Chronic Obstructive Pulmonary DiseasePhase 2NCT02951312
Assessment of the Safety and Ability of a Once-a-day Dose of an Orally Inhaled Medicine [ie, Glycopyrrolate Inhalation Solution = GIS] to Improve Airflow in the Lungs When Delivered With an Electronic eFlow Nebulizer System in Patients With Chronic Obstructive Pulmonary Disease (COPD)
A Phase 2 study testing Glycopyrrolate Inhalation Solution 25mg, Glycopyrrolate Inhalation Solution 75mg and Glycopyrrolate Inhalation Solution 200mg in people with Chronic Obstructive Pulmonary Disease, run by Sunovion Respiratory Development Inc..
Trial summary
The study assessed the safety and ability of several doses of an orally inhaled medicine [ie, Glycopyrrolate Inhalation Solution = GIS] to improve airflow in the lungs when delivered with an electronic eFlow nebulizer system in patients with 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
- What is being tested?
- Glycopyrrolate Inhalation Solution 25mg, Glycopyrrolate Inhalation Solution 75mg and Glycopyrrolate Inhalation Solution 200mg
- Type of treatment
- Pill or oral medicine
- Could I receive a placebo?
- Yes, some participants may receive a placebo
- How many people
- 12 participants
- Where
- No sites listed yet
- Study dates
- May 2009to Jul 2009
- 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
- Male and female patients aged 40 through 75 years, inclusive
- A clinical diagnosis of COPD according to the GOLD guidelines
- Current smokers or ex-smokers with at least 10 pack-year smoking history (e.g., at least 1 pack/day for 10 years, or 10 packs/day for 1 year)
- Post-bronchodilator FEV1 40-80% of predicted normal
- Post-bronchodilator FEV1/FVC ratio < 0.70
- Improvement in FEV1 >12% (minimum 150 mL) following inhalation of ipratropium bromide
Show all 17Show fewer
- Ability to perform reproducible spirometry according to the ATS/ERS guidelines
- If female and of childbearing potential, must have had a negative pregnancy test and was not lactating at the Screening Visit, and was using one of the following acceptable means of birth control throughout the study:
- Post-menopausal for at least two years
- Surgically sterile
- Oral contraceptives (taken for at least one month prior to the Screening Visit)
- Approved implantable or injectable contraceptives (e.g., Norplant®, Depo-Provera® or equivalent)
- Barrier methods (e.g., condoms with spermicide)
- Intrauterine device (i.e., IUD)
- Vasectomy of male partner
- Non-heterosexual life style
- Willing and able to provide written informed consent
Who cannot join
- Current evidence or recent history of any clinically significant disease (other than COPD) or abnormality in the opinion of the Investigator that would put the patients at risk or which would compromise the quality of the study data; including but not limited to cardiovascular disease, myocardial infraction, hypertension, arrhythmia, diabetes, neurological or neuromuscular disease, liver disease, gastrointestinal disease or electrolyte abnormalities.
- Recent history of an exacerbation of airway disease within 3 months or need for increased treatments for COPD within 6 weeks prior to the Screening Visit.
- Regular use of daily oxygen therapy.
- Use of systemic (e.g., intramuscular or intravenous) steroids within 3 months prior to the Screening Visit
- Respiratory tract infection within 6 weeks prior to the Screening Visit
- History of tuberculosis, bronchiectasis or other non-specific pulmonary disease
Show all 12Show fewer
- History of urinary retention or bladder neck obstruction type symptoms
- History of narrow-angle glaucoma
- Current or recent history (previous 12 months) of excessive use or abuse of alcohol
- Current evidence or history of abusing legal drugs or the use of illegal drugs or substances
- History of hypersensitivity or intolerance to aerosol medications
- Participation in another investigational drug study where drug was received within 30 days prior to the Screening Visit
About this study
Official title: Single-dose, Dose Escalation Study to Assess the Safety, Tolerability, Pharmacokinetics and Bronchodilatory Effects of Glycopyrrolate Inhalation Solution (GIS) Using a High Efficiency Nebulizer in Patients With COPD
The study assessed the safety and ability of several doses of an orally inhaled medicine [ie, Glycopyrrolate Inhalation Solution = GIS] to improve airflow in the lungs when delivered with an electronic eFlow nebulizer system in patients with Chronic Obstructive Pulmonary Disease (COPD). The study was conducted in 12 patients in 2 parts. Part 1 was designed to find the once-a- day GIS dose that produced the highest improvement in lung airflow. Part 2 tested the GIS dose with the highest improvement in lung airflow and a placebo (ie, no drug) delivered by a general purpose nebulizer. The airflow improvements of the same GIS dose were compared between the two nebulizer systems to determine what effect the device had on GIS delivery.
