AsthmaPhase 4ANDA3NCT01894048
Targeted Small Airways Therapy in Persistent Asthma
A Phase 4 study testing Qvar® (beclometasone dipropionate HFA) in people with Asthma, run by University of Dundee at 1 site in United Kingdom.
Trial summary
The mainstay of asthma treatment is with inhaled steroids (commonly called a 'preventer') to keep the symptoms of asthma under control. Increasing strengths of steroid inhaler may be required in order to gain control of asthma, and this is usually guided both by symptoms and simple measurements of lung function such… Read more about this study
- Who is it for?
- Ages 18 to 65 years
- Conditions the study is for
- Asthma
- What is being tested?
- Qvar® (beclometasone dipropionate HFA)
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 26 participants
- Where
- 1 siteUnited Kingdom
- Study dates
- 28 Oct 2013to 25 Jun 2018
- 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
- Male and female volunteers aged 18-65, with persistent asthma
- Asthma Control Questionnaire score >1.0 (at end of run-in)
- FEV1 >60% predicted
- R5>130% predicted and R5-R20>0.03kPa/L/s
- Ability to perform spirometry, impulse oscillometry, bronchial challenge and all domiciliary measurements
- Ability to give informed consent
- Asthmatic patients receiving treatment at Step 2, 3, or 4 of British Thoracic Society asthma guidelines
- Ability to withhold long-acting beta-agonists for the duration of the study
Who cannot join
- Patients already receiving extra-fine particle inhaled corticosteroids (Qvar, Fostair, Alvesco)
- Pregnancy or lactation
- Known or suspected sensitivity to the Investigational Medicinal Product
- Inability to comply with protocol
- Any clinically significant medical conditions that may either endanger the health or safety of the participant, or jeopardise the protocol
- An asthma exacerbation requiring systemic steroid therapy or lower respiratory tract infection requiring antibiotics within 3 months prior to study commencement
- Participation in previous trial within 30 days
Trial locations and contacts
1 site in 1 country.
About this study
The mainstay of asthma treatment is with inhaled steroids (commonly called a 'preventer') to keep the symptoms of asthma under control. Increasing strengths of steroid inhaler may be required in order to gain control of asthma, and this is usually guided both by symptoms and simple measurements of lung function such as peak flow.
The airways (breathing tubes) in the lungs get smaller the further into the lungs they go. Most simple measurements of lung function only reflect the larger 'central' airways and don't provide information on the smaller 'peripheral' airways.Newer measurements have been developed that can now give us accurate information on how the smaller airways are working.Indeed the small airways seem to play a significant role in asthma in terms of inflammation and airway narrowing.
Read more
Recently, new types of steroid inhalers have been developed that have a much smaller particle size than other standard inhaled steroids.These have been shown to go deeper into the lungs, thus getting into the smaller airways. There have been a few studies suggesting that this might improve asthma control. However, we do not know if when small airway function is shown to be abnormal, whether this improves with extra-fine particle inhaled steroids, nor whether by improving small airway function specifically this translates into improved asthma control.
In this study we wish to study asthmatic patients who are not completely controlled on standard particle size inhaled steroids, in addition to having evidence of abnormal small airway function. By doing this we want to find out whether changing to the same dose of an extra-fine particle inhaled steroid instead will improve asthma control by getting deeper into the lungs and improving small airway function.
Read the detailed description
A single centre, open-label, single subject study over a 12-24 week period. Invited participants will receive a written 'Participant Information Sheet' (PIS) detailing the requirements of the trial and the extent of their participation before attending for a screening visit. Participants will be given at least 24 hours to read the PIS.
Prior to screen (and any subsequent challenge visit) participants will withhold LABAs (or combination inhaler containing LABA) for 48 hours; and salbutamol for 6 hours. Verbal consent will be obtained from the patient over the telephone for withholding medications prior to screen and it will be explained that this in no way means they have consented to the full study at this stage.
At the screening visit a member of the research team will discuss the PIS with the participant, answer any questions posed and written informed consent will be obtained and witnessed by the member of staff asking for the consent of the patient.
A general physical examination will be carried out by a qualified medical practitioner.
A pregnancy test will be performed on all female patients with advice issued to both male and female participants to use contraception throughout the duration of the study.
The following will be measured:
- Asthma Control Questionnaire
- Mini-Asthma Quality of Life Questionnaire
- Fractional exhaled nitric oxide levels
- Impulse oscillometry
- Spirometry
- Skin prick test to common allergens
- Full blood count, renal function, electrolytes, liver enzymes and random blood glucose.
