Single-dose Crossover Study to Investigate Pharmacodynamics of AZD3199

May 8, 2014 updated by: AstraZeneca

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.

Study Overview

Status

Status

Indicates the current recruitment status or the expanded access status.
Completed

Conditions

Conditions

The disease, disorder, syndrome, illness, or injury that is being studied. On ClinicalTrials.gov, conditions may also include other health-related issues, such as lifespan, quality of life, and health risks.

Intervention / Treatment

Intervention / Treatment

A process or action that is the focus of a clinical study. Interventions include drugs, medical devices, procedures, vaccines, and other products that are either investigational or already available. Interventions can also include noninvasive approaches, such as education or modifying diet and exercise.

Study Type

Study Type

Describes the nature of a clinical study. Study types include interventional studies (also called clinical trials), observational studies (including patient registries), and expanded access.
Interventional

Enrollment (Actual)

Enrollment

The number of participants in a clinical study. The "anticipated" enrollment is the target number of participants that the researchers need for the study.
37

Phase

Phase

The stage of a clinical trial studying a drug or biological product, based on definitions developed by the U.S. Food and Drug Administration (FDA). The phase is based on the study's objective, the number of participants, and other characteristics. There are five phases: Early Phase 1 (formerly listed as Phase 0), Phase 1, Phase 2, Phase 3, and Phase 4. Not Applicable is used to describe trials without FDA-defined phases, including trials of devices or behavioral interventions.
  • Phase 2

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

  • Denmark
      • Hvidovre, Denmark
        • Research Site
  • Sweden
      • Gothenburg, Sweden
        • Research Site
      • Lulea, Sweden
        • Research Site
      • Lund, Sweden
        • Research Site

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Eligibility Criteria

The key requirements that people who want to participate in a clinical study must meet or the characteristics they must have. Eligibility criteria consist of both inclusion criteria (which are required for a person to participate in the study) and exclusion criteria (which prevent a person from participating). Types of eligibility criteria include whether a study accepts healthy volunteers, has age or age group requirements, or is limited by sex.

Ages Eligible for Study

18 years and older (Adult, Older Adult)

Accepts Healthy Volunteers

No

Genders Eligible for Study

All

Description

Inclusion Criteria:

  • 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

Exclusion Criteria:

  • 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

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: Treatment
  • Allocation: Randomized
  • Interventional Model: Crossover Assignment
  • Masking: Quadruple

Arms and Interventions

Participant Group / Arm

Participant Group / Arm

A group or subgroup of participants in a clinical trial that receives a specific intervention/treatment, or no intervention, according to the trial's protocol.
Intervention / Treatment

Intervention / Treatment

A process or action that is the focus of a clinical study. Interventions include drugs, medical devices, procedures, vaccines, and other products that are either investigational or already available. Interventions can also include noninvasive approaches, such as education or modifying diet and exercise.
Experimental: crossover dose 1
AZD3199 120 microgram
Drug: AZD3199
Dry powder for inhalation, single dose
Experimental: crossover dose 2
AZD3199 480 microgram
Drug: AZD3199
Dry powder for inhalation, single dose
Experimental: crossover dose 3
AZD3199 1920 microgram
Drug: AZD3199
Dry powder for inhalation, single dose
Placebo Comparator: crossover dose 4
Placebo
Drug: Placebo
Dry powder for inhalation, single dose
Active Comparator: crossover dose 5
Formoterol 9 microgram
Drug: Formoterol
Dry powder for inhalation, single dose
Other Names:
  • Oxis
Active Comparator: crossover dose 6
Formoterol 36 microgram
Drug: Formoterol
Dry powder for inhalation, single dose
Other Names:
  • Oxis

What is the study measuring?

