AsthmaPhase 2NCT00736489

Single-dose Crossover Study to Investigate Pharmacodynamics of AZD3199

A Phase 2 study testing AZD3199 and Formoterol in people with Asthma and Airway Obstruction, run by AstraZeneca at 4 sites in 2 countries.

Completed

Finished. The study has ended and is not enrolling. Results may be posted on the official record.

Official record

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Trial summary

The purpose of this study is to investigate the pharmacodynamics of single doses of AZD3199 in asthmatic patients. Read more about this study

Who is it for?: Ages 18 years and older
Conditions the study is for: Asthma, Airway Obstruction
What is being tested?: AZD3199 and Formoterol
Could I receive a placebo?: Yes, some participants may receive a placebo
How many people: 37 participants
Where: 4 sitesin 2 countries
Study dates: Aug 2008to Dec 2008
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 18 years and older
All sexes
No healthy volunteers
Adult, Older adult

Who may be able to join

Asthmatic patients with pre-bronchodilatory FEV1 above 60% of predicted normal and above 1.5 liters.
Men and post-menopausal women above 18 years of age.
Reversible airway obstruction in response to classical beta2-agonist (salbutamol)
Non/ex-smokers

Who cannot join

Any clinically significant disease or disorder other than asthma
Any clinically relevant abnormal findings at screening examinations
Treatment with systemic glucocorticosteroids within the past 30 days
Inhaled corticosteroid use if dosing is not kept constant

Trial locations and contacts

4 sites in 2 countries.

Country

City, postcode or hospital

4 sites in 2 countries

Sweden3 sites

Research Site
Gothenburg
Research Site
Luleå
Research Site
Lund

Other trials in Sweden

Denmark1 site

Research Site
Hvidovre

Other trials in Denmark

About this study

Official title: A Phase II, Double-blind, Placebo-controlled, Randomised, 6-way Cross-over, Single-dose Study to Investigate the Local and Systemic Effects of 3 Doses of Inhaled AZD3199 (a β2-agonist) Compared to Formoterol in Asthmatic Patients

The purpose of this study is to investigate the pharmacodynamics of single doses of AZD3199 in asthmatic patients.

Conditions: Asthma, Airway Obstruction
Being tested: AZD3199, Formoterol, Placebo
Keywords: Asthma, airway obstruction, beta2-agonist, efficacy, inhalation
Medical subject headings: Asthma, Airway Obstruction, Respiratory Aspiration

What participants receive

What participants receive. In a randomised study each person is assigned to one group by chance.

AZD3199Drug
Dry powder for inhalation, single dose
FormoterolDrug
Also called Oxis
Dry powder for inhalation, single dose
PlaceboDrug
Dry powder for inhalation, single dose

Study groups in NCT00736489
Study group	Role	What they receive
crossover dose 1	Experimental	AZD3199 120 microgram Receives: Drug: AZD3199
crossover dose 2	Experimental	AZD3199 480 microgram Receives: Drug: AZD3199
crossover dose 3	Experimental	AZD3199 1920 microgram Receives: Drug: AZD3199
crossover dose 4	Placebo comparator	Placebo Receives: Drug: Placebo
crossover dose 5	Active comparator	Formoterol 9 microgram Receives: Drug: Formoterol
crossover dose 6	Active comparator	Formoterol 36 microgram Receives: Drug: Formoterol

What is being measured

The primary outcome is the main question the study is designed to answer.

FEV1 Peak Effect Within 0 - 24 h Post-dose
Maximum FEV1 value
Measured: 0, 5min, 15min, 30min, 1h, 2h, 4h, 6h, 8h, 10h, 12h, 14h, 18h, 22h, 24h
E22-26: the Average of the FEV1 Value Between 22 and 26 h Post Dose for Every Treatment Visit.
Residual FEV1 24 h post-dose
Measured: 22- 26 h post dose
S-potassium, Peak Effect Over 0 - 4 h Post-dose
Minimum S-potassium concentration (A well-known effect of beta2-agonists (AZD3199 is a beta2-agonist) is a reduction in serum potassium levels. The minimum value has therefore been evaluated.
Measured: 0, 15min, 30min,1h, 2h, 4h
S-potassium, Average Effect Over 0 - 4 h Post-dose
Average S-potassium concentration
Measured: 0, 15min, 30min,1h, 2h, 4h

Secondary outcomes (20)

