Healthy VolunteersPhase 1NCT02178059

Relative Bioavailability Study to Compare Inhalation of Terbutaline Sulphate 1,5mg Via Turbuhaler M3 With Turbuhaler M2

A Phase 1 study testing terbutaline sulphate delivered dose and terbutaline sulphate metered dose in people with Healthy Volunteers, run by AstraZeneca at 1 site in United Kingdom.

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

Relative bioavailability study to compare inhalation of Terbutaline Sulphate 1,5mg via current version of Turbuhaler with inhalation via a new version Read more about this study

Who is it for?: Ages 18 to 65 yearsHealthy volunteers can take part
Conditions the study is for: Healthy Volunteers
What is being tested?: terbutaline sulphate delivered dose and terbutaline sulphate metered dose
Could I receive a placebo?: No, everyone receives an active treatment
How many people: 34 participants
Where: 1 siteUnited Kingdom
Study dates: Aug 2014to Nov 2014
Phase: Phase 1
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 to 65 years
All sexes
Healthy volunteers accepted
Adult, Older adult

Who may be able to join

Female and male volunteers aged between 18 and 65 years, both inclusive
Healthy as judged by the Principal Investigator after medical history, physical examination, 12-lead ECG, laboratory tests (including HIV, HBsAg and hepatitis C antibody tests) and assessments of pulse rate and blood pressure
Ability to use a Turbuhaler according to the provided instructions, as judged by the Principal Investigator or the study nurse
Have a body mass index (BMI) between 18 and 30 kg/m2 inclusive and weighing at least 50 kg and no more than 100 kg -

Who cannot join

History or presence of respiratory, gastrointestinal, hepatic or renal disease or any other condition known to interfere with absorption, distribution, metabolism or excretion of drugs (except for cholecystectomy)
Current smokers or those who have smoked or used nicotine products within the previous 3 months should be excluded
Plasma donation within 1 month of screening or any blood donation or blood loss of more than 500 mL during the 3 months prior to screening
History of severe allergy/hypersensitivity or ongoing allergy/hypersensitivity, as judged by the Principal Investigator or history of hypersensitivity to terbutaline (or drugs of a similar chemical structure or class) or inhaled lactose
Positive screen for drugs of abuse and/or alcohol and/or cotinine at screening (Visit 1) or on admission to the study centre (Day -1) prior to administration of the investigational medical product (IMP) on Day 1 -

Trial locations and contacts

1 site in 1 country.

United Kingdom1 site

Research Site
London

Other trials in United Kingdom

About this study

Official title: An Open-label, Single-dose, 2-period Cross Over Study in Healthy Volunteers to Assess Relative Bioavailability of Terbutaline Sulphate 1.5 mg After Inhalation Via the M3 Turbuhaler Compared With the M2 Turbuhaler

Relative bioavailability study to compare inhalation of Terbutaline Sulphate 1,5mg via current version of Turbuhaler with inhalation via a new version

Read the detailed description

An Open-label, Single-dose, 2-period Cross over Study in Healthy Male and Female Volunteers to Assess Relative Bioavailability of Terbutaline Sulphate 1.5 mg after Inhalation via the M3 Turbuhaler (New Version) Compared with the M2 Turbuhaler (Current Version)

Conditions: Healthy Volunteers
Being tested: terbutaline sulphate delivered dose, terbutaline sulphate metered dose
Keywords: Healthy volunteers, pharmacokinetic, inhalation
Medical subject headings: Respiratory Aspiration

What participants receive

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

terbutaline sulphate delivered doseDrug
Also called Turbuhaler New Version
0.4 mg terbutaline sulphate (delivered dose) per inhalation
terbutaline sulphate metered doseDrug
Also called Turbuhaler Current Version
0.5 mg terbutaline sulphate (metered dose) per inhalation

