COPDPhase 2NCT03443414
Dose Ranging Study of RPL554 in Chronic Obstructive Pulmonary Disease (COPD) Patients
A Phase 2 study testing RPL554 suspension in people with COPD, run by Verona Pharma, Inc., a subsidiary of Merck & Co., Inc. (Rahway, New Jersey USA at 49 sites in 6 countries.
Trial summary
The study investigates the effect of 4 weeks of twice daily treatment of four different doses of RPL554 (a phosphodiesterase [PDE]3/4 inhibitor) or placebo in patients with moderate to severe chronic obstructive pulmonary disease (COPD). Patients will be equally allocated to one of the five treatment options. Read more about this study
- Who is it for?
- Ages 40 to 75 years
- Conditions the study is for
- COPD
- What is being tested?
- RPL554 suspension
- Could I receive a placebo?
- Yes, some participants may receive a placebo
- How many people
- 405 participants
- Where
- 49 sitesin 6 countries
- Study dates
- 1 Jun 2017to 7 Feb 2018
- Phase
- Phase 2
- Are there results?
- Yes, posted in the registrySummary in the doctors' view
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
- Provide informed consent
- Male or female aged 40 to 75 years
- Meeting specified contraception requirements
- 12-lead electrocardiogram with heart rate 50-90 beats per minute, QT interval corrected using Fridericia's formula (QTcF) ≤450 msec (males) or ≤470 msec (females), QRS interval ≤120 msec, PR interval ≤200 msec and no clinically significant abnormalities
- Capable of complying with all study restrictions and procedures, including ability to use the study nebulizer correctly.
- Body mass index (BMI) 18 to 35 kg/m2 and minimum weight 45 kg.
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- COPD diagnosis with symptoms compatible with COPD for at least 1 year
- Clinically stable COPD in the previous 4 weeks
- Ability to perform acceptable and reproducible spirometry.
- Post-bronchodilator spirometry at screening must demonstrate FEV1/forced vital capacity (FVC) ratio of ≤0.70 and FEV1 must be ≥40 % to ≤80% of predicted normal
- Chest X-ray (posterior-anterior) at screening, or chest X-ray, magnetic resonance imaging (MRI) or computed tomography (CT) scan in the last 12 months, showing no abnormalities which are both clinically significant and unrelated to COPD.
- Meet the concomitant medication restrictions and be expected to do so for the rest of the study.
- Current and former smokers with a smoking history of ≥10 pack years.
- Capable of withdrawing long acting bronchodilators until the end of the treatment period, and short acting bronchodilators for 8 hours prior to administration of study medication.
Who cannot join
- A history of life-threatening COPD including Intensive Care Unit admission and requiring intubation.
- COPD exacerbation requiring oral steroids in the previous 3 months
- A history of one or more hospitalizations for COPD in the previous 6 months
- Lower respiratory tract infection treated with antibiotics in the previous 3 months
- Evidence of cor pulmonale or clinically significant pulmonary hypertension.
- Patients with a current diagnosis of asthma, active tuberculosis, lung cancer, bronchiectasis, sarcoidosis, lung fibrosis, interstitial lung diseases, sleep apnea, known alpha-1 antitrypsin deficiency or other active pulmonary diseases.
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- Previous lung resection or lung reduction surgery.
- Oral therapies for COPD (e.g. oral steroids, theophylline, and roflumilast) in the previous 3 months and throughout the study.
- Pulmonary rehabilitation, unless such treatment has been stable from 4 weeks prior to Visit 1) and remains stable during the trial.
- A history of, or reason to believe a subject has, drug or alcohol abuse in the previous 3 years.
- Received an experimental drug within 30 days or five half-lives of the first dose
- Prior exposure to RPL554.
- Women who are pregnant or breast-feeding.
- Patients with a history of current uncontrolled disease that the Investigator believes are clinically significant.
- myocardial infarction in the previous 6 month; congestive heart failure, a history of unstable or uncontrolled hypertension, or has been diagnosed with hypertension in last 3 months.
