AsthmaPhase 4PAW01NCT00829257
Additive Effects of QVAR to (Seretide) on Surrogate Markers of Airway Inflammation in Refractory Asthma
A Phase 4 study testing HFA-BDP, Fluticasone and Seretide in people with Asthma, run by University of Dundee at 1 site in United Kingdom.
Trial summary
The purpose of this study is to establish whether addition of extra-fine particle steroid inhalers achieve additional suppression of small airways inflammation when added to 'standard' Fluticasone/Salmeterol combination therapy in refractory asthma. Read more about this study
- Who is it for?
- Ages 18 to 65 years
- Conditions the study is for
- Asthma
- What is being tested?
- HFA-BDP, Fluticasone and Seretide
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 15 participants
- Where
- 1 siteUnited Kingdom
- Study dates
- Jan 2009to Jul 2010
- 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
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- Refractory, non-smoking asthmatics with FEV1 les than 80% predicted
- RV greater than 100% predicted and CANO greater than 3ppb when stepped up to 1000µg of fluticasone per day, with or without additional asthma medication.
- Informed consent and ability to perform exhaled nitric oxide assessment.
- Participants must be on greater than 500mcg of fluticasone per day to enter dose ramp run-in.
Who cannot join
- Recent respiratory infection or oral steroid use.
- Pregnancy or lactation.
- Known or suspected contra-indication to any of the IMP's.
- CANO less than 3ppb, FEV1 greater than 80% or RV less than 100% at post-optimisation visit.
Trial locations and contacts
1 site in 1 country.
United Kingdom1 site
Asthma and Allergy Research Group, Ninewells Hospital and Medical School
Dundee, Scotland, DD1 9SY
About this study
Official title: A Proof of Concept Study to Evaluate the Additive Effects of HFA-BDP (Qvar) to Fluticasone/Salmeterol (Seretide) on Surrogate Markers of Small and Large Airway Inflammation in Refractory Asthma
The purpose of this study is to establish whether addition of extra-fine particle steroid inhalers achieve additional suppression of small airways inflammation when added to 'standard' Fluticasone/Salmeterol combination therapy in refractory asthma.
- Conditions
- Asthma
- Being tested
- HFA-BDP, Fluticasone, Seretide
- Medical subject headings
- Asthma
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
HFA-BDPDrug
HFA-BDP (Qvar) 100ug 2puff b.i.d
FluticasoneDrug
Fluticasone propionate Accuhaler 250ug b.i.d.
SeretideDrug
Fluticasone/Salmeterol (Seretide) 500/50ug, 1 puff b.i.d
| Study group | Role | What they receive |
|---|---|---|
| Fine particle steroid inhaler | Experimental | HFA-BDP plus Fluticasone/Salmeterol Combination Receives: Drug: HFA-BDP; Drug: Seretide |
| Coarse Particle Inhaler | Active comparator | FP plus Fluticasone/Salmeterol combination Receives: Drug: Fluticasone; Drug: Seretide |
What is being measured
The primary outcome is the main question the study is designed to answer.
Alveolar nitric oxide
Measured: 16 weeks
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted27 Jan 2009 (estimated)
- Study startJan 2009
- Primary completionJul 2010
- Study completionJul 2010
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
- None (open label)
- Enrolment
- 15 participants (actual)
Sponsor and investigators
- Lead sponsor
- University of Dundee
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Brian J Lipworth, University of Dundee
- Investigators
- Peter A Williamson, Principal investigator, University of Dundee
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT00829257
- Sponsor's protocol ID
- PAW01
- Other IDs
- Eudract no: 2008-001811-40
- Acronym
- PAW01
- Status last verified
- Apr 2019
- First submitted
- 26 Jan 2009
- Last updated
- 12 Apr 2019
- Results posted
- No
- Data monitoring committee
- Yes
Publications
Williamson PA, Short PM, Vaidyanathan S, Lipworth BJ. Inhaled and systemic corticosteroid response in severe asthma assessed by alveolar nitric oxide: a randomized crossover pilot study of add-on therapy. Br J Clin Pharmacol. 2013 Jan;75(1):93-102. doi: 10.1111/j.1365-2125.2012.04319.x.
PubMed 22568828
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
- A Proof of Concept Study to Evaluate the Additive Effects of HFA-BDP (Qvar) to Fluticasone/Salmeterol (Seretide) on Surrogate Markers of Small and Large Airway Inflammation in Refractory Asthma
- ClinicalTrials.gov ID
- NCT00829257
- Acronym / sponsor ID
- PAW01 / PAW01
- Conditions
- Asthma
- Phase
- Phase 4
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 15 participants (actual)
- Lead sponsor
- University of DundeeUniversity, hospital or other
- Study start
- Jan 2009
- Primary completion
- Jul 2010 (actual)
- Study completion
- Jul 2010 (actual)
- First posted
- 27 Jan 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 establish whether addition of extra-fine particle steroid inhalers achieve additional suppression of small airways inflammation when added to 'standard' Fluticasone/Salmeterol combination therapy in refractory asthma.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Crossover
- Masking
- None (open label)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Fine particle steroid inhaler | Experimental | Drug: HFA-BDP, Drug: SeretideHFA-BDP plus Fluticasone/Salmeterol Combination |
| Coarse Particle Inhaler | Active comparator | Drug: Fluticasone, Drug: SeretideFP plus Fluticasone/Salmeterol combination |
Who may qualify
- Ages
- 18 to 65 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (4 listed)
- Refractory, non-smoking asthmatics with FEV1 les than 80% predicted
- RV greater than 100% predicted and CANO greater than 3ppb when stepped up to 1000µg of fluticasone per day, with or without additional asthma medication.
- Informed consent and ability to perform exhaled nitric oxide assessment.
- Participants must be on greater than 500mcg of fluticasone per day to enter dose ramp run-in.
Key exclusion criteria (4 listed)
- Recent respiratory infection or oral steroid use.
- Pregnancy or lactation.
- Known or suspected contra-indication to any of the IMP's.
- CANO less than 3ppb, FEV1 greater than 80% or RV less than 100% at post-optimisation visit.
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 |
|---|---|---|
| HFA-BDPHFA-BDP (Qvar) 100ug 2puff b.i.d | Drug | Fine particle steroid inhaler |
| FluticasoneFluticasone propionate Accuhaler 250ug b.i.d. | Drug | Coarse Particle Inhaler |
| SeretideFluticasone/Salmeterol (Seretide) 500/50ug, 1 puff b.i.d | Drug | Coarse Particle Inhaler, Fine particle steroid inhaler |
Primary outcome
Alveolar nitric oxide
Time frame: 16 weeks
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 22568828Williamson PA, Short PM, Vaidyanathan S, Lipworth BJ. Inhaled and systemic corticosteroid response in severe asthma assessed by alveolar nitric oxide: a randomized crossover pilot study of add-on therapy. Br J Clin Pharmacol. 2013 Jan;75(1):93-102. doi: 10.1111/j.1365-2125.2012.04319.x.
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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.
Peter A Williamson principal investigator
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 HFA-BDP, Fluticasone and Seretide in people with Asthma, run by University of Dundee 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 4 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?
Alveolar nitric oxide (time frame: 16 weeks). 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 NCT00829257, 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.