Chronic Obstructive Pulmonary Disease (COPD)Phase 4TRIFLOWNCT03842904

A Study Comparing the Effects of Trimbow to Fostair in COPD

A Phase 4 study testing Trimbow pMDI and Fostair pMDI in people with Chronic Obstructive Pulmonary Disease (COPD), run by Medicines Evaluation Unit Ltd at 1 site in United Kingdom.

Completed

Finished. The study has ended and is not enrolling. Results may be posted on the official record.

Official record

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Trial summary

A randomised, open label 2-way cross-over study to compare the effects of inhaled Beclometasone/Formoterol/Glycopyrronium (TRIMBOW) pMDI to Beclometasone/Formoterol (FOSTAIR) pMDI on hyperinflation and expiratory flow limitation in moderate to severe chronic obstructive pulmonary disease (COPD). Read more about this study

Who is it for?: Ages 40 to 75 years
Conditions the study is for: Chronic Obstructive Pulmonary Disease (COPD)
What is being tested?: Trimbow pMDI and Fostair pMDI
Could I receive a placebo?: No, everyone receives an active treatment
How many people: 23 participants
Where: 1 siteUnited Kingdom
Study dates: 13 Dec 2018to 6 Aug 2019
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 40 to 75 years
All sexes
No healthy volunteers
Adult, Older adult

Who may be able to join

Male and female adults aged 40 to 75 years with written informed consent obtained prior to any study-related procedure.
COPD diagnosis: Subjects with a diagnosis of moderate to severe COPD according to the GOLD 2018 COPD recommendations, with symptoms compatible with COPD for at least 1 year prior to screening.
Clinically stable COPD in the 6 weeks prior to screening and during the run-in period prior to randomisation.
Body mass index (BMI) in the range of 18.0 to 33.0 kg/m2 and with a minimum weight of 50 kg at screening.
Current smokers or ex-smokers with a smoking history of at least 10 pack years [pack-years = (number of cigarettes per day x number of years)/20].
A post-bronchodilator FEV1 ≥ 30 % and ≤ 70% of the predicted normal value and a post-bronchodilator FEV1/FVC ratio < 0.7 at screening.

Show all 14Show fewer

Evidence of pre-bronchodilator hyperinflation (RV>120% predicted) at screening (V1) and baseline (V2).
Subject is willing and, in the opinion of the Investigator, able to change current COPD therapy as required by the protocol.
Subject is treated with double or triple therapy for at least 1 month prior to screening visit with either:
Inhaled corticosteroids/long-acting β2-agonist, combination treatment (fixed and/or free)
Inhaled corticosteroids and long-acting muscarinic antagonist
inhaled corticosteroids/long-acting β2-agonist/long-acting muscarinic antagonist, combination treatment (fixed and/or free) In addition to the above subjects may be currently taking inhaled short acting β2-agonists and/or inhaled short acting anticholinergics.
A cooperative attitude and ability to be trained to correctly use the pMDI inhaler.
Compliance with inhaled Beclometasone run-in medication of between 80 to 120% at Visit 2 (baseline visit) and Visit 3 (Treatment Period 1, Day 1)

Who cannot join

Inability to comply with study procedures, required restrictions, study treatment intake or any other reason that the Investigator considers makes the patient unsuitable to participate.
COPD exacerbation requiring oral steroids and/or antibiotics, in the 8 weeks prior to screening or prior to randomisation.
Use of antibiotics for a respiratory tract infection in the 8 weeks prior to screening or prior to randomisation.
Inability to perform technically acceptable impulse oscillometry, whole body plethysmography or spirometry at screening, (V1) or baseline (V2).
Pregnant, lactating or breastfeeding women at screening, baseline or prior to randomisation. Positive urine pregnancy test at screening, baseline or prior to randomisation.
A history of one or more hospitalisations for COPD in the 12 months prior to screening or prior to randomisation.