- Use of oral beta blockers.
- Major surgery (requiring general anesthesia) in the previous 6 weeks, lack of full recovery from surgery at screening, or planned surgery through the end of the study.
- History of malignancy of any organ system within 5 years, with the exception of localized skin cancers (basal or squamous cell).
- Clinically significant abnormal values for safety laboratory tests
- Significant non-compliance in previous investigational studies or with prescribed medications.
- Requirement for oxygen therapy, even on an occasional basis.
- Known hypersensitivity to RPL554 or its excipients/components.
- Abnormal clinically significant 12 lead Holter findings,
- Any other reason that the Investigator considers makes the subject unsuitable to participate.
Trial locations and contacts
49 sites in 6 countries.
49 sites in 6 countries
Germany17 sites
Aerzte fuer Lungen- und
Berlin
Charite Campus Mitte
Berlin
emovis GmbH
Berlin
Studienpraxis Berlin
Berlin
IKF Pneumologie GmbH & Co. KG
Frankfurt
Praxis Dr. Keller
Frankfurt
Inamed GmbH
Gauting
PRI Pulmonary Research
Großhansdorf
Hamburger Institut fuer
Hamburg
Gemeinschaftspraxis Dres
Koblenz
POIS Leipzig GbR
Leipzig
SALVUS UG Centre for Clinial Trials
Leipzig
KLB Gesundheitsforschung
Lübeck
Pneumologische Praxis Pasing
München
Pneumologie Odeonsplatz
Munich
Ballenberger Freytag Wenisch
Neu-Isenburg
Dr. Christian Schlenska
Peine
Poland14 sites
CERMED
Bialystok
Indywidualna Specjalistyczna
Bialystok
KLIMED Marek Klimkiewicz
Bychawa
Silmedic sp. z o.o.
Katowice
Grazyna Pulka Specjalistyczny
Krakow
Malopolskie Centrum Alergologii
Krakow
Centrum Terapii Wspólczesnej
Lodz
Uniwersytecki Szpital Klin
Lodz
NZOZ Alergo-MEDSpecjalistyczna
Poznan
ETG Network Sp z o o
Skierniewice
Centrum Medyczne Pratia
Warsaw
Mazowieckie Centrum Medyczne
Warsaw
Centrum Badan Klinicznych
Wroclaw
Specjalistyczna Opieka
Wroclaw
Bulgaria8 sites
Clinic for pneumonology
Pleven
SHATPPD-Ruse EOOD
Rousse
Fifth MHAT - Sofia EAD
Sofia
MHAT 'Lyulin', EAD
Sofia
NMTH Tsar Boris III
Sofia
UMHAT 'Alexandrovska' EAD
Sofia
UMHAT 'Sveta Anna' AD
Sofia
Medical Center Nov
Stara Zagora
Romania7 sites
S.C Angisan S.R.L
Bragadiru
S.C Clinica Pneumomedica S.R.L
Brasov
Fundatia Dr. Victor Babes
Bucharest
Spitalul Clinic de Urgenta
Bucharest
Spitalul Cl. Pneumoftiziologie
Cluj-Napoca
Spitalul CldePneumoftiziologie
Constanța
Spitalul CldePneumoftiziologie
Iași
Czechia2 sites
MediTrial s.r.o.
Jindřichův Hradec
Plicni stredisko Teplice
Teplice
About this study
Official title: Phase IIb, Randomized, Double Blind, Placebo Controlled, Dose Ranging Study to Assess the Effect of RPL554 in Patients With Moderate to Severe COPD.
The study investigates the effect of 4 weeks of twice daily treatment of four different doses of RPL554 (a phosphodiesterase [PDE]3/4 inhibitor) or placebo in patients with moderate to severe chronic obstructive pulmonary disease (COPD). Patients will be equally allocated to one of the five treatment options.
