Chronic Obstructive Pulmonary DiseasePhase 2NCT03256552
Study to Assess the Efficacy and Safety of Three Doses of PT001 in Japanese Subjects With Moderate to Severe COPD
A Phase 2 study testing Glycopyrronium MDI 28.8 micrograms, Glycopyrronium MDI 14.4 micrograms and Glycopyrronium MDI 7.2 micrograms in people with Chronic Obstructive Pulmonary Disease, run by Pearl Therapeutics, Inc. at 18 sites in Japan.
Trial summary
The overall objective of this study was to assess the efficacy and safety of GP MDI relative to placebo in Japanese subjects with moderate to severe COPD. Each subject received the 4 separate study treatments, scheduled as four, 7-day, treatment periods for a total treatment duration of 28 days. Read more about this study
- Who is it for?
- Ages 40 to 80 years
- Conditions the study is for
- Chronic Obstructive Pulmonary Disease
- What is being tested?
- Glycopyrronium MDI 28.8 micrograms, Glycopyrronium MDI 14.4 micrograms and Glycopyrronium MDI 7.2 micrograms
- Could I receive a placebo?
- Yes, some participants may receive a placebo
- How many people
- 66 participants
- Where
- 18 sitesJapan
- Study dates
- 28 Jan 2015to 5 Sep 2015
- 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 80 years
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- Clinical history of COPD with a moderate to severe classification
- Current and former smokers with a history of at least 10 pack-years of cigarette smoking.
- -Post-bronchodilator FEV1 must be ≥30% and <80% predicted normal value-
Who cannot join
- Pregnancy
- Primary asthma diagnosis; Poorly controlled COPD defined as acute worsening of COPD that required treatment with corticosteroids or antibiotics in the 6-week interval prior to Screening or between Screening and Visit 2;
- Clinically significant abnormal ECG
- Other active pulmonary disease such as active tuberculosis, lung cancer, bronchiectasis, sarcoidosis, lung fibrosis, primary pulmonary hypertension, interstitial lung disease, and uncontrolled sleep apnea; Cancer that was not in complete remission for at least 5 years;
- Diagnosis of angle closure glaucoma
- A documented myocardial infarction within 1 year of Screening.
Trial locations and contacts
18 sites in 1 country.
18 sites in 1 country
Japan18 sites
Pearl Investigative Site
Ako-shi, Hyōgo
Pearl Investigative Site
Chūōku, Tokyo-To
Pearl Investigative Site
Fukuoka, Fukuoka
Pearl Investigative Site
Hamamatsu, Shizuoka
Pearl Investigative Site
Himeji-shi, Hyōgo
Pearl Investigative Site
Iizuka-shi, Fukuoka
Pearl Investigative Site
Kakogawa-shi, Hyōgo
Pearl Investigative Site
Kasaoka-shi, Okayama-ken
Pearl Investigative Site
Kawasaki-shi, Kanagawa
Pearl Investigative Site
Kishiwada-shi, Osaka
Pearl Investigative Site
Kobe, Hyōgo
Pearl Investigative Site
Kyoto, Kyoto
Pearl Investigative Site
Mizunami-shi, Gifu
Pearl Investigative Site
Naka-gun, Ibaraki
Pearl Investigative Site
Nishinomiya-shi, Hyōgo
Pearl Investigative Site
Osaka, Osaka
Pearl Investigative Site
Sapporo, Hokkaido
Pearl Investigative Site
Toshima-ku, Tokyo-To
About this study
Official title: A Randomized, Double-Blind, Chronic Dosing (7-Day), Four-Period, Four-Treatment, Placebo-Controlled, Cross-Over, Multi-Center Study to Assess the Efficacy and Safety of Three Doses of PT001 in Japanese Subjects With Moderate to Severe COPD
The overall objective of this study was to assess the efficacy and safety of GP MDI relative to placebo in Japanese subjects with moderate to severe COPD. Each subject received the 4 separate study treatments, scheduled as four, 7-day, treatment periods for a total treatment duration of 28 days.
