COPDPhase 4NCT01488019
Study to Evaluate the Safety of Long-Term Use of Perforomist® (Formoterol Fumarate)
A Phase 4 study testing Perforomist, nebulization, COPD in people with COPD, run by Dey at 1 site in United States.
Trial summary
This study is a multi-center, randomized, placebo-controlled study to evaluate the long-term safety of Perforomist® inhalation therapy in subjects with Chronic Obstructive Pulmonary Disease (COPD). Individual participation is approximately 54 weeks, including 52 weeks of double-blind treatment. Read more about this study
- Who is it for?
- Ages 40 years and older
- Conditions the study is for
- COPD
- What is being tested?
- Perforomist, nebulization, COPD
- Could I receive a placebo?
- Yes, some participants may receive a placebo
- How many people
- 1,071 participants
- Where
- 1 siteUnited States
- Study dates
- Mar 2012to Jan 2016
- Phase
- Phase 4
- 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 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- Able to understand the study requirements, provide written informed consent, and agree to abide by the study protocol and its restrictions
- Male and female subjects at least 40 years of age with a medical diagnosis of COPD (i.e. persistent presence of dyspnea, cough or sputum production and a history of exposure to risk factors for the disease, such as tobacco smoke)
- A current or prior history of at least 10 pack-years of cigarette smoking and a baseline breathlessness severity grade of >=2 (Modified Medical Research Council [MMRC] Dyspnea Scale Score) at randomization.
- Women of child-bearing potential (WOCBP) must have a negative pregnancy test at the screening visit and agree to avoid becoming pregnant for the duration of study by using adequate contraception at study entry and throughout the trial. WOCBP will be advised to notify the Investigator of any change in their pregnancy status. WOCBP include: any female who has experienced menarche and is not post-menopausal (defined as amenorrhea for at least 12 consecutive months), or has not undergone surgical sterilization (hysterectomy, bilateral oophorectomy, or bilateral tubal ligation). Women who are using acceptable contraceptive medications or devices to prevent pregnancy or practicing abstinence or where partner is sterile (e.g., vasectomy) will be considered WOCBP.
- Able to complete all aspects of the study through the end of the study, including all visits and tests, and self-administration of study medications.
Who cannot join
- A medical diagnosis of asthma. Indication of a past history of asthma that is deemed inaccurate to a subject's current condition by the Investigator must be adequately addressed in the medical history.
- Clinically significant abnormal chest x-ray (CXR) (within the past 12 months) diagnostic of active/significant disease other than COPD.
- Evidence of any unstable or clinically significant hematopoietic, malignant, cardiovascular, hepatic, renal, neurologic, psychiatric, autoimmune disorder, or condition or disease other than COPD that, in the opinion of the Investigator, could place the subject at increased risk of complications, interfere with study participation, or confound any of the study objectives.
- Subjects who had radiation or chemotherapy within the previous 12 months.
- An abnormal laboratory test at screening deemed clinically significant and exclusionary by the Investigator.
- A history of hypersensitivity to study drugs or their components, including albuterol rescue.
- -
Trial locations and contacts
1 site in 1 country.
About this study
Official title: A Randomized, Double-blind, Placebo-controlled Study to Evaluate the Safety of Long-Term Use of Perforomist® (Formoterol Fumarate) Inhalation Solution in Subjects With Chronic Obstructive Pulmonary Disease (COPD)
This study is a multi-center, randomized, placebo-controlled study to evaluate the long-term safety of Perforomist® inhalation therapy in subjects with Chronic Obstructive Pulmonary Disease (COPD). Individual participation is approximately 54 weeks, including 52 weeks of double-blind treatment.
Read the detailed description
None provided.
- Conditions
- COPD
- Being tested
- Perforomist-Placebo, Perforomist, nebulization, 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.
Perforomist-PlaceboDrug
Also called Perforomist
Placebo vehicle, 2mL, twice daily for 52 weeks
Perforomist, nebulization, COPDDrug
Also called Formoterol fumarate
Perforomist, 20 mcg/2 mL, twice daily for 52 weeks
| Study group | Role | What they receive |
|---|---|---|
| Perforomist, nebulization, COPD | Experimental | Active Receives: Drug: Perforomist, nebulization, COPD |
| Perforomist-Placebo | Placebo comparator | Placebo Receives: Drug: Perforomist-Placebo |
What is being measured
The primary outcome is the main question the study is designed to answer.
