Pulmonary Disease, Chronic ObstructivePhase 1NCT02207452
Helium-3 MRI Imaging Study in COPD
A Phase 1 study testing He-3 MRI, Salbutamol and Ipratropium in people with Pulmonary Disease, Chronic Obstructive, run by GlaxoSmithKline at 1 site in United Kingdom.
Trial summary
This protocol describes the investigation of the use of hyperpolarised helium magnetic resonance imaging (MRI) in reflecting the regional differences in lung function of moderate to severe Chronic Obstructive Pulmonary Disease (COPD) patients. Read more about this study
- Who is it for?
- Ages 50 years and older
- Conditions the study is for
- Pulmonary Disease, Chronic Obstructive
- What is being tested?
- He-3 MRI, Salbutamol and Ipratropium
- Type of treatment
- Medical device
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 11 participants
- Where
- 1 siteUnited Kingdom
- Study dates
- 5 Aug 2010to 4 Jul 2011
- 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 50 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- Diagnosis of Chronic Obstructive Pulmonary Disease (COPD) diagnosis: an established clinical history of chronic pulmonary disorder in accordance with the following description by the American Thoracic Society / European Respiratory Society [ATS / ETS, 2004]
- Chronic obstructive pulmonary disease is a preventable and treatable disease characterised by airflow limitation that is not fully reversible. The airflow limitation is usually progressive and is associated with an abnormal inflammatory response of the lungs to noxious particles or gases, primarily caused by cigarette smoking. Although COPD affects the lungs, it also produces significant systemic consequences.
- The patient is clinically stable with no change in symptoms or medication, no admissions to hospital, and with neither antibiotic therapy nor systemic steroid use for at least 6 weeks prior to screening. (Screening may be rescheduled after an appropriate period of stability)
- Male and female patients aged ≥50 years
- A female patient is eligible to participate if she is of non-childbearing potential defined as pre-menopausal females with a documented tubal ligation or hysterectomy; or postmenopausal defined as 12 months of spontaneous amenorrhea (in questionable cases a blood sample with simultaneous follicle stimulating hormone (FSH) ≥40 M1U/mL and estradiol ≤ 40 pg/mL (≤140 pmol/L) is confirmatory).
- Subjects have refrained from short-acting bronchodilators for 8 hours, long-acting β2-agonists (including any long-acting β2 agonist containing inhaler) and theophyllines for 24 hours and Tiotropium, phosphodiesterase-4 (PDE4) inhibitors (e.g. Roflumilast) and ultra long-acting beta-adrenoceptor agonists (e.g. Indacaterol) for 48 hours prior to admission to the unit on study days.
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- Subjects with a post-bronchodilator FEV1 to FVC ratio (FEV1/FVC) < 0.7
- Subjects with a post-bronchodilator FEV1 ≥ 30% and ≤ 80% of predicted normal for height, age and sex at screening.
- Subjects with a cigarette smoking history of ≥10 pack years (1 pack year = 20 cigarettes smoked per day for 1 year or the equivalent). Both current and former smokers are eligible to be enrolled.
- Resting SpO2 of >90% on room air
- QTcB or QTcF < 450 msec; or QTc < 480 msec in subjects with Bundle Branch Block (based on a single ECG value).
- The patient is able to understand and comply with protocol requirements, instructions and protocol-stated restrictions, and to give informed consent.
Who cannot join
- Unstable cardiac disease or history of clinically significant arrhythmia (including established atrial fibrillation).
- Patients with a primary diagnosis of α-1 antitrypsin deficiency.
- Patients with other significant respiratory disorders.
- Patients with any acute infection, exacerbation of COPD or other unstable medical condition.
- Patients in whom inhaled beta-2 agonists or anticholinergics are contraindicated.
- Patients who have undergone thoracic surgery including lung volume reduction surgery or have conditions that prevent them from performing spirometry and other physiological testing.
