Pulmonary Disease, Chronic ObstructivePhase 4NCT01483625
Tiotropium (18mcg) in Chronic Obstructive Pulmonary Disease (COPD) Patients With a Respiratory Infection
A Phase 4 study testing tiotropium in people with Pulmonary Disease, Chronic Obstructive, run by Boehringer Ingelheim at 27 sites in United States.
Trial summary
The aim of the study is to investigate whether the early introduction of maintenance bronchodilator therapy during an acute symptomatic episode of the disease shows benefits on the recovery of symptoms. 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
- Could I receive a placebo?
- Yes, some participants may receive a placebo
- How many people
- 140 participants
- Where
- 27 sitesUnited States
- Study dates
- Nov 2011to Dec 2012
- 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
- All patients must sign an informed consent consistent with International Conference on Harmonization - Good Clinical Practice (ICH-GCP) guidelines prior to participation in the trial and conducting any study procedures.
- Male or female patients 40 years of age or older.
- Ability to independently read and understand English and/or Spanish.
- Any self-reported history of smoking (e.g. = 100 cigarettes (~5 packs) during life-time).
- Acute respiratory symptoms for up to 7 days
- All patients must have a diagnosis of COPD, and must have an airway obstruction with a post-bronchodilator (Forced Expiratory Volume in 1 second (FEV1)/Forced Vital Capacity (FVC)) <0.7. The diagnosis of COPD can be made at Visit 1.
- The clinical assessment of the enrolled patient in the judgement of the investigator supports the introduction of COPD maintenance therapy.
- Patients must be able to inhale medication in a competent manner from the HandiHaler® device and from a metered dose inhaler (MDI)
Who cannot join
- Therapy with any long-acting bronchodilator, short-acting anticholinergic, inhaled corticosteroid or regular maintenance use (>14 consecutive days) of systemic corticosteroid (the latter for respiratory indications) during the previous 6 months (short course of systemic corticosteroid for up to 14 days for respiratory indications allowed); in case of use of systemic corticosteroid medication for other than respiratory conditions, then exclusion of unstable doses (i.e., less than six weeks on stable dose) or at doses in excess of the equivalent of 10 mg prednisolone-equivalent per day. In addition, daily use of short-acting beta2-agonist for more than a week prior to Visit 0 not allowed.
- The following exclusion criteria apply at Visit 1:
- Significant diseases other than COPD. A significant disease is defined as a disease or condition which, in the opinion of the investigator, may put the patient at risk because of participation in the study or may influence the patient¿s ability to participate in the study.
- A recent history (i.e., six months or less) of myocardial infarction. Patients being stable with a history of cardiac stents prior to six month are permitted.
- Any unstable or life-threatening cardiac arrhythmia requiring intervention or change in drug therapy during the last year.
- Hospitalisation for cardiac failure (New York Heart Association (NYHA) Class III or IV) during the past year.
Show all 23Show fewer
- Any significant or new ECG findings at V1 as judged by the investigator, including, but not limited to signs of ischemia, arrhythmia, heart failure, or the report of chest pain.
- Known active tuberculosis.
- Current asthma (patient treated for asthma in the last 2 years), cystic fibrosis, clinical diagnosis of bronchiectasis, interstitial lung disease, or pulmonary thromboembolic disease.
- A history of thoracotomy with pulmonary resection. Patients with a history of thoracotomy for other reasons should be evaluated as per exclusion criterion no. 2.
- Malignancy for which the patient has undergone resection, radiation, chemotherapy or biological treatments within the last year or is currently on active radiation therapy, chemotherapy or biological treatment. Patients with treated basal cell carcinoma are allowed.
- At visit 0 or 1, a severe respiratory infection, e.g. pneumonia (as suspected by investigator), any condition or exacerbation requiring ER visit or hospitalization, need for oxygen treatment.
- Known hypersensitivity to anticholinergic drugs, lactose, or any other components of the HandiHaler® or MDI inhalation solution delivery system.
- Treatment with any restricted pulmonary medication
- Requirement of supplemental oxygen therapy for = 24 hours during the previous 6 months.
- Known moderate to severe renal impairment.
- Known narrow angle glaucoma.
- Significant symptomatic prostatic hyperplasia or bladder-neck obstruction. Patients whose symptoms are controlled on treatment may be included.
- 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 subdermal implants e.g., Norplant®) for at least three months prior to and for the duration of the trial.
- Significant alcohol or drug abuse within the past 12 months.
- Actively participating in a pulmonary rehabilitation program.
- Previously randomized in this study or currently participating in another interventional study.
- Visual impairment that as judged by the investigator does not allow the patient to independently read and complete the questionnaires and electronic diary (eDiary).
Trial locations and contacts
27 sites in 1 country.
27 sites in 1 country
United States27 sites
205.479.01006 Boehringer Ingelheim Investigational Site
Charleston, South Carolina
205.479.01033 Boehringer Ingelheim Investigational Site
Chattanooga, Tennessee
205.479.01022 Boehringer Ingelheim Investigational Site
Chelsea, Michigan
205.479.01003 Boehringer Ingelheim Investigational Site
Cincinnati, Ohio
205.479.01001 Boehringer Ingelheim Investigational Site
Columbia, South Carolina
205.479.01043 Boehringer Ingelheim Investigational Site
DeLand, Florida
205.479.01007 Boehringer Ingelheim Investigational Site
Easley, South Carolina
205.479.01038 Boehringer Ingelheim Investigational Site
Ettrick, Virginia
205.479.01026 Boehringer Ingelheim Investigational Site
Fort Mill, South Carolina
205.479.01031 Boehringer Ingelheim Investigational Site
Gaffney, South Carolina
205.479.01012 Boehringer Ingelheim Investigational Site
Greenville, South Carolina
205.479.01048 Boehringer Ingelheim Investigational Site
Hodges, South Carolina
205.479.01028 Boehringer Ingelheim Investigational Site
Killeen, Texas
205.479.01047 Boehringer Ingelheim Investigational Site
Norfolk, Virginia
205.479.01041 Boehringer Ingelheim Investigational Site
Picayune, Mississippi
205.479.01002 Boehringer Ingelheim Investigational Site
Pittsburgh, Pennsylvania
205.479.01039 Boehringer Ingelheim Investigational Site
Rapid City, South Dakota
205.479.01036 Boehringer Ingelheim Investigational Site
Riverside, California
205.479.01024 Boehringer Ingelheim Investigational Site
San Diego, California
205.479.01004 Boehringer Ingelheim Investigational Site
Spartanburg, South Carolina
205.479.01037 Boehringer Ingelheim Investigational Site
St Louis, Missouri
205.479.01040 Boehringer Ingelheim Investigational Site
St. Petersburg, Florida
205.479.01005 Boehringer Ingelheim Investigational Site
Tabor City, North Carolina
205.479.01044 Boehringer Ingelheim Investigational Site
Tipton, Pennsylvania
205.479.01017