Read the detailed description
This was a randomized, double-blind, chronic-dosing (7-day), four-period, four-treatment, placebo-controlled, crossover, multi-center study to assess the efficacy and safety of 3 doses of GP MDI (28.8, 14.4, and 7.2 μg ex-actuator, BID) in Japanese subjects with moderate to severe COPD.
Subjects who met the entry criteria had their maintenance therapy for COPD adjusted, as specified in the protocol. To allow for an adequate washout of previous maintenance medications, subjects underwent a washout period of at least 7 days, but not greater than 28 days duration prior to returning to the clinic for Visit 2 (Randomization Visit; Day 1 of Treatment Period 1).
The 4 study treatments were GP MDI 28.8, 14.4, and 7.2 μg ex-actuator, and Placebo MDI BID. Subjects were randomly assigned to 1 of the following 4 treatment sequences (ABCD, BDAC, CADB, DCBA) in a 1:1:1:1 ratio using an Interactive Web Response System where each letter represented 1 of the 4 treatments included in the study by random assignment.
Subjects were to complete 7 days of dosing in each of the 4 Treatment Periods, with each Treatment Period separated by a washout period of 5 to 21 days.
- Conditions
- Chronic Obstructive Pulmonary Disease
- Being tested
- Glycopyrronium MDI 28.8 micrograms, Glycopyrronium MDI 14.4 micrograms, Glycopyrronium MDI 7.2 micrograms, Placebo MDI
- 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.
Glycopyrronium MDI 28.8 microgramsDrug
Glycopyrronium MDI 28.8 micrograms
Glycopyrronium MDI 14.4 microgramsDrug
Glycopyrronium MDI 14.4 micrograms
Glycopyrronium MDI 7.2 microgramsDrug
Glycopyrronium MDI 7.2 micrograms
Placebo MDIDrug
Placebo Inhalation Aerosol
| Study group | Role | What they receive |
|---|---|---|
| GP MDI 28.8 micrograms | Active comparator | Glycopyrronium Metered Dose Inhaler 28.8 micrograms Receives: Drug: Glycopyrronium MDI 28.8 micrograms |
| GP MDI 14.4 micrograms | Active comparator | Glycopyrronium Metered Dose Inhaler 14.4 micrograms Receives: Drug: Glycopyrronium MDI 14.4 micrograms |
| GP MDI 7.2 micrograms | Active comparator | Glycopyrronium Metered Dose Inhaler 7.2 micrograms Receives: Drug: Glycopyrronium MDI 7.2 micrograms |
| Placebo MDI | Placebo comparator | Placebo Inhalation Aerosol Receives: Drug: Placebo MDI |
What is being measured
The primary outcome is the main question the study is designed to answer.
Morning Pre-dose Trough FEV1
Change from Baseline in Morning Pre-dose Trough FEV1
Measured: Baseline, Day 8
Secondary outcomes (3)
FEV1 AUC0-2
Change from Baseline in FEV1 AUC0-2 normalized for length of follow-up. FEV1 was measured at 15 min, 30 min, 1 hour, and 2 hours post dose.
Measured: Day 1 and Day 8
Peak Change in FEV1
Peak Change from Baseline in FEV1
Measured: Day 1 and Day 8
FVC AUC0-2
Change from Baseline in FVC AUC0-2 on Day 8 normalized for length of follow-up. FVC was measured at 15 min, 30 min, 1 hour, and 2 hours post dose.
Measured: Baseline, Day 8
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted22 Aug 2017
- Study start28 Jan 2015
- Primary completion5 Sep 2015
- Study completion5 Sep 2015
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.
- Publications (1)Papers the sponsor has linked to this study.
