Healthy VolunteersPhase 1NCT00975754
Lung Deposition Via Different Inhalation Devices
A Phase 1 study testing Pulmicort pMDI HFA, Budesonide pMDI HFA and Pulmicort Repulses in people with Healthy Volunteers, run by AstraZeneca at 1 site in Sweden.
Trial summary
The purpose of this study is to assess the deposition of budesonide to the lung after inhalation with 5 different devices and to relate the findings to in vitro properties of inhaled budesonide. Read more about this study
- Who is it for?
- Ages 18 to 45 yearsHealthy volunteers can take part
- Conditions the study is for
- Healthy Volunteers
- What is being tested?
- Pulmicort pMDI HFA, Budesonide pMDI HFA and Pulmicort Repulses
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 16 participants
- Where
- 1 siteSweden
- Study dates
- Sep 2009to Nov 2009
- Phase
- Phase 1
- Are there results?
- None posted in the registry
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 45 years
- All sexes
- Healthy volunteers accepted
- Adult
Who may be able to join
- Provision of informed consent prior to any study specific procedures
- BMI between 18 and 30 kg/m2
- Non-smokers/non-snuffers
Who cannot join
- Pregnant and/or lactating women
- Use of oral contraceptives or hormonal implants
- Known or suspected hypersensitivity to glucocorticosteroids, inhaled lactose, or other excipients in study drugs
Trial locations and contacts
1 site in 1 country.
About this study
Official title: A Phase I, Randomized, Open-label, 5-way Crossover, Single Centre Study in Healthy Subjects to Assess the Lung Deposition of Inhaled Budesonide Delivered Via Different Inhalation Devices
The purpose of this study is to assess the deposition of budesonide to the lung after inhalation with 5 different devices and to relate the findings to in vitro properties of inhaled budesonide.
- Conditions
- Healthy Volunteers
- Being tested
- Pulmicort pMDI HFA, Budesonide pMDI HFA, Pulmicort Repulses, Pulmicort Turbohaler
- Keywords
- Inhalation, lung deposition
- Medical subject headings
- Respiratory Aspiration
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Pulmicort pMDI HFADrug
Inhalation aerosol, 200 μg/ metered dose. Each subject receive a single dose from 4 inhalations
Budesonide pMDI HFADrug
Inhalation aerosol, 160 μg/ metered dose. Each subject receive a single dose from 4 inhalations
Pulmicort RepulsesDrug
Suspension for nebulisation, 0.5 mg/mL. Each subject receive a single dose from 100 inhalations
Pulmicort TurbohalerDrug
Inhaled powder, 200 μg/ metered dose. Each subject receive a single dose from 4 inhalations
| Study group | Role | What they receive |
|---|---|---|
| 1 | Experimental | Pulmicort pMDI Receives: Drug: Pulmicort pMDI HFA |
| 2 | Experimental | Budesonide pMDI Receives: Drug: Budesonide pMDI HFA |
| 3 | Experimental | Budesonide pMDI + Aerochamber Zero-stat spacer Receives: Drug: Budesonide pMDI HFA |
| 4 | Experimental | Pulmicort repulses via Spira Nebuliser Receives: Drug: Pulmicort Repulses |
| 5 | Experimental | Pulmicort Turbohaler Receives: Drug: Pulmicort Turbohaler |
What is being measured
The primary outcome is the main question the study is designed to answer.