Primary Outcome Measures

Primary Outcome Measures

In a clinical study's protocol, the planned outcome measure that is the most important for evaluating the effect of an intervention/treatment. Most clinical studies have one primary outcome measure, but some have more than one.
Outcome Measure
Measure Description
Time Frame
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
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.
Time Frame: 22- 26 h post dose
Residual FEV1 24 h post-dose
22- 26 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.
0, 15min, 30min,1h, 2h, 4h
S-potassium, Average Effect Over 0 - 4 h Post-dose
Time Frame: 0, 15min, 30min,1h, 2h, 4h
Average S-potassium concentration
0, 15min, 30min,1h, 2h, 4h

Secondary Outcome Measures

Secondary Outcome Measures

In a clinical study's protocol, a planned outcome measure that is not as important as the primary outcome measure for evaluating the effect of an intervention but is still of interest. Most clinical studies have more than one secondary outcome measure.
Outcome Measure
Measure Description
Time Frame
FEV1 Effect at 5 Min Post-dose
Time Frame: 5min
FEV1 at 5 minutes
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 24 h dosing interval
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 h day-time period
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
FEV1 average effect over 12 h night-time period
12h, 14h, 18h, 22h, 24h
Systolic Blood Pressure, Peak Effect Over 0 - 4 h Post-dose
Time Frame: 0, 30min, 2h, 4h
Maximum SBP value over 4 h
0, 30min, 2h, 4h
Systolic Blood Pressure, Average Effect Over 0 - 4 h Post-dose
Time Frame: 0, 30min, 2h, 4h
Average SBP value over 4 h
0, 30min, 2h, 4h
Diastolic Blood Pressure, Peak Effect Over 0 - 4 h Post-dose
Time Frame: 0, 30min, 2h, 4h
Minimum DBP value over 4 h
0, 30min, 2h, 4h
Diastolic Blood Pressure, Average Effect Over 0 - 4 h Post-dose
Time Frame: 0, 30min, 2h, 4h
Average DBP value over 4 h
0, 30min, 2h, 4h
Pulse, Peak Effect Over 0 - 4 h Post-dose
Time Frame: 0, 30min, 2h, 4h
Maximum pulse over 4 h
0, 30min, 2h, 4h
Pulse, Average Effect Over 0 - 4 h Post-dose
Time Frame: 0, 30min, 2h, 4h
Average pulse over 4 h
0, 30min, 2h, 4h
Heart Rate, Peak Effect Over 0 - 4 h Post-dose
Time Frame: 0, 30min, 2h, 4h
Maximum heart rate over 4 h
0, 30min, 2h, 4h
Heart Rate, Average Effect Over 0 - 4 h Post-dose
Time Frame: 0, 30min, 2h, 4h
Average heart rate over 4 h
0, 30min, 2h, 4h
QTcB, Peak Effect Over 0 - 4 h Post-dose
Time Frame: 0, 30min, 2h, 4h
Maximum QTc Bazett over 4 h
0, 30min, 2h, 4h
QTcB, Average Effect Over 0 - 4 h Post-dose
Time Frame: 0, 30min, 2h, 4h
Average QTc Bazett over 4 h
0, 30min, 2h, 4h
Tremor, Peak Effect Over 0 - 4 h Post-dose
Time Frame: 0, 15min, 30min, 1h, 2h, 4h
Maximum tremor score (4 grade scale: 0=no, 1=mild, 2=moderate or 3=severe) over 4 h.
0, 15min, 30min, 1h, 2h, 4h
Tremor, Average Effect Over 0 - 4 h Post-dose
Time Frame: 0, 15min, 30min, 1h, 2h, 4h
Average tremor score (4 grade scale: 0=no, 1=mild, 2=moderate or 3=severe) over 4 h.
0, 15min, 30min, 1h, 2h, 4h
Palpitations, Peak Effect Over 0 - 4 h Post-dose
Time Frame: 0, 15min, 30min, 1h, 2h, 4h
Maximum palpitation score (4 grade scale: 0=no, 1=mild, 2=moderate or 3=severe) over 4 h
0, 15min, 30min, 1h, 2h, 4h
Palpitations, Average Effect Over 0 - 4 h Post-dose
Time Frame: 0, 15min, 30min, 1h, 2h, 4h
Average palpitation score (4 grade scale: 0=no, 1=mild, 2=moderate or 3=severe) over 4 h
0, 15min, 30min, 1h, 2h, 4h
Plasma AZD3199 Cmax
Time Frame: 0, 5min, 15min, 30min, 1h, 2h, 4h, 8h, 12h, 24h
Maximum plasma concentration of AZD3199 measured
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
Area under the plasma concentration curve from time 0 to 24 h post-dose
0, 5min, 15min, 30min, 1h, 2h, 4h, 8h, 12h, 24h