Show all 19Show fewer

Requires oxygen therapy, even on an occasional basis.
Known respiratory disorders other than COPD which may impact the efficacy or the safety of the study drug according to investigator's judgement. This can include but is not limited to known alpha-1 antitrypsin deficiency, active tuberculosis, lung cancer and bronchial carcinoma, bronchiectasis, sarcoidosis, lung fibrosis, pulmonary hypertension and interstitial lung disease.
An abnormal and clinically significant 12-lead ECG which may impact the safety of the patient according to investigator's judgement.
N.B: Subject whose electrocardiogram (ECG) (12 lead) shows QTcF>450 males or QTcF> 470 ms for females at screening are not eligible.
Medical diagnosis of narrow-angle glaucoma, prostatic hypertrophy or bladder neck obstruction that in the opinion of the investigator would prevent use of anticholinergic agents.
History of hypersensitivity to anticholinergics, β2-agonist, corticosteroids or any of the excipients contained in any of the formulations used in the trial which may raise contra-indications or impact the efficacy of the study drug according to the investigator's judgement.
Clinically significant laboratory abnormalities at screening indicating a significant or unstable concomitant disease which may impact the efficacy of the study drug or the safety of the patient, according to investigator's judgement.
Subjects with a history of chronic uncontrolled disease including, but not limited to, endocrine, active hyperthyroidism, neurological, hepatic, gastrointestinal, renal, haematological, urological, immunological, or ophthalmic diseases that the Investigator believes are clinically significant.
Uncontrolled cardiovascular disease: arrhythmias, angina, recent or suspected myocardial infarction, congestive heart failure, a history of unstable, or uncontrolled hypertension, or has been diagnosed with hypertension in the 3 months prior to screening or randomisation.
History of alcohol abuse and/or substance/drug abuse within 2 years prior to screening visit.
Has had major surgery, (requiring general anaesthesia) in the 8 weeks prior to screening or prior to randomisation, or has planned surgery through the end of the study.
Previous lung resection or lung reduction surgery.
Participation in another clinical trial and received investigational drug within 30 days (or 5 half-lives whichever is longer). N.B.: For biologic products with slow elimination a washout of at least 6 months needs to be met prior to screening visit.

Trial locations and contacts

1 site in 1 country.

United Kingdom1 site

The Medicines Evaluation Unit (MEU)
Manchester, M23 9QZ

Other trials in United Kingdom

About this study

Official title: A Randomised, Open Label 2-Way Cross-over Study to Compare the Effects of Inhaled Beclometasone/Formoterol/Glycopyrronium (TRIMBOW) pMDI to Beclometasone/Formoterol (FOSTAIR) pMDI on Hyperinflation and Expiratory Flow Limitation in Moderate to Severe Chronic Obstructive Pulmonary Disease (COPD)

Read the detailed description

This study will investigate the contributions of extra-fine glycopyrronium and formoterol (within triple therapy) to improvements in small airway function in COPD patients. This will be achieved by recruiting patients with hyperinflation, and measuring improvements in hyperinflation and expiratory flow limitation as measurements of small airway disease.

This study will help understand the mechanisms of action of the bronchodilators within BDP/FF/GB, and potentially encourage treatment of small airway disease in COPD with extra-fine bronchodilator treatments. This trial will be conducted in compliance with the Declaration of Helsinki (1964 and amendments) current Good Clinical Practices and all other applicable laws and regulations.

Conditions: Chronic Obstructive Pulmonary Disease (COPD)
Being tested: Trimbow pMDI, Fostair pMDI
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.

Trimbow pMDIDrug
Clinical Trial of an Investigational Medicinal Product (CTIMP)
Fostair pMDIDrug
Clinical Trial of an Investigational Medicinal Product (CTIMP)

Study groups in NCT03842904
Study group	Role	What they receive
Trimbow pMDI	Experimental	Trimbow 87 micrograms/5 micrograms/9 micrograms pressurised inhalation solution. Receives: Drug: Trimbow pMDI
Fostair pMDI	Active comparator	Fostair 100/6 micrograms per actuation pressurised inhalation solution. Receives: Drug: Fostair pMDI

What is being measured

The primary outcome is the main question the study is designed to answer.