Read the detailed description
In Part I, 12 subjects were randomly allocated to one of 2 cohorts, running in parallel. The 6 cohort 1 subjects received 25 mg and then 200 mg during their treatment periods 1 and 2, respectively. The 6 cohort 2 subjects received 75mg, 500mg, and 1000 mg during their treatment periods 1, 2, and 3, respectively. During Part II of the study, the same 12 subjects from Part I were randomized to receive either 200 mg jet or placebo in a 1:1 ratio.
- Conditions
- Chronic Obstructive Pulmonary Disease
- Being tested
- Glycopyrrolate Inhalation Solution 25mg, Glycopyrrolate Inhalation Solution 75mg, Glycopyrrolate Inhalation Solution 200mg, Glycopyrrolate Inhalation Solution 200mg Jet, Glycopyrrolate Inhalation Solution 500mg
- Keywords
- Emphysema, Chronic bronchitis, COPD, Chronic Obstructive Pulmonary Disease
- Medical subject headings
- Pulmonary Disease, Chronic Obstructive, Emphysema, Bronchitis, Chronic
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Glycopyrrolate Inhalation Solution 25mgDrug
Also called GIS
25 μg oral inhalation via eFlow Nebulizer, once daily
Glycopyrrolate Inhalation Solution 75mgDrug
Also called GIS
75 μg oral inhalation via eFlow Nebulizer, once daily
Glycopyrrolate Inhalation Solution 200mgDrug
Also called GIS
200 μg oral inhalation via eFlow Nebulizer, once daily
Glycopyrrolate Inhalation Solution 200mg JetDrug
Also called GIS
200 μg oral inhalation via inhalation via jet nebulizer, once daily
Glycopyrrolate Inhalation Solution 500mgDrug
Also called GIS
500 μg oral inhalation via eFlow nebulizer, once daily
Glycopyrrolate Inhalation Solution1000mgDrug
Also called GIS
1000 μg oral inhalation via eFlow nebulizer, once daily
PlaceboDrug
Placebo 0.5 mL oral inhalation via jet nebulizer, once daily
| Study group | Role | What they receive |
|---|---|---|
| Glycopyrrolate Inhalation Solution 25mg | Experimental | Glycopyrrolate Inhalation Solution 25 μg via eFlow nebulizer, once daily Receives: Drug: Glycopyrrolate Inhalation Solution 25mg |
| Glycopyrrolate Inhalation Solution 75mg | Experimental | Glycopyrrolate Inhalation Solution 75 μg via eFlow nebulizer, once daily Receives: Drug: Glycopyrrolate Inhalation Solution 75mg |
| Glycopyrrolate Inhalation Solution 200mg | Experimental | Glycopyrrolate Inhalation Solution 200 μg via eFlow nebulizer, once daily Receives: Drug: Glycopyrrolate Inhalation Solution 200mg |
| Glycopyrrolate Inhalation Solution 200mg Jet | Experimental | Glycopyrrolate Inhalation Solution 200 μg via jet nebulizer, once daily Receives: Drug: Glycopyrrolate Inhalation Solution 200mg Jet |
| Glycopyrrolate Inhalation Solution 500mg | Experimental | Glycopyrrolate Inhalation Solution 500 μg via eFlow nebulizer, once daily Receives: Drug: Glycopyrrolate Inhalation Solution 500mg |
| Glycopyrrolate Inhalation Solution1000mg | Experimental | Glycopyrrolate Inhalation Solution 1000 μg via eFlow nebulizer, once daily Receives: Drug: Glycopyrrolate Inhalation Solution1000mg |
| Placebo 0.5 mL | Placebo comparator | Placebo 0.5 mL via jet nebulizer, once daily Receives: Drug: Placebo |
What is being measured
The primary outcome is the main question the study is designed to answer.