Read the detailed description
RPL554 is a dual inhibitor of PDE3 and PDE4 which are known to have a role in modulating the inflammatory airway response in respiratory diseases, including COPD. PDE3 inhibitors act as bronchodilators whilst PDE4 inhibitors have anti-inflammatory properties and there is also evidence to suggest that combined inhibition of PDE3 and PDE4 can have additive or synergistic anti-inflammatory and bronchodilator effects. PDE4 inhibitors (administered orally) have, however been associated with unfavorable gastrointestinal side effects such as nausea, emesis, diarrhea, abdominal pain, loss of appetite and weight loss. Dual PDE3/PDE4 inhibitors (administered by inhalation) have exhibited both bronchodilator and anti-inflammatory actions, with a more favorable side effect profile. It is plausible that increased efficacy with reduced side effects may be achievable with administration of a dual PDE3/4 inhibitor by the inhaled route compared to orally administered PDE3 or PDE4 inhibitors.
The purpose of this study is to investigate the dose response of RPL554 in patients with COPD over 4 weeks. This length of time should allow for study of the bronchodilator response, measured predominantly by the peak forced expiratory volume in one second (FEV1), and the anti-inflammatory response, as measured predominantly by trough FEV1.
- Conditions
- COPD
- Being tested
- RPL554 suspension, Placebo
- Keywords
- COPD, bronchodilation, FEV1
- 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.
RPL554 suspensionDrug
A dual PDE3/PDE 4 inhibitor
PlaceboDrug
Placebo solution
| Study group | Role | What they receive |
|---|---|---|
| 0.75 mg RPL554 | Experimental | Not described Receives: Drug: RPL554 suspension |
| 1.5 mg RPL554 | Experimental | Not described Receives: Drug: RPL554 suspension |
| 3 mg RPL554 | Experimental | Not described Receives: Drug: RPL554 suspension |
| 6 mg RPL554 | Experimental | Not described Receives: Drug: RPL554 suspension |
| Placebo | Placebo comparator | Not described Receives: Drug: Placebo |
What is being measured
The primary outcome is the main question the study is designed to answer.
Mean Change From Baseline in Peak FEV1 (Over 3 Hours) at Week 4
Spirometry assessments were used to assess pulmonary function including the forced expiratory volume in 1 second (FEV1). Peak FEV1 at Week 4 was defined as the maximum post-dose value among the 30 minutes, 1, 2 and 3 hour assessments collected at Visit 6. Baseline was defined as the FEV1 pre-dose assessment (-15 minutes) collected at Visit 2. A mixed model for repeated measures (MMRM) was used to model the change from baseline FEV1 using baseline FEV1 as a continuous fixed effect, randomized treatment, week and treatment-by-week as categorical fixed effect, and patient as random effect.
The least squares (LS) mean change from baseline FEV1 to peak FEV1 (as measured over 3 hours) at Week 4 is presented.
Measured: Baseline (pre-dose, Visit 2) and Week 4 (Visit 6).
Secondary outcomes (5)
Mean Change From Baseline FEV1 to Morning Trough FEV1 at Week 4
Morning trough FEV1 was defined as the last pre-dose value at Visit 6. Baseline was defined as the FEV1 pre-dose assessment (-15 minutes) collected at Visit 2. MMRM was used to model the change from baseline FEV1 using baseline FEV1 as a continuous fixed effect, randomized treatment, week and treatment-by-week as categorical fixed effect, and patient as random effect.
The LS mean change from baseline FEV1 to morning trough FEV1 at Week 4 is presented.
Measured: Baseline (pre-dose, Visit 2) and Week 4 (Visit 6).
Mean Change From Baseline FEV1 to Average FEV1 (Over 12 Hours) at Day 1 and Week 4
Average FEV1 over 12 hours was defined as the area under the curve from 0 to 12 hours post-dose (AUC[0-12]) of the FEV1 values collected during the visit under analysis (Day 1 or Week 4), divided by the length of the time interval of interest (in hours). The AUC was calculated using the trapezoidal rule. Baseline was defined as the FEV1 pre-dose assessment (-15 minutes) collected at Visit 2. MMRM was used to model the change from baseline FEV1 using baseline FEV1 as a continuous fixed effect, randomized treatment, week and treatment-by-week as categorical fixed effect, and patient as random effect.