Number of Subjects With a Primary Event of Respiratory Death, First COPD-Related Emergency Room Visit, or First COPD Exacerbation-Related Hospitalisation
The primary endpoint was the combined incidence of respiratory death, first COPD-related ER visit or first COPD exacerbation-related hospitalization (whichever occurred first from the time of randomization to the end of the study). The time-to-first event was measured and analyzed in units of weeks and was summarized by treatment for subjects in the Safety Set. An independent Mortality Adjudication Board was used to evaluate all deaths that occurred in the study and for assigning cause of death and COPD-relatedness.
Measured: 0 to 52 weeks
Kaplan-Meier Probability of Respiratory Death, First COPD-Related Emergency Room Visit, or First COPD Exacerbation-Related Hospitalisation at 52 Weeks
The primary endpoint was the combined incidence of respiratory death, first COPD-related ER visit or first COPD exacerbation-related hospitalization (whichever occurred first from the time of randomization to the end of the study). The time-to-first event was measured and analyzed in units of weeks and was summarized by treatment for subjects in the Safety Set. An independent Mortality Adjudication Board was used to evaluate all deaths that occurred in the study and for assigning cause of death and COPD-relatedness.
Measured: 0 to 52 weeks
Secondary outcomes (12)
Summary of All Cause Mortality, COPD Related Mortality and Respiratory Related Mortality
An independent Mortality Adjudication Board was used to evaluate all deaths that occurred in the study and for assigning cause of death and COPD-relatedness.
Measured: 0 to 52 weeks
Individual Components of the Primary Composite Endpoint - First COPD-related ER Visit and First COPD Exacerbation-Related Hospitalization
Measured: 0 to 52 weeks
Number of Subjects With Protocol-Defined COPD Exacerbation
COPD exacerbations were defined as events in the natural course of disease characterized by an increase from baseline in two of the following symptoms: dyspnea, cough, and sputum production that was beyond normal day-to-day variations, was acute in onset, that persisted for at least two consecutive days, and that warranted a change in their regular medication. The change could be either the initiation of additional treatment(s) or the intensification of a treatment the subject was already receiving, and the change must have been specifically to address the exacerbation event. COPD exacerbations occurring after the time of withdrawal or completion of the study were not included.
Measured: 0 to 52 weeks
Kaplan-Meier Probability of Protocol Defined COPD Exacerbation at 52 Weeks
COPD exacerbations were defined as events in the natural course of disease characterized by an increase from baseline in two of the following symptoms: dyspnea, cough, and sputum production that was beyond normal day-to-day variations, was acute in onset, that persisted for at least two consecutive days, and that warranted a change in their regular medication.The change could be either the initiation of additional treatment(s) or the intensification of a treatment the subject was already receiving, and the change must have been specifically to address the exacerbation event. COPD exacerbations occurring after the time of withdrawal or completion of the study were not included.
Measured: 0 to 52 weeks
FEV1 Changes From Baseline at Months 3, 6, 9 and 12
Measured: On treatment at months 3, 6, 9 and 12
FVC Changes From Baseline at Months 3, 6, 9 and 12
Measured: On treatment at months 3, 6, 9 and 12
IC Changes From Baseline at Months 3, 6, 9 and 12
Measured: On treatment at months 3, 6, 9 and 12
Saint Georges Respiratory Questionnaire Scores: Changes From Baseline at Months 3, 6, 9, 12
Saint Georges Respiratory Questionnaire comprises 50 items in 3 sections, Symptoms, Activity, Impact, measuring health status in chronic airflow limitation. Symptoms captures level of symptomatology. Activity and Impact responses are either "yes" or "no". Scoring is from 0 to 100; 0 = no life quality impairment. A summary score for all items is calculated and ranges from 0 to 100, where 0 indicates best possible health status, 100 represents worst possible health status. Scores are calculated using weights attached to each item in the questionnaire - 4 unit changes are clinically meaningful.
Measured: On treatment at months 3, 6, 9 and 12
Transition Dyspnea Index
The Transition Dyspnea Index (TDI) measures changes in dyspnea severity from the baseline as established by the BDI. It has 3 components: change in functional impairment, change in magnitude of task, and change in magnitude of effort, and each component is rated on a scale ranging from -3 (major deterioration) to +3 (major improvement). The 3 components are summed to provide a total score ranging from -9 to +9. The lower the score, the more deterioration in severity of dyspnea.