Participants will be checked against all inclusion and exclusion criteria. Those found to be eligible will proceed to the step down and/or run-in period. This will last for a minimum of 4 weeks.
Participants will be issued with a pre-labelled container for the collection of an overnight urine sample the night prior to visit V1 with written instruction as to how this should be done. A sample will be collected prior to visits V2 and V3 as well.
If a potential participant who at screening is receiving ≥200µg/day ICS (BDP) without additional LABA has an ACQ >1.0 they will directly enter the 4 week run-in period.
At 2 weeks into the run-in period the participant will be contacted to reassess their ACQ score. If their ACQ>1.0 they will continue in the run-in period for the remaining 2 weeks at the same dose of ICS. If their ACQ is not >1.0 then their ICS dose will be approximately halved (or reduced to a minimum of 200µg/day if this is greater than half the original ICS dose) and one (if any) second line medication (e.g. theophylline, LTRA) will be discontinued at the discretion of a study doctor. They will then restart the 4 week run-in period. If they are already receiving 200µg/day ICS (i.e. the dose cannot be reduced further) then they will be withdrawn from the study at this juncture.
At the end of the 4 week period if the participant still has an ACQ>1.0 they will proceed to visit V1.
If a potential participant who at screening is receiving ≥200µg/day ICS (BDP) with additional LABA has an ACQ score >1.0, their LABA will be discontinued and they will directly enter the 4 week run-in period. If the participant is receiving their LABA as part of a combination inhaler, they will be converted to an equivalent ICS alone inhaler (i.e. coarse particle ICS) and enter the 4 week run-in period. Progress through run-in will then be as described before.
If a potential participant who at screening is receiving ≥200µg/day ICS (BDP) with additional LABA has an ACQ not >1.0, then their LABA will be discontinued as per 3.6.2 and their ICS dose will be approximately halved (or reduced to a minimum of 200µg/day if this is greater than half the original ICS dose). For example, Seretide 250µg b.i.d. would convert to Flixotide 125µg b.i.d. They will subsequently enter the 4 week run-in period progressing through it as described..
Participants will be asked to perform and record twice daily domiciliary PEF and to complete a daily diary of reliever use and symptoms from the beginning of the step-down/run-in period through to the end of the study. Participants will be advised to contact the investigators if they feel their asthma significantly worsening in the interim. They will also be given a card with 24 hour emergency contact details.
At the end of the 4 week run-in period, participants will be checked against all inclusion and exclusion criteria to confirm the subject's suitability to receive the study drug according to study protocol. Those eligible will proceed to study visit 1. Those who do not fulfil the study criteria will be returned to their pre-study medication and their GP informed of any medically relevant data.
Study visits V1, V2 and V3 Full study visits will occur at the end of the run-in period (baseline), at 4 weeks and 8 weeks.
Participants will be asked to withhold their reliever as per the screening visit. (LABAs are withheld for the duration of the study).
Participants will attend the unit on the morning of the visit day. The overnight urine collection will be received from the participant for analysis.
Peak flow records will be reviewed along with daily domiciliary symptom and reliever use diaries.
Participants will be asked to complete an ACQ and Mini-AQLQ. A venous blood sample will be drawn for FBC. A venous blood sample will be drawn for ECP. FeNO, IOS, and spirometry will be performed in that order. Mannitol bronchial challenge will then be performed
Participants will be converted to Qvar (HFA-beclometasone) at an equivalent therapeutic dose to their original ICS, e.g. Qvar 100µg = Clenil 200µg = Pulmicort 200µg = Flixotide 100µg = Asmanex 100µg. A Qvar 50µg or 100µg inhaler will be used to achieve this based on the dose requirement. An approximately equivalent inhaler device to the one the patient had been originally using will be used. Equally if the participant normally used a spacer device with their ICS, this will be provided to use with a Qvar pMDI.
A Participant Instruction and Appointment Leaflet will be issued, detailing:
Emergency contact numbers How to perform PEF How to write in the diary Record adverse events and concomitant medication use Withholding times for drugs The Patient Instruction Leaflet will be discussed fully with the subject and any questions answered
Participants will be issued with a pre-labelled container for the collection of an overnight urine sample the night prior to visits V2 and V3 respectively, with written instruction as to how this should be done.
Visit 2 (V2): Sections 3.7.2 to 3.7.10 and 3.7.13 will be repeated. Visit 3 (V3): Sections 3.7.2 to 3.7.10 will be repeated. The study will end at this point with the patient returned to their prescribed medications.