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- Patients who are non Magnetic Resonance Imaging (MRI) compatible (ferro-magnetic metallic implants, pacemakers) as per the MRI questionnaire.
- Patients with renal complaints relating to potential adverse reactions to Gd-DTPA intravascular MRI contrast agent.
- Patients who suffer from claustrophobia.
- The patient has participated in a clinical trial and has received an investigational product within the following time period prior to the first study day in the current study: 30 days, 5 half-lives or twice the duration of the biological effect of the investigational product (whichever is longer) of that study.
- Exposure to more than four new chemical entities within 12 months prior to the first dosing day.
- History of sensitivity to any of the study medications, or components thereof or a history of drug or other allergy that, in the opinion of the investigator or GSK Medical Monitor, contraindicates their participation.
- Subjects must abstain from taking prescription (not related to their COPD) or nonprescription drugs (including vitamins and dietary or herbal supplements), within 7 days (or 14 days if the drug is a potential enzyme inducer) or 5 half-lives (whichever is longer) prior to the first study day until completion of the follow-up visit, unless in the opinion of the Investigator and sponsor the medication will not interfere with the study.
- Unwillingness or inability to follow the procedures outlined in the protocol.
Trial locations and contacts
1 site in 1 country.
About this study
Official title: A Randomized, Methodology Study to Investigate the Use of 3He-MRI Lung Ventilation and Proton MRI Perfusion Imaging to Detect Changes in Ventilation Perfusion Relationships in Chronic Obstructive Pulmonary Disease (COPD) Patients; a Proof of Concept Study.
This protocol describes the investigation of the use of hyperpolarised helium magnetic resonance imaging (MRI) in reflecting the regional differences in lung function of moderate to severe Chronic Obstructive Pulmonary Disease (COPD) patients.
Since finalisation of the original protocol, new medications for COPD have received Market Authorisation Approvals. Protocol Amendment 02 has been prepared to include these medications in the protocol eligibility criteria and restrictions for the study.
Read the detailed description
Chronic Obstructive Pulmonary Disease (COPD) is an important cause of morbidity, mortality, and healthcare costs worldwide. COPD is characterized by progressive airflow limitation that is not fully reversible and is associated with an abnormal inflammatory response of the lungs to noxious particles or gases. It has become clear that simple measures of airflow obstruction are inadequate to relate lung function to exercise capacity or symptoms, and that complex expressions such as dynamic hyper-inflation need to be invoked in seeking to understand overall physiology. In addition to abnormalities of air flow, gas exchange is also deranged. Therefore in considering new treatment approaches, both abnormalities need to be addressed.
Techniques to study ventilation variation and perfusion matching across the lung exist but are invasive and exacting, and do not give an indication of the anatomical distribution of changes. There is a clear need for techniques which can provide sensitive, useful and safe repeated measures reflecting regional changes in ventilation and gas exchange in COPD. This study investigates use of hyperpolarised helium magnetic resonance imaging (MRI) in reflecting the regional differences in lung function of moderate to severe COPD patients. A Beta2 bronchodilator - Salbutamol - and a anticholinergic - Ipratropium - will be used in this study.
- Conditions
- Pulmonary Disease, Chronic Obstructive
- Being tested
- He-3 MRI, Salbutamol, Ipratropium, MRI
- Keywords
- Hyperpolarised helium-3, Lung Imaging, Magnetic Resonance Imaging
- Medical subject headings
- Pulmonary Disease, Chronic Obstructive
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
He-3 MRIDevice
Also called Hyperpolarised Helium-3 MRI, He-3 Magnetic Resonance Imaging
Hyperpolarised helium-3 Magnetic Resonance Imaging (MRI) scan pre-bronchodilator and 1 hour post-bronchodilator (after 1 hour post-bronchodilator assessments/procedures completed).
