AsthmaPhase 4NCT01194700
Comparative Study of Lung Bioavailability of HFA-Seretide Via Current Spacer Devices in Healthy Volunteers
A Phase 4 study testing Seretide 250(8puffs) via Evohaler actuator in people with Asthma, run by Brian J Lipworth at 1 site in United Kingdom.
Trial summary
The purpose of this study is to determine the effect of plastic spacers and breath actuated spacers on respirable drug delivery of combination steroid inhaler (Seretide/Advair) and whether electrostatic charge within plastic spacers has a clinically relevant impact on the inhaled steroid delivery. Read more about this study
- Who is it for?
- Ages 18 to 65 yearsHealthy volunteers can take part
- Conditions the study is for
- Asthma
- What is being tested?
- Seretide 250(8puffs) via Evohaler actuator
- Could I receive a placebo?
- Yes, some participants may receive a placebo
- How many people
- 19 participants
- Where
- 1 siteUnited Kingdom
- Study dates
- Nov 2009to Dec 2009
- Phase
- Phase 4
- 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 65 years
- All sexes
- Healthy volunteers accepted
- Adult, Older adult
Who may be able to join
- Healthy Volunteers
- Male or female 18-65
- Informed Consent
- Ability to comply with the requirements of the protocol
Who cannot join
- No respiratory disease
- Smokers
- Recent respiratory tract infection (2 months).
- Any other clinically significant medical condition such as unstable angina, acute myocardial infarction in the preceding 3 months, recent TIA/ CVA,that may endanger the health or safety of the participant, or jeopardise the protocol.
- Any significant abnormal laboratory result as deemed by the investigators
- Pregnancy, planned pregnancy or lactation
- Known or suspected contra-indication to any of the IMP's
- Concomitant use of medicines (prescribed, over the counter or herbal) that may interfere with the trial
Trial locations and contacts
1 site in 1 country.
United Kingdom1 site
Asthma & Allergy Research Group, Department of cardiovascular & lung biology, Division of medicine, Ninewells Hospital & Medical School
Dundee, Tayside, DD1 9SY
About this study
The purpose of this study is to determine the effect of plastic spacers and breath actuated spacers on respirable drug delivery of combination steroid inhaler (Seretide/Advair) and whether electrostatic charge within plastic spacers has a clinically relevant impact on the inhaled steroid delivery.
Read the detailed description
Conventional plastic spacers are bulky and can be influenced by electrostatic charge, which can reduce respirable dose delivery especially when used brand new "out of the box". Breath actuated integrated vortex spacer (Synchro-Breathe) is a compact palm sized antistatic device with a vortex chamber which is designed to be more patient friendly and free from the effects of electrostatic charge. The systemic bioavailability from the lung of inhaled fluticasone and salmeterol is dependent on respirable dose delivery, and hence the performance of inhaler devices can be quantified by measuring the degree of adrenal suppression and fall in serum potassium(K) as surrogates for delivered lung dose. This study attempts to compares the systemic bioavailability from the lung in real life conditions for Fluticasone/Salmeterol combination (measured in terms of relative adrenal suppression and fall in serum K) via the breath actuated Synchro-Breathe device, pMDI( Seretide Evohaler), and Aerochamber Plus \& Volumatic spacer used brand new "out of the box" in healthy volunteers.
- Conditions
- Asthma
- Being tested
- Seretide 250(8puffs) via Evohaler actuator, Seretide 250 (8 puffs)/placebo via Volumatic spacer, Seretide 250/placebo 8 puffs via Aerochamber Plus spacer, Seretide 250/placebo via Synchro-Breathe
- Keywords
- lung bioavailability, asthma, seretide, Spacer
- Medical subject headings
- Asthma
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Seretide 250(8puffs) via Evohaler actuatorDrug
Also called Advair
8 puffs of Seretide250/Placebo via Evohaler actuator
Seretide 250 (8 puffs)/placebo via Volumatic spacerDrug
Also called Advair
8 puffs of Seretide 250/placebo via volumatic spacer
Seretide 250/placebo 8 puffs via Aerochamber Plus spacerDrug
Also called Advair
Seretide 250/placebo 8 puffs via Aerochamber Plus
Seretide 250/placebo via Synchro-BreatheDrug
Also called Advair
Seretide 250/placebo 8puffs via breath actuated Synchro-Breathe device
| Study group | Role | What they receive |
|---|---|---|
| Evohaler | Experimental | Not described Receives: Drug: Seretide 250(8puffs) via Evohaler actuator; Drug: Seretide 250 (8 puffs)/placebo via Volumatic spacer; Drug: Seretide 250/placebo 8 puffs via Aerochamber Plus spacer; Drug: Seretide 250/placebo via Synchro-Breathe |
| Volumatic spacer | Experimental | Not described Receives: Drug: Seretide 250(8puffs) via Evohaler actuator; Drug: Seretide 250 (8 puffs)/placebo via Volumatic spacer; Drug: Seretide 250/placebo 8 puffs via Aerochamber Plus spacer; Drug: Seretide 250/placebo via Synchro-Breathe |
| Aerochamber Plus | Experimental | Not described Receives: Drug: Seretide 250(8puffs) via Evohaler actuator; Drug: Seretide 250 (8 puffs)/placebo via Volumatic spacer; Drug: Seretide 250/placebo 8 puffs via Aerochamber Plus spacer; Drug: Seretide 250/placebo via Synchro-Breathe |
| Synchro-Breathe | Experimental | Not described Receives: Drug: Seretide 250(8puffs) via Evohaler actuator; Drug: Seretide 250 (8 puffs)/placebo via Volumatic spacer; Drug: Seretide 250/placebo 8 puffs via Aerochamber Plus spacer; Drug: Seretide 250/placebo via Synchro-Breathe |
What is being measured
The primary outcome is the main question the study is designed to answer.