Study groups in NCT02178059
Study group	Role	What they receive
Bricanyl Turbuhaler M3	Experimental	0.4 mg terbutaline sulphate (delivered dose) per inhalation Receives: Drug: terbutaline sulphate delivered dose
Bricanyl Turbuhaler M2	Active comparator	0.5 mg terbutaline sulphate (metered dose) per inhalation Receives: Drug: terbutaline sulphate metered dose

What is being measured

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

Area Under the Plasma Concentration-time Curve From Zero to the Time of Last Measurable Concentration [AUC(0-t)]
These will be taken at each treatment period
Measured: Samples will be taken at predose, and at 5, 10, 20, 40, 80, 100 minutes and at 2, 4, 6, 9, 12, 18, 24, 30, and 36 hours postdose
Maximum Observed Plasma Concentration (Cmax)
These will be taken at each treatment period
Measured: Samples will be taken at predose, and at 5, 10, 20, 40, 80, 100 minutes and at 2, 4, 6, 9, 12, 18, 24, 30, and 36 hours postdose

Secondary outcomes (4)

Time to Reach Maximum Observed Plasma Concentration (Tmax)
These will be taken at each treatment period
Measured: Samples will be taken at predose, and at 5, 10, 20, 40, 80, 100 minutes and at 2, 4, 6, 9, 12, 18, 24, 30, and 36 hours postdose
Area Under the Plasma Concentration-time Curve From Zero Extrapolated to Infinity (AUC)
These will be taken at each treatment period
Measured: Samples will be taken at predose, and at 5, 10, 20, 40, 80, 100 minutes and at 2, 4, 6, 9, 12, 18, 24, 30, and 36 hours postdose
Area Under the Plasma Concentration-time Curve From Zero to 36 Hours Postdose [AUC(0-36)]
These will be taken at each treatment period
Measured: Samples will be taken at predose, and at 5, 10, 20, 40, 80, 100 minutes and at 2, 4, 6, 9, 12, 18, 24, 30, and 36 hours postdose
Terminal Half-life (t1/2)
These will be taken at each treatment period
Measured: Samples will be taken at predose, and at 5, 10, 20, 40, 80, 100 minutes and at 2, 4, 6, 9, 12, 18, 24, 30, and 36 hours postdose

Timeline

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

Aug 2014Nov 2014

First posted30 Jun 2014 (estimated)
Study startAug 2014
Primary completionNov 2014
Study completionNov 2014

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 Healthy VolunteersStudies 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 1
Primary purpose: Basic science
Allocation: Randomised
Intervention model: Crossover
Masking: None (open label)
Enrolment: 34 participants (actual)

IDs, dates and publications

ClinicalTrials.gov ID: NCT02178059
Sponsor's protocol ID: D4711C00002
Status last verified: Jan 2017
First submitted: 27 Jun 2014
Last updated: 1 Mar 2017
Results posted: Yes, on ClinicalTrials.gov
Data monitoring committee: No

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?

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Study at a glance

From the registry record, last updated by the sponsor on 1 Mar 2017. Recruitment status is as the sponsor reported it: confirm with the study team.

Official title: An Open-label, Single-dose, 2-period Cross Over Study in Healthy Volunteers to Assess Relative Bioavailability of Terbutaline Sulphate 1.5 mg After Inhalation Via the M3 Turbuhaler Compared With the M2 Turbuhaler
ClinicalTrials.gov ID: NCT02178059
Acronym / sponsor ID: D4711C00002
Conditions: Healthy Volunteers
Keywords: Healthy volunteers, pharmacokinetic, inhalation
Phase: Phase 1
Study type: Interventional
Recruitment status: Completed
Enrolment: 34 participants (actual)
Lead sponsor: AstraZenecaIndustry (pharma, biotech, devices)
Study start: Aug 2014
Primary completion: Nov 2014 (actual)
Study completion: Nov 2014 (actual)
First posted: 30 Jun 2014 (estimated)
Results: Posted 2 Aug 2016

