Chronic Obstructive Pulmonary DiseasePhase 2NCT01350128
PT001 MDI Versus Atrovent Study in Moderate to Severe Chronic Obstructive Pulmonary Disease (COPD)
A Phase 2 study testing PT001 MDI and Ipratropium Bromide HFA Inhalation Aerosol in people with Chronic Obstructive Pulmonary Disease, run by Pearl Therapeutics, Inc. at 8 sites in United States.
Trial summary
The overall objective of this study is to determine an optimal dose and dosing regimen of PT001 MDI for further evaluation in later stage studies. 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?
- PT001 MDI and Ipratropium Bromide HFA Inhalation Aerosol
- Could I receive a placebo?
- Yes, some participants may receive a placebo
- How many people
- 103 participants
- Where
- 8 sitesUnited States
- Study dates
- 1 May 2011to 1 Oct 2011
- 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
- Signed written informed consent
- 40 - 80 years of age
- Clinical history of COPD with airflow limitation that is not fully reversible
- Females of non-child bearing potential or females of child bearing potential with negative pregnancy test; and acceptable contraceptive methods
- Current/former smokers with at least a 10 pack-year history of cigarette smoking
- A measured post- bronchodilator FEV1/FVC ratio of < or = 0.70
- A measured post- bronchodilator FEV1 > or = 750ml or 30% predicted and < or = 80% of predicted normal values
- Able to change COPD treatment as required by protocol
Who cannot join
- Women who are pregnant or lactating
- Primary diagnosis of asthma
- Alpha-1 antitrypsin deficiency as the cause of COPD
- Active pulmonary diseases
- Prior lung volume reduction surgery
- Abnormal chest X-ray (or CT scan) not due to the presence of COPD
Show all 11Show fewer
- Hospitalized due to poorly controlled COPD within 3 months of Screening
- Clinically significant medical conditions that preclude participation in the study (e.g. clinically significant abnormal ECG, uncontrolled hypertension, glaucoma, symptomatic prostatic hypertrophy)
- Cancer that has not been in complete remission for at least 5 years
- Treatment with investigational study drug or participation in another clinical trial or study within the last 30 days or 5 half lives
- Other inclusion/exclusion criteria as defined in the protocol
Trial locations and contacts
8 sites in 1 country.
8 sites in 1 country
United States8 sites
Pearl Investigative Site
Charlotte, North Carolina
Pearl Investigative Site
Cherry Hill, New Jersey
Pearl Investigative Site
Longview, Texas
Pearl Investigative Site
Medford, Oregon
Pearl Investigative Site
Panama City, Florida
Pearl Investigative Site
Richmond, Virginia
Pearl Investigative Site
Summit, New Jersey
Pearl Investigative Site
Winter Park, Florida
About this study
Official title: A Randomized, Double-Blind, Chronic Dosing (7 Days), Three-Period, Six-Treatment, Placebo-Controlled, Incomplete Block, Cross-Over, Multi-Center Study to Assess Efficacy and Safety of Four Doses of PT001 in Patients With Moderate to Severe COPD, Compared With Atrovent® HFA Inhalation Aerosol (Open-Label) as An Active Control
The overall objective of this study is to determine an optimal dose and dosing regimen of PT001 MDI for further evaluation in later stage studies.
Read the detailed description
The primary objective of this study is to demonstrate efficacy relative to placebo of PT001 MDI in patients with moderate to severe chronic obstructive pulmonary disease (COPD) within the range of doses evaluated in this protocol. To this end, each dose of PT001 MDI will be compared to placebo with respect to the primary efficacy endpoint, FEV1 AUC0-12 relative to baseline.
- Conditions
- Chronic Obstructive Pulmonary Disease
- Being tested
- PT001 MDI, Ipratropium Bromide HFA Inhalation Aerosol, Placebo MDI
- Keywords
- COPD
- 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.
