AsthmaPhase 2CHASE 2NCT01136655
A Study in Asthmatic Children (6 to <12 Yrs) Comparing Single Doses of Formoterol and Foradil® Evaluating Efficacy
A Phase 2 study testing 80/2.25 μg Symbicort pMDI, 80/4.5 μg Symbicort pMDI and Foradil Aerolizer 12 μg in people with Asthma, run by AstraZeneca at 34 sites in 6 countries.
Trial summary
This purpose of the study is to investigate the bronchodilating effects of 3 different dosages of formoterol given in combination with budesonide as Symbicort pMDI. Read more about this study
- Who is it for?
- Ages 6 to 11 years
- Conditions the study is for
- Asthma
- What is being tested?
- 80/2.25 μg Symbicort pMDI, 80/4.5 μg Symbicort pMDI and Foradil Aerolizer 12 μg
- Could I receive a placebo?
- Yes, some participants may receive a placebo
- How many people
- 54 participants
- Where
- 34 sitesin 6 countries
- Study dates
- Sep 2010to Dec 2011
- 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 1
- Has a FEV1 measured at least 6 hours after the last dose of inhaled, short-acting β2-agonist (SABA) and at least 48 hours after the last dose of inhaled long-acting β2-agonist of =60% and =85% of predicted normal.
- Demonstrated reversibility of FEV1 of =15% from pre short acting beta agonist level within 15 to 30 minutes after administration of a standard dose of short acting beta agonist
Who cannot join
- Has been hospitalized for >24 hours at least once or required emergency treatment or urgent care visit more than once for an asthma-related condition during the 6 months prior to Visit 1
- Has required treatment with systemic corticosteroids (eg, oral, parenteral, or rectal) for any reason within the 12 weeks prior to Visit 1.
Trial locations and contacts
34 sites in 6 countries.
34 sites in 6 countries
United States20 sites
Research Site
Altoona, Pennsylvania
Research Site
Charleston, South Carolina
Research Site
El Paso, Texas
Research Site
Eugene, Oregon
Research Site
Huntington, California
Research Site
Lake Oswego, Oregon
Research Site
Long Beach, California
Research Site
Medford, Oregon
Research Site
Mission Viejo, California
Research Site
Morrisville, North Carolina
Research Site
Omaha, Nebraska
Research Site
Orange, California
Research Site
Portland, Oregon
Research Site
Raleigh, North Carolina
Research Site
Rolling Hills Estate, California
Research Site
San Antonio, Texas
Research Site
Sarasota, Florida
Research Site
Springfield, Virginia
Research Site
Upland, Pennsylvania
Research Site
Waco, Texas
South Africa7 sites
Research Site
Cape Town, South Africa
Research Site
Cape Town, W Cape
Research Site
Claremont, W Cape
Research Site
Dublin
Research Site
Durban, Kz-natal
Research Site
Krugersdorp, Gauteng
Research Site
Pietermariztburg, KwaZulu-Natal
Hungary4 sites
Research Site
Budapest
Research Site
Dublin
Research Site
Miskolc
Research Site
Sopron
About this study
Official title: A Phase 2, Randomized, Blinded, 5-period Cross-over, Placebo and Active Controlled, Multicenter, Dose-finding Study Comparing Single Doses of Formoterol 2.25 µg, 4.5 µg, and 9 µg Delivered Via Symbicort pMDI and Foradil® 12 µg Evaluating the Relative Bronchodilating Effects and Safety in Children
This purpose of the study is to investigate the bronchodilating effects of 3 different dosages of formoterol given in combination with budesonide as Symbicort pMDI.
Read the detailed description
A Phase 2, randomized, blinded, 5-period cross-over, placebo and active controlled, multicenter, dose-finding study comparing single doses of formoterol 2.25 µg, 4.5 µg, and 9 µg delivered via Symbicort pMDI and Foradil® 12 µg evaluating the relative bronchodilating effects and safety in children.