- 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
- Crossover
- Model description
- randomized, double-blind, chronic-dosing (7-day), four-period, four-treatment, placebo-controlled, crossover, multi-center
- Masking
- Quadruple blind
- Who is masked
- Participant, Care provider, Investigator, Outcomes assessor
- Enrolment
- 66 participants (actual)
Sponsor and investigators
- Lead sponsor
- Pearl Therapeutics, Inc.
- Sponsor type
- Industry (pharma, biotech, devices)
- Responsible party
- Sponsor
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT03256552
- Sponsor's protocol ID
- PT001004
- Status last verified
- Dec 2017
- First submitted
- 17 Aug 2017
- Last updated
- 23 Jan 2018
- Results posted
- Yes, on ClinicalTrials.gov
- Data monitoring committee
- No
- FDA-regulated drug
- Yes
- FDA-regulated device
- No
Publications
Fukushima Y, Nakatani Y, Ide Y, Sekino H, St Rose E, Siddiqui S, Maes A, Reisner C. Randomized, double-blind, placebo-controlled trial to assess the efficacy and safety of three doses of co-suspension delivery technology glycopyrronium MDI in Japanese patients with moderate-to-severe COPD. Int J Chron Obstruct Pulmon Dis. 2018 Apr 13;13:1187-1194. doi: 10.2147/COPD.S159246. eCollection 2018.
PubMed 29695902
Study at a glance
From the registry record, last updated by the sponsor on 23 Jan 2018. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- A Randomized, Double-Blind, Chronic Dosing (7-Day), Four-Period, Four-Treatment, Placebo-Controlled, Cross-Over, Multi-Center Study to Assess the Efficacy and Safety of Three Doses of PT001 in Japanese Subjects With Moderate to Severe COPD
- ClinicalTrials.gov ID
- NCT03256552
- Acronym / sponsor ID
- PT001004
- Conditions
- Chronic Obstructive Pulmonary Disease
- Phase
- Phase 2
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 66 participants (actual)
- Lead sponsor
- Pearl Therapeutics, Inc.Industry (pharma, biotech, devices)
- Study start
- 28 Jan 2015 (actual)
- Primary completion
- 5 Sep 2015 (actual)
- Study completion
- 5 Sep 2015 (actual)
- First posted
- 22 Aug 2017 (actual)
- Results
- Posted 23 Jan 2018
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
The overall objective of this study was to assess the efficacy and safety of GP MDI relative to placebo in Japanese subjects with moderate to severe COPD. Each subject received the 4 separate study treatments, scheduled as four, 7-day, treatment periods for a total treatment duration of 28 days.
Detailed description
This was a randomized, double-blind, chronic-dosing (7-day), four-period, four-treatment, placebo-controlled, crossover, multi-center study to assess the efficacy and safety of 3 doses of GP MDI (28.8, 14.4, and 7.2 μg ex-actuator, BID) in Japanese subjects with moderate to severe COPD.
Subjects who met the entry criteria had their maintenance therapy for COPD adjusted, as specified in the protocol. To allow for an adequate washout of previous maintenance medications, subjects underwent a washout period of at least 7 days, but not greater than 28 days duration prior to returning to the clinic for Visit 2 (Randomization Visit; Day 1 of Treatment Period 1).
The 4 study treatments were GP MDI 28.8, 14.4, and 7.2 μg ex-actuator, and Placebo MDI BID. Subjects were randomly assigned to 1 of the following 4 treatment sequences (ABCD, BDAC, CADB, DCBA) in a 1:1:1:1 ratio using an Interactive Web Response System where each letter represented 1 of the 4 treatments included in the study by random assignment.