Measured: On treatment at months 3, 6, 9 and 12
Health Care Utilization and Economic Impact - Number of Emergency Department Visits
Measured: 0 to 52 weeks
Summary of Subjects Requiring Intubation or Non-Invasive Ventilation
Measured: 0 to 52 weeks
Rescue Medication Usage
Number of puffs of rescue medication (albuterol pMDI) used per day
Measured: 0 to 52 weeks
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted8 Dec 2011 (estimated)
- Study startMar 2012
- Primary completionJan 2016
- Study completionJan 2016
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 4
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Quadruple blind
- Who is masked
- Participant, Care provider, Investigator, Outcomes assessor
- Enrolment
- 1,071 participants (actual)
Sponsor and investigators
- Lead sponsor
- Dey
- Sponsor type
- Industry (pharma, biotech, devices)
- Responsible party
- Sponsor
- Investigators
- Dik Ng, Study director, Mylan Pharma UK Ltd.
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT01488019
- Sponsor's protocol ID
- 201-085
- Status last verified
- May 2017
- First submitted
- 29 Nov 2011
- Last updated
- 12 Jun 2017
- Results posted
- Yes, on ClinicalTrials.gov
- Data monitoring committee
- No
- Individual data sharing
- No
Study at a glance
From the registry record, last updated by the sponsor on 12 Jun 2017. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- A Randomized, Double-blind, Placebo-controlled Study to Evaluate the Safety of Long-Term Use of Perforomist® (Formoterol Fumarate) Inhalation Solution in Subjects With Chronic Obstructive Pulmonary Disease (COPD)
- ClinicalTrials.gov ID
- NCT01488019
- Acronym / sponsor ID
- 201-085
- Conditions
- COPD
- Phase
- Phase 4
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 1,071 participants (actual)
- Lead sponsor
- DeyIndustry (pharma, biotech, devices)
- Study start
- Mar 2012
- Primary completion
- Jan 2016 (actual)
- Study completion
- Jan 2016 (actual)
- First posted
- 8 Dec 2011 (estimated)
- Results
- Posted 12 Jun 2017
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
This study is a multi-center, randomized, placebo-controlled study to evaluate the long-term safety of Perforomist® inhalation therapy in subjects with Chronic Obstructive Pulmonary Disease (COPD). Individual participation is approximately 54 weeks, including 52 weeks of double-blind treatment.
Detailed description
None provided.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Quadruple blind (participant, care provider, investigator, outcomes assessor)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Perforomist, nebulization, COPD | Experimental | Drug: Perforomist, nebulization, COPDActive |
| Perforomist-Placebo | Placebo comparator | Drug: Perforomist-PlaceboPlacebo |
Who may qualify
- Ages
- 40 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (5 listed)
- Able to understand the study requirements, provide written informed consent, and agree to abide by the study protocol and its restrictions
- Male and female subjects at least 40 years of age with a medical diagnosis of COPD (i.e. persistent presence of dyspnea, cough or sputum production and a history of exposure to risk factors for the disease, such as tobacco smoke)
- A current or prior history of at least 10 pack-years of cigarette smoking and a baseline breathlessness severity grade of >=2 (Modified Medical Research Council [MMRC] Dyspnea Scale Score) at randomization.
- Women of child-bearing potential (WOCBP) must have a negative pregnancy test at the screening visit and agree to avoid becoming pregnant for the duration of study by using adequate contraception at study entry and throughout the trial. WOCBP will be advised to notify the Investigator of any change in their pregnancy status. WOCBP include: any female who has experienced menarche and is not post-menopausal (defined as amenorrhea for at least 12 consecutive months), or has not undergone surgical sterilization (hysterectomy, bilateral oophorectomy, or bilateral tubal ligation). Women who are using acceptable contraceptive medications or devices to prevent pregnancy or practicing abstinence or where partner is sterile (e.g., vasectomy) will be considered WOCBP.
- Able to complete all aspects of the study through the end of the study, including all visits and tests, and self-administration of study medications.
Key exclusion criteria (7 listed)
- A medical diagnosis of asthma. Indication of a past history of asthma that is deemed inaccurate to a subject's current condition by the Investigator must be adequately addressed in the medical history.