FEV1 Effect at 5 Min Post-dose
FEV1 at 5 minutes
Measured: 5min
FEV1 Average Effect Over 0 - 24 h Post-dose
FEV1 average effect over 24 h dosing interval
Measured: 0, 5min, 15min, 30min, 1h, 2h, 4h, 6h, 8h, 10h, 12h, 14h, 18h, 22h, 24h
FEV1 Average Effect Over 0 - 12 h Post-dose
FEV1 average effect over 12 h day-time period
Measured: 0, 5min, 15min, 30min, 1h, 2h, 4h, 6h, 8h, 10h, 12h
FEV1 Average Effect Over 12 - 24 h Post-dose
FEV1 average effect over 12 h night-time period
Measured: 12h, 14h, 18h, 22h, 24h
Systolic Blood Pressure, Peak Effect Over 0 - 4 h Post-dose
Maximum SBP value over 4 h
Measured: 0, 30min, 2h, 4h
Systolic Blood Pressure, Average Effect Over 0 - 4 h Post-dose
Average SBP value over 4 h
Measured: 0, 30min, 2h, 4h
Diastolic Blood Pressure, Peak Effect Over 0 - 4 h Post-dose
Minimum DBP value over 4 h
Measured: 0, 30min, 2h, 4h
Diastolic Blood Pressure, Average Effect Over 0 - 4 h Post-dose
Average DBP value over 4 h
Measured: 0, 30min, 2h, 4h
Pulse, Peak Effect Over 0 - 4 h Post-dose
Maximum pulse over 4 h
Measured: 0, 30min, 2h, 4h
Pulse, Average Effect Over 0 - 4 h Post-dose
Average pulse over 4 h
Measured: 0, 30min, 2h, 4h
Heart Rate, Peak Effect Over 0 - 4 h Post-dose
Maximum heart rate over 4 h
Measured: 0, 30min, 2h, 4h
Heart Rate, Average Effect Over 0 - 4 h Post-dose
Average heart rate over 4 h
Measured: 0, 30min, 2h, 4h
QTcB, Peak Effect Over 0 - 4 h Post-dose
Maximum QTc Bazett over 4 h
Measured: 0, 30min, 2h, 4h
QTcB, Average Effect Over 0 - 4 h Post-dose
Average QTc Bazett over 4 h
Measured: 0, 30min, 2h, 4h
Tremor, Peak Effect Over 0 - 4 h Post-dose
Maximum tremor score (4 grade scale: 0=no, 1=mild, 2=moderate or 3=severe) over 4 h.
Measured: 0, 15min, 30min, 1h, 2h, 4h
Tremor, Average Effect Over 0 - 4 h Post-dose
Average tremor score (4 grade scale: 0=no, 1=mild, 2=moderate or 3=severe) over 4 h.
Measured: 0, 15min, 30min, 1h, 2h, 4h
Palpitations, Peak Effect Over 0 - 4 h Post-dose
Maximum palpitation score (4 grade scale: 0=no, 1=mild, 2=moderate or 3=severe) over 4 h
Measured: 0, 15min, 30min, 1h, 2h, 4h
Palpitations, Average Effect Over 0 - 4 h Post-dose
Average palpitation score (4 grade scale: 0=no, 1=mild, 2=moderate or 3=severe) over 4 h
Measured: 0, 15min, 30min, 1h, 2h, 4h
Plasma AZD3199 Cmax
Maximum plasma concentration of AZD3199 measured
Measured: 0, 5min, 15min, 30min, 1h, 2h, 4h, 8h, 12h, 24h
Plasma AZD3199 AUC0-24
Area under the plasma concentration curve from time 0 to 24 h post-dose
Measured: 0, 5min, 15min, 30min, 1h, 2h, 4h, 8h, 12h, 24h

Timeline

From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.

Aug 2008Dec 2008

First posted18 Aug 2008 (estimated)
Study startAug 2008
Primary completionDec 2008
Study completionDec 2008

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: 37 participants (actual)

IDs, dates and publications

ClinicalTrials.gov ID: NCT00736489
Sponsor's protocol ID: D0570C00007
Other IDs: ToBe
Status last verified: Apr 2014
First submitted: 15 Aug 2008
Last updated: 19 May 2014
Results posted: Yes, on ClinicalTrials.gov
Data monitoring committee: No

Publications

Bjermer L, Rosenborg J, Bengtsson T, Lotvall J. Comparison of the bronchodilator and systemic effects of AZD3199, an inhaled ultra-long-acting beta(2)-adrenoceptor agonist, with formoterol in patients with asthma. Ther Adv Respir Dis. 2013 Oct;7(5):264-71. doi: 10.1177/1753465813497527. Epub 2013 Aug 1.
PubMed 23907810

Want to know more?

