Evaluation of the Pharmacokinetics and the Pharmacodynamics of Different Dry Powder Inhalation Formulations of AZD3199 in Patients With Asthma

January 28, 2013 updated by: AstraZeneca

A Randomised, Double-blind, Double-dummy, Placebo-controlled, Multicentre, 6-way Crossover, Single-dose, Phase IIa Study to Evaluate the Pharmacokinetics and Pharmacodynamics of Different Dry Powder Inhalation Formulations of AZD3199 Administered Via Single Inhalation Device Compared to AZD3199 Administered Via Turbuhaler™ Inhaler in Patients With Asthma

The purpose of this study is to evaluate the pharmacokinetics and pharmacodynamics of single doses of three different dry powder inhalation formulations of AZD3199 administered via Single Inhalation Device (SID) compared to AZD3199 administered via Turbuhaler™ Inhaler and compared to placebo in patients with persistent asthma.

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.
39

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

  • Sweden
      • Göteborg, Sweden
        • Research Site
      • Luleå, 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:

  • Provision of signed and dated written informed consent prior to any study specific procedures
  • Men or women, age ≥ 18 years. Women must be of non-childbearing potential or stable on a highly effective contraceptive method for at least 3 months prior to Visit 1 and be willing to continue on the chosen contraceptive method throughout the study.
  • Be a non-smoker or ex-smoker who has stopped smoking for >6 months prior to study start
  • A history of asthma for at least 6 months.
  • Body Mass Index (BMI) 19-30 kg/m2

Exclusion Criteria:

  • Significant disease or disorder which, in the opinion of the Investigator, may either put the patient at risk because of participation in the study, or influence the result of the study, or the patient's ability to participate in the study
  • History of severe allergy/hypersensitivity or ongoing allergy/hypersensitivity, as judged by the Investigator or history of hypersensitivity to β2-agonists in general or to AZD3199 and/or excipients
  • Prolonged QTcF > 450 msec or shortened QTcF <340 msec
  • History of alcohol/drug abuse or excessive intake of alcohol as judged by the Investigator
  • Pregnancy or lactation

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: Triple

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: 1
AZD3199 800 µg inhaled via single inhaler device (SID), single dose
Drug: AZD3199
Inhaled via single inhaler device (SID)
Drug: AZD3199
Inhaled via Turbuhaler inhaler
Experimental: 2
AZD3199 880 µg inhaled via SID, single dose
Drug: AZD3199
Inhaled via single inhaler device (SID)
Drug: AZD3199
Inhaled via Turbuhaler inhaler
Experimental: 3
AZD3199 1400 µg inhaled via SID, single dose
Drug: AZD3199
Inhaled via single inhaler device (SID)
Drug: AZD3199
Inhaled via Turbuhaler inhaler
Experimental: 4
AZD3199 300 µg inhaled via Turbuhaler inhaler, single dose
Drug: AZD3199
Inhaled via single inhaler device (SID)
Drug: AZD3199
Inhaled via Turbuhaler inhaler
Experimental: 5
AZD3199 1200 µg inhaled via Turbuhaler inhaler, single dose
Drug: AZD3199
Inhaled via single inhaler device (SID)
Drug: AZD3199
Inhaled via Turbuhaler inhaler
Placebo Comparator: 6
Placebo inhaled via Turbuhaler inhaler and SID, single dose
Other: AZD3199 Placebo
Inhaled via Turbuhaler inhaler and SID

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
Emax: Maximum Value of FEV1 for Every Treatment Visits
Time Frame: 0-24 hrs
Peak effect (Emax) within 0-24 hours of FEV1, for treatment visits 2 to 7.
0-24 hrs
E22-26h: The Average of the FEV1 Values Between 22 and 26 h for Every Treatment Visit
Time Frame: 22-26 hrs.
Trough effect (E22-26h) will be computed from the repeated measurements collected after each single dose during 22-26 hours of FEV1 from visit 2 to 7.
22-26 hrs.

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
tEmax: Time to Maximum Value of FEV1 for Every Treatment Visit
Time Frame: 0 - 24 hrs.
Time to peak effect (tEmax), within 0-24 hours of FEV1, for treatment visits 2 to 7.
0 - 24 hrs.
E5min: The Value of FEV1 at 5 Min for Every Treatment Visit.
Time Frame: FEV1 at 5 min
Onset of effect (E5min), observed at 5 min. FEV1 for treatment visits 2 to 7.
FEV1 at 5 min
E0-24h: The Average of the FEV1 Values Between 0 and 24 h for Every Treatment Visit
Time Frame: 0 - 24 hrs
Average effect over 0-24 hours of FEV1 (E0-24h), for treatment visits 2 to 7.
0 - 24 hrs
Emax: Maximum Value of Pulse for Every Treatment Visits
Time Frame: 0 - 4 hrs.
Peak effect (Emax) within 0-4 hours of pulse, for treatment visits 2 to 7.
0 - 4 hrs.
E0-4h: The Average of the Pulse Values Between 0 and 4 h for Every Treatment Visit
Time Frame: 0 - 4 hrs.
Average effect (E0-4h) of Pulse, for treatment visits 2 to 7.
0 - 4 hrs.
Cmax: Maximum Plasma Concentration
Time Frame: 0 - 120 hrs for first two treatment visit 2 and 3 and 0 - 48 hrs for other treatment visits.
Maximum plasma concentration (Cmax) for AZD3199 doses
0 - 120 hrs for first two treatment visit 2 and 3 and 0 - 48 hrs for other treatment visits.
AUC: Area Under the Plasma Concentration-time Curve From Zero to Infinity (AUC),
Time Frame: 0 - 120 hrs for first two treatment visit 2 and 3 and 0 - 48 hrs for other treatment visits.
Area under the plasma concentration-time curve from zero to infinity (AUC), for AZD3199 doses
0 - 120 hrs for first two treatment visit 2 and 3 and 0 - 48 hrs for other treatment visits.
Tmax:Time to Maximum Plasma Concentration
Time Frame: 0 - 120 hrs for first two treatment visit 2 and 3 and 0 - 48 hrs for other treatment visits.
Time to maximum plasma concentration (tmax), for AZD3199 doses
0 - 120 hrs for first two treatment visit 2 and 3 and 0 - 48 hrs for other treatment visits.
t1/2 :Terminal Half-life
Time Frame: 0 - 120 hrs for first two treatment visit 2 and 3 and 0 - 48 hrs for other treatment visits.
Terminal half-life (t1/2),for AZD3199 doses
0 - 120 hrs for first two treatment visit 2 and 3 and 0 - 48 hrs for other treatment visits.

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

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.
May 1, 2011

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.
February 1, 2012

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.
February 1, 2012

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).
May 3, 2011

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.
May 4, 2011

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.
May 5, 2011

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.
March 5, 2013

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.
January 28, 2013

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.
January 1, 2013

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.
  • D0570C00011
  • 2011-000133-37 (EudraCT Number)

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

No

Studies a U.S. FDA-regulated device product

No

product manufactured in and exported from the U.S.

No

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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