- Conditions
- Asthma
- Being tested
- Qvar® (beclometasone dipropionate HFA)
- Keywords
- asthma control, small airways, extra-fine particle inhaled corticosteroids
- Medical subject headings
- Asthma
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Qvar® (beclometasone dipropionate HFA)Drug
Participants will be converted to Qvar (HFA-beclometasone) at an equivalent therapeutic dose to their original inhaled corticosteroids. The treatment duration will for 8 weeks after a run-in period.
| Study group | Role | What they receive |
|---|---|---|
| Qvar® (beclometasone dipropionate HFA) | Experimental | Participants will be converted to Qvar (HFA-beclometasone) at an equivalent therapeutic dose to their original inhaled corticosteroids. The treatment duration will for 8 weeks after a run-in period. Receives: Drug: Qvar® (beclometasone dipropionate HFA) |
What is being measured
The primary outcome is the main question the study is designed to answer.
Change in Asthma Control Questionnaire score from post-run-in baseline
Measured: 8 weeks
Secondary outcomes (10)
Impulse oscillometry
Measured: 8 weeks
Spirometry
Measured: 8 weeks
Blood eosinophilic cationic protein
Measured: 8 weeeks
Blood eosinophils
Measured: 8 weeks
Exhaled Nitric Oxide
Measured: 8 weeks
Mannitol PD15
Measured: 8 weeks
Overnight urinary cortisol/creatinine ratio
Measured: 8 weeks
Domiciliary peak expiratory flow
Measured: 8 weeks
Symptoms and reliever use
Measured: 8 weeks
Mini Asthma Quality of Life Questionnaire
Measured: 8 weeks
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted9 Jul 2013 (estimated)
- Study start28 Oct 2013
- Primary completion25 Jun 2018
- Study completion25 Jun 2018
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
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Enrolment
- 26 participants (actual)
Sponsor and investigators
- Lead sponsor
- University of Dundee
- Sponsor type
- University, hospital or other
- Collaborators
- Teva Pharmaceuticals USA
- Responsible party
- Principal investigator, Brian J Lipworth, University of Dundee
- Investigators
- Brian Lipworth, MD, Principal investigator, University of DundeeWilliam Anderson, MBChB, Principal investigator, University of Dundee
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT01894048
- Sponsor's protocol ID
- 2012RC16
- Other IDs
- 2012-003923-39, 13/ES/0064
- Acronym
- ANDA3
- Status last verified
- Sep 2019
- First submitted
- 2 Jul 2013
- Last updated
- 9 Sep 2019
- Results posted
- No
- Data monitoring committee
- No
Publications
Kuo CR, Jabbal S, Anderson W, Lipworth BJ. Pragmatic evaluation of inhaled corticosteroid particle size formulations on asthma control. Clin Exp Allergy. 2019 Oct;49(10):1321-1327. doi: 10.1111/cea.13453. Epub 2019 Aug 6.
PubMed 31264282
Study at a glance
From the registry record, last updated by the sponsor on 9 Sep 2019. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Targeted Small Airways Therapy in Persistent Asthma
- ClinicalTrials.gov ID
- NCT01894048
- Acronym / sponsor ID
- ANDA3 / 2012RC16
- Conditions
- Asthma
- Keywords
- asthma control, small airways, extra-fine particle inhaled corticosteroids
- Phase
- Phase 4
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 26 participants (actual)
- Lead sponsor
- University of DundeeUniversity, hospital or other
- Collaborators
- Teva Pharmaceuticals USA
- Study start
- 28 Oct 2013 (actual)
- Primary completion
- 25 Jun 2018 (actual)
- Study completion
- 25 Jun 2018 (actual)
- First posted
- 9 Jul 2013 (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 mainstay of asthma treatment is with inhaled steroids (commonly called a 'preventer') to keep the symptoms of asthma under control. Increasing strengths of steroid inhaler may be required in order to gain control of asthma, and this is usually guided both by symptoms and simple measurements of lung function such as peak flow.
The airways (breathing tubes) in the lungs get smaller the further into the lungs they go. Most simple measurements of lung function only reflect the larger 'central' airways and don't provide information on the smaller 'peripheral' airways.Newer measurements have been developed that can now give us accurate information on how the smaller airways are working.Indeed the small airways seem to play a significant role in asthma in terms of inflammation and airway narrowing.
Recently, new types of steroid inhalers have been developed that have a much smaller particle size than other standard inhaled steroids.These have been shown to go deeper into the lungs, thus getting into the smaller airways. There have been a few studies suggesting that this might improve asthma control. However, we do not know if when small airway function is shown to be abnormal, whether this improves with extra-fine particle inhaled steroids, nor whether by improving small airway function specifically this translates into improved asthma control.
