Pulmonary Disease, Chronic ObstructivePhase 4NCT01663987
Investigate the Impact of Early Treatment Initiation With Tiotropium in Patients Recovering From Hospitalization for an Acute COPD Exacerbation 1
A Phase 4 study testing tiotropium bromide in people with Pulmonary Disease, Chronic Obstructive, run by Boehringer Ingelheim at 50 sites in 2 countries.
Trial summary
A randomized, placebo-controlled, double-blind, parallel group, multi center study to assess the safety and efficacy of tiotropium bromide (18 µg) delivered via the HandiHaler® in Chronic Obstructive Pulmonary Disease (COPD) subjects recovering from hospitalization for an acute exacerbation (Hospital Discharge 1) Read more about this study
- Who is it for?
- Ages 40 years and older
- Conditions the study is for
- Pulmonary Disease, Chronic Obstructive
- What is being tested?
- tiotropium bromide
- Type of treatment
- Pill or oral medicine
- Could I receive a placebo?
- Yes, some participants may receive a placebo
- How many people
- 79 participants
- Where
- 50 sitesin 2 countries
- Study dates
- 1 Aug 2012to 1 May 2014
- 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
- The following inclusion criteria apply at Visit 0:
- All subjects must sign an informed consent consistent with the International Conference on Harmonization - Good Clinical Practice (ICH-GCP) guidelines prior to participation in the trial and conducting any study procedures.
- Male or female subjects 40 years of age or older.
- Hospitalization for a primary diagnosis of acute COPD exacerbation for =14 days. Determination of accuracy of admission diagnosis will be at the discretion of the investigator.
- Patient reported hospital length of stay and discharge date (confirmed with hospital discharge summary/hospital records; however, medical record confirmation may occur following randomization).
- The following inclusion criteria apply at Visit 1:
Show all 10Show fewer
- Discharged from the hospital =10 days from date of randomization.
- All subjects must have a diagnosis of COPD (P12-01205), and have documented airway obstruction with a post-bronchodilator Force expiratory volume in 1 second (FEV1)/Force vital capacity (FVC )<0.7(See Section 5.1.2, Pulmonary Function Testing). The diagnosis of COPD can be made at Visit 1 if no Pulmonary Function Testing (PFT) data available within the past 12 months.
- Subjects must be current or ex-smoker with a smoking history of =10 pack-years:
- Pack-years = Number of cigarettes/day x years of smoking 20 cigarettes/ pack 8. Subjects must be able to inhale medication in a competent manner from the HandiHaler® device (Appendix 10.1) and from a metered dose inhaler (MDI).
Who cannot join
- The following exclusion criterion applies at Visit 0:
- No more than 30 days of therapy with any long-acting inhaled anticholinergic over preceding 3 months prior to discharge from the hospital, and no therapy with any long acting anticholinergic post discharge (no use between hospital discharge and randomization) or any other restricted concomitant medications
- The following exclusion criteria apply at Visit 1:
- Presence of a significant disease (in the opinion of the investigator) which may put the subject at risk because of participation in the study or may influence the subject's ability to participate in the study for up to 2 years.
- A documented history of myocardial infarction during the hospitalization preceding randomization. Subjects being stable with a history of cardiac stents are permitted.
- Any unstable or life-threatening cardiac arrhythmia requiring intervention or change in drug therapy during the last year.
Show all 15Show fewer
- Subjects with asthma (subject treated for asthma in the last 2 years, history of childhood asthma is permitted), cystic fibrosis, clinical diagnosis of bronchiectasis, interstitial lung disease, pulmonary thromboembolic disease or known active tuberculosis.
- 7. Malignancy for which the subject has undergone resection, radiation, chemotherapy or biological treatments within the last two years or is currently on active radiation therapy, chemotherapy or biological treatment. Subjects with treated basal cell carcinoma and non-invasive squamous cell skin carcinoma are allowed.
- 8. Hospitalization for cardiac failure (New York Heart Association (NYHA) class III or IV) during the hospitalization preceding randomization.
- 9. Known hypersensitivity to anticholinergic drugs, lactose, or any other components of the HandiHaler® or MDI inhalation solution delivery system.