The LS mean change from baseline FEV1 to average FEV1 over 12 hours at Day 1 and at Week 4 is presented.
Measured: Baseline (pre-dose, Visit 2), up to 12 hours post-dose at Visit 2 (Day 1) and Visit 6 (Week 4).
Mean Change From Baseline in COPD Symptoms Using the Exacerbations of Chronic Pulmonary Disease Tool Patient-Reported Outcome (EXACT-PRO) Scoring at Week 4
Patients completed an electronic diary (e-diary) once daily which used the 14-item EXACT-PRO instrument to assess COPD symptoms. The EXACT-PRO instrument contains 11 respiratory symptom questions that comprise the derivative Evaluating Respiratory Symptoms (E-RS) instrument that was used to measure the effect of treatment with RPL554 on the severity of COPD symptoms overall. The E-RS tool contains 3 subscales to assess breathlessness, cough/sputum and chest symptoms. In addition to the subscale scores, a total score for the E-RS part was obtained. The raw totals for the E-RS score and for each of the subscales were converted to a scale range of 0 to 100 (least symptomatic to most symptomatic). MMRM was used to model the change from baseline using baseline as a continuous fixed effect, randomized treatment, week and treatment-by-week as categorical fixed effect, and patient as random effect. Baseline was the last non-missing assessment taken prior to investigational product start date.
Measured: Baseline (pre-dose, Visit 2) and Week 4 (Visit 6).
Mean Change From Baseline in Breathlessness as Assessed Using the St George's Respiratory Questionnaire (SGRQ) at Week 4
Patients completed the COPD specific SGRQ (SGRQ-C) consisting of 14 items each weighted from 0 to a possible maximum of 100. Items 1-7 produced the symptoms score, 9-12 the activity score, and items 8, 10, 11, 13 and 14 the impacts score. Each component sub-score was calculated as a percentage of the summed weights of each item out of the sum of the maximum possible weight for that component (range 0-100). The total score was calculated by summing the weights to all positive responses in each component, where a positive item indicated the presence of symptoms, expressed as a percentage (range 0-100). Higher scores indicate a worse outcome. Baseline assessment was pre-dose at Visit 2. MMRM was used to model the change from baseline using baseline as a continuous fixed effect, randomized treatment, week and treatment-by-week as categorical fixed effect, patient as random effect. The LS mean change from baseline in the total, symptoms, activity and impact SGRQ-C scores are presented.
Measured: Baseline (pre-dose, Visit 2) and Week 4 (Visit 6).
Number of Patients With Treatment Emergent Adverse Events (TEAEs)
The number of patients with TEAEs for each the following categories are presented: any TEAE, any drug-related TEAE, any severe TEAE, any serious TEAE, serious drug-related TEAE, any TEAE leading to drug interruption, any TEAE leading to drug discontinuation, and any TEAE leading to death.
All AEs which started after the first dose of investigational product.or started prior to first dose and worsened, based on the Investigator assessment of severity, on or after first dose were considered to be treatment-emergent.
Measured: Up to end of study (approximately 6 weeks)
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted23 Feb 2018
- Study start1 Jun 2017
- Primary completion23 Jan 2018
- Study completion7 Feb 2018
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Posted resultsParticipant flow, outcome measures and adverse events reported by the sponsor.
