AsthmaPhase 2NCT01348139
Evaluation of the Pharmacokinetics and the Pharmacodynamics of Different Dry Powder Inhalation Formulations of AZD3199 in Patients With Asthma
A Phase 2 study testing AZD3199 in people with Asthma, run by AstraZeneca at 3 sites in Sweden.
Trial summary
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… Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Asthma
- What is being tested?
- AZD3199
- Could I receive a placebo?
- Yes, some participants may receive a placebo
- How many people
- 39 participants
- Where
- 3 sitesSweden
- Study dates
- May 2011to Feb 2012
- 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
- 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
Who cannot join
- 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
Trial locations and contacts
3 sites in 1 country.
About this study
Official title: 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.
- Conditions
- Asthma
- Being tested
- AZD3199, AZD3199 Placebo
- Keywords
- Asthma, patients, lung function
- Medical subject headings
- Asthma
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
AZD3199Drug
Inhaled via single inhaler device (SID)
AZD3199Drug
Inhaled via Turbuhaler inhaler
AZD3199 PlaceboOther
Inhaled via Turbuhaler inhaler and SID
| Study group | Role | What they receive |
|---|---|---|
| 1 | Experimental | AZD3199 800 µg inhaled via single inhaler device (SID), single dose Receives: Drug: AZD3199 |
| 2 | Experimental | AZD3199 880 µg inhaled via SID, single dose Receives: Drug: AZD3199 |
| 3 | Experimental | AZD3199 1400 µg inhaled via SID, single dose Receives: Drug: AZD3199 |
| 4 | Experimental | AZD3199 300 µg inhaled via Turbuhaler inhaler, single dose Receives: Drug: AZD3199 |
| 5 | Experimental | AZD3199 1200 µg inhaled via Turbuhaler inhaler, single dose Receives: Drug: AZD3199 |
| 6 | Placebo comparator | Placebo inhaled via Turbuhaler inhaler and SID, single dose Receives: Other: AZD3199 Placebo |
What is being measured
The primary outcome is the main question the study is designed to answer.
Emax: Maximum Value of FEV1 for Every Treatment Visits
Peak effect (Emax) within 0-24 hours of FEV1, for treatment visits 2 to 7.
Measured: 0-24 hrs
E22-26h: The Average of the FEV1 Values Between 22 and 26 h for Every Treatment Visit
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.
Measured: 22-26 hrs.
Secondary outcomes (9)
tEmax: Time to Maximum Value of FEV1 for Every Treatment Visit
Time to peak effect (tEmax), within 0-24 hours of FEV1, for treatment visits 2 to 7.
Measured: 0 - 24 hrs.
E5min: The Value of FEV1 at 5 Min for Every Treatment Visit.
Onset of effect (E5min), observed at 5 min. FEV1 for treatment visits 2 to 7.
Measured: FEV1 at 5 min
E0-24h: The Average of the FEV1 Values Between 0 and 24 h for Every Treatment Visit
Average effect over 0-24 hours of FEV1 (E0-24h), for treatment visits 2 to 7.
Measured: 0 - 24 hrs
Emax: Maximum Value of Pulse for Every Treatment Visits
Peak effect (Emax) within 0-4 hours of pulse, for treatment visits 2 to 7.
Measured: 0 - 4 hrs.
E0-4h: The Average of the Pulse Values Between 0 and 4 h for Every Treatment Visit
Average effect (E0-4h) of Pulse, for treatment visits 2 to 7.
Measured: 0 - 4 hrs.
Cmax: Maximum Plasma Concentration
Maximum plasma concentration (Cmax) for AZD3199 doses
Measured: 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),
Area under the plasma concentration-time curve from zero to infinity (AUC), for AZD3199 doses
Measured: 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 to maximum plasma concentration (tmax), for AZD3199 doses
Measured: 0 - 120 hrs for first two treatment visit 2 and 3 and 0 - 48 hrs for other treatment visits.
t1/2 :Terminal Half-life
Terminal half-life (t1/2),for AZD3199 doses
Measured: 0 - 120 hrs for first two treatment visit 2 and 3 and 0 - 48 hrs for other treatment visits.