Number of Subjects Who Died
Measured: 0-47 days
Number of Subjects With Treatment Emergent SAEs
AEs are defined as existing conditions which worsen or events which occur during the course of the clinical trial after treatment.AEs are defined as existing conditions which worsen or events which occur during the course of the clinical trial after treatment. SAEs are AEs that result in the following outcomes: death, are life-threatening, persistent or significant disability/incapacity, congenital anomaly/birth defect, or important medical events that may have been considered a SAE when, based upon appropriate medical judgment, they may have jeopardized the subject and may have required medical or surgical intervention to prevent one of the outcomes listed in the definition.
Measured: 0-47 days
Number of Subjects Who Discontinued Due to AE
AEs are defined as existing conditions which worsen or events which occur during the course of the clinical trial after treatment.
Measured: 0-47 days
Percentage of Subjects With Treatment Emergent AEs
AEs are defined as existing conditions which worsen or events which occur during the course of the clinical trial after treatment.
Measured: 0-47 days
Number of Subjects With Clinically Significant Abnormal Vital Signs Reported During the Study
Vital signs were measured at screening, during the study (pre-dose, and 30 and 60 minutes and 2, 4, 8, 12, 24 and 30 hours post-dose) and at post study assessment. The clinical significance of each out of normal range vital sign parameter was determined by the investigator during the study.
Measured: 30 hrs post dose
Number of Subjects With Clinically Significant Abnormal Laboratory Results Reported During the Study
Clinical safety lab parameters were collected at screening and at the post study follow-up assessment. The clinical significance of each out of normal range laboratory parameter was determined by the investigator during the study.
Measured: day 47 (post studyfollow-up assessment)
Number of Subjects With Clinically Significant ECG Parameters Reported During the Study
ECGs were measured at screening, during the study (pre-dose, and 30 and 60 minutes and 2, 4, 8, 12, 24 and 30 hours post-dose) and at post study follow-up assessment.
Measured: 30hr post dose
Number of Subjects With Clinically Significant Abnormal Laboratory Results Reported During the Study
Clinical safety lab parameters were collected at screening and at the post study follow-up assessment. The clinical significance of each out of normal range laboratory parameter was determined by the investigator during the study.
Measured: post study follow-up assessment (Day 47)
Number of Subjects With Treatment Emergent AEs
AEs are defined as existing conditions which worsen or events which occur during the course of the clinical trial after treatment. SAEs are AEs that result in the following outcomes: death, are life-threatening, persistent or significant disability/incapacity, congenital anomaly/birth defect, or important medical events that may have been considered a SAE when, based upon appropriate medical judgment, they may have jeopardized the subject and may have required medical or surgical intervention to prevent one of the outcomes listed in the definition.
Measured: 0-47 days
Secondary outcomes (9)
Trough FEV1 (Change From Baseline)
Spirometry measurements were conducted in accordance with the current ATS/ERS 2005 guidelines. Trough FEV1 was defined as the spirometry value collected at 24 hours post dose within each Treatment Period.
Measured: 24hr post dose
Peak FEV1 (Percent Change)
Spirometry measurements were conducted in accordance with the current ATS/ERS 2005 guidelines.
Measured: 0 to 4hr
Peak FEV1 (Change From Baseline )
Spirometry measurements were conducted in accordance with the current ATS/ERS 2005 guidelines.
Measured: 0 to 4hr
FEV1 AUC0-24 Area Under the FEV1 Over Time Curve (Change From Baseline)
Spirometry measurements were conducted in accordance with the current ATS/ERS 2005 guidelines.
Measured: 0 to 24hr post dose
Cmax Maximum Observed Plasma Concentration
Pk parameters are calculated from glycopyrrolate plasma concentration analysed from serial blood samples collected between 0 and 12 hr
Measured: 0 to 12 hours post dose
Tmax Time to Maximum Observed Plasma Concentration
Pk parameters are calculated from glycopyrrolate plasma concentration analysed from serial blood samples collected between 0 and 12 hr
Measured: 0 to 12 hours post dose
AUC0-t Area Under the Plasma Concentration-time Curve From Time Zero to the Last Quantifiable Concentration
Pk parameters are calculated from glycopyrrolate plasma concentration analysed from serial blood samples collected between 0 and 12 hr
Measured: 0 to 12 hourr post dose
AUC0-inf Area Under the Plasma Concentration-time Curve From Time Zero to Infinity
Pk parameters are calculated from glycopyrrolate plasma concentration analysed from serial blood samples collected between 0 and 12 hr
Measured: 0 to 12 hours post dose
t1/2 Plasma Half-life
Pk parameters are calculated from glycopyrrolate plasma concentration analysed from serial blood samples collected between 0 and 12 hr.