In this study we wish to study asthmatic patients who are not completely controlled on standard particle size inhaled steroids, in addition to having evidence of abnormal small airway function. By doing this we want to find out whether changing to the same dose of an extra-fine particle inhaled steroid instead will improve asthma control by getting deeper into the lungs and improving small airway function.
Detailed description
A single centre, open-label, single subject study over a 12-24 week period. Invited participants will receive a written 'Participant Information Sheet' (PIS) detailing the requirements of the trial and the extent of their participation before attending for a screening visit. Participants will be given at least 24 hours to read the PIS.
Prior to screen (and any subsequent challenge visit) participants will withhold LABAs (or combination inhaler containing LABA) for 48 hours; and salbutamol for 6 hours. Verbal consent will be obtained from the patient over the telephone for withholding medications prior to screen and it will be explained that this in no way means they have consented to the full study at this stage.
At the screening visit a member of the research team will discuss the PIS with the participant, answer any questions posed and written informed consent will be obtained and witnessed by the member of staff asking for the consent of the patient.
A general physical examination will be carried out by a qualified medical practitioner.
A pregnancy test will be performed on all female patients with advice issued to both male and female participants to use contraception throughout the duration of the study.
The following will be measured:
- Asthma Control Questionnaire
- Mini-Asthma Quality of Life Questionnaire
- Fractional exhaled nitric oxide levels
- Impulse oscillometry
- Spirometry
- Skin prick test to common allergens
- Full blood count, renal function, electrolytes, liver enzymes and random blood glucose.
Participants will be checked against all inclusion and exclusion criteria. Those found to be eligible will proceed to the step down and/or run-in period. This will last for a minimum of 4 weeks.
Participants will be issued with a pre-labelled container for the collection of an overnight urine sample the night prior to visit V1 with written instruction as to how this should be done. A sample will be collected prior to visits V2 and V3 as well.
If a potential participant who at screening is receiving ≥200µg/day ICS (BDP) without additional LABA has an ACQ >1.0 they will directly enter the 4 week run-in period.
At 2 weeks into the run-in period the participant will be contacted to reassess their ACQ score. If their ACQ>1.0 they will continue in the run-in period for the remaining 2 weeks at the same dose of ICS. If their ACQ is not >1.0 then their ICS dose will be approximately halved (or reduced to a minimum of 200µg/day if this is greater than half the original ICS dose) and one (if any) second line medication (e.g. theophylline, LTRA) will be discontinued at the discretion of a study doctor. They will then restart the 4 week run-in period. If they are already receiving 200µg/day ICS (i.e. the dose cannot be reduced further) then they will be withdrawn from the study at this juncture.
At the end of the 4 week period if the participant still has an ACQ>1.0 they will proceed to visit V1.
If a potential participant who at screening is receiving ≥200µg/day ICS (BDP) with additional LABA has an ACQ score >1.0, their LABA will be discontinued and they will directly enter the 4 week run-in period. If the participant is receiving their LABA as part of a combination inhaler, they will be converted to an equivalent ICS alone inhaler (i.e. coarse particle ICS) and enter the 4 week run-in period. Progress through run-in will then be as described before.
If a potential participant who at screening is receiving ≥200µg/day ICS (BDP) with additional LABA has an ACQ not >1.0, then their LABA will be discontinued as per 3.6.2 and their ICS dose will be approximately halved (or reduced to a minimum of 200µg/day if this is greater than half the original ICS dose). For example, Seretide 250µg b.i.d. would convert to Flixotide 125µg b.i.d. They will subsequently enter the 4 week run-in period progressing through it as described..
Participants will be asked to perform and record twice daily domiciliary PEF and to complete a daily diary of reliever use and symptoms from the beginning of the step-down/run-in period through to the end of the study. Participants will be advised to contact the investigators if they feel their asthma significantly worsening in the interim. They will also be given a card with 24 hour emergency contact details.
At the end of the 4 week run-in period, participants will be checked against all inclusion and exclusion criteria to confirm the subject's suitability to receive the study drug according to study protocol. Those eligible will proceed to study visit 1. Those who do not fulfil the study criteria will be returned to their pre-study medication and their GP informed of any medically relevant data.
Study visits V1, V2 and V3 Full study visits will occur at the end of the run-in period (baseline), at 4 weeks and 8 weeks.
Participants will be asked to withhold their reliever as per the screening visit. (LABAs are withheld for the duration of the study).