Clinical summary

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

Relative bioavailability study to compare inhalation of Terbutaline Sulphate 1,5mg via current version of Turbuhaler with inhalation via a new version

Detailed description

Study design

Primary purpose: Basic science
Allocation: Randomised
Intervention model: Crossover
Masking: None (open label)
Number of arms: 2

Arm	Type	Receives
Bricanyl Turbuhaler M3	Experimental	Drug: terbutaline sulphate delivered dose0.4 mg terbutaline sulphate (delivered dose) per inhalation
Bricanyl Turbuhaler M2	Active comparator	Drug: terbutaline sulphate metered dose0.5 mg terbutaline sulphate (metered dose) per inhalation

Who may qualify

Ages: 18 to 65 years
Sex: All
Healthy volunteers: Accepted
Age groups: Adult, Older adult

Key inclusion criteria (4 listed)

Female and male volunteers aged between 18 and 65 years, both inclusive
Healthy as judged by the Principal Investigator after medical history, physical examination, 12-lead ECG, laboratory tests (including HIV, HBsAg and hepatitis C antibody tests) and assessments of pulse rate and blood pressure
Ability to use a Turbuhaler according to the provided instructions, as judged by the Principal Investigator or the study nurse
Have a body mass index (BMI) between 18 and 30 kg/m2 inclusive and weighing at least 50 kg and no more than 100 kg -

Key exclusion criteria (5 listed)

History or presence of respiratory, gastrointestinal, hepatic or renal disease or any other condition known to interfere with absorption, distribution, metabolism or excretion of drugs (except for cholecystectomy)
Current smokers or those who have smoked or used nicotine products within the previous 3 months should be excluded
Plasma donation within 1 month of screening or any blood donation or blood loss of more than 500 mL during the 3 months prior to screening
History of severe allergy/hypersensitivity or ongoing allergy/hypersensitivity, as judged by the Principal Investigator or history of hypersensitivity to terbutaline (or drugs of a similar chemical structure or class) or inhaled lactose
Positive screen for drugs of abuse and/or alcohol and/or cotinine at screening (Visit 1) or on admission to the study centre (Day -1) prior to administration of the investigational medical product (IMP) on Day 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
terbutaline sulphate delivered doseAlso: Turbuhaler New Version0.4 mg terbutaline sulphate (delivered dose) per inhalation	Drug	Bricanyl Turbuhaler M3
terbutaline sulphate metered doseAlso: Turbuhaler Current Version0.5 mg terbutaline sulphate (metered dose) per inhalation	Drug	Bricanyl Turbuhaler M2

Primary outcome

Area Under the Plasma Concentration-time Curve From Zero to the Time of Last Measurable Concentration [AUC(0-t)]
Time frame: Samples will be taken at predose, and at 5, 10, 20, 40, 80, 100 minutes and at 2, 4, 6, 9, 12, 18, 24, 30, and 36 hours postdose
These will be taken at each treatment period
Maximum Observed Plasma Concentration (Cmax)
Time frame: Samples will be taken at predose, and at 5, 10, 20, 40, 80, 100 minutes and at 2, 4, 6, 9, 12, 18, 24, 30, and 36 hours postdose
These will be taken at each treatment period

4 secondary outcomes

Time to Reach Maximum Observed Plasma Concentration (Tmax)
Time frame: Samples will be taken at predose, and at 5, 10, 20, 40, 80, 100 minutes and at 2, 4, 6, 9, 12, 18, 24, 30, and 36 hours postdose
Area Under the Plasma Concentration-time Curve From Zero Extrapolated to Infinity (AUC)
Time frame: Samples will be taken at predose, and at 5, 10, 20, 40, 80, 100 minutes and at 2, 4, 6, 9, 12, 18, 24, 30, and 36 hours postdose
Area Under the Plasma Concentration-time Curve From Zero to 36 Hours Postdose [AUC(0-36)]
Time frame: Samples will be taken at predose, and at 5, 10, 20, 40, 80, 100 minutes and at 2, 4, 6, 9, 12, 18, 24, 30, and 36 hours postdose
Terminal Half-life (t1/2)
Time frame: Samples will be taken at predose, and at 5, 10, 20, 40, 80, 100 minutes and at 2, 4, 6, 9, 12, 18, 24, 30, and 36 hours postdose

Results and safety

Results posted to the registry on 2 Aug 2016, as reported by the sponsor. Figures are copied from the record, not re-analysed. Full results on ClinicalTrials.gov.