Forced Expired Volume in 1 second (FEV1), L.
To compare the effect of Trimbow and Fostair on FEV1 [(forced expiratory volume in 1 sec - changes from pre-dose day 1)].
Measured: Pre-dose Day 1 and Day 5 (treatment period 1 & 2 - pre-dose, 30 minutes, 1, 2, 4, 6, 8, 10 and 12 hours post dose)
Residual Volume (RV), L.
To compare the effect of Trimbow and Fostair on RV [(residual volume) - changes from pre-dose day 1)].
Measured: Pre-dose Day 1 and Day 5 (treatment period 1 & 2 - pre-dose, 1, 2, 4, 8 and 12 hours post dose)

Secondary outcomes (15)

Peripheral Respiratory Resistance (R5-R20), kPa/L/s.
Impulse Oscillometry measurement
Measured: Pre-dose Day 1 and Day 5 (treatment period 1 & 2 - pre-dose, 30 mins, 1, 2, 4, 6, 8, 10 & 12 hrs post dose)
Expiratory Flow Limitation (Delta X5), kPa/L/s.
Impulse Oscillometry measurement
Measured: Pre-dose Day 1 and Day 5 (treatment period 1 & 2 - pre-dose, 30 mins, 1, 2, 4, 6, 8, 10 & 12 hrs post dose)
Forced Vital Capacity (FVC), L
Spirometry measurement
Measured: Baseline, Pre-dose Day 1 and Day 5 (treatment period 1 & 2 - pre-dose, 30 mins, 1, 2, 4, 6, 8, 10 & 12 hrs post dose)
Forced Expiratory Flow between 25-75% of FVC (FEF25-75%), L/s
Spirometry measurement
Measured: Baseline, Pre-dose Day 1 and Day 5 (treatment period 1 & 2 - pre-dose, 30 mins, 1, 2, 4, 6, 8, 10 & 12 hrs post dose)
Resistance at 5Hz (R5), kPa/L/s
Impulse Oscillometry measurement
Measured: Baseline, Pre-dose Day 1 and Day 5 (treatment period 1 & 2 - pre-dose, 30 mins, 1, 2, 4, 6, 8, 10 & 12 hrs post dose)
Reactance at 5Hz (X5), kPa/L/s
Impulse Oscillometry measurement
Measured: Baseline, Pre-dose Day 1 and Day 5 (treatment period 1 & 2 - pre-dose, 30 mins, 1, 2, 4, 6, 8, 10 & 12 hrs post dose)
Resonance Frequency (Fres), Hz
Impulse Oscillometry measurement
Measured: Baseline, Pre-dose Day 1 and Day 5 (treatment period 1 & 2 - pre-dose, 30 mins, 1, 2, 4, 6, 8, 10 & 12 hrs post dose)
Reactance Area (AX), kPa/L
Impulse Oscillometry measurement
Measured: Baseline, Pre-dose Day 1 and Day 5 (treatment period 1 & 2 - pre-dose, 30 mins, 1, 2, 4, 6, 8, 10 & 12 hrs post dose)
Total Lung Capacity (TLC), L
Plethysmography measurement
Measured: Baseline, Pre-dose Day 1 and Day 5 (treatment period 1 & 2 - pre-dose, 1, 2, 4, 8 & 12 hrs post dose)
Functional Residual Capacity (FRC), L
Plethysmography measurement
Measured: Baseline, Pre-dose Day 1 and Day 5 (treatment period 1 & 2 - pre-dose, 1, 2, 4, 8 & 12 hrs post dose)
Inspiratory Capacity (IC), L
Plethysmography measurement
Measured: Baseline, Pre-dose Day 1 and Day 5 (treatment period 1 & 2 - pre-dose, 1, 2, 4, 8 & 12 hrs post dose)
Specific Airway Conductance (SGaw), L/s/kPa/L
Plethysmography measurement
Measured: Baseline, Pre-dose Day 1 and Day 5 (treatment period 1 & 2 - pre-dose, 1, 2, 4, 8 & 12 hrs post dose)
Airway Resistance (Raw), kPa/L/s
Plethysmography measurement
Measured: Baseline, Pre-dose Day 1 and Day 5 (treatment period 1 & 2 - pre-dose, 1, 2, 4, 8 & 12 hrs post dose)
Forced Expired Volume in 1 second (FEV1), L.
Spirometry measurement
Measured: Baseline and Day 5 (treatment period 1 & 2 - pre-dose, 30 mins, 1, 2, 4, 6, 8, 10 & 12 hrs post dose)
Residual Volume (RV), L.
Plethysmography measurement
Measured: Baseline and Day 5 (treatment period 1 & 2 - pre-dose, 1, 2, 4, 8 & 12 hrs post dose)