Overnight Urinary Cortisol creatinine ratio
This outcome measure evaluates the amount of cortisol being suppressed after inhaled steroid administration. This helps to assess the systemic effect of steroid inhalation and therefore the propensity for adrenal suppression which is a noted adverse effect with high dose inhaled steroids
Measured: within 24 hours after study drug inhalation
Secondary outcomes (1)
Serum Potassium
The serum potassium is monitored 60 minutes post study drug inhalation to assess the systemic beta-2-adrenoreceptor metabolic response. Long acting beta agonists like Salmeterol exhibit dose related reduction in serum potassium.
Measured: 60 minutes post treatment
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted3 Sep 2010 (estimated)
- Study startNov 2009
- Primary completionDec 2009
- Study completionDec 2009
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (1)Papers the sponsor has linked to this study.
- Other trials for AsthmaStudies of the same condition, open and under way.
- 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 4
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Crossover
- Masking
- Quadruple blind
- Who is masked
- Participant, Care provider, Investigator, Outcomes assessor
- Enrolment
- 19 participants (actual)
Sponsor and investigators
- Lead sponsor
- Brian J Lipworth
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor-investigator, Brian J Lipworth, University of Dundee
- Investigators
- Arun Nair, Principal investigator, University of DundeeBrian J Lipworth, Study director, University of Dundee
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT01194700
- Sponsor's protocol ID
- NAI008
- Other IDs
- 2007-003627-20
- Status last verified
- Apr 2019
- First submitted
- 2 Sep 2010
- Last updated
- 12 Apr 2019
- Results posted
- No
- Data monitoring committee
- No
Publications
Nair A, McKinlay L, Williamson P, Short P, Burns P, Lipworth BJ. Comparative lung bioavailability of fluticasone/salmeterol via a breath-actuated spacer and conventional plastic spacers. Eur J Clin Pharmacol. 2011 Apr;67(4):355-363. doi: 10.1007/s00228-010-0989-9. Epub 2011 Jan 15.
PubMed 21240480
Study at a glance
From the registry record, last updated by the sponsor on 12 Apr 2019. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Comparative Study of Lung Bioavailability of HFA-Seretide Via Current Spacer Devices in Healthy Volunteers
- ClinicalTrials.gov ID
- NCT01194700
- Acronym / sponsor ID
- NAI008
- Conditions
- Asthma
- Keywords
- lung bioavailability, asthma, seretide, Spacer
- Phase
- Phase 4
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 19 participants (actual)
- Lead sponsor
- Brian J LipworthUniversity, hospital or other
- Study start
- Nov 2009
- Primary completion
- Dec 2009 (actual)
- Study completion
- Dec 2009 (actual)
- First posted
- 3 Sep 2010 (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 determine the effect of plastic spacers and breath actuated spacers on respirable drug delivery of combination steroid inhaler (Seretide/Advair) and whether electrostatic charge within plastic spacers has a clinically relevant impact on the inhaled steroid delivery.