- Clinically significant abnormal chest x-ray (CXR) (within the past 12 months) diagnostic of active/significant disease other than COPD.
- Evidence of any unstable or clinically significant hematopoietic, malignant, cardiovascular, hepatic, renal, neurologic, psychiatric, autoimmune disorder, or condition or disease other than COPD that, in the opinion of the Investigator, could place the subject at increased risk of complications, interfere with study participation, or confound any of the study objectives.
- Subjects who had radiation or chemotherapy within the previous 12 months.
- An abnormal laboratory test at screening deemed clinically significant and exclusionary by the Investigator.
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 |
|---|---|---|
| Perforomist-PlaceboAlso: PerforomistPlacebo vehicle, 2mL, twice daily for 52 weeks | Drug | Perforomist-Placebo |
| Perforomist, nebulization, COPDAlso: Formoterol fumaratePerforomist, 20 mcg/2 mL, twice daily for 52 weeks | Drug | Perforomist, nebulization, COPD |
Primary outcome
Number of Subjects With a Primary Event of Respiratory Death, First COPD-Related Emergency Room Visit, or First COPD Exacerbation-Related Hospitalisation
Time frame: 0 to 52 weeks
The primary endpoint was the combined incidence of respiratory death, first COPD-related ER visit or first COPD exacerbation-related hospitalization (whichever occurred first from the time of randomization to the end of the study). The time-to-first event was measured and analyzed in units of weeks and was summarized by treatment for subjects in the Safety Set. An independent Mortality Adjudication Board was used to evaluate all deaths that occurred in the study and for assigning cause of death and COPD-relatedness.
Kaplan-Meier Probability of Respiratory Death, First COPD-Related Emergency Room Visit, or First COPD Exacerbation-Related Hospitalisation at 52 Weeks
Time frame: 0 to 52 weeks
The primary endpoint was the combined incidence of respiratory death, first COPD-related ER visit or first COPD exacerbation-related hospitalization (whichever occurred first from the time of randomization to the end of the study). The time-to-first event was measured and analyzed in units of weeks and was summarized by treatment for subjects in the Safety Set. An independent Mortality Adjudication Board was used to evaluate all deaths that occurred in the study and for assigning cause of death and COPD-relatedness.
12 secondary outcomes
Summary of All Cause Mortality, COPD Related Mortality and Respiratory Related Mortality
Time frame: 0 to 52 weeks
Individual Components of the Primary Composite Endpoint - First COPD-related ER Visit and First COPD Exacerbation-Related Hospitalization
Time frame: 0 to 52 weeks
Number of Subjects With Protocol-Defined COPD Exacerbation
Time frame: 0 to 52 weeks
Kaplan-Meier Probability of Protocol Defined COPD Exacerbation at 52 Weeks
Time frame: 0 to 52 weeks
FEV1 Changes From Baseline at Months 3, 6, 9 and 12
Time frame: On treatment at months 3, 6, 9 and 12
FVC Changes From Baseline at Months 3, 6, 9 and 12
Time frame: On treatment at months 3, 6, 9 and 12
IC Changes From Baseline at Months 3, 6, 9 and 12
Time frame: On treatment at months 3, 6, 9 and 12
Saint Georges Respiratory Questionnaire Scores: Changes From Baseline at Months 3, 6, 9, 12
Time frame: On treatment at months 3, 6, 9 and 12
Transition Dyspnea Index
Time frame: On treatment at months 3, 6, 9 and 12
Health Care Utilization and Economic Impact - Number of Emergency Department Visits
Time frame: 0 to 52 weeks
Summary of Subjects Requiring Intubation or Non-Invasive Ventilation
Time frame: 0 to 52 weeks
Rescue Medication Usage
Time frame: 0 to 52 weeks
Results and safety
Loading the posted results from ClinicalTrials.gov…
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 12 Jun 2017.
- 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.
Dik Ng study director
Mylan Pharma UK 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 Perforomist, nebulization, COPD in people with COPD, run by Dey at 1 site 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 5 inclusion and 7 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 12 Jun 2017. 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 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 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?
Yes. Results are posted in the registry (first posted 12 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?
Number of Subjects With a Primary Event of Respiratory Death, First COPD-Related Emergency Room Visit, or First COPD Exacerbation-Related Hospitalisation (time frame: 0 to 52 weeks). 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?
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 12 Jun 2017; AzTrials last refreshed its copy on 6 Nov 2026.