- 10. Known moderate to severe renal impairment as judged by the investigator. 11. Known narrow angle glaucoma as judged by the investigator. 12. Significant symptomatic prostatic hyperplasia or bladder-neck obstruction. Subjects whose symptoms are controlled on treatment may be included. 13. Pregnant or nursing women or women of childbearing potential not using a medically approved means of contraception (i.e., oral contraceptives, intrauterine devices, diaphragm or sub dermal implants e.g., Norplant) for at least three months prior to and for the duration of the trial.
- 14. Significant alcohol or drug abuse within the past 12 months. 15. Previously randomized in this study or currently participating in another interventional study.
- 16. Visual impairment that as judged by the investigator does not allow the subject to independently read and complete the questionnaires and eDiary.
- 17. Any significant or new ECG findings at Visit 1 as judged by the investigator, including, but not limited to signs of acute ischemia, arrhythmia.
- 18. Treatment with any restricted pulmonary medication. 19. Residing in an assisted living facility.
Trial locations and contacts
50 sites in 2 countries.
50 sites in 2 countries
United States49 sites
205.477.001030 Boehringer Ingelheim Investigational Site
Abingdon, Virginia
205.477.001028 Boehringer Ingelheim Investigational Site
Anderson, South Carolina
205.477.001007 Boehringer Ingelheim Investigational Site
Baltimore, Maryland
205.477.001064 Boehringer Ingelheim Investigational Site
Belleville, Illinois
205.477.001039 Boehringer Ingelheim Investigational Site
Birmingham, Alabama
205.477.001050 Boehringer Ingelheim Investigational Site
Birmingham, Alabama
205.477.001051 Boehringer Ingelheim Investigational Site
Brandon, Florida
205.477.001027 Boehringer Ingelheim Investigational Site
Burlington, North Carolina
205.477.001019 Boehringer Ingelheim Investigational Site
Charleston, South Carolina
205.477.001034 Boehringer Ingelheim Investigational Site
Cincinnati, Ohio
205.477.001044 Boehringer Ingelheim Investigational Site
Clearwater, Florida
205.477.001014 Boehringer Ingelheim Investigational Site
Columbia, Maryland
205.477.001053 Boehringer Ingelheim Investigational Site
Columbus, Ohio
205.477.001035 Boehringer Ingelheim Investigational Site
Cooperstown, New York
205.477.001022 Boehringer Ingelheim Investigational Site
Corsicana, Texas
205.477.001011 Boehringer Ingelheim Investigational Site
Dayton, Ohio
205.477.001004 Boehringer Ingelheim Investigational Site
Decatur, Georgia
205.477.001083 Boehringer Ingelheim Investigational Site
Downingtown, Pennsylvania
205.477.001012 Boehringer Ingelheim Investigational Site
Duluth, Georgia
205.477.001037 Boehringer Ingelheim Investigational Site
Eustis, Florida
205.477.001021 Boehringer Ingelheim Investigational Site
Florence, Alabama
205.477.001010 Boehringer Ingelheim Investigational Site
Fort Mill, South Carolina
205.477.001055 Boehringer Ingelheim Investigational Site
Fort Worth, Texas
205.477.001046 Boehringer Ingelheim Investigational Site
Fountain Valley, California
205.477.001025 Boehringer Ingelheim Investigational Site
Gaffney, South Carolina
205.477.001032 Boehringer Ingelheim Investigational Site
Huntersville, North Carolina
205.477.001054 Boehringer Ingelheim Investigational Site
Katy, Texas
205.477.001018 Boehringer Ingelheim Investigational Site
Livonia, Michigan
205.477.001017 Boehringer Ingelheim Investigational Site
Miami, Florida
205.477.001063 Boehringer Ingelheim Investigational Site
Miami, Florida
205.477.001031 Boehringer Ingelheim Investigational Site
Monroeville, Pennsylvania
205.477.001038 Boehringer Ingelheim Investigational Site
Muncie, Indiana
205.477.001013 Boehringer Ingelheim Investigational Site
Nashville, Tennessee
205.477.001023 Boehringer Ingelheim Investigational Site
New York, New York
205.477.001006 Boehringer Ingelheim Investigational Site
Portland, Oregon
205.477.001008 Boehringer Ingelheim Investigational Site
Roanoke, Virginia
205.477.001002 Boehringer Ingelheim Investigational Site
Rock Hill, South Carolina
205.477.001052 Boehringer Ingelheim Investigational Site
Sacramento, California
205.477.001059 Boehringer Ingelheim Investigational Site
San Diego, California
205.477.001020 Boehringer Ingelheim Investigational Site