Lung deposition of budesonide (AUC)
Measured: Before dose and repeatadly during the 8-hour period after dose
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted11 Sep 2009 (estimated)
- Study startSep 2009
- Study completionNov 2009
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- 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
- 16 participants (estimated)
Sponsor and investigators
- Lead sponsor
- AstraZeneca
- Sponsor type
- Industry (pharma, biotech, devices)
- Investigators
- Carin Jorup, Study director, AstraZeneca R&D Lund, SwedenPia Lena Berg, Principal investigator, Clinical Pharmacology Unit, AstraZeneca R&D Lund, Sweden
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT00975754
- Sponsor's protocol ID
- D5252M00001
- Status last verified
- Dec 2009
- First submitted
- 10 Sep 2009
- Last updated
- 11 Dec 2009
- Results posted
- No
- Data monitoring committee
- No
Study at a glance
From the registry record, last updated by the sponsor on 11 Dec 2009. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- A Phase I, Randomized, Open-label, 5-way Crossover, Single Centre Study in Healthy Subjects to Assess the Lung Deposition of Inhaled Budesonide Delivered Via Different Inhalation Devices
- ClinicalTrials.gov ID
- NCT00975754
- Acronym / sponsor ID
- D5252M00001
- Conditions
- Healthy Volunteers
- Keywords
- Inhalation, lung deposition
- Phase
- Phase 1
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 16 participants (estimated)
- Lead sponsor
- AstraZenecaIndustry (pharma, biotech, devices)
- Study start
- Sep 2009
- Study completion
- Nov 2009 (actual)
- First posted
- 11 Sep 2009 (estimated)
- Results
- Not posted in the source record
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 assess the deposition of budesonide to the lung after inhalation with 5 different devices and to relate the findings to in vitro properties of inhaled budesonide.
Study design
- Primary purpose
- Basic science
- Allocation
- Randomised
- Intervention model
- Crossover
- Masking
- None (open label)
- Number of arms
- 5
| Arm | Type | Receives |
|---|---|---|
| 1 | Experimental | Drug: Pulmicort pMDI HFAPulmicort pMDI |
| 2 | Experimental | Drug: Budesonide pMDI HFABudesonide pMDI |
| 3 | Experimental | Drug: Budesonide pMDI HFABudesonide pMDI + Aerochamber Zero-stat spacer |
| 4 | Experimental | Drug: Pulmicort RepulsesPulmicort repulses via Spira Nebuliser |
| 5 | Experimental | Drug: Pulmicort TurbohalerPulmicort Turbohaler |
Who may qualify
- Ages
- 18 to 45 years
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult
Key inclusion criteria (3 listed)
- Provision of informed consent prior to any study specific procedures
- BMI between 18 and 30 kg/m2
- Non-smokers/non-snuffers
Key exclusion criteria (3 listed)
- Pregnant and/or lactating women
- Use of oral contraceptives or hormonal implants
- Known or suspected hypersensitivity to glucocorticosteroids, inhaled lactose, or other excipients in study drugs
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 |
|---|---|---|
| Pulmicort pMDI HFAInhalation aerosol, 200 μg/ metered dose. Each subject receive a single dose from 4 inhalations | Drug | 1 |
| Budesonide pMDI HFAInhalation aerosol, 160 μg/ metered dose. Each subject receive a single dose from 4 inhalations | Drug | 2, 3 |
| Pulmicort RepulsesSuspension for nebulisation, 0.5 mg/mL. Each subject receive a single dose from 100 inhalations | Drug | 4 |
| Pulmicort TurbohalerInhaled powder, 200 μg/ metered dose. Each subject receive a single dose from 4 inhalations | Drug | 5 |
Primary outcome
Lung deposition of budesonide (AUC)
Time frame: Before dose and repeatadly during the 8-hour period after dose
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 11 Dec 2009.
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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.
Carin Jorup study director
AstraZeneca R&D Lund, Sweden
Pia Lena Berg principal investigator
Clinical Pharmacology Unit, AstraZeneca R&D Lund, 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 Pulmicort pMDI HFA, Budesonide pMDI HFA and Pulmicort Repulses in people with Healthy Volunteers, run by AstraZeneca at 1 site 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 3 inclusion and 3 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 11 Dec 2009. 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 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. 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?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
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?
Lung deposition of budesonide (AUC) (time frame: Before dose and repeatadly during the 8-hour period after dose). 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 11 Dec 2009; AzTrials last refreshed its copy on 29 Oct 2026.