PT001 MDIDrug
PT001 MDI administered as two puffs BID for 7 days
Ipratropium Bromide HFA Inhalation AerosolDrug
Also called Atrovent
Taken as 2 inhalations of the 17 µg per actuation strength MDI QID
Placebo MDIOther
Matching placebo to PT001 MDI administered as two puffs BID for 7 days
| Study group | Role | What they receive |
|---|---|---|
| PT001 MDI (Dose 1) | Experimental | PT001 MDI Receives: Drug: PT001 MDI |
| PT001 MDI (Dose 2) | Experimental | PT001 MDI Receives: Drug: PT001 MDI |
| PT001 MDI (Dose 3) | Experimental | PT001 MDI Receives: Drug: PT001 MDI |
| PT001 MDI (Dose 4) | Experimental | PT001 MDI Receives: Drug: PT001 MDI |
| Ipratropium Bromide HFA Inhalation Aerosol | Active comparator | Ipratropium Bromide HFA Inhalation Aerosol Receives: Drug: Ipratropium Bromide HFA Inhalation Aerosol |
| Placebo MDI | Placebo comparator | PT001 Placebo MDI Receives: Other: Placebo MDI |
What is being measured
The primary outcome is the main question the study is designed to answer.
FEV1 AUC0-12
FEV1 AUC0-12 following chronic dosing (1 week), normalized.
Measured: Day 7 ( -1 hour, -30 min, 15 min, 30 min, 1 hour, 2 hours, 4 hours, 5.5 hours, 6.5 hours, 8 hours, 10 hours, 11.5 hours, and 12 hours)
Secondary outcomes (8)
Peak Change From Baseline in FEV1 on Day 1
Highest value of FEV1 post-dose minus baseline on Day 1 (baseline-adjusted)
Measured: Day 1
Time to Onset of Action ( ≥10% Improvement in FEV1) on Day 1
Time to onset of action ( ≥10% improvement in FEV1)
Measured: Day 1 (15 min, 30 min, 1 hour, 2 hours)
Proportion of Subjects Achieving at Least 12% Improvement in FEV1 on Day 1
Proportion of subjects achieving at least 12% improvement in FEV1 (relative to baseline)
Measured: Day 1
Peak Change From Baseline in IC on Day 1
Peak change from baseline in Inspiratory Capacity (IC) on Day 1 (mean of 1 and 2 hours post-dose minus baseline on Day 1)
Measured: Day 1
Change From Baseline in Morning Pre-dose FEV1 on Day 7
Change from baseline in morning pre-dose FEV1
Measured: Day 7
Peak Change From Baseline in FEV1 on Day 7
Peak change from baseline in FEV1
Measured: Day 7
Peak Change From Baseline in IC on Day 7
Peak change from baseline in IC
Measured: Day 7
Change From Baseline in 12-hour Post-dose Trough FEV1 on Day 7
Change from baseline in 12-hour post-dose trough FEV1
Measured: Day 7
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted9 May 2011 (estimated)
- Study start1 May 2011
- Primary completion1 Oct 2011
- Study completion1 Oct 2011
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
- Masking
- Quadruple blind
- Who is masked
- Participant, Care provider, Investigator, Outcomes assessor
- Enrolment
- 103 participants (actual)
Sponsor and investigators
- Lead sponsor
- Pearl Therapeutics, Inc.
- Sponsor type
- Industry (pharma, biotech, devices)
- Responsible party
- Sponsor
- Investigators
- Colin Reisner, M.D., Study director, Pearl Therapeutics, Inc.
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT01350128
- Sponsor's protocol ID
- PT001002
- Status last verified
- May 2018
- First submitted
- 5 May 2011
- Last updated
- 20 Jun 2018
- Results posted
- Yes, on ClinicalTrials.gov
- Data monitoring committee
- No
Publications
Kerwin EM, Spangenthal S, Kollar C, St Rose E, Reisner C. A phase IIb randomized, chronic-dosing, incomplete block, cross-over study of glycopyrronium, delivered via metered dose inhaler, compared with a placebo and an active control in patients with moderate-to-severe COPD. Respir Res. 2018 Mar 5;19(1):38. doi: 10.1186/s12931-018-0739-6.