Timeline

From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.

13 Dec 20186 Aug 2019

First posted15 Feb 2019
Study start13 Dec 2018
Primary completion30 Jul 2019
Study completion6 Aug 2019

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 Chronic Obstructive Pulmonary Disease (COPD)Studies 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
Model description: This is a phase IV, open-label, randomised, single centre, 2-way crossover study.
Masking: None (open label)
Enrolment: 23 participants (actual)

IDs, dates and publications

ClinicalTrials.gov ID: NCT03842904
Sponsor's protocol ID: MEU 17/361
Other IDs: 2018-003113-17, 2018
Acronym: TRIFLOW
Status last verified: Jan 2020
First submitted: 11 Feb 2019
Last updated: 27 Jan 2020
Results posted: No
Data monitoring committee: No
FDA-regulated drug: No
FDA-regulated device: No
Individual data sharing: No

Publications

Dean J, Panainte C, Khan N, Singh D. The TRIFLOW study: a randomised, cross-over study evaluating the effects of extrafine beclometasone/formoterol/glycopyrronium on gas trapping in COPD. Respir Res. 2020 Dec 9;21(1):323. doi: 10.1186/s12931-020-01589-5.
PubMed 33298062

Want to know more?

The sponsor has not listed a contact. The official record may have more details.

Talk to your doctor first and take this page with you. Only the study team can confirm whether you can join.

Questions to ask the study team

What is the study trying to find out?
What would I need to do, and how often would I visit?
Could I receive a placebo instead of the treatment?
What are the possible risks and benefits for me?
Will it cost me anything? Are travel or time paid for?
Can I keep seeing my own doctor during the study?
What happens when the study ends?

See locations

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Study at a glance

From the registry record, last updated by the sponsor on 27 Jan 2020. Recruitment status is as the sponsor reported it: confirm with the study team.

Official title: A Randomised, Open Label 2-Way Cross-over Study to Compare the Effects of Inhaled Beclometasone/Formoterol/Glycopyrronium (TRIMBOW) pMDI to Beclometasone/Formoterol (FOSTAIR) pMDI on Hyperinflation and Expiratory Flow Limitation in Moderate to Severe Chronic Obstructive Pulmonary Disease (COPD)
ClinicalTrials.gov ID: NCT03842904
Acronym / sponsor ID: TRIFLOW / MEU 17/361
Conditions: Chronic Obstructive Pulmonary Disease (COPD)
Phase: Phase 4
Study type: Interventional
Recruitment status: Completed
Enrolment: 23 participants (actual)
Lead sponsor: Medicines Evaluation Unit LtdIndustry (pharma, biotech, devices)
Collaborators: Chiesi UK
Study start: 13 Dec 2018 (actual)
Primary completion: 30 Jul 2019 (actual)
Study completion: 6 Aug 2019 (actual)
First posted: 15 Feb 2019 (actual)
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.