- Conditions
- Asthma
- Being tested
- 80/2.25 μg Symbicort pMDI, 80/4.5 μg Symbicort pMDI, Foradil Aerolizer 12 μg, 40 μg budesonide HFA pMDI, placebo HFA pMDI
- Keywords
- asthmatic children, Symbicort, Foradil
- Medical subject headings
- Asthma
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
80/2.25 μg Symbicort pMDIDrug
inhalation
80/4.5 μg Symbicort pMDIDrug
inhalation
Foradil Aerolizer 12 μgDrug
inhalation
40 μg budesonide HFA pMDIDrug
inhalation
placebo HFA pMDIDrug
inhalation
| Study group | Role | What they receive |
|---|---|---|
| BUD 160/FM 2.25 | Experimental | 2.25 μg formoterol (as 80/2.25 μg Symbicort pMDI × 1 inhalation) + 40 μg budesonide HFA pMDI × 2 inhalations Receives: Drug: 80/2.25 μg Symbicort pMDI; Drug: 40 μg budesonide HFA pMDI |
| BUD 160/FM 4.5 | Experimental | placebo HFA pMDI × 1 inhalation + 4.5 μg formoterol (as 80/2.25 μg Symbicort pMDI × 2 inhalations) Receives: Drug: 80/2.25 μg Symbicort pMDI; Drug: placebo HFA pMDI |
| BUD 160/FM 9.0 | Experimental | placebo HFA pMDI × 1 inhalation + 9 μg formoterol (as 80/4.5 μg Symbicort pMDI × 2 inhalations) Receives: Drug: 80/4.5 μg Symbicort pMDI; Drug: placebo HFA pMDI |
| BUD 160 | Placebo comparator | placebo HFA pMDI × 1 inhalation + 80 μg budesonide HFA pMDI × 2 inhalations Receives: Drug: 40 μg budesonide HFA pMDI; Drug: placebo HFA pMDI |
| BUD 160/Foradil 12.0 | Active comparator | Foradil Aerolizer 12 μg × 1 inhalation + 80 μg budesonide HFA pMDI × 2 inhalations Receives: Drug: Foradil Aerolizer 12 μg; Drug: 40 μg budesonide HFA pMDI |
What is being measured
The primary outcome is the main question the study is designed to answer.
Average 12 Hour Forced Expiratory Volume in 1 Second (FEV1)
Pulmonary function tests consisted of 3 forced expiratory maneuvers in which the patient expired forcefully from total lung capacity to residual volume, recorded using a spirometer. FEV1 was obtained from the full expiratory flow-volume-time curve. FEV1 was measured at 3, 9, 15, 60, 120, 180, 240, 360, 480, 600 and 720 minutes post administration of randomized study medication. Twelve-hour serial FEV1 was calculated through an AUC determination and then divided by time, so that the final value is expressed in liters. One subject was incorrectly administered BUD 160/ formoterol (FM) 9.0 rather than BUD 160/ Foradil 12.0 at Period 4. Hence this subject is included in the Efficacy Analysis Set, but not the Safety Analysis Set for BUD 160/ Foradil 12.0.
Measured: at 3, 9, 15, 60, 120, 180, 240, 360, 480, 600 and 720 minutes postdose
Secondary outcomes (3)
FEV1 at 12 Hours After Study Medication Inhalation
Pulmonary function tests consisted of 3 forced expiratory maneuvers in which the patient expired forcefully from total lung capacity to residual volume, recorded using a spirometer. The FEV1 value at 12 hours after dosing was taken as the 12-hour measurement (720 minutes) from the serial spirometry. One subject was incorrectly administered BUD 160/ formoterol (FM) 9.0 rather than BUD 160/ Foradil 12.0 at Period 4. Hence this subject is included in the Efficacy Analysis Set, but not the Safety Analysis Set for BUD 160/ Foradil 12.0.
Measured: 12 hours after dosing
Maximal FEV1 During the 12-hour Study Period
Pulmonary function tests consisted of 3 forced expiratory maneuvers in which the patient expired forcefully from total lung capacity to residual volume, recorded using a spirometer. FEV1 was measured at 3, 9, 15, 60, 120, 180, 240, 360, 480, 600 and 720 minutes post administration of randomized study medication. The maximum FEV1 value was defined as the largest observed FEV1 value recorded during each 12-hour serial spirometry procedure. One subject was incorrectly administered BUD 160/ formoterol (FM) 9.0 rather than BUD 160/ Foradil 12.0 at Period 4. Hence this subject is included in the Efficacy Analysis Set, but not the Safety Analysis Set for BUD 160/ Foradil 12.0.