Seneca, North Carolina
205.477.001026 Boehringer Ingelheim Investigational Site
Spartanburg, South Carolina
205.477.001001 Boehringer Ingelheim Investigational Site
St. Petersburg, Florida
205.477.001009 Boehringer Ingelheim Investigational Site
Stamford, Connecticut
205.477.001061 Boehringer Ingelheim Investigational Site
Staten Island, New York
205.477.001057 Boehringer Ingelheim Investigational Site
Tulsa, Oklahoma
205.477.001062 Boehringer Ingelheim Investigational Site
Tyler, Texas
205.477.001068 Boehringer Ingelheim Investigational Site
Union, New Jersey
205.477.001015 Boehringer Ingelheim Investigational Site
Union, South Carolina
205.477.001040 Boehringer Ingelheim Investigational Site
Waterbury, Connecticut
Puerto Rico1 site
205.477.001043 Boehringer Ingelheim Investigational Site
San Juan
About this study
Official title: A Randomized, Placebo-controlled, Double-blind, Parallel Group, Multi Center Study to Assess the Safety and Efficacy of Tiotropium Bromide (18 µg) Delivered Via the HandiHaler® in Chronic Obstructive Pulmonary Disease (COPD) Subjects Recovering From Hospitalization for an Acute Exacerbation (Hospital Discharge Study 1)
A randomized, placebo-controlled, double-blind, parallel group, multi center study to assess the safety and efficacy of tiotropium bromide (18 µg) delivered via the HandiHaler® in Chronic Obstructive Pulmonary Disease (COPD) subjects recovering from hospitalization for an acute exacerbation (Hospital Discharge 1)
- Conditions
- Pulmonary Disease, Chronic Obstructive
- Being tested
- tiotropium bromide, Placebo
- 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.
tiotropium bromideDrug
18 mcg once a day (QD)
PlaceboDrug
once a day (QD)
| Study group | Role | What they receive |
|---|---|---|
| 18 mcg tiotropium | Active comparator | Patient to receive one tiotropium bromide inhalation powder capsule daily (in the morning) via HandiHaler Receives: Drug: tiotropium bromide |
| Placebo | Placebo comparator | Patient to receive one placebo capsule daily (in the morning) identical to those containing tiotropium bromide inhalation powder via HandiHaler Receives: Drug: Placebo |
What is being measured
The primary outcome is the main question the study is designed to answer.
Change From Baseline of Trough FEV1 at 12 Weeks on Study Drug
Change from baseline in trough forced expiratory volume in 1 second (FEV1) at 12 weeks on study medication. Trough FEV1 is defined as FEV1 measurement prior to the next dosing of study drug and approximately 24 hours after the last inhalation of drug.
Measured: Baseline and 12 weeks
Percentage of Patients With Next Adverse Clinical Outcome Event From the Two Twin Trials, Present 205.477 (NCT01663987) and 205.478 (NCT01662986)
Percentage of patients with next adverse clinical outcome event occured during the study, defined as the combined endpoint of chronic obstructive pulmonary disease (COPD) exacerbations per Boehringer Ingelheim (BI) definition, all-cause re-hospitalization, or all-cause mortality.
Time to the next adverse clinical outcome event from the two twin trials, was defined as a primary endpoint but was not analysed numerically, so this endpoint is presented instead.
This endpoint was analysed using combined data, as specified in the analysis plan.
Measured: From first drug administration to the last timepoint with information of clinical adverse outcome available, up to 2 years
Secondary outcomes (10)
Change From Baseline of Trough FVC at 12 Weeks on Study Drug
Change from baseline of trough Forced Vital Capacity (FVC) at 12 weeks on study drug.
Measured: Baseline and 12 weeks
Percentage of Patients With Adverse Clinical Event on Study
Percentage of patients with adverse clinical event during on study, which is defined as the combined endpoint of chronic obstructive pulmonary disease (COPD) exacerbations per Boehringer Ingelheim (BI) definition, all-cause re-hospitalisation, or all cause mortality.
Measured: From first drug administration to the last timepoint with information of clinical adverse outcome available, up to 2 years
Change From Baseline of Trough FEV1 at 12 Weeks on Study Drug From the Two Twin Trials, Present 205.477 (NCT01663987) and 205.478 (NCT01662986)
Change from baseline of Trough FEV1 (forced expiratory volume in one second) at 12 weeks on study drug.