Measured: 0 to 12 hours post-dose
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted1 Nov 2016 (estimated)
- Study startMay 2009
- Primary completionJul 2009
- Study completionJul 2009
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 Chronic Obstructive Pulmonary DiseaseStudies 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
- Triple blind
- Who is masked
- Participant, Care provider, Outcomes assessor
- Enrolment
- 12 participants (actual)
Sponsor and investigators
- Lead sponsor
- Sunovion Respiratory Development Inc.
- Sponsor type
- Industry (pharma, biotech, devices)
- Responsible party
- Sponsor
- Investigators
- Ahmet Tutuncu, MD, PhD, Study chair, Elevation Pharmaceuticals, Inc.(now known as Sunovion Respiratory Development Inc.)
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT02951312
- Sponsor's protocol ID
- EP-101-01
- Other IDs
- 2009-010821-38, 2009
- Status last verified
- Mar 2018
- First submitted
- 26 Oct 2016
- Last updated
- 30 Apr 2018
- Results posted
- Yes, on ClinicalTrials.gov
- Data monitoring committee
- No
Study at a glance
From the registry record, last updated by the sponsor on 30 Apr 2018. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Single-dose, Dose Escalation Study to Assess the Safety, Tolerability, Pharmacokinetics and Bronchodilatory Effects of Glycopyrrolate Inhalation Solution (GIS) Using a High Efficiency Nebulizer in Patients With COPD
- ClinicalTrials.gov ID
- NCT02951312
- Acronym / sponsor ID
- EP-101-01
- Conditions
- Chronic Obstructive Pulmonary Disease
- Keywords
- Emphysema, Chronic bronchitis, COPD, Chronic Obstructive Pulmonary Disease
- Phase
- Phase 2
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 12 participants (actual)
- Lead sponsor
- Sunovion Respiratory Development Inc.Industry (pharma, biotech, devices)
- Study start
- May 2009
- Primary completion
- Jul 2009 (actual)
- Study completion
- Jul 2009 (actual)
- First posted
- 1 Nov 2016 (estimated)
- Results
- Posted 30 Apr 2018
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
The study assessed the safety and ability of several doses of an orally inhaled medicine [ie, Glycopyrrolate Inhalation Solution = GIS] to improve airflow in the lungs when delivered with an electronic eFlow nebulizer system in patients with Chronic Obstructive Pulmonary Disease (COPD). The study was conducted in 12 patients in 2 parts. Part 1 was designed to find the once-a- day GIS dose that produced the highest improvement in lung airflow. Part 2 tested the GIS dose with the highest improvement in lung airflow and a placebo (ie, no drug) delivered by a general purpose nebulizer. The airflow improvements of the same GIS dose were compared between the two nebulizer systems to determine what effect the device had on GIS delivery.