PubMed 29506504
Study at a glance
From the registry record, last updated by the sponsor on 20 Jun 2018. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- A Randomized, Double-Blind, Chronic Dosing (7 Days), Three-Period, Six-Treatment, Placebo-Controlled, Incomplete Block, Cross-Over, Multi-Center Study to Assess Efficacy and Safety of Four Doses of PT001 in Patients With Moderate to Severe COPD, Compared With Atrovent® HFA Inhalation Aerosol (Open-Label) as An Active Control
- ClinicalTrials.gov ID
- NCT01350128
- Acronym / sponsor ID
- PT001002
- Conditions
- Chronic Obstructive Pulmonary Disease
- Keywords
- COPD
- Phase
- Phase 2
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 103 participants (actual)
- Lead sponsor
- Pearl Therapeutics, Inc.Industry (pharma, biotech, devices)
- Study start
- 1 May 2011 (actual)
- Primary completion
- 1 Oct 2011 (actual)
- Study completion
- 1 Oct 2011 (actual)
- First posted
- 9 May 2011 (estimated)
- Results
- Posted 8 Jun 2017
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 is to determine an optimal dose and dosing regimen of PT001 MDI for further evaluation in later stage studies.
Detailed description
The primary objective of this study is to demonstrate efficacy relative to placebo of PT001 MDI in patients with moderate to severe chronic obstructive pulmonary disease (COPD) within the range of doses evaluated in this protocol. To this end, each dose of PT001 MDI will be compared to placebo with respect to the primary efficacy endpoint, FEV1 AUC0-12 relative to baseline.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Crossover
- Masking
- Quadruple blind (participant, care provider, investigator, outcomes assessor)
- Number of arms
- 6
| Arm | Type | Receives |
|---|---|---|
| PT001 MDI (Dose 1) | Experimental | Drug: PT001 MDIPT001 MDI |
| PT001 MDI (Dose 2) | Experimental | Drug: PT001 MDIPT001 MDI |
| PT001 MDI (Dose 3) | Experimental | Drug: PT001 MDIPT001 MDI |
| PT001 MDI (Dose 4) | Experimental | Drug: PT001 MDIPT001 MDI |
| Ipratropium Bromide HFA Inhalation Aerosol | Active comparator | Drug: Ipratropium Bromide HFA Inhalation AerosolIpratropium Bromide HFA Inhalation Aerosol |
| Placebo MDI | Placebo comparator | Other: Placebo MDIPT001 Placebo MDI |
Who may qualify
- Ages
- 40 to 80 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (8 listed)
- Signed written informed consent
- 40 - 80 years of age
- Clinical history of COPD with airflow limitation that is not fully reversible
- Females of non-child bearing potential or females of child bearing potential with negative pregnancy test; and acceptable contraceptive methods
- Current/former smokers with at least a 10 pack-year history of cigarette smoking
Key exclusion criteria (11 listed)
- Women who are pregnant or lactating
- Primary diagnosis of asthma
- Alpha-1 antitrypsin deficiency as the cause of COPD
- Active pulmonary diseases
- Prior lung volume reduction surgery
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 |
|---|---|---|
| PT001 MDIPT001 MDI administered as two puffs BID for 7 days | Drug | PT001 MDI (Dose 1), PT001 MDI (Dose 2), PT001 MDI (Dose 3), PT001 MDI (Dose 4) |
| Ipratropium Bromide HFA Inhalation AerosolAlso: AtroventTaken as 2 inhalations of the 17 µg per actuation strength MDI QID | Drug | Ipratropium Bromide HFA Inhalation Aerosol |
| Placebo MDIMatching placebo to PT001 MDI administered as two puffs BID for 7 days | Other | Placebo MDI |
Primary outcome
FEV1 AUC0-12
Time frame: Day 7 ( -1 hour, -30 min, 15 min, 30 min, 1 hour, 2 hours, 4 hours, 5.5 hours, 6.5 hours, 8 hours, 10 hours, 11.5 hours, and 12 hours)
FEV1 AUC0-12 following chronic dosing (1 week), normalized.