Measured: at 3, 9, 15, 60, 120, 180, 240, 360, 480, 600 and 720 minutes postdose
Urinary Excretion of Formoterol During the 12 Hours Following Inhalation of Study Drug
The amount of formoterol excreted unchanged in urine over the 12-hour period after administration [Ae(0-12h)] was calculated from the concentration of formoterol in urine multiplied by the total volume of urine collected. Volume was determined from the weight of the collected urine times an assumed urine density of 1020 g/L. The data for six patients who did not have measurable formoterol in their urine on the Foradil 12 μg treatment day was excluded from the analysis. All other urine concentrations below the lower limit of quantification were set to zero. One subject was incorrectly administered BUD 160/ formoterol (FM) 9.0 rather than BUD 160/ Foradil 12.0 at Period 4. Hence this subject is included in the Efficacy Analysis Set, but not the Safety Analysis Set for BUD 160/ Foradil 12.0.
Measured: 0 to 12 hours
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 startSep 2010
- Primary completionDec 2011
- Study completionDec 2011
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
- Crossover
- Masking
- Quadruple blind
- Who is masked
- Participant, Care provider, Investigator, Outcomes assessor
- Enrolment
- 54 participants (actual)
Sponsor and investigators
- Lead sponsor
- AstraZeneca
- Sponsor type
- Industry (pharma, biotech, devices)
- Responsible party
- Sponsor
- Investigators
- Lars-Goran Carlsson, MD, Study director, AstraZeneca
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT01136655
- Sponsor's protocol ID
- D589GC00002
- Acronym
- CHASE 2
- Status last verified
- Oct 2013
- First submitted
- 1 Jun 2010
- Last updated
- 31 Oct 2013
- Results posted
- Yes, on ClinicalTrials.gov
- Data monitoring committee
- No
Publications
Berger WE, Gillen M, Eckerwall G, Uryniak T, Trudo FJ, Lampl KL. Bronchodilator effect of single-dose formoterol administered by pressurized metered-dose inhaler in children with asthma aged 6 to <12 years receiving budesonide. Allergy Asthma Proc. 2014 Mar-Apr;35(2):134-40. doi: 10.2500/aap.2014.35.3746.
PubMed 24717790
Study at a glance
From the registry record, last updated by the sponsor on 31 Oct 2013. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- A Phase 2, Randomized, Blinded, 5-period Cross-over, Placebo and Active Controlled, Multicenter, Dose-finding Study Comparing Single Doses of Formoterol 2.25 µg, 4.5 µg, and 9 µg Delivered Via Symbicort pMDI and Foradil® 12 µg Evaluating the Relative Bronchodilating Effects and Safety in Children
- ClinicalTrials.gov ID
- NCT01136655
- Acronym / sponsor ID
- CHASE 2 / D589GC00002
- Conditions
- Asthma
- Keywords
- asthmatic children, Symbicort, Foradil
- Phase
- Phase 2
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 54 participants (actual)
- Lead sponsor
- AstraZenecaIndustry (pharma, biotech, devices)
- Study start
- Sep 2010
- Primary completion
- Dec 2011 (actual)
- Study completion
- Dec 2011 (actual)
- First posted
- 3 Jun 2010 (estimated)
- Results
- Posted 30 Aug 2013
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 the bronchodilating effects of 3 different dosages of formoterol given in combination with budesonide as Symbicort pMDI.
Detailed description
A Phase 2, randomized, blinded, 5-period cross-over, placebo and active controlled, multicenter, dose-finding study comparing single doses of formoterol 2.25 µg, 4.5 µg, and 9 µg delivered via Symbicort pMDI and Foradil® 12 µg evaluating the relative bronchodilating effects and safety in children.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Crossover
- Masking
- Quadruple blind (participant, care provider, investigator, outcomes assessor)
- Number of arms
- 5
| Arm | Type | Receives |
|---|---|---|
| BUD 160/FM 2.25 | Experimental | Drug: 80/2.25 μg Symbicort pMDI, Drug: 40 μg budesonide HFA pMDI2.25 μg formoterol (as 80/2.25 μg Symbicort pMDI × 1 inhalation) + 40 μg budesonide HFA pMDI × 2 inhalations |
| BUD 160/FM 4.5 | Experimental | Drug: 80/2.25 μg Symbicort pMDI, Drug: placebo HFA pMDIplacebo HFA pMDI × 1 inhalation + 4.5 μg formoterol (as 80/2.25 μg Symbicort pMDI × 2 inhalations) |
| BUD 160/FM 9.0 | Experimental | Drug: 80/4.5 μg Symbicort pMDI, Drug: placebo HFA pMDIplacebo HFA pMDI × 1 inhalation + 9 μg formoterol (as 80/4.5 μg Symbicort pMDI × 2 inhalations) |
| BUD 160 | Placebo comparator | Drug: 40 μg budesonide HFA pMDI, Drug: placebo HFA pMDIplacebo HFA pMDI × 1 inhalation + 80 μg budesonide HFA pMDI × 2 inhalations |
| BUD 160/Foradil 12.0 | Active comparator | Drug: Foradil Aerolizer 12 μg, Drug: 40 μg budesonide HFA pMDIForadil Aerolizer 12 μg × 1 inhalation + 80 μg budesonide HFA pMDI × 2 inhalations |
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 1
- Has a FEV1 measured at least 6 hours after the last dose of inhaled, short-acting β2-agonist (SABA) and at least 48 hours after the last dose of inhaled long-acting β2-agonist of =60% and =85% of predicted normal.