- Other trials for COPDStudies 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 2
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Double blind
- Who is masked
- Investigator, Outcomes assessor
- Enrolment
- 405 participants (actual)
Sponsor and investigators
- Lead sponsor
- Verona Pharma, Inc., a subsidiary of Merck & Co., Inc. (Rahway, New Jersey USA
- Sponsor type
- Industry (pharma, biotech, devices)
- Responsible party
- Sponsor
- Investigators
- Dr Singh, Principal investigator, Medicines Evaluation Unit (MEU)
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT03443414
- Sponsor's protocol ID
- RPL554-CO-203
- Status last verified
- Jun 2019
- First submitted
- 7 Feb 2018
- Last updated
- 4 Jun 2019
- Results posted
- Yes, on ClinicalTrials.gov
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Study at a glance
From the registry record, last updated by the sponsor on 4 Jun 2019. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Phase IIb, Randomized, Double Blind, Placebo Controlled, Dose Ranging Study to Assess the Effect of RPL554 in Patients With Moderate to Severe COPD.
- ClinicalTrials.gov ID
- NCT03443414
- Acronym / sponsor ID
- RPL554-CO-203
- Conditions
- COPD
- Keywords
- COPD, bronchodilation, FEV1
- Phase
- Phase 2
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 405 participants (actual)
- Lead sponsor
- Verona Pharma, Inc., a subsidiary of Merck & Co., Inc. (Rahway, New Jersey USAIndustry (pharma, biotech, devices)
- Study start
- 1 Jun 2017 (actual)
- Primary completion
- 23 Jan 2018 (actual)
- Study completion
- 7 Feb 2018 (actual)
- First posted
- 23 Feb 2018 (actual)
- Results
- Posted 4 Jun 2019
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
The study investigates the effect of 4 weeks of twice daily treatment of four different doses of RPL554 (a phosphodiesterase [PDE]3/4 inhibitor) or placebo in patients with moderate to severe chronic obstructive pulmonary disease (COPD). Patients will be equally allocated to one of the five treatment options.
Detailed description
RPL554 is a dual inhibitor of PDE3 and PDE4 which are known to have a role in modulating the inflammatory airway response in respiratory diseases, including COPD. PDE3 inhibitors act as bronchodilators whilst PDE4 inhibitors have anti-inflammatory properties and there is also evidence to suggest that combined inhibition of PDE3 and PDE4 can have additive or synergistic anti-inflammatory and bronchodilator effects. PDE4 inhibitors (administered orally) have, however been associated with unfavorable gastrointestinal side effects such as nausea, emesis, diarrhea, abdominal pain, loss of appetite and weight loss. Dual PDE3/PDE4 inhibitors (administered by inhalation) have exhibited both bronchodilator and anti-inflammatory actions, with a more favorable side effect profile. It is plausible that increased efficacy with reduced side effects may be achievable with administration of a dual PDE3/4 inhibitor by the inhaled route compared to orally administered PDE3 or PDE4 inhibitors.
The purpose of this study is to investigate the dose response of RPL554 in patients with COPD over 4 weeks. This length of time should allow for study of the bronchodilator response, measured predominantly by the peak forced expiratory volume in one second (FEV1), and the anti-inflammatory response, as measured predominantly by trough FEV1.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Double blind (investigator, outcomes assessor)
- Number of arms
- 5
| Arm | Type | Receives |
|---|---|---|
| 0.75 mg RPL554 | Experimental | Drug: RPL554 suspension |
| 1.5 mg RPL554 | Experimental | Drug: RPL554 suspension |
| 3 mg RPL554 | Experimental | Drug: RPL554 suspension |
| 6 mg RPL554 | Experimental | Drug: RPL554 suspension |
| Placebo | Placebo comparator | Drug: Placebo |
Who may qualify
- Ages
- 40 to 75 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (14 listed)
- Provide informed consent
- Male or female aged 40 to 75 years
- Meeting specified contraception requirements
- 12-lead electrocardiogram with heart rate 50-90 beats per minute, QT interval corrected using Fridericia's formula (QTcF) ≤450 msec (males) or ≤470 msec (females), QRS interval ≤120 msec, PR interval ≤200 msec and no clinically significant abnormalities
- Capable of complying with all study restrictions and procedures, including ability to use the study nebulizer correctly.