8 secondary outcomes
Peak Change From Baseline in FEV1 on Day 1
Time frame: Day 1
Time to Onset of Action ( ≥10% Improvement in FEV1) on Day 1
Time frame: Day 1 (15 min, 30 min, 1 hour, 2 hours)
Proportion of Subjects Achieving at Least 12% Improvement in FEV1 on Day 1
Time frame: Day 1
Peak Change From Baseline in IC on Day 1
Time frame: Day 1
Change From Baseline in Morning Pre-dose FEV1 on Day 7
Time frame: Day 7
Peak Change From Baseline in FEV1 on Day 7
Time frame: Day 7
Peak Change From Baseline in IC on Day 7
Time frame: Day 7
Change From Baseline in 12-hour Post-dose Trough FEV1 on Day 7
Time frame: Day 7
Results and safety
Loading the posted results from ClinicalTrials.gov…
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 20 Jun 2018.
- Posted resultsParticipant flow, baseline, all outcome measures and adverse events.
- Derived from this study: PubMed 29506504Kerwin EM, Spangenthal S, Kollar C, St Rose E, Reisner C. A phase IIb randomized, chronic-dosing, incomplete block, cross-over study of glycopyrronium, delivered via metered dose inhaler, compared with a placebo and an active control in patients with moderate-to-severe COPD. Respir Res. 2018 Mar 5;19(1):38. doi: 10.1186/s12931-018-0739-6.
- Related InfoLink provided by the sponsor.
Related trials for Chronic Obstructive Pulmonary Disease
Active, not recruiting
Symptoms and Functions in Patients With COPD and Chronic Bronchitis Switching From CIG to THS
COPD, Smoking
Not yet recruitingPhase 2/3
An Open-Label Extension Study to Evaluate Inhaled Treprostinil SMI in Participants With Pulmonary Hypertension Associated With Chronic Obstructive Pulmonary Disease (PH-COPD)
Pulmonary Hypertension Associated With Chronic Obstructive Pulmonary Disease
Not yet recruiting
The Aim of the Study is to Decipher the Alterations in Signalling Pathways of Skeletal Muscle Stem Cells (Satellite Cells (SCs)) in Individuals With COPD, as Well as to Examine the Effect of Exercise Training on SCs.
COPD (Chronic Obstructive Pulmonary Disease), Sarcopenia in Elderly
Not yet recruitingPhase 2
Study of Treprostinil Administered Via Soft Mist Inhaler (SMI) in Participants With Pulmonary Hypertension Associated With Chronic Obstructive Pulmonary Disease (PH-COPD)
Pulmonary Hypertension Associated With Chronic Obstructive Pulmonary Disease
RecruitingPhase 3
A Study to Investigate the Efficacy and Safety of Belumosudil Compared With Best Available Therapy in Participants Aged 12 Years or Older With Chronic Graft-versus-host Disease
Chronic Graft Versus Host Disease
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.
Colin Reisner, M.D. study director
Pearl Therapeutics, Inc.
8 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 PT001 MDI and Ipratropium Bromide HFA Inhalation Aerosol in people with Chronic Obstructive Pulmonary Disease, run by Pearl Therapeutics, Inc. at 8 sites in United States.
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 8 inclusion and 11 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 20 Jun 2018. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 8 sites in United States. 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 8 Jun 2017). 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?
FEV1 AUC0-12 (time frame: Day 7 ( -1 hour, -30 min, 15 min, 30 min, 1 hour, 2 hours, 4 hours, 5.5 hours, 6.5 hours, 8 hours, 10 hours, 11.5 hours, and 12 hours)). 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 NCT01350128, 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 20 Jun 2018.