The sponsor has not listed a contact. The official record may have more details.

Talk to your doctor first and take this page with you. Only the study team can confirm whether you can join.

Questions to ask the study team

What is the study trying to find out?
What would I need to do, and how often would I visit?
Could I receive a placebo instead of the treatment?
What are the possible risks and benefits for me?
Will it cost me anything? Are travel or time paid for?
Can I keep seeing my own doctor during the study?
What happens when the study ends?

See locations

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All Asthma trials

Study at a glance

From the registry record, last updated by the sponsor on 19 May 2014. Recruitment status is as the sponsor reported it: confirm with the study team.

Official title: A Phase II, Double-blind, Placebo-controlled, Randomised, 6-way Cross-over, Single-dose Study to Investigate the Local and Systemic Effects of 3 Doses of Inhaled AZD3199 (a β2-agonist) Compared to Formoterol in Asthmatic Patients
ClinicalTrials.gov ID: NCT00736489
Acronym / sponsor ID: D0570C00007
Conditions: Asthma, Airway Obstruction
Keywords: Asthma, airway obstruction, beta2-agonist, efficacy, inhalation
Phase: Phase 2
Study type: Interventional
Recruitment status: Completed
Enrolment: 37 participants (actual)
Lead sponsor: AstraZenecaIndustry (pharma, biotech, devices)
Study start: Aug 2008
Primary completion: Dec 2008 (actual)
Study completion: Dec 2008 (actual)
First posted: 18 Aug 2008 (estimated)
Results: Posted 3 Apr 2014

Clinical summary

The research question as the sponsor registered it. This describes what the study plans to test, not what it found.

The purpose of this study is to investigate the pharmacodynamics of single doses of AZD3199 in asthmatic patients.

Study design

Primary purpose: Treatment
Allocation: Randomised
Intervention model: Crossover
Masking: Quadruple blind (participant, care provider, investigator, outcomes assessor)
Number of arms: 6

Arm	Type	Receives
crossover dose 1	Experimental	Drug: AZD3199AZD3199 120 microgram
crossover dose 2	Experimental	Drug: AZD3199AZD3199 480 microgram
crossover dose 3	Experimental	Drug: AZD3199AZD3199 1920 microgram
crossover dose 4	Placebo comparator	Drug: PlaceboPlacebo
crossover dose 5	Active comparator	Drug: FormoterolFormoterol 9 microgram
crossover dose 6	Active comparator	Drug: FormoterolFormoterol 36 microgram

Who may qualify

Ages: 18 years and older
Sex: All
Healthy volunteers: Not accepted
Age groups: Adult, Older adult

Key inclusion criteria (4 listed)

Asthmatic patients with pre-bronchodilatory FEV1 above 60% of predicted normal and above 1.5 liters.
Men and post-menopausal women above 18 years of age.
Reversible airway obstruction in response to classical beta2-agonist (salbutamol)
Non/ex-smokers

Key exclusion criteria (4 listed)

Any clinically significant disease or disorder other than asthma
Any clinically relevant abnormal findings at screening examinations
Treatment with systemic glucocorticosteroids within the past 30 days
Inhaled corticosteroid use if dosing is not kept constant

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
AZD3199Dry powder for inhalation, single dose	Drug	crossover dose 1, crossover dose 2, crossover dose 3
FormoterolAlso: OxisDry powder for inhalation, single dose	Drug	crossover dose 5, crossover dose 6
PlaceboDry powder for inhalation, single dose	Drug	crossover dose 4

Primary outcome

FEV1 Peak Effect Within 0 - 24 h Post-dose
Time frame: 0, 5min, 15min, 30min, 1h, 2h, 4h, 6h, 8h, 10h, 12h, 14h, 18h, 22h, 24h
Maximum FEV1 value
E22-26: the Average of the FEV1 Value Between 22 and 26 h Post Dose for Every Treatment Visit.
Time frame: 22- 26 h post dose
Residual FEV1 24 h post-dose
S-potassium, Peak Effect Over 0 - 4 h Post-dose
Time frame: 0, 15min, 30min,1h, 2h, 4h
Minimum S-potassium concentration (A well-known effect of beta2-agonists (AZD3199 is a beta2-agonist) is a reduction in serum potassium levels. The minimum value has therefore been evaluated.
S-potassium, Average Effect Over 0 - 4 h Post-dose
Time frame: 0, 15min, 30min,1h, 2h, 4h
Average S-potassium concentration

