AsthmaPhase 4SPIRANCT01171365
Small Particle Steroids in Refractory Asthma
A Phase 4 study testing Ciclesonide in people with Asthma, run by University of Nottingham at 2 sites in United Kingdom.
Trial summary
The purpose of this study is to determine whether an inhaled steroid with a small particle size can be an additional treatment option in patients with refractory eosinophilic asthma. Read more about this study
- Who is it for?
- Ages 18 to 80 years
- Conditions the study is for
- Asthma
- What is being tested?
- Ciclesonide
- Could I receive a placebo?
- Yes, some participants may receive a placebo
- How many people
- 30 participants
- Where
- 2 sitesUnited Kingdom
- Study dates
- Jan 2010to Dec 2013
- 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 80 years
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- Age 18-80
- ACQ >1.5 or a requirement for oral steroids twice a year or more
- High dose inhaled steroid (>1000mcg BDP or equivalent)
- Treatment with or unsuccessful trial of:
- long-acting beta agonist
- leukotriene antagonist
Show all 11Show fewer
- Sputum eosinophil count >3% despite high dose inhaled steroid or >2% with serum eosinophils >0.4x10exp9/l
- Clinical response to 2 weeks of oral prednisolone: (any one)
- reduction in ACQ by 0.5 or more
- increase in FEV1 by 200ml
- normalisation of exhaled nitric oxide or reduction of >25ppb
Who cannot join
- Current smoker, or ex-smoker for <12 months
- Current treatment with an extrafine steroid inhaler
- Respiratory infection within the last 4 weeks
- Pregnancy or lactation
- Poor compliance with usual asthma medication
- Clinical diagnosis of significant bronchiectasis
Show all 9Show fewer
- Use of a medication which may interact with ciclesonide:
- ketoconazole or itraconazole
- ritonavir, nelfinavir
Trial locations and contacts
2 sites in 1 country.
United Kingdom2 sites
University Hospitals of Leicester NHS Trust
Leicester, Leicestershire, LE3 9QP
Nottingham University Hospitals NHS Trust
Nottingham, Nottinghamshire, NG5 1PB
About this study
Official title: Small Particle Inhaled Steroids in Refractory Steroid-responsive Asthma
The purpose of this study is to determine whether an inhaled steroid with a small particle size can be an additional treatment option in patients with refractory eosinophilic asthma.
Read the detailed description
We have identified a group of patients with refractory asthma who have ongoing eosinophilic airway inflammation despite high dose inhaled corticosteroids.
Traditional inhaled steroids have a relatively proximal airway distribution which may lead to inadequate treatment of the distal airways.
We aim to demonstrate that a steroid inhaler with a smaller particle size which targets the distal airways can be a useful additional treatment option in this group of patients.
- Conditions
- Asthma
- Being tested
- Ciclesonide, Placebo
- Keywords
- Ciclesonide, Asthma, Therapeutic Uses, Pulmonary Eosinophilia, Nitric Oxide, Lung Diseases, Respiratory Tract Diseases
- Medical subject headings
- Asthma, Pulmonary Eosinophilia, Lung Diseases, Respiratory Tract Diseases
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
CiclesonideDrug
Also called Alvesco
Inhaled ciclesonide 320mcg twice daily
PlaceboDrug
Matched placebo inhaler two inhalations twice daily
| Study group | Role | What they receive |
|---|---|---|
| Ciclesonide | Active comparator | Ciclesonide 320 microgrammes twice daily Receives: Drug: Ciclesonide |
| Placebo | Placebo comparator | Placebo 2 inhalations twice daily Receives: Drug: Placebo |
What is being measured
The primary outcome is the main question the study is designed to answer.
Change in sputum eosinophil count over the trial period
Sputum will be processed for a differential cell count, with the primary outcome the difference in sputum eosinophil count between active and placebo groups at 8 weeks
Measured: 0 weeks (start), 8 weeks (finish)
Secondary outcomes (7)
Change in alveolar nitric oxide level over the trial period
alveolar nitric oxide has been shown to correlate with eosinophil count on BAL samples. Measured by measuring exhaled nitric oxide at multiple flow rates.
Measured: 0 weeks (start), 4 weeks, 8 weeks (finish)
Change in bronchial nitric oxide level
Measured by single flow exhaled nitric oxide at 50 ml/s
Measured: 0 weeks (start), 4 weeks, 8 weeks (finish)
Change in prebronchodilator FEV1
Prebronchodilator FEV1 and FVC will be recorded with a Vitalograph Wedge Bellows spirometer
Measured: 0 weeks (start), 4 weeks, 8 weeks (finish)
Change in Juniper Asthma Control Questionnaire (ACQ) score
UK English Version 2001
Measured: 0 weeks (start), 4 weeks, 8 weeks (finish)
Change in Juniper Asthma Quality of Life Questionnaire (AQLQ) score
Self-administered United Kingdom Version 1994
Measured: 0 weeks (start), 4 weeks, 8 weeks (finish)
Use of oral steroid over the trial period
Dose and duration of any additional oral corticosteroid will be documented
Measured: 0-8 weeks
Number of patients with adverse events as a measure of safety and tolerability
Adverse events will be recorded throughout the trial period
Measured: 0-8 weeks
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted28 Jul 2010 (estimated)
- Study startJan 2010
- Primary completionOct 2013
- Study completionDec 2013
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
- Parallel groups
- Masking
- Quadruple blind
- Who is masked
- Participant, Care provider, Investigator, Outcomes assessor
- Enrolment
- 30 participants (actual)
Sponsor and investigators
- Lead sponsor
- University of Nottingham
- Sponsor type
- University, hospital or other
- Collaborators
- Nottingham University Hospitals NHS Trust, University Hospitals, Leicester
- Responsible party
- Sponsor
- Investigators
- Tim Harrison, Principal investigator, University of NottinghamIan Pavord, Principal investigator, University Hospitals, Leicester
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT01171365
- Sponsor's protocol ID
- 09115
- Acronym
- SPIRA
- Status last verified
- Jan 2014
- First submitted
- 24 Jun 2010
- Last updated
- 31 Jan 2014
- Results posted
- No
- Data monitoring committee
- No
Publications
Hodgson D, Anderson J, Reynolds C, Meakin G, Bailey H, Pavord I, Shaw D, Harrison T. A randomised controlled trial of small particle inhaled steroids in refractory eosinophilic asthma (SPIRA). Thorax. 2015 Jun;70(6):559-65. doi: 10.1136/thoraxjnl-2014-206481. Epub 2015 Apr 9.