Trough FEV1 is defined as the FEV1 measurement prior to the next dosing of study drug and approximately 24 hours after last inhalation of drug.
This endpoint was analysed using combined data, as specified in the analysis plan.
Measured: Baseline and 12 weeks
Change From Baseline of Trough FVC at 12 Weeks From the Two Twin Trials, Present 205.477 (NCT01663987) and 205.478 (NCT01662986)
Change from baseline of trough Forced Vital Capacity (FVC) at 12 weeks on study drug.
This endpoint was analysed using combined data, as specified in the analysis plan.
Measured: Baseline and 12 weeks
Percentage of Patients With COPD Exacerbation From the Two Twin Trials, Present 205.477 (NCT01663987) and 205.478 (NCT01662986)
Percentage of patients with COPD exacerbation on study was analysed for the combined study.
A COPD exacerbation was defined as a complex of lower respiratory events/symptoms (increase or new onset) related to the underlying COPD with duration of three days or more, requiring a change in treatment where a complex of lower respiratory events/symptoms was defined as at least two of the following: 1) Shortness of breath; 2) Sputum production (volume); 3)Occurrence of purulent sputum; 4) Cough; 5) Wheezing; 6) Chest tightness. Onset of exacerbation was defined by the onset of first recorded symptom.The end of exacerbation was decided by the investigator based on clinical judgment.
A required change in treatment included either prescription of antibiotics and/or systemic steroids; and a newly prescribed maintenance respiratory medication (i.e. bronchodilators including theophyllines and PDE4-inhibitors).
This endpoint was analysed using combined data, as specified in the analysis plan.
Measured: from first drug administration to the last timepoint with information of clinical adverse outcome available, up to 2 years
Percentage of Patients With All-cause Hospitalization From the Two Twin Trials, Present 205.477 (NCT01663987) and 205.478 (NCT01662986)
Percentage of patients with all-cause hospitalization outcome event occured during the study was analysed for the combined study.
All-cause hospitalization included all hospitalizations, except planned hospitalizations for elective procedures. Hospitalizations occurring on the same day as discharge were not considered a separate admission.
This endpoint was analysed using combined data, as specified in the analysis plan.
Measured: from first drug administration to the last timepoint with information of clinical adverse outcome available, Up to 2 years
Percentage of Patients With 30-day Readmission Rates Outcome Event From the Two Twin Trials, Present 205.477 (NCT01663987) and 205.478 (NCT01662986)
Percentage of patients with 30-day hospital readmission rates outcome events was analysed.
Days to hospital readmission were calculated as:Hospital readmission days = Readmission date - Date of hospital discharge + 1.
The 30-day hospital readmission analysis summarized the frequency of patients with hospital readmission and readmission days >1 and <31 days using the TS.
This endpoint was analysed using combined data, as specified in the analysis plan.
Measured: from date of hospital discharge prior to randomization up to readmission days >1 and <31 days
Number of COPD Exacerbation Events From the Two Twin Trials, Present 205.477 (NCT01663987) and 205.478 (NCT01662986)
Number of COPD exacerbation per patient year outcome event occured during the study was analysed descriptively by calculating average occurrence (number of events per patient year drug exposure) by treatment group for on study period using the TS.
This endpoint was analysed using combined data, as specified in the analysis plan.
Measured: Start of treatment to the last timepoint with information of clinical adverse outcome available, up to 2 years
Number of All-cause Hospitalization Event From the Two Twin Trials, Present 205.477 (NCT01663987) and 205.478 (NCT01662986)
Number of all-cause hospitalization per patient year outcome event occured during the study was analysed descriptively by calculating average occurrence (number of events per patient year drug exposure) by treatment group for on study period using the TS.
This endpoint was analysed using combined data, as specified in the analysis plan.
Measured: From first drug administration to the last timepoint with information of clinical adverse outcome available, up to 2 years
Time to Event: Time to Recovery (EXACT-PRO) From the Two Twin Trials, Present 205.477 (NCT01663987) and 205.478 (NCT01662986)
Time to event: Time to recovery based on EXACT-PRO total score. The percentage of observed patients recovered by end of study was reported.
Time to recovery was assessed with the EXACT-PRO questionnaire. EXACT-PRO total scores were transformed to smooth scores for determining time to recovery and all other endpoints related to the EXACT questionnaire. The day-2 score was transformed to the mean of the total scores recorded on Day 1, 2, and 3. Similarly, each subsequent day's score was transformed to the mean score using a rolling 3-day average.