SalbutamolDrug
Salbutamol 5mg nebulised single dose
IpratropiumDrug
Ipratropium 500mcg nebulised single dose
MRIDevice
Also called 1H MRI
Proton Magnetic Resonance Imaging (MRI) scan pre-bronchodilator and 1 hour post-bronchodilator (after 1 hour post-bronchodilator assessments/procedures completed).
| Study group | Role | What they receive |
|---|---|---|
| Salbutamol + Ipratropium | Other | Treatment period 1: Salbutamol 5mg nebulised, single Dose. Treatment period 2: Ipratropium 500mcg nebulised, single dose. Receives: Device: He-3 MRI; Drug: Salbutamol; Drug: Ipratropium; Device: MRI |
| Ipratropium + Salbutamol | Other | Treatment period 1: Ipratropium 500mcg nebulised, single dose. Treatment period 2: Salbutamol 5mg nebulised, single Dose. Receives: Device: He-3 MRI; Drug: Salbutamol; Drug: Ipratropium; Device: MRI |
What is being measured
The primary outcome is the main question the study is designed to answer.
Changes in Oxygen Saturation
To correlate changes in oxygen saturation pre- and post- bronchodilator (as a reflection of ventilation/perfusion matching) with changes in distribution of regional ventilation/perfusion (V/Q) demonstrated by hyperpolarized helium ventilation MRI/spatially registered proton perfusion.
Measured: Baseline measurement at screening visit (up to 30 days prior to first dose). Pre-treatment Day 1 (0.5-2 hours pre-dose) and post-dose Day 1 (1 hour post dose), for both treatment periods.
Changes in distribution of regional ventilation/perfusion assessed by spatially registered Helium-3 Magnetic Resonance Imaging (MRI) and proton perfusion MRI.
To correlate changes in oxygen saturation pre- and post- bronchodilator (as a reflection of ventilation/perfusion matching) with changes in distribution of regional ventilation/perfusion (V/Q) demonstrated by hyperpolarized helium ventilation MRI/spatially registered proton perfusion.
Measured: Pre-treatment Day 1 (0.5-2 hours pre-dose) and post-dose Day 1 (1 hour post-dose), for both treatment periods.
Secondary outcomes (10)
Changes in lung volumes.
To compare lung volumes assessed by plethysmography with registered Helium-3 ventilation MRI and proton MRI.
Measured: Pre-treatment Day 1 (0.5-2 hours pre-dose) and post-dose Day 1 (1 hour post-dose), for both treatment periods.
Changes in standard lung function parameters.
To compare changes in ventilatory parameters as assessed by pulmonary function tests (spirometry) and Helium-3 MRI.
Measured: Baseline measurement at screening visit (up to 30 days prior to first dose). Pre-treatment Day 1 (0.5-2 hours pre-dose) and post-dose Day 1 (1 hour post dose), for both treatment periods.
Number of adverse events
To monitor the safety of Helium-3 MRI through adverse events and clinical lung function.
Measured: From screening (up to 30 days prior to Day 1) to follow-up (7-14 days after last dose).
Reproducibility of Helium-3 MRI
To evaluate reproducibility of Helium-3 MRI (pre-bronchodilator) over a 2 week period.
Measured: Pre-treatment Day 1 (0.5-2 hours pre-dose) for both treatment periods.
Symptomatic effects of bronchodilators.
To correlate the symptomatic effects of bronchodilators with measures of lung function derived from physiological measures and from 3He MRI and proton MRI.
Measured: Pre-treatment Day 1 (0.5-2 hours pre-dose) and post-dose Day 1 (1 hour post-dose), for both treatment periods.
Regional lung oxygen uptake (pO2)
To compare regional oxygen uptake (direct V/Q) from 3He MRI pO2 mapping with regional V/Q derived from the ratio of 3He ventilation MRI (V) and spatially registered contrast enhanced proton perfusion MRI (Q).