20 secondary outcomes

FEV1 Effect at 5 Min Post-dose
Time frame: 5min
FEV1 Average Effect Over 0 - 24 h Post-dose
Time frame: 0, 5min, 15min, 30min, 1h, 2h, 4h, 6h, 8h, 10h, 12h, 14h, 18h, 22h, 24h
FEV1 Average Effect Over 0 - 12 h Post-dose
Time frame: 0, 5min, 15min, 30min, 1h, 2h, 4h, 6h, 8h, 10h, 12h
FEV1 Average Effect Over 12 - 24 h Post-dose
Time frame: 12h, 14h, 18h, 22h, 24h
Systolic Blood Pressure, Peak Effect Over 0 - 4 h Post-dose
Time frame: 0, 30min, 2h, 4h
Systolic Blood Pressure, Average Effect Over 0 - 4 h Post-dose
Time frame: 0, 30min, 2h, 4h
Diastolic Blood Pressure, Peak Effect Over 0 - 4 h Post-dose
Time frame: 0, 30min, 2h, 4h
Diastolic Blood Pressure, Average Effect Over 0 - 4 h Post-dose
Time frame: 0, 30min, 2h, 4h
Pulse, Peak Effect Over 0 - 4 h Post-dose
Time frame: 0, 30min, 2h, 4h
Pulse, Average Effect Over 0 - 4 h Post-dose
Time frame: 0, 30min, 2h, 4h
Heart Rate, Peak Effect Over 0 - 4 h Post-dose
Time frame: 0, 30min, 2h, 4h
Heart Rate, Average Effect Over 0 - 4 h Post-dose
Time frame: 0, 30min, 2h, 4h
QTcB, Peak Effect Over 0 - 4 h Post-dose
Time frame: 0, 30min, 2h, 4h
QTcB, Average Effect Over 0 - 4 h Post-dose
Time frame: 0, 30min, 2h, 4h
Tremor, Peak Effect Over 0 - 4 h Post-dose
Time frame: 0, 15min, 30min, 1h, 2h, 4h
Tremor, Average Effect Over 0 - 4 h Post-dose
Time frame: 0, 15min, 30min, 1h, 2h, 4h
Palpitations, Peak Effect Over 0 - 4 h Post-dose
Time frame: 0, 15min, 30min, 1h, 2h, 4h
Palpitations, Average Effect Over 0 - 4 h Post-dose
Time frame: 0, 15min, 30min, 1h, 2h, 4h
Plasma AZD3199 Cmax
Time frame: 0, 5min, 15min, 30min, 1h, 2h, 4h, 8h, 12h, 24h
Plasma AZD3199 AUC0-24
Time frame: 0, 5min, 15min, 30min, 1h, 2h, 4h, 8h, 12h, 24h

Results and safety

Results posted to the registry on 3 Apr 2014, as reported by the sponsor. Figures are copied from the record, not re-analysed. Full results on ClinicalTrials.gov.

Participant flow

Group	Started	Completed
APCDEBa	6	5
BADEPCa	5	5
CBEPADa	6	6
DCPABEa	7	7
EDABCPa	7	7
PEBCDAa	6	5

Primary outcome: FEV1 Peak Effect Within 0 - 24 h Post-dose

Time frame: 0, 5min, 15min, 30min, 1h, 2h, 4h, 6h, 8h, 10h, 12h, 14h, 18h, 22h, 24h. Mean (Standard Deviation). Unit: L

Measure	AZD3199 120 mcg n = 35	AZD3199 480 mcg n = 35	AZD3199 1920 mcg n = 35	Formoterol 9 mcg n = 35	Formoterol 36 mcg n = 35	Placebo n = 34
Value	3.56 (0.94)	3.62 (0.94)	3.70 (1.02)	3.62 (1.01)	3.69 (0.97)	3.44 (0.99)

Population analysed: Two patients discontinued after the first treatment period and were excluded from pharmacodynamic analysis set since these patients are non-informative regarding treatment differences. One patient on Placebo treatment had data not sufficient for computing PD parameters and for subsequent analysis.

Primary outcome: E22-26: the Average of the FEV1 Value Between 22 and 26 h Post Dose for Every Treatment Visit.