Participants will attend the unit on the morning of the visit day. The overnight urine collection will be received from the participant for analysis.
Peak flow records will be reviewed along with daily domiciliary symptom and reliever use diaries.
Participants will be asked to complete an ACQ and Mini-AQLQ. A venous blood sample will be drawn for FBC. A venous blood sample will be drawn for ECP. FeNO, IOS, and spirometry will be performed in that order. Mannitol bronchial challenge will then be performed
Participants will be converted to Qvar (HFA-beclometasone) at an equivalent therapeutic dose to their original ICS, e.g. Qvar 100µg = Clenil 200µg = Pulmicort 200µg = Flixotide 100µg = Asmanex 100µg. A Qvar 50µg or 100µg inhaler will be used to achieve this based on the dose requirement. An approximately equivalent inhaler device to the one the patient had been originally using will be used. Equally if the participant normally used a spacer device with their ICS, this will be provided to use with a Qvar pMDI.
A Participant Instruction and Appointment Leaflet will be issued, detailing:
Emergency contact numbers How to perform PEF How to write in the diary Record adverse events and concomitant medication use Withholding times for drugs The Patient Instruction Leaflet will be discussed fully with the subject and any questions answered
Participants will be issued with a pre-labelled container for the collection of an overnight urine sample the night prior to visits V2 and V3 respectively, with written instruction as to how this should be done.
Visit 2 (V2): Sections 3.7.2 to 3.7.10 and 3.7.13 will be repeated. Visit 3 (V3): Sections 3.7.2 to 3.7.10 will be repeated. The study will end at this point with the patient returned to their prescribed medications.
Study design
- Primary purpose
- Treatment
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| Qvar® (beclometasone dipropionate HFA) | Experimental | Drug: Qvar® (beclometasone dipropionate HFA)Participants will be converted to Qvar (HFA-beclometasone) at an equivalent therapeutic dose to their original inhaled corticosteroids. The treatment duration will for 8 weeks after a run-in period. |
Who may qualify
- Ages
- 18 to 65 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (8 listed)
- Male and female volunteers aged 18-65, with persistent asthma
- Asthma Control Questionnaire score >1.0 (at end of run-in)
- FEV1 >60% predicted
- R5>130% predicted and R5-R20>0.03kPa/L/s
- Ability to perform spirometry, impulse oscillometry, bronchial challenge and all domiciliary measurements
Key exclusion criteria (7 listed)
- Patients already receiving extra-fine particle inhaled corticosteroids (Qvar, Fostair, Alvesco)
- Pregnancy or lactation
- Known or suspected sensitivity to the Investigational Medicinal Product
- Inability to comply with protocol
- Any clinically significant medical conditions that may either endanger the health or safety of the participant, or jeopardise the protocol
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 |
|---|---|---|
| Qvar® (beclometasone dipropionate HFA)Participants will be converted to Qvar (HFA-beclometasone) at an equivalent therapeutic dose to their original inhaled corticosteroids. The treatment duration will for 8 weeks after a run-in period. | Drug | Qvar® (beclometasone dipropionate HFA) |
Primary outcome
Change in Asthma Control Questionnaire score from post-run-in baseline
Time frame: 8 weeks
10 secondary outcomes
Impulse oscillometry
Time frame: 8 weeks
Spirometry
Time frame: 8 weeks
Blood eosinophilic cationic protein
Time frame: 8 weeeks
Blood eosinophils
Time frame: 8 weeks
Exhaled Nitric Oxide
Time frame: 8 weeks
Mannitol PD15
Time frame: 8 weeks
Overnight urinary cortisol/creatinine ratio
Time frame: 8 weeks
Domiciliary peak expiratory flow
Time frame: 8 weeks
Symptoms and reliever use
Time frame: 8 weeks
Mini Asthma Quality of Life Questionnaire
Time frame: 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 9 Sep 2019.
- Results publication: PubMed 31264282Kuo CR, Jabbal S, Anderson W, Lipworth BJ. Pragmatic evaluation of inhaled corticosteroid particle size formulations on asthma control. Clin Exp Allergy. 2019 Oct;49(10):1321-1327. doi: 10.1111/cea.13453. Epub 2019 Aug 6.
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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.
Brian Lipworth, MD principal investigator
University of Dundee
William Anderson, MBChB 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 Qvar® (beclometasone dipropionate HFA) 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 8 inclusion and 7 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 9 Sep 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?
Change in Asthma Control Questionnaire score from post-run-in baseline (time frame: 8 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 NCT01894048, 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 9 Sep 2019.