Measured: Pre-treatment Day 1 (0.5-2 hours pre-dose) and post-dose Day 1 (1 hour post-dose), for both treatment periods.
Change in breathlessness
Change in breathlessness according to the Modified Borg Scale of breathlessness.
Measured: From screening (up to 30 days prior to Day 1) to follow-up (7-14 days after last dose).
Helium-3 apparent diffusion coefficient measurements
Helium-3 apparent diffusion coefficient measurements (sensitivity to emphysematous alveolar destruction and minor airway size).
Measured: Pre-treatment Day 1 (0.5-2 hours pre-dose) and post-dose Day 1 (1 hour post-dose), for both treatment periods.
Distribution of flow velocities in major airways
Distribution of flow velocities in major airways assessed by helium-3 MRI
Measured: Pre-treatment Day 1 (0.5-2 hours pre-dose) and post-dose Day 1 (1 hour post-dose), for both treatment periods.
Changes in dyspnoea
Changes in shortness of breath/air hunger monitored throughout the study.
Measured: From screening (up to 30 days prior to first dose) to follow-up (7-14 days after last dose).
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted4 Aug 2014 (estimated)
- Study start5 Aug 2010
- Primary completion4 Jul 2011
- Study completion4 Jul 2011
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Pulmonary Disease, Chronic ObstructiveStudies of the same condition, open and under way.
- More trials run by GlaxoSmithKlineThe 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
- Diagnosis
- Allocation
- Randomised
- Intervention model
- Crossover
- Masking
- None (open label)
- Enrolment
- 11 participants (actual)
Sponsor and investigators
- Lead sponsor
- GlaxoSmithKline
- Sponsor type
- Industry (pharma, biotech, devices)
- Responsible party
- Sponsor
- Investigators
- GSK Clinical Trials, Study director, GlaxoSmithKline
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT02207452
- Sponsor's protocol ID
- 111175
- Status last verified
- Jun 2017
- First submitted
- 12 Jan 2012
- Last updated
- 27 Jun 2017
- Results posted
- No
Study at a glance
From the registry record, last updated by the sponsor on 27 Jun 2017. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- A Randomized, Methodology Study to Investigate the Use of 3He-MRI Lung Ventilation and Proton MRI Perfusion Imaging to Detect Changes in Ventilation Perfusion Relationships in Chronic Obstructive Pulmonary Disease (COPD) Patients; a Proof of Concept Study.
- ClinicalTrials.gov ID
- NCT02207452
- Acronym / sponsor ID
- 111175
- Conditions
- Pulmonary Disease, Chronic Obstructive
- Keywords
- Hyperpolarised helium-3, Lung Imaging, Magnetic Resonance Imaging
- Phase
- Phase 1
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 11 participants (actual)
- Lead sponsor
- GlaxoSmithKlineIndustry (pharma, biotech, devices)
- Study start
- 5 Aug 2010 (actual)
- Primary completion
- 4 Jul 2011 (actual)
- Study completion
- 4 Jul 2011 (actual)
- First posted
- 4 Aug 2014 (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.
This protocol describes the investigation of the use of hyperpolarised helium magnetic resonance imaging (MRI) in reflecting the regional differences in lung function of moderate to severe Chronic Obstructive Pulmonary Disease (COPD) patients.
Since finalisation of the original protocol, new medications for COPD have received Market Authorisation Approvals. Protocol Amendment 02 has been prepared to include these medications in the protocol eligibility criteria and restrictions for the study.
Detailed description
Chronic Obstructive Pulmonary Disease (COPD) is an important cause of morbidity, mortality, and healthcare costs worldwide. COPD is characterized by progressive airflow limitation that is not fully reversible and is associated with an abnormal inflammatory response of the lungs to noxious particles or gases. It has become clear that simple measures of airflow obstruction are inadequate to relate lung function to exercise capacity or symptoms, and that complex expressions such as dynamic hyper-inflation need to be invoked in seeking to understand overall physiology. In addition to abnormalities of air flow, gas exchange is also deranged. Therefore in considering new treatment approaches, both abnormalities need to be addressed.