Detailed description

Study design

Primary purpose: Treatment
Allocation: Randomised
Intervention model: Crossover
Masking: None (open label)
Number of arms: 2
Model description: This is a phase IV, open-label, randomised, single centre, 2-way crossover study.

Arm	Type	Receives
Trimbow pMDI	Experimental	Drug: Trimbow pMDITrimbow 87 micrograms/5 micrograms/9 micrograms pressurised inhalation solution.
Fostair pMDI	Active comparator	Drug: Fostair pMDIFostair 100/6 micrograms per actuation pressurised inhalation solution.

Who may qualify

Ages: 40 to 75 years
Sex: All
Healthy volunteers: Not accepted
Age groups: Adult, Older adult

Key inclusion criteria (14 listed)

Male and female adults aged 40 to 75 years with written informed consent obtained prior to any study-related procedure.
COPD diagnosis: Subjects with a diagnosis of moderate to severe COPD according to the GOLD 2018 COPD recommendations, with symptoms compatible with COPD for at least 1 year prior to screening.
Clinically stable COPD in the 6 weeks prior to screening and during the run-in period prior to randomisation.
Body mass index (BMI) in the range of 18.0 to 33.0 kg/m2 and with a minimum weight of 50 kg at screening.
Current smokers or ex-smokers with a smoking history of at least 10 pack years [pack-years = (number of cigarettes per day x number of years)/20].

Key exclusion criteria (19 listed)

Inability to comply with study procedures, required restrictions, study treatment intake or any other reason that the Investigator considers makes the patient unsuitable to participate.
COPD exacerbation requiring oral steroids and/or antibiotics, in the 8 weeks prior to screening or prior to randomisation.
Use of antibiotics for a respiratory tract infection in the 8 weeks prior to screening or prior to randomisation.
Inability to perform technically acceptable impulse oscillometry, whole body plethysmography or spirometry at screening, (V1) or baseline (V2).
Pregnant, lactating or breastfeeding women at screening, baseline or prior to randomisation. Positive urine pregnancy test at screening, baseline or prior to randomisation.

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
Trimbow pMDIClinical Trial of an Investigational Medicinal Product (CTIMP)	Drug	Trimbow pMDI
Fostair pMDIClinical Trial of an Investigational Medicinal Product (CTIMP)	Drug	Fostair pMDI

Primary outcome

Forced Expired Volume in 1 second (FEV1), L.
Time frame: Pre-dose Day 1 and Day 5 (treatment period 1 & 2 - pre-dose, 30 minutes, 1, 2, 4, 6, 8, 10 and 12 hours post dose)
To compare the effect of Trimbow and Fostair on FEV1 [(forced expiratory volume in 1 sec - changes from pre-dose day 1)].
Residual Volume (RV), L.
Time frame: Pre-dose Day 1 and Day 5 (treatment period 1 & 2 - pre-dose, 1, 2, 4, 8 and 12 hours post dose)
To compare the effect of Trimbow and Fostair on RV [(residual volume) - changes from pre-dose day 1)].