Subjects were to complete 7 days of dosing in each of the 4 Treatment Periods, with each Treatment Period separated by a washout period of 5 to 21 days.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Crossover
- Masking
- Quadruple blind (participant, care provider, investigator, outcomes assessor)
- Number of arms
- 4
- Model description
- randomized, double-blind, chronic-dosing (7-day), four-period, four-treatment, placebo-controlled, crossover, multi-center
| Arm | Type | Receives |
|---|---|---|
| GP MDI 28.8 micrograms | Active comparator | Drug: Glycopyrronium MDI 28.8 microgramsGlycopyrronium Metered Dose Inhaler 28.8 micrograms |
| GP MDI 14.4 micrograms | Active comparator | Drug: Glycopyrronium MDI 14.4 microgramsGlycopyrronium Metered Dose Inhaler 14.4 micrograms |
| GP MDI 7.2 micrograms | Active comparator | Drug: Glycopyrronium MDI 7.2 microgramsGlycopyrronium Metered Dose Inhaler 7.2 micrograms |
| Placebo MDI | Placebo comparator | Drug: Placebo MDIPlacebo Inhalation Aerosol |
Who may qualify
- Ages
- 40 to 80 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (3 listed)
- Clinical history of COPD with a moderate to severe classification
- Current and former smokers with a history of at least 10 pack-years of cigarette smoking.
- -Post-bronchodilator FEV1 must be ≥30% and <80% predicted normal value-
Key exclusion criteria (6 listed)
- Pregnancy
- Primary asthma diagnosis; Poorly controlled COPD defined as acute worsening of COPD that required treatment with corticosteroids or antibiotics in the 6-week interval prior to Screening or between Screening and Visit 2;
- Clinically significant abnormal ECG
- Other active pulmonary disease such as active tuberculosis, lung cancer, bronchiectasis, sarcoidosis, lung fibrosis, primary pulmonary hypertension, interstitial lung disease, and uncontrolled sleep apnea; Cancer that was not in complete remission for at least 5 years;
- Diagnosis of angle closure glaucoma
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 |
|---|---|---|
| Glycopyrronium MDI 28.8 microgramsGlycopyrronium MDI 28.8 micrograms | Drug | GP MDI 28.8 micrograms |
| Glycopyrronium MDI 14.4 microgramsGlycopyrronium MDI 14.4 micrograms | Drug | GP MDI 14.4 micrograms |
| Glycopyrronium MDI 7.2 microgramsGlycopyrronium MDI 7.2 micrograms | Drug | GP MDI 7.2 micrograms |
| Placebo MDIPlacebo Inhalation Aerosol | Drug | Placebo MDI |
Primary outcome
Morning Pre-dose Trough FEV1
Time frame: Baseline, Day 8
Change from Baseline in Morning Pre-dose Trough FEV1
3 secondary outcomes
FEV1 AUC0-2
Time frame: Day 1 and Day 8
Peak Change in FEV1
Time frame: Day 1 and Day 8
FVC AUC0-2
Time frame: Baseline, Day 8
Results and safety
Loading the posted results from ClinicalTrials.gov…
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 23 Jan 2018.
- Posted resultsParticipant flow, baseline, all outcome measures and adverse events.
- Derived from this study: PubMed 29695902Fukushima Y, Nakatani Y, Ide Y, Sekino H, St Rose E, Siddiqui S, Maes A, Reisner C. Randomized, double-blind, placebo-controlled trial to assess the efficacy and safety of three doses of co-suspension delivery technology glycopyrronium MDI in Japanese patients with moderate-to-severe COPD. Int J Chron Obstruct Pulmon Dis. 2018 Apr 13;13:1187-1194. doi: 10.2147/COPD.S159246. eCollection 2018.
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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.
The record lists no contact. Use the official record to reach the sponsor.
18 sites in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 2 study testing Glycopyrronium MDI 28.8 micrograms, Glycopyrronium MDI 14.4 micrograms and Glycopyrronium MDI 7.2 micrograms in people with Chronic Obstructive Pulmonary Disease, run by Pearl Therapeutics, Inc. at 18 sites in Japan.
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 3 inclusion and 6 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 23 Jan 2018. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 18 sites in Japan. 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 23 Jan 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?
Morning Pre-dose Trough FEV1 (time frame: Baseline, Day 8). 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 NCT03256552, 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 23 Jan 2018.