Techniques to study ventilation variation and perfusion matching across the lung exist but are invasive and exacting, and do not give an indication of the anatomical distribution of changes. There is a clear need for techniques which can provide sensitive, useful and safe repeated measures reflecting regional changes in ventilation and gas exchange in COPD. This study investigates use of hyperpolarised helium magnetic resonance imaging (MRI) in reflecting the regional differences in lung function of moderate to severe COPD patients. A Beta2 bronchodilator - Salbutamol - and a anticholinergic - Ipratropium - will be used in this study.
Study design
- Primary purpose
- Diagnosis
- Allocation
- Randomised
- Intervention model
- Crossover
- Masking
- None (open label)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Salbutamol + Ipratropium | Other | Device: He-3 MRI, Drug: Salbutamol, Drug: Ipratropium, Device: MRITreatment period 1: Salbutamol 5mg nebulised, single Dose. Treatment period 2: Ipratropium 500mcg nebulised, single dose. |
| Ipratropium + Salbutamol | Other | Device: He-3 MRI, Drug: Salbutamol, Drug: Ipratropium, Device: MRITreatment period 1: Ipratropium 500mcg nebulised, single dose. Treatment period 2: Salbutamol 5mg nebulised, single Dose. |
Who may qualify
- Ages
- 50 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (12 listed)
- Diagnosis of Chronic Obstructive Pulmonary Disease (COPD) diagnosis: an established clinical history of chronic pulmonary disorder in accordance with the following description by the American Thoracic Society / European Respiratory Society [ATS / ETS, 2004]
- Chronic obstructive pulmonary disease is a preventable and treatable disease characterised by airflow limitation that is not fully reversible. The airflow limitation is usually progressive and is associated with an abnormal inflammatory response of the lungs to noxious particles or gases, primarily caused by cigarette smoking. Although COPD affects the lungs, it also produces significant systemic consequences.
- The patient is clinically stable with no change in symptoms or medication, no admissions to hospital, and with neither antibiotic therapy nor systemic steroid use for at least 6 weeks prior to screening. (Screening may be rescheduled after an appropriate period of stability)
- Male and female patients aged ≥50 years
- A female patient is eligible to participate if she is of non-childbearing potential defined as pre-menopausal females with a documented tubal ligation or hysterectomy; or postmenopausal defined as 12 months of spontaneous amenorrhea (in questionable cases a blood sample with simultaneous follicle stimulating hormone (FSH) ≥40 M1U/mL and estradiol ≤ 40 pg/mL (≤140 pmol/L) is confirmatory).
Key exclusion criteria (14 listed)
- Unstable cardiac disease or history of clinically significant arrhythmia (including established atrial fibrillation).
- Patients with a primary diagnosis of α-1 antitrypsin deficiency.
- Patients with other significant respiratory disorders.
- Patients with any acute infection, exacerbation of COPD or other unstable medical condition.
- Patients in whom inhaled beta-2 agonists or anticholinergics are contraindicated.
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 |
|---|---|---|
| He-3 MRIAlso: Hyperpolarised Helium-3 MRI, He-3 Magnetic Resonance ImagingHyperpolarised helium-3 Magnetic Resonance Imaging (MRI) scan pre-bronchodilator and 1 hour post-bronchodilator (after 1 hour post-bronchodilator assessments/procedures completed). | Device | Ipratropium + Salbutamol, Salbutamol + Ipratropium |
| SalbutamolSalbutamol 5mg nebulised single dose | Drug | Ipratropium + Salbutamol, Salbutamol + Ipratropium |
| IpratropiumIpratropium 500mcg nebulised single dose | Drug | Ipratropium + Salbutamol, Salbutamol + Ipratropium |
| MRIAlso: 1H MRIProton Magnetic Resonance Imaging (MRI) scan pre-bronchodilator and 1 hour post-bronchodilator (after 1 hour post-bronchodilator assessments/procedures completed). | Device | Ipratropium + Salbutamol, Salbutamol + Ipratropium |
Primary outcome
Changes in Oxygen Saturation
Time frame: Baseline measurement at screening visit (up to 30 days prior to first dose). Pre-treatment Day 1 (0.5-2 hours pre-dose) and post-dose Day 1 (1 hour post dose), for both treatment periods.