Analysis based on Kaplan Meier estimate.
Measured: From first drug administration to the last timepoint with information of EXACT-PRO, up to 2 years
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted14 Aug 2012 (estimated)
- Study start1 Aug 2012
- Primary completion1 May 2014
- Study completion1 May 2014
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 Pulmonary Disease, Chronic ObstructiveStudies of the same condition, open and under way.
- More trials run by Boehringer IngelheimThe sponsor's other registered studies.
- 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
- Double blind
- Enrolment
- 79 participants (actual)
Sponsor and investigators
- Lead sponsor
- Boehringer Ingelheim
- Sponsor type
- Industry (pharma, biotech, devices)
- Responsible party
- Sponsor
- Investigators
- Boehringer Ingelheim, Study chair, Boehringer Ingelheim
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT01663987
- Sponsor's protocol ID
- 205.477
- Status last verified
- Sep 2018
- First submitted
- 9 Aug 2012
- Last updated
- 17 Oct 2018
- Results posted
- Yes, on ClinicalTrials.gov
Study at a glance
From the registry record, last updated by the sponsor on 17 Oct 2018. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- A Randomized, Placebo-controlled, Double-blind, Parallel Group, Multi Center Study to Assess the Safety and Efficacy of Tiotropium Bromide (18 µg) Delivered Via the HandiHaler® in Chronic Obstructive Pulmonary Disease (COPD) Subjects Recovering From Hospitalization for an Acute Exacerbation (Hospital Discharge Study 1)
- ClinicalTrials.gov ID
- NCT01663987
- Acronym / sponsor ID
- 205.477
- Conditions
- Pulmonary Disease, Chronic Obstructive
- Phase
- Phase 4
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 79 participants (actual)
- Lead sponsor
- Boehringer IngelheimIndustry (pharma, biotech, devices)
- Study start
- 1 Aug 2012 (actual)
- Primary completion
- 1 May 2014 (actual)
- Study completion
- 1 May 2014 (actual)
- First posted
- 14 Aug 2012 (estimated)
- Results
- Posted 9 Jul 2015
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
A randomized, placebo-controlled, double-blind, parallel group, multi center study to assess the safety and efficacy of tiotropium bromide (18 µg) delivered via the HandiHaler® in Chronic Obstructive Pulmonary Disease (COPD) subjects recovering from hospitalization for an acute exacerbation (Hospital Discharge 1)
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Double blind
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| 18 mcg tiotropium | Active comparator | Drug: tiotropium bromidePatient to receive one tiotropium bromide inhalation powder capsule daily (in the morning) via HandiHaler |
| Placebo | Placebo comparator | Drug: PlaceboPatient to receive one placebo capsule daily (in the morning) identical to those containing tiotropium bromide inhalation powder via HandiHaler |
Who may qualify
- Ages
- 40 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (10 listed)
- All subjects must sign an informed consent consistent with the International Conference on Harmonization - Good Clinical Practice (ICH-GCP) guidelines prior to participation in the trial and conducting any study procedures.
- Male or female subjects 40 years of age or older.
- Hospitalization for a primary diagnosis of acute COPD exacerbation for =14 days. Determination of accuracy of admission diagnosis will be at the discretion of the investigator.
- Patient reported hospital length of stay and discharge date (confirmed with hospital discharge summary/hospital records; however, medical record confirmation may occur following randomization).
- Discharged from the hospital =10 days from date of randomization.
Key exclusion criteria (15 listed)
- No more than 30 days of therapy with any long-acting inhaled anticholinergic over preceding 3 months prior to discharge from the hospital, and no therapy with any long acting anticholinergic post discharge (no use between hospital discharge and randomization) or any other restricted concomitant medications
- Presence of a significant disease (in the opinion of the investigator) which may put the subject at risk because of participation in the study or may influence the subject's ability to participate in the study for up to 2 years.
- A documented history of myocardial infarction during the hospitalization preceding randomization. Subjects being stable with a history of cardiac stents are permitted.
- Any unstable or life-threatening cardiac arrhythmia requiring intervention or change in drug therapy during the last year.
- Subjects with asthma (subject treated for asthma in the last 2 years, history of childhood asthma is permitted), cystic fibrosis, clinical diagnosis of bronchiectasis, interstitial lung disease, pulmonary thromboembolic disease or known active tuberculosis.