PubMed 25858909
Study at a glance
From the registry record, last updated by the sponsor on 31 Jan 2014. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Small Particle Inhaled Steroids in Refractory Steroid-responsive Asthma
- ClinicalTrials.gov ID
- NCT01171365
- Acronym / sponsor ID
- SPIRA / 09115
- Conditions
- Asthma
- Keywords
- Ciclesonide, Asthma, Therapeutic Uses, Pulmonary Eosinophilia, Nitric Oxide, Lung Diseases, Respiratory Tract Diseases
- Phase
- Phase 4
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 30 participants (actual)
- Lead sponsor
- University of NottinghamUniversity, hospital or other
- Collaborators
- Nottingham University Hospitals NHS Trust, University Hospitals, Leicester
- Study start
- Jan 2010
- Primary completion
- Oct 2013 (actual)
- Study completion
- Dec 2013 (actual)
- First posted
- 28 Jul 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 whether an inhaled steroid with a small particle size can be an additional treatment option in patients with refractory eosinophilic asthma.
Detailed description
We have identified a group of patients with refractory asthma who have ongoing eosinophilic airway inflammation despite high dose inhaled corticosteroids.
Traditional inhaled steroids have a relatively proximal airway distribution which may lead to inadequate treatment of the distal airways.
We aim to demonstrate that a steroid inhaler with a smaller particle size which targets the distal airways can be a useful additional treatment option in this group of patients.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Quadruple blind (participant, care provider, investigator, outcomes assessor)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Ciclesonide | Active comparator | Drug: CiclesonideCiclesonide 320 microgrammes twice daily |
| Placebo | Placebo comparator | Drug: PlaceboPlacebo 2 inhalations twice daily |
Who may qualify
- Ages
- 18 to 80 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (11 listed)
- Age 18-80
- ACQ >1.5 or a requirement for oral steroids twice a year or more
- High dose inhaled steroid (>1000mcg BDP or equivalent)
- Treatment with or unsuccessful trial of:
- Sputum eosinophil count >3% despite high dose inhaled steroid or >2% with serum eosinophils >0.4x10exp9/l
Key exclusion criteria (9 listed)
- Current smoker, or ex-smoker for <12 months
- Current treatment with an extrafine steroid inhaler
- Respiratory infection within the last 4 weeks
- Pregnancy or lactation
- Poor compliance with usual asthma medication
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 |
|---|---|---|
| CiclesonideAlso: AlvescoInhaled ciclesonide 320mcg twice daily | Drug | Ciclesonide |
| PlaceboMatched placebo inhaler two inhalations twice daily | Drug | Placebo |
Primary outcome
Change in sputum eosinophil count over the trial period
Time frame: 0 weeks (start), 8 weeks (finish)
Sputum will be processed for a differential cell count, with the primary outcome the difference in sputum eosinophil count between active and placebo groups at 8 weeks
7 secondary outcomes
Change in alveolar nitric oxide level over the trial period
Time frame: 0 weeks (start), 4 weeks, 8 weeks (finish)
Change in bronchial nitric oxide level
Time frame: 0 weeks (start), 4 weeks, 8 weeks (finish)
Change in prebronchodilator FEV1
Time frame: 0 weeks (start), 4 weeks, 8 weeks (finish)
Change in Juniper Asthma Control Questionnaire (ACQ) score
Time frame: 0 weeks (start), 4 weeks, 8 weeks (finish)
Change in Juniper Asthma Quality of Life Questionnaire (AQLQ) score
Time frame: 0 weeks (start), 4 weeks, 8 weeks (finish)
Use of oral steroid over the trial period
Time frame: 0-8 weeks
Number of patients with adverse events as a measure of safety and tolerability
Time frame: 0-8 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 31 Jan 2014.
- Derived from this study: PubMed 25858909Hodgson D, Anderson J, Reynolds C, Meakin G, Bailey H, Pavord I, Shaw D, Harrison T. A randomised controlled trial of small particle inhaled steroids in refractory eosinophilic asthma (SPIRA). Thorax. 2015 Jun;70(6):559-65. doi: 10.1136/thoraxjnl-2014-206481. Epub 2015 Apr 9.
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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.
Tim Harrison principal investigator
University of Nottingham
Ian Pavord principal investigator
University Hospitals, Leicester
2 sites in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 4 study testing Ciclesonide in people with Asthma, run by University of Nottingham at 2 sites 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 11 inclusion and 9 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 31 Jan 2014. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 2 sites 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. 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 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?
Change in sputum eosinophil count over the trial period (time frame: 0 weeks (start), 8 weeks (finish)). 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 NCT01171365, 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 31 Jan 2014.