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted5 May 2011 (estimated)
- Study startMay 2011
- Primary completionFeb 2012
- Study completionFeb 2012
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.
- 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
- Triple blind
- Who is masked
- Participant, Investigator, Outcomes assessor
- Enrolment
- 39 participants (actual)
Sponsor and investigators
- Lead sponsor
- AstraZeneca
- Sponsor type
- Industry (pharma, biotech, devices)
- Responsible party
- Sponsor
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT01348139
- Sponsor's protocol ID
- D0570C00011
- Other IDs
- 2011-000133-37
- Status last verified
- Jan 2013
- First submitted
- 3 May 2011
- Last updated
- 5 Mar 2013
- Results posted
- Yes, on ClinicalTrials.gov
Study at a glance
From the registry record, last updated by the sponsor on 5 Mar 2013. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- 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
- ClinicalTrials.gov ID
- NCT01348139
- Acronym / sponsor ID
- D0570C00011
- Conditions
- Asthma
- Keywords
- Asthma, patients, lung function
- Phase
- Phase 2
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 39 participants (actual)
- Lead sponsor
- AstraZenecaIndustry (pharma, biotech, devices)
- Study start
- May 2011
- Primary completion
- Feb 2012 (actual)
- Study completion
- Feb 2012 (actual)
- First posted
- 5 May 2011 (estimated)
- Results
- Posted 5 Mar 2013
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 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 design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Crossover
- Masking
- Triple blind (participant, investigator, outcomes assessor)
- Number of arms
- 6
| Arm | Type | Receives |
|---|---|---|
| 1 | Experimental | Drug: AZD3199AZD3199 800 µg inhaled via single inhaler device (SID), single dose |
| 2 | Experimental | Drug: AZD3199AZD3199 880 µg inhaled via SID, single dose |
| 3 | Experimental | Drug: AZD3199AZD3199 1400 µg inhaled via SID, single dose |
| 4 | Experimental | Drug: AZD3199AZD3199 300 µg inhaled via Turbuhaler inhaler, single dose |
| 5 | Experimental | Drug: AZD3199AZD3199 1200 µg inhaled via Turbuhaler inhaler, single dose |
| 6 | Placebo comparator | Other: AZD3199 PlaceboPlacebo inhaled via Turbuhaler inhaler and SID, single dose |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (5 listed)
- 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
Key exclusion criteria (5 listed)
- 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
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 |
|---|---|---|
| AZD3199Inhaled via single inhaler device (SID) | Drug | 1, 2, 3 |
| AZD3199Inhaled via Turbuhaler inhaler | Drug | 4, 5 |
| AZD3199 PlaceboInhaled via Turbuhaler inhaler and SID | Other | 6 |
Primary outcome
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.
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.
9 secondary outcomes
tEmax: Time to Maximum Value of FEV1 for Every Treatment Visit
Time frame: 0 - 24 hrs.
E5min: The Value of FEV1 at 5 Min for Every Treatment Visit.
Time frame: 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
Emax: Maximum Value of Pulse for Every Treatment Visits
Time frame: 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.
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.
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.
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.
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.
Results and safety
Loading the posted results from ClinicalTrials.gov…
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 5 Mar 2013.
- Posted resultsParticipant flow, baseline, all outcome measures and adverse events.
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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.
The record lists no contact. Use the official record to reach the sponsor.
3 sites in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 2 study testing AZD3199 in people with Asthma, run by AstraZeneca at 3 sites in Sweden.
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 5 inclusion and 5 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 5 Mar 2013. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 3 sites in Sweden. 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 5 Mar 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?
Emax: Maximum Value of FEV1 for Every Treatment Visits (time frame: 0-24 hrs). The study lists 2 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
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 5 Mar 2013.