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Sponsor

The organization or person who initiates the study and who has authority and control over the study.
AstraZeneca

Investigators

Investigators

A researcher involved in a clinical study. Related terms include site principal investigator, site sub-investigator, study chair, study director, and study principal investigator.
  • Principal Investigator: Prof Leif Bjermer, MD, PhD, University Hospital in Lund, Sweden

Publications and helpful links

The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.

General Publications

Helpful Links

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start

Study Start

The actual date on which the first participant was enrolled in a clinical study. The "anticipated" study start date is the date that the researchers think will be the study start date.
August 1, 2008

Primary Completion (Actual)

Primary Completion

The date on which the last participant in a clinical study was examined or received an intervention to collect final data for the primary outcome measure. Whether the clinical study ended according to the protocol or was terminated does not affect this date. For clinical studies with more than one primary outcome measure with different completion dates, this term refers to the date on which data collection is completed for all the primary outcome measures. The "anticipated" primary completion date is the date that the researchers think will be the primary completion date for the study.
December 1, 2008

Study Completion (Actual)

Study Completion

The date on which the last participant in a clinical study was examined or received an intervention/treatment to collect final data for the primary outcome measures, secondary outcome measures, and adverse events (that is, the last participant's last visit). The "anticipated" study completion date is the date that the researchers think will be the study completion date.
December 1, 2008

Study Registration Dates

First Submitted

First Submitted

The date on which the study sponsor or investigator first submitted a study record to ClinicalTrials.gov. There is typically a delay of a few days between the first submitted date and the record's availability on ClinicalTrials.gov (the first posted date).
August 15, 2008

First Submitted That Met QC Criteria

First Submitted That Met QC Criteria

The date on which the study sponsor or investigator first submits a study record that is consistent with National Library of Medicine (NLM) quality control (QC) review criteria. The sponsor or investigator may need to revise and submit a study record one or more times before NLM's QC review criteria are met. It is the responsibility of the sponsor or investigator to ensure that the study record is consistent with the NLM QC review criteria.
August 15, 2008

First Posted (Estimate)

First Posted

The date on which the study record was first available on ClinicalTrials.gov after National Library of Medicine (NLM) quality control (QC) review has concluded. There is typically a delay of a few days between the date the study sponsor or investigator submitted the study record and the first posted date.
August 18, 2008

Study Record Updates

Last Update Posted (Estimate)

Last Update Posted

The most recent date on which changes to a study record were made available on ClinicalTrials.gov. There may be a delay between when the changes were submitted to ClinicalTrials.gov by the study's sponsor or investigator (the last update submitted date) and the last update posted date.
May 19, 2014

Last Update Submitted That Met QC Criteria

Last Update Submitted That Met QC Criteria

The most recent date on which the study sponsor or investigator submitted changes to a study record that are consistent with National Library of Medicine (NLM) quality control (QC) review criteria. It is the responsibility of the sponsor or investigator to ensure that the study record is consistent with the NLM QC review criteria.
May 8, 2014

Last Verified

Last Verified

The most recent date on which the study sponsor or investigator confirmed the information about a clinical study on ClinicalTrials.gov as accurate and current. If a study with a recruitment status of recruiting; not yet recruiting; or active, not recruiting has not been confirmed within the past 2 years, the study's recruitment status is shown as unknown.
April 1, 2014

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

Other Study ID Numbers

Identifiers or ID numbers other than the NCT number that are assigned to a clinical study by the study's sponsor, funders, or others. These numbers may include unique identifiers from other trial registries and National Institutes of Health grant numbers.
  • D0570C00007
  • ToBe

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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