- Demonstrated reversibility of FEV1 of =15% from pre short acting beta agonist level within 15 to 30 minutes after administration of a standard dose of short acting beta agonist
Key exclusion criteria (2 listed)
- Has been hospitalized for >24 hours at least once or required emergency treatment or urgent care visit more than once for an asthma-related condition during the 6 months prior to Visit 1
- Has required treatment with systemic corticosteroids (eg, oral, parenteral, or rectal) for any reason within the 12 weeks prior to Visit 1.
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 |
|---|---|---|
| 80/2.25 μg Symbicort pMDIinhalation | Drug | BUD 160/FM 2.25, BUD 160/FM 4.5 |
| 80/4.5 μg Symbicort pMDIinhalation | Drug | BUD 160/FM 9.0 |
| Foradil Aerolizer 12 μginhalation | Drug | BUD 160/Foradil 12.0 |
| 40 μg budesonide HFA pMDIinhalation | Drug | BUD 160, BUD 160/FM 2.25, BUD 160/Foradil 12.0 |
| placebo HFA pMDIinhalation | Drug | BUD 160, BUD 160/FM 4.5, BUD 160/FM 9.0 |
Primary outcome
Average 12 Hour Forced Expiratory Volume in 1 Second (FEV1)
Time frame: at 3, 9, 15, 60, 120, 180, 240, 360, 480, 600 and 720 minutes postdose
Pulmonary function tests consisted of 3 forced expiratory maneuvers in which the patient expired forcefully from total lung capacity to residual volume, recorded using a spirometer. FEV1 was obtained from the full expiratory flow-volume-time curve. FEV1 was measured at 3, 9, 15, 60, 120, 180, 240, 360, 480, 600 and 720 minutes post administration of randomized study medication. Twelve-hour serial FEV1 was calculated through an AUC determination and then divided by time, so that the final value is expressed in liters. One subject was incorrectly administered BUD 160/ formoterol (FM) 9.0 rather than BUD 160/ Foradil 12.0 at Period 4. Hence this subject is included in the Efficacy Analysis Set, but not the Safety Analysis Set for BUD 160/ Foradil 12.0.
3 secondary outcomes
FEV1 at 12 Hours After Study Medication Inhalation
Time frame: 12 hours after dosing
Maximal FEV1 During the 12-hour Study Period
Time frame: at 3, 9, 15, 60, 120, 180, 240, 360, 480, 600 and 720 minutes postdose
Urinary Excretion of Formoterol During the 12 Hours Following Inhalation of Study Drug
Time frame: 0 to 12 hours
Results and safety
Loading the posted results from ClinicalTrials.gov…
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 31 Oct 2013.
- Posted resultsParticipant flow, baseline, all outcome measures and adverse events.
- Derived from this study: PubMed 24717790Berger WE, Gillen M, Eckerwall G, Uryniak T, Trudo FJ, Lampl KL. Bronchodilator effect of single-dose formoterol administered by pressurized metered-dose inhaler in children with asthma aged 6 to <12 years receiving budesonide. Allergy Asthma Proc. 2014 Mar-Apr;35(2):134-40. doi: 10.2500/aap.2014.35.3746.
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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.
Lars-Goran Carlsson, MD study director
AstraZeneca
34 sites in 6 countries: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 2 study testing 80/2.25 μg Symbicort pMDI, 80/4.5 μg Symbicort pMDI and Foradil Aerolizer 12 μg in people with Asthma, run by AstraZeneca at 34 sites in 6 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 31 Oct 2013. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 34 sites in United States, South Africa, Hungary, Bulgaria, Czechia and 1 more country. 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 30 Aug 2013). 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?
Average 12 Hour Forced Expiratory Volume in 1 Second (FEV1) (time frame: at 3, 9, 15, 60, 120, 180, 240, 360, 480, 600 and 720 minutes postdose). 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 NCT01136655, 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 31 Oct 2013.