Detailed description
In Part I, 12 subjects were randomly allocated to one of 2 cohorts, running in parallel. The 6 cohort 1 subjects received 25 mg and then 200 mg during their treatment periods 1 and 2, respectively. The 6 cohort 2 subjects received 75mg, 500mg, and 1000 mg during their treatment periods 1, 2, and 3, respectively. During Part II of the study, the same 12 subjects from Part I were randomized to receive either 200 mg jet or placebo in a 1:1 ratio.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Triple blind (participant, care provider, outcomes assessor)
- Number of arms
- 7
| Arm | Type | Receives |
|---|---|---|
| Glycopyrrolate Inhalation Solution 25mg | Experimental | Drug: Glycopyrrolate Inhalation Solution 25mgGlycopyrrolate Inhalation Solution 25 μg via eFlow nebulizer, once daily |
| Glycopyrrolate Inhalation Solution 75mg | Experimental | Drug: Glycopyrrolate Inhalation Solution 75mgGlycopyrrolate Inhalation Solution 75 μg via eFlow nebulizer, once daily |
| Glycopyrrolate Inhalation Solution 200mg | Experimental | Drug: Glycopyrrolate Inhalation Solution 200mgGlycopyrrolate Inhalation Solution 200 μg via eFlow nebulizer, once daily |
| Glycopyrrolate Inhalation Solution 200mg Jet | Experimental | Drug: Glycopyrrolate Inhalation Solution 200mg JetGlycopyrrolate Inhalation Solution 200 μg via jet nebulizer, once daily |
| Glycopyrrolate Inhalation Solution 500mg | Experimental | Drug: Glycopyrrolate Inhalation Solution 500mgGlycopyrrolate Inhalation Solution 500 μg via eFlow nebulizer, once daily |
| Glycopyrrolate Inhalation Solution1000mg | Experimental | Drug: Glycopyrrolate Inhalation Solution1000mgGlycopyrrolate Inhalation Solution 1000 μg via eFlow nebulizer, once daily |
| Placebo 0.5 mL | Placebo comparator | Drug: PlaceboPlacebo 0.5 mL via jet nebulizer, once daily |
Who may qualify
- Ages
- 40 to 75 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (17 listed)
- Male and female patients aged 40 through 75 years, inclusive
- A clinical diagnosis of COPD according to the GOLD guidelines
- Current smokers or ex-smokers with at least 10 pack-year smoking history (e.g., at least 1 pack/day for 10 years, or 10 packs/day for 1 year)
- Post-bronchodilator FEV1 40-80% of predicted normal
- Post-bronchodilator FEV1/FVC ratio < 0.70
Key exclusion criteria (12 listed)
- Current evidence or recent history of any clinically significant disease (other than COPD) or abnormality in the opinion of the Investigator that would put the patients at risk or which would compromise the quality of the study data; including but not limited to cardiovascular disease, myocardial infraction, hypertension, arrhythmia, diabetes, neurological or neuromuscular disease, liver disease, gastrointestinal disease or electrolyte abnormalities.
- Recent history of an exacerbation of airway disease within 3 months or need for increased treatments for COPD within 6 weeks prior to the Screening Visit.
- Regular use of daily oxygen therapy.
- Use of systemic (e.g., intramuscular or intravenous) steroids within 3 months prior to the Screening Visit
- Respiratory tract infection within 6 weeks prior to the Screening Visit
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 |
|---|---|---|
| Glycopyrrolate Inhalation Solution 25mgAlso: GIS25 μg oral inhalation via eFlow Nebulizer, once daily | Drug | Glycopyrrolate Inhalation Solution 25mg |
| Glycopyrrolate Inhalation Solution 75mgAlso: GIS75 μg oral inhalation via eFlow Nebulizer, once daily | Drug | Glycopyrrolate Inhalation Solution 75mg |
| Glycopyrrolate Inhalation Solution 200mgAlso: GIS200 μg oral inhalation via eFlow Nebulizer, once daily | Drug | Glycopyrrolate Inhalation Solution 200mg |
| Glycopyrrolate Inhalation Solution 200mg JetAlso: GIS200 μg oral inhalation via inhalation via jet nebulizer, once daily | Drug | Glycopyrrolate Inhalation Solution 200mg Jet |
| Glycopyrrolate Inhalation Solution 500mgAlso: GIS500 μg oral inhalation via eFlow nebulizer, once daily | Drug | Glycopyrrolate Inhalation Solution 500mg |
| Glycopyrrolate Inhalation Solution1000mgAlso: GIS1000 μg oral inhalation via eFlow nebulizer, once daily | Drug | Glycopyrrolate Inhalation Solution1000mg |
| PlaceboPlacebo 0.5 mL oral inhalation via jet nebulizer, once daily | Drug | Placebo 0.5 mL |
Primary outcome
Number of Subjects Who Died
Time frame: 0-47 days
Number of Subjects With Treatment Emergent SAEs
Time frame: 0-47 days
AEs are defined as existing conditions which worsen or events which occur during the course of the clinical trial after treatment.AEs are defined as existing conditions which worsen or events which occur during the course of the clinical trial after treatment. SAEs are AEs that result in the following outcomes: death, are life-threatening, persistent or significant disability/incapacity, congenital anomaly/birth defect, or important medical events that may have been considered a SAE when, based upon appropriate medical judgment, they may have jeopardized the subject and may have required medical or surgical intervention to prevent one of the outcomes listed in the definition.