Detailed description
Conventional plastic spacers are bulky and can be influenced by electrostatic charge, which can reduce respirable dose delivery especially when used brand new "out of the box". Breath actuated integrated vortex spacer (Synchro-Breathe) is a compact palm sized antistatic device with a vortex chamber which is designed to be more patient friendly and free from the effects of electrostatic charge. The systemic bioavailability from the lung of inhaled fluticasone and salmeterol is dependent on respirable dose delivery, and hence the performance of inhaler devices can be quantified by measuring the degree of adrenal suppression and fall in serum potassium(K) as surrogates for delivered lung dose. This study attempts to compares the systemic bioavailability from the lung in real life conditions for Fluticasone/Salmeterol combination (measured in terms of relative adrenal suppression and fall in serum K) via the breath actuated Synchro-Breathe device, pMDI( Seretide Evohaler), and Aerochamber Plus \& Volumatic spacer used brand new "out of the box" in healthy volunteers.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Crossover
- Masking
- Quadruple blind (participant, care provider, investigator, outcomes assessor)
- Number of arms
- 4
| Arm | Type | Receives |
|---|---|---|
| Evohaler | Experimental | Drug: Seretide 250(8puffs) via Evohaler actuator, Drug: Seretide 250 (8 puffs)/placebo via Volumatic spacer, Drug: Seretide 250/placebo 8 puffs via Aerochamber Plus spacer, Drug: Seretide 250/placebo via Synchro-Breathe |
| Volumatic spacer | Experimental | Drug: Seretide 250(8puffs) via Evohaler actuator, Drug: Seretide 250 (8 puffs)/placebo via Volumatic spacer, Drug: Seretide 250/placebo 8 puffs via Aerochamber Plus spacer, Drug: Seretide 250/placebo via Synchro-Breathe |
| Aerochamber Plus | Experimental | Drug: Seretide 250(8puffs) via Evohaler actuator, Drug: Seretide 250 (8 puffs)/placebo via Volumatic spacer, Drug: Seretide 250/placebo 8 puffs via Aerochamber Plus spacer, Drug: Seretide 250/placebo via Synchro-Breathe |
| Synchro-Breathe | Experimental | Drug: Seretide 250(8puffs) via Evohaler actuator, Drug: Seretide 250 (8 puffs)/placebo via Volumatic spacer, Drug: Seretide 250/placebo 8 puffs via Aerochamber Plus spacer, Drug: Seretide 250/placebo via Synchro-Breathe |
Who may qualify
- Ages
- 18 to 65 years
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (4 listed)
- Healthy Volunteers
- Male or female 18-65
- Informed Consent
- Ability to comply with the requirements of the protocol
Key exclusion criteria (8 listed)
- No respiratory disease
- Smokers
- Recent respiratory tract infection (2 months).
- Any other clinically significant medical condition such as unstable angina, acute myocardial infarction in the preceding 3 months, recent TIA/ CVA,that may endanger the health or safety of the participant, or jeopardise the protocol.
- Any significant abnormal laboratory result as deemed by the investigators
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 |
|---|---|---|
| Seretide 250(8puffs) via Evohaler actuatorAlso: Advair8 puffs of Seretide250/Placebo via Evohaler actuator | Drug | Aerochamber Plus, Evohaler, Synchro-Breathe, Volumatic spacer |
| Seretide 250 (8 puffs)/placebo via Volumatic spacerAlso: Advair8 puffs of Seretide 250/placebo via volumatic spacer | Drug | Aerochamber Plus, Evohaler, Synchro-Breathe, Volumatic spacer |
| Seretide 250/placebo 8 puffs via Aerochamber Plus spacerAlso: AdvairSeretide 250/placebo 8 puffs via Aerochamber Plus | Drug | Aerochamber Plus, Evohaler, Synchro-Breathe, Volumatic spacer |
| Seretide 250/placebo via Synchro-BreatheAlso: AdvairSeretide 250/placebo 8puffs via breath actuated Synchro-Breathe device | Drug | Aerochamber Plus, Evohaler, Synchro-Breathe, Volumatic spacer |
Primary outcome
Overnight Urinary Cortisol creatinine ratio
Time frame: within 24 hours after study drug inhalation
This outcome measure evaluates the amount of cortisol being suppressed after inhaled steroid administration. This helps to assess the systemic effect of steroid inhalation and therefore the propensity for adrenal suppression which is a noted adverse effect with high dose inhaled steroids
1 secondary outcome
Serum Potassium
Time frame: 60 minutes post treatment
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 12 Apr 2019.
- Results publication: PubMed 21240480Nair A, McKinlay L, Williamson P, Short P, Burns P, Lipworth BJ. Comparative lung bioavailability of fluticasone/salmeterol via a breath-actuated spacer and conventional plastic spacers. Eur J Clin Pharmacol. 2011 Apr;67(4):355-363. doi: 10.1007/s00228-010-0989-9. Epub 2011 Jan 15.
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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.
Arun Nair principal investigator
University of Dundee
Brian J Lipworth study director
University of Dundee
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 4 study testing Seretide 250(8puffs) via Evohaler actuator in people with Asthma, run by Brian J Lipworth 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 8 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 12 Apr 2019. 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 4 studies take place after a treatment is approved, to learn more about its long-term benefits and risks in everyday use.
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?
Overnight Urinary Cortisol creatinine ratio (time frame: within 24 hours after study drug inhalation). 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 NCT01194700, which also lists 1 linked publication.
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 12 Apr 2019.