Participant flow

Group	Started	Completed
M3 First, Then M2	17	17
M2 First, Then M3	17	17

Primary outcome: Area Under the Plasma Concentration-time Curve From Zero to the Time of Last Measurable Concentration [AUC(0-t)]

Time frame: Samples will be taken at predose, and at 5, 10, 20, 40, 80, 100 minutes and at 2, 4, 6, 9, 12, 18, 24, 30, and 36 hours postdose. Geometric mean (95% Confidence Interval). Unit: nmol*h/L

Measure	Bricanyl Turbuhaler M3 n = 34	Bricanyl Turbuhaler M2 n = 33
Value	89.04 (80.84 to 98.07)	100.9 (91.54 to 111.3)

Bricanyl Turbuhaler M3 vs Bricanyl Turbuhaler M2: Ratio of geometric means (%): 88.20 (90% CI 81.03 to 96.02)

Population analysed: The PK analysis set included all healthy subjects who received at least 1 dose of the IMP and had at least 1 postdose PK measurement without important protocol deviations/violations or events thought to significantly affect the PK of the IMP.

Primary outcome: Maximum Observed Plasma Concentration (Cmax)

Time frame: Samples will be taken at predose, and at 5, 10, 20, 40, 80, 100 minutes and at 2, 4, 6, 9, 12, 18, 24, 30, and 36 hours postdose. Geometric mean (95% Confidence Interval). Unit: nmol/L

Measure	Bricanyl Turbuhaler M3 n = 34	Bricanyl Turbuhaler M2 n = 33
Value	12.00 (10.73 to 13.40)	13.12 (11.73 to 14.67)

Bricanyl Turbuhaler M3 vs Bricanyl Turbuhaler M2: Ratio of geometric means (%): 91.44 (90% CI 84.82 to 98.58)

4 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
Bricanyl Turbuhaler M3	0 of 34 (0%)	12 of 34 (35.3%)	Not reported
Bricanyl Turbuhaler M2	0 of 33 (0%)	11 of 33 (33.3%)	Not reported

Loading the posted results from ClinicalTrials.gov…

Research links

Official record on ClinicalTrials.govLast updated by the sponsor 1 Mar 2017.
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.

Amitava Ganguli, MB ChB, MRCP principal investigator

Quintiles London United Kingdom

Göran Eckervall, MD study director

Astrazeneca Mölndal, Sweden

Ola Beckman, MD study chair

Astrazeneca Mölndal, Sweden

1 site in 1 country: see every site and its status.

Questions about this trial

What is this clinical trial studying?

A Phase 1 study testing terbutaline sulphate delivered dose and terbutaline sulphate metered dose in people with Healthy Volunteers, run by AstraZeneca at 1 site in United Kingdom.

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 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 1 Mar 2017. Status can change between updates, so confirm with the study contact before making plans.

Where is the study taking place?

The record lists 1 site in United Kingdom. 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. 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 1 studies test a treatment in a small group of people for the first time or in a new way, mainly to check safety and find the right dose.

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 2 Aug 2016). 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?

Area Under the Plasma Concentration-time Curve From Zero to the Time of Last Measurable Concentration [AUC(0-t)] (time frame: Samples will be taken at predose, and at 5, 10, 20, 40, 80, 100 minutes and at 2, 4, 6, 9, 12, 18, 24, 30, and 36 hours postdose). 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?

On the ClinicalTrials.gov record for NCT02178059.

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 1 Mar 2017.