Number of Subjects Who Discontinued Due to AE
Time frame: 0-47 days
AEs are defined as existing conditions which worsen or events which occur during the course of the clinical trial after treatment.
Percentage of Subjects With Treatment Emergent AEs
Time frame: 0-47 days
AEs are defined as existing conditions which worsen or events which occur during the course of the clinical trial after treatment.
Number of Subjects With Clinically Significant Abnormal Vital Signs Reported During the Study
Time frame: 30 hrs post dose
Vital signs were measured at screening, during the study (pre-dose, and 30 and 60 minutes and 2, 4, 8, 12, 24 and 30 hours post-dose) and at post study assessment. The clinical significance of each out of normal range vital sign parameter was determined by the investigator during the study.
Number of Subjects With Clinically Significant Abnormal Laboratory Results Reported During the Study
Time frame: day 47 (post studyfollow-up assessment)
Clinical safety lab parameters were collected at screening and at the post study follow-up assessment. The clinical significance of each out of normal range laboratory parameter was determined by the investigator during the study.
Number of Subjects With Clinically Significant ECG Parameters Reported During the Study
Time frame: 30hr post dose
ECGs were measured at screening, during the study (pre-dose, and 30 and 60 minutes and 2, 4, 8, 12, 24 and 30 hours post-dose) and at post study follow-up assessment.
Number of Subjects With Clinically Significant Abnormal Laboratory Results Reported During the Study
Time frame: post study follow-up assessment (Day 47)
Clinical safety lab parameters were collected at screening and at the post study follow-up assessment. The clinical significance of each out of normal range laboratory parameter was determined by the investigator during the study.
Number of Subjects With Treatment Emergent AEs
Time frame: 0-47 days
AEs are defined as existing conditions which worsen or events which occur during the course of the clinical trial after treatment. SAEs are AEs that result in the following outcomes: death, are life-threatening, persistent or significant disability/incapacity, congenital anomaly/birth defect, or important medical events that may have been considered a SAE when, based upon appropriate medical judgment, they may have jeopardized the subject and may have required medical or surgical intervention to prevent one of the outcomes listed in the definition.
9 secondary outcomes
Trough FEV1 (Change From Baseline)
Time frame: 24hr post dose
Peak FEV1 (Percent Change)
Time frame: 0 to 4hr
Peak FEV1 (Change From Baseline )
Time frame: 0 to 4hr
FEV1 AUC0-24 Area Under the FEV1 Over Time Curve (Change From Baseline)
Time frame: 0 to 24hr post dose
Cmax Maximum Observed Plasma Concentration
Time frame: 0 to 12 hours post dose
Tmax Time to Maximum Observed Plasma Concentration
Time frame: 0 to 12 hours post dose
AUC0-t Area Under the Plasma Concentration-time Curve From Time Zero to the Last Quantifiable Concentration
Time frame: 0 to 12 hourr post dose
AUC0-inf Area Under the Plasma Concentration-time Curve From Time Zero to Infinity
Time frame: 0 to 12 hours post dose
t1/2 Plasma Half-life
Time frame: 0 to 12 hours post-dose
Results and safety
Loading the posted results from ClinicalTrials.gov…
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 30 Apr 2018.
- Posted resultsParticipant flow, baseline, all outcome measures and adverse events.
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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.
Ahmet Tutuncu, MD, PhD study chair
Elevation Pharmaceuticals, Inc.(now known as Sunovion Respiratory Development Inc.)
Questions about this trial
What is this clinical trial studying?
A Phase 2 study testing Glycopyrrolate Inhalation Solution 25mg, Glycopyrrolate Inhalation Solution 75mg and Glycopyrrolate Inhalation Solution 200mg in people with Chronic Obstructive Pulmonary Disease, run by Sunovion Respiratory Development Inc..
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 17 inclusion and 12 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 30 Apr 2018. Status can change between updates, so confirm with the study contact before making plans.
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 30 Apr 2018). 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?
Number of Subjects Who Died (time frame: 0-47 days). The study lists 9 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 30 Apr 2018.