Key exclusion criteria (24 listed)
- A history of life-threatening COPD including Intensive Care Unit admission and requiring intubation.
- COPD exacerbation requiring oral steroids in the previous 3 months
- A history of one or more hospitalizations for COPD in the previous 6 months
- Lower respiratory tract infection treated with antibiotics in the previous 3 months
- Evidence of cor pulmonale or clinically significant pulmonary hypertension.
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 |
|---|---|---|
| RPL554 suspensionA dual PDE3/PDE 4 inhibitor | Drug | 0.75 mg RPL554, 1.5 mg RPL554, 3 mg RPL554, 6 mg RPL554 |
| PlaceboPlacebo solution | Drug | Placebo |
Primary outcome
Mean Change From Baseline in Peak FEV1 (Over 3 Hours) at Week 4
Time frame: Baseline (pre-dose, Visit 2) and Week 4 (Visit 6).
Spirometry assessments were used to assess pulmonary function including the forced expiratory volume in 1 second (FEV1). Peak FEV1 at Week 4 was defined as the maximum post-dose value among the 30 minutes, 1, 2 and 3 hour assessments collected at Visit 6. Baseline was defined as the FEV1 pre-dose assessment (-15 minutes) collected at Visit 2. A mixed model for repeated measures (MMRM) was used to model the change from baseline FEV1 using baseline FEV1 as a continuous fixed effect, randomized treatment, week and treatment-by-week as categorical fixed effect, and patient as random effect. The least squares (LS) mean change from baseline FEV1 to peak FEV1 (as measured over 3 hours) at Week 4 is presented.
5 secondary outcomes
Mean Change From Baseline FEV1 to Morning Trough FEV1 at Week 4
Time frame: Baseline (pre-dose, Visit 2) and Week 4 (Visit 6).
Mean Change From Baseline FEV1 to Average FEV1 (Over 12 Hours) at Day 1 and Week 4
Time frame: Baseline (pre-dose, Visit 2), up to 12 hours post-dose at Visit 2 (Day 1) and Visit 6 (Week 4).
Mean Change From Baseline in COPD Symptoms Using the Exacerbations of Chronic Pulmonary Disease Tool Patient-Reported Outcome (EXACT-PRO) Scoring at Week 4
Time frame: Baseline (pre-dose, Visit 2) and Week 4 (Visit 6).
Mean Change From Baseline in Breathlessness as Assessed Using the St George's Respiratory Questionnaire (SGRQ) at Week 4
Time frame: Baseline (pre-dose, Visit 2) and Week 4 (Visit 6).
Number of Patients With Treatment Emergent Adverse Events (TEAEs)
Time frame: Up to end of study (approximately 6 weeks)
Results and safety
Loading the posted results from ClinicalTrials.gov…
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 4 Jun 2019.
- Posted resultsParticipant flow, baseline, all outcome measures and adverse events.
- 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.
Dr Singh principal investigator
Medicines Evaluation Unit (MEU)
49 sites in 6 countries: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 2 study testing RPL554 suspension in people with COPD, run by Verona Pharma, Inc., a subsidiary of Merck & Co., Inc. (Rahway, New Jersey USA at 49 sites in 6 countries.
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 24 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 4 Jun 2019. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 49 sites in Germany, Poland, Bulgaria, Romania, Czechia and 1 more country. 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 2 studies give the treatment to a larger group to see whether it has the intended effect and to keep checking safety.
Not every study follows the same path, and some studies (observational studies, device studies) have no phase.
Are results available for this study?
Yes. Results are posted in the registry (first posted 4 Jun 2019). A summary is in the For doctors view, and the full results are on ClinicalTrials.gov.
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?
Mean Change From Baseline in Peak FEV1 (Over 3 Hours) at Week 4 (time frame: Baseline (pre-dose, Visit 2) and Week 4 (Visit 6).). 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 4 Jun 2019.