15 secondary outcomes

Peripheral Respiratory Resistance (R5-R20), kPa/L/s.
Time frame: Pre-dose Day 1 and Day 5 (treatment period 1 & 2 - pre-dose, 30 mins, 1, 2, 4, 6, 8, 10 & 12 hrs post dose)
Expiratory Flow Limitation (Delta X5), kPa/L/s.
Time frame: Pre-dose Day 1 and Day 5 (treatment period 1 & 2 - pre-dose, 30 mins, 1, 2, 4, 6, 8, 10 & 12 hrs post dose)
Forced Vital Capacity (FVC), L
Time frame: Baseline, Pre-dose Day 1 and Day 5 (treatment period 1 & 2 - pre-dose, 30 mins, 1, 2, 4, 6, 8, 10 & 12 hrs post dose)
Forced Expiratory Flow between 25-75% of FVC (FEF25-75%), L/s
Time frame: Baseline, Pre-dose Day 1 and Day 5 (treatment period 1 & 2 - pre-dose, 30 mins, 1, 2, 4, 6, 8, 10 & 12 hrs post dose)
Resistance at 5Hz (R5), kPa/L/s
Time frame: Baseline, Pre-dose Day 1 and Day 5 (treatment period 1 & 2 - pre-dose, 30 mins, 1, 2, 4, 6, 8, 10 & 12 hrs post dose)
Reactance at 5Hz (X5), kPa/L/s
Time frame: Baseline, Pre-dose Day 1 and Day 5 (treatment period 1 & 2 - pre-dose, 30 mins, 1, 2, 4, 6, 8, 10 & 12 hrs post dose)
Resonance Frequency (Fres), Hz
Time frame: Baseline, Pre-dose Day 1 and Day 5 (treatment period 1 & 2 - pre-dose, 30 mins, 1, 2, 4, 6, 8, 10 & 12 hrs post dose)
Reactance Area (AX), kPa/L
Time frame: Baseline, Pre-dose Day 1 and Day 5 (treatment period 1 & 2 - pre-dose, 30 mins, 1, 2, 4, 6, 8, 10 & 12 hrs post dose)
Total Lung Capacity (TLC), L
Time frame: Baseline, Pre-dose Day 1 and Day 5 (treatment period 1 & 2 - pre-dose, 1, 2, 4, 8 & 12 hrs post dose)
Functional Residual Capacity (FRC), L
Time frame: Baseline, Pre-dose Day 1 and Day 5 (treatment period 1 & 2 - pre-dose, 1, 2, 4, 8 & 12 hrs post dose)
Inspiratory Capacity (IC), L
Time frame: Baseline, Pre-dose Day 1 and Day 5 (treatment period 1 & 2 - pre-dose, 1, 2, 4, 8 & 12 hrs post dose)
Specific Airway Conductance (SGaw), L/s/kPa/L
Time frame: Baseline, Pre-dose Day 1 and Day 5 (treatment period 1 & 2 - pre-dose, 1, 2, 4, 8 & 12 hrs post dose)
Airway Resistance (Raw), kPa/L/s
Time frame: Baseline, Pre-dose Day 1 and Day 5 (treatment period 1 & 2 - pre-dose, 1, 2, 4, 8 & 12 hrs post dose)
Forced Expired Volume in 1 second (FEV1), L.
Time frame: Baseline and Day 5 (treatment period 1 & 2 - pre-dose, 30 mins, 1, 2, 4, 6, 8, 10 & 12 hrs post dose)
Residual Volume (RV), L.
Time frame: Baseline and Day 5 (treatment period 1 & 2 - pre-dose, 1, 2, 4, 8 & 12 hrs post 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 Jan 2020.
Derived from this study: PubMed 33298062Dean J, Panainte C, Khan N, Singh D. The TRIFLOW study: a randomised, cross-over study evaluating the effects of extrafine beclometasone/formoterol/glycopyrronium on gas trapping in COPD. Respir Res. 2020 Dec 9;21(1):323. doi: 10.1186/s12931-020-01589-5.
Research facility websiteLink provided by the sponsor.
Individual participant dataSharing planned: No

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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.

David Rogers study director

Medicines Evaluation Unit Ltd

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 Trimbow pMDI and Fostair pMDI in people with Chronic Obstructive Pulmonary Disease (COPD), run by Medicines Evaluation Unit Ltd 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 14 inclusion and 19 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 Jan 2020. 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?

Forced Expired Volume in 1 second (FEV1), L. (time frame: Pre-dose Day 1 and Day 5 (treatment period 1 & 2 - pre-dose, 30 minutes, 1, 2, 4, 6, 8, 10 and 12 hours post dose)). 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?

On the ClinicalTrials.gov record for NCT03842904, 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 27 Jan 2020.