To correlate changes in oxygen saturation pre- and post- bronchodilator (as a reflection of ventilation/perfusion matching) with changes in distribution of regional ventilation/perfusion (V/Q) demonstrated by hyperpolarized helium ventilation MRI/spatially registered proton perfusion.
Changes in distribution of regional ventilation/perfusion assessed by spatially registered Helium-3 Magnetic Resonance Imaging (MRI) and proton perfusion MRI.
Time frame: Pre-treatment Day 1 (0.5-2 hours pre-dose) and post-dose Day 1 (1 hour post-dose), for both treatment periods.
To correlate changes in oxygen saturation pre- and post- bronchodilator (as a reflection of ventilation/perfusion matching) with changes in distribution of regional ventilation/perfusion (V/Q) demonstrated by hyperpolarized helium ventilation MRI/spatially registered proton perfusion.
10 secondary outcomes
Changes in lung volumes.
Time frame: Pre-treatment Day 1 (0.5-2 hours pre-dose) and post-dose Day 1 (1 hour post-dose), for both treatment periods.
Changes in standard lung function parameters.
Time frame: Baseline measurement at screening visit (up to 30 days prior to first dose). Pre-treatment Day 1 (0.5-2 hours pre-dose) and post-dose Day 1 (1 hour post dose), for both treatment periods.
Number of adverse events
Time frame: From screening (up to 30 days prior to Day 1) to follow-up (7-14 days after last dose).
Reproducibility of Helium-3 MRI
Time frame: Pre-treatment Day 1 (0.5-2 hours pre-dose) for both treatment periods.
Symptomatic effects of bronchodilators.
Time frame: Pre-treatment Day 1 (0.5-2 hours pre-dose) and post-dose Day 1 (1 hour post-dose), for both treatment periods.
Regional lung oxygen uptake (pO2)
Time frame: Pre-treatment Day 1 (0.5-2 hours pre-dose) and post-dose Day 1 (1 hour post-dose), for both treatment periods.
Change in breathlessness
Time frame: From screening (up to 30 days prior to Day 1) to follow-up (7-14 days after last dose).
Helium-3 apparent diffusion coefficient measurements
Time frame: Pre-treatment Day 1 (0.5-2 hours pre-dose) and post-dose Day 1 (1 hour post-dose), for both treatment periods.
Distribution of flow velocities in major airways
Time frame: Pre-treatment Day 1 (0.5-2 hours pre-dose) and post-dose Day 1 (1 hour post-dose), for both treatment periods.
Changes in dyspnoea
Time frame: From screening (up to 30 days prior to first dose) to follow-up (7-14 days after last 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 27 Jun 2017.
- Results for study 111175 can be found on the GSK Clinical Study Register.Link provided by the sponsor.
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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.
GSK Clinical Trials study director
GlaxoSmithKline
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 He-3 MRI, Salbutamol and Ipratropium in people with Pulmonary Disease, Chronic Obstructive, run by GlaxoSmithKline 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 12 inclusion and 14 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 27 Jun 2017. 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 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?
Changes in Oxygen Saturation (time frame: Baseline measurement at screening visit (up to 30 days prior to first dose). Pre-treatment Day 1 (0.5-2 hours pre-dose) and post-dose Day 1 (1 hour post dose), for both treatment periods.). The study lists 2 primary outcomes in all. 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 27 Jun 2017.