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 |
|---|---|---|
| tiotropium bromide18 mcg once a day (QD) | Drug | 18 mcg tiotropium |
| Placeboonce a day (QD) | Drug | Placebo |
Primary outcome
Change From Baseline of Trough FEV1 at 12 Weeks on Study Drug
Time frame: Baseline and 12 weeks
Change from baseline in trough forced expiratory volume in 1 second (FEV1) at 12 weeks on study medication. Trough FEV1 is defined as FEV1 measurement prior to the next dosing of study drug and approximately 24 hours after the last inhalation of drug.
Percentage of Patients With Next Adverse Clinical Outcome Event From the Two Twin Trials, Present 205.477 (NCT01663987) and 205.478 (NCT01662986)
Time frame: From first drug administration to the last timepoint with information of clinical adverse outcome available, up to 2 years
Percentage of patients with next adverse clinical outcome event occured during the study, defined as the combined endpoint of chronic obstructive pulmonary disease (COPD) exacerbations per Boehringer Ingelheim (BI) definition, all-cause re-hospitalization, or all-cause mortality. Time to the next adverse clinical outcome event from the two twin trials, was defined as a primary endpoint but was not analysed numerically, so this endpoint is presented instead. This endpoint was analysed using combined data, as specified in the analysis plan.
10 secondary outcomes
Change From Baseline of Trough FVC at 12 Weeks on Study Drug
Time frame: Baseline and 12 weeks
Percentage of Patients With Adverse Clinical Event on Study
Time frame: From first drug administration to the last timepoint with information of clinical adverse outcome available, up to 2 years
Change From Baseline of Trough FEV1 at 12 Weeks on Study Drug From the Two Twin Trials, Present 205.477 (NCT01663987) and 205.478 (NCT01662986)
Time frame: Baseline and 12 weeks
Change From Baseline of Trough FVC at 12 Weeks From the Two Twin Trials, Present 205.477 (NCT01663987) and 205.478 (NCT01662986)
Time frame: Baseline and 12 weeks
Percentage of Patients With COPD Exacerbation From the Two Twin Trials, Present 205.477 (NCT01663987) and 205.478 (NCT01662986)
Time frame: from first drug administration to the last timepoint with information of clinical adverse outcome available, up to 2 years
Percentage of Patients With All-cause Hospitalization From the Two Twin Trials, Present 205.477 (NCT01663987) and 205.478 (NCT01662986)
Time frame: from first drug administration to the last timepoint with information of clinical adverse outcome available, Up to 2 years
Percentage of Patients With 30-day Readmission Rates Outcome Event From the Two Twin Trials, Present 205.477 (NCT01663987) and 205.478 (NCT01662986)
Time frame: from date of hospital discharge prior to randomization up to readmission days >1 and <31 days
Number of COPD Exacerbation Events From the Two Twin Trials, Present 205.477 (NCT01663987) and 205.478 (NCT01662986)
Time frame: Start of treatment to the last timepoint with information of clinical adverse outcome available, up to 2 years
Number of All-cause Hospitalization Event From the Two Twin Trials, Present 205.477 (NCT01663987) and 205.478 (NCT01662986)
Time frame: From first drug administration to the last timepoint with information of clinical adverse outcome available, up to 2 years
Time to Event: Time to Recovery (EXACT-PRO) From the Two Twin Trials, Present 205.477 (NCT01663987) and 205.478 (NCT01662986)
Time frame: From first drug administration to the last timepoint with information of EXACT-PRO, up to 2 years
Results and safety
Loading the posted results from ClinicalTrials.gov…
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 17 Oct 2018.
- Posted resultsParticipant flow, baseline, all outcome measures and adverse events.
- Related InfoLink provided by the sponsor.
Related trials for Pulmonary Disease, Chronic Obstructive
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.
Boehringer Ingelheim study chair
Boehringer Ingelheim
50 sites in 2 countries: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 4 study testing tiotropium bromide in people with Pulmonary Disease, Chronic Obstructive, run by Boehringer Ingelheim at 50 sites in 2 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 10 inclusion and 15 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 17 Oct 2018. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 50 sites in United States, Puerto Rico. 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 9 Jul 2015). 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?
Change From Baseline of Trough FEV1 at 12 Weeks on Study Drug (time frame: Baseline and 12 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 17 Oct 2018.