measured: Baseline to 6 weeks
Change in Nighttime Reliever Medication Use From Baseline to Treatment Period Average
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?"
Measured: Baseline to 6 weeks
Number of Withdrawals Due to Pre-defined Asthma Events
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.
Measured: Baseline to 6 weeks
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted3 Jun 2010 (estimated)
- Study startJul 2010
- Primary completionApr 2013
- Study completionApr 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.
- Publications (1)Papers the sponsor has linked to this study.
- Other trials for AsthmaStudies of the same condition, open and under way.
- More trials run by AstraZenecaThe sponsor's other registered studies.
- 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 2
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Quadruple blind
- Who is masked
- Participant, Care provider, Investigator, Outcomes assessor
- Enrolment
- 304 participants (actual)
Sponsor and investigators
- Lead sponsor
- AstraZeneca
- Sponsor type
- Industry (pharma, biotech, devices)
- Responsible party
- Sponsor
- Investigators
- Göran Eckerwall, MD, Study director, AZ R&D Mölndal
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT01136382
- Sponsor's protocol ID
- D589GC00001
- Acronym
- CHASE 1
- Status last verified
- Jul 2014
- First submitted
- 1 Jun 2010
- Last updated
- 1 Aug 2014
- Results posted
- Yes, on ClinicalTrials.gov
- Data monitoring committee
- No
Publications
Meltzer EO, Pearlman DS, Eckerwall G, Uryniak T, DePietro M, Lampl K. Efficacy and safety of budesonide administered by pressurized metered-dose inhaler in children with asthma. Ann Allergy Asthma Immunol. 2015 Dec;115(6):516-22. doi: 10.1016/j.anai.2015.09.007. Epub 2015 Oct 13.
PubMed 26460293
Study at a glance
From the registry record, last updated by the sponsor on 1 Aug 2014. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- 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
- ClinicalTrials.gov ID
- NCT01136382
- Acronym / sponsor ID
- CHASE 1 / D589GC00001
- Conditions
- Asthma
- Keywords
- asthma, children, budesonide pMDI
- Phase
- Phase 2
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 304 participants (actual)
- Lead sponsor
- AstraZenecaIndustry (pharma, biotech, devices)
- Study start
- Jul 2010
- Primary completion
- Apr 2013 (actual)
- Study completion
- Apr 2013 (actual)
- First posted
- 3 Jun 2010 (estimated)
- Results
- Posted 21 Jul 2014
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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
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 design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Quadruple blind (participant, care provider, investigator, outcomes assessor)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| 1 | Experimental | Drug: budesonideBudesonide pMDI 160 ug bid (80 ug x 2 inhalations bid) |
| 2 | Placebo comparator | Drug: placeboPlacebo pMDI 2 inhalations bid |
Who may qualify
- Ages
- 6 to 11 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Child
Key inclusion criteria (3 listed)
- 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.
Key exclusion criteria (2 listed)
- 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
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 |
|---|---|---|
| budesonidepMDI, inhalation, bid, 6 weeks | Drug | 1 |
| placebopMDI, inhalation, bid, 6 weeks | Drug | 2 |
Primary outcome
Change in Morning Peak Expiratory Flow (PEF) From Baseline to the Treatment Period Average
Time frame: Baseline to 6 weeks
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.
10 secondary outcomes
Change in Forced Expiratory Volume in 1 Second (FEV1) From Baseline to Treatment Period Average
Time frame: Baseline to 6 weeks
Change in Evening PEF From Baseline to the Treatment Period Average
Time frame: Baseline to 6 weeks
Change in Forced Vital Capacity (FVC) From Baseline to Treatment Period Average
Time frame: Baseline to 6 weeks
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
Change in Total Daily and Daytime Asthma Symptom Scores From Baseline to Treatment Period Average
Time frame: Baseline to 6 weeks
Change in Nighttime Asthma Symptom Score From Baseline to Treatment Period Average
Time frame: Baseline to 6 weeks
Change in Nighttime Awakenings and Nighttime Awakenings With Reliever Medication Use From Baseline to Treatment Period Average
Time frame: Baseline to 6 weeks
Change in Total Daily and Daytime Reliever Medication Use From Baseline to Treatment Period Average
Time frame: Baseline to 6 weeks
Change in Nighttime Reliever Medication Use From Baseline to Treatment Period Average
Time frame: Baseline to 6 weeks
Number of Withdrawals Due to Pre-defined Asthma Events
Time frame: Baseline to 6 weeks
Results and safety
Loading the posted results from ClinicalTrials.gov…
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 1 Aug 2014.
- Posted resultsParticipant flow, baseline, all outcome measures and adverse events.
- Derived from this study: PubMed 26460293Meltzer EO, Pearlman DS, Eckerwall G, Uryniak T, DePietro M, Lampl K. Efficacy and safety of budesonide administered by pressurized metered-dose inhaler in children with asthma. Ann Allergy Asthma Immunol. 2015 Dec;115(6):516-22. doi: 10.1016/j.anai.2015.09.007. Epub 2015 Oct 13.
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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.
Göran Eckerwall, MD study director
AZ R&D Mölndal
87 sites in 7 countries: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 2 study testing budesonide in people with Asthma, run by AstraZeneca at 87 sites in 7 countries.
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 3 inclusion and 2 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 1 Aug 2014. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 87 sites in United States, Hungary, Poland, South Africa, Bulgaria and 2 more countries. 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 2 studies give the treatment to a larger group to see whether it has the intended effect and to keep checking safety.
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 21 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 in Morning Peak Expiratory Flow (PEF) From Baseline to the Treatment Period Average (time frame: Baseline to 6 weeks). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT01136382, which also lists 1 linked publication.
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 1 Aug 2014.