Time frame: 22- 26 h post dose. Mean (Standard Deviation). Unit: L

Measure	AZD3199 120 mcg n = 35	AZD3199 480 mcg n = 35	AZD3199 1920 mcg n = 35	Formoterol 9 mcg n = 35	Formoterol 36 mcg n = 35	Placebo n = 34
Value	3.31 (0.96)	3.35 (0.93)	3.40 (0.94)	3.26 (0.94)	3.36 (0.97)	3.23 (0.96)

Primary outcome: S-potassium, Peak Effect Over 0 - 4 h Post-dose

Time frame: 0, 15min, 30min,1h, 2h, 4h. Mean (Standard Deviation). Unit: mmol/L

Measure	AZD3199 120 mcg n = 35	AZD3199 480 mcg n = 35	AZD3199 1920 mcg n = 33	Formoterol 9 mcg n = 35	Formoterol 36 mcg n = 35	Placebo n = 35
Value	4.04 (0.19)	4.03 (0.25)	3.98 (0.28)	4.04 (0.20)	3.84 (0.21)	4.04 (0.23)

Population analysed: Two patients discontinued after the first treatment period and were excluded from pharmacodynamic analysis set since these patients are non-informative regarding treatment differences. Two patients on AZD3199 1920 mcg had data not sufficient for computing PD parameters and for subsequent analysis.

Primary outcome: S-potassium, Average Effect Over 0 - 4 h Post-dose

Time frame: 0, 15min, 30min,1h, 2h, 4h. Mean (Standard Deviation). Unit: mmol/L

Measure	AZD3199 120 mcg n = 35	AZD3199 480 mcg n = 35	AZD3199 1920 mcg n = 33	Formoterol 9 mcg n = 35	Formoterol 36 mcg n = 35	Placebo n = 35
Value	4.22 (0.19)	4.21 (0.26)	4.17 (0.26)	4.19 (0.20)	3.99 (0.17)	4.21 (0.25)

Population analysed: Two patients discontinued after the first treatment period and were excluded from pharmacodynamic analysis set since these patients are non-informative regarding treatment differences. Two patients on AZD3199 1920 mcg had data not sufficient for computing PD parameters and for subsequent analysis.

20 secondary outcomes are reported in the full results.

Adverse events

Other adverse events reported at 5% frequency or more

Group	Serious adverse events	Other adverse events	Deaths
AZD3199 120 mcg	0 of 36 (0%)	4 of 36 (11.1%)	Not reported
AZD3199 480 mcg	0 of 35 (0%)	3 of 35 (8.6%)	Not reported
AZD3199 1920 mcg	0 of 35 (0%)	10 of 35 (28.6%)	Not reported
Formoterol 9 mcg	0 of 35 (0%)	2 of 35 (5.7%)	Not reported
Formoterol 36 mcg	0 of 35 (0%)	4 of 35 (11.4%)	Not reported
Placebo	0 of 36 (0%)	6 of 36 (16.7%)	Not reported

Loading the posted results from ClinicalTrials.gov…

Research links

Official record on ClinicalTrials.govLast updated by the sponsor 19 May 2014.
Posted resultsParticipant flow, baseline, all outcome measures and adverse events.
Derived from this study: PubMed 23907810Bjermer L, Rosenborg J, Bengtsson T, Lotvall J. Comparison of the bronchodilator and systemic effects of AZD3199, an inhaled ultra-long-acting beta(2)-adrenoceptor agonist, with formoterol in patients with asthma. Ther Adv Respir Dis. 2013 Oct;7(5):264-71. doi: 10.1177/1753465813497527. Epub 2013 Aug 1.
Related InfoLink provided by the sponsor.
D0570C00007 CSR SynopsisLink provided by the sponsor.

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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.

Prof Leif Bjermer, MD, PhD principal investigator

University Hospital in Lund, Sweden

4 sites in 2 countries: see every site and its status.

Questions about this trial

What is this clinical trial studying?

A Phase 2 study testing AZD3199 and Formoterol in people with Asthma and Airway Obstruction, run by AstraZeneca at 4 sites in 2 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 4 inclusion and 4 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 19 May 2014. Status can change between updates, so confirm with the study contact before making plans.

Where is the study taking place?

The record lists 4 sites in Sweden, Denmark. 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 3 Apr 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?

FEV1 Peak Effect Within 0 - 24 h Post-dose (time frame: 0, 5min, 15min, 30min, 1h, 2h, 4h, 6h, 8h, 10h, 12h, 14h, 18h, 22h, 24h). The study lists 4 primary outcomes in all. 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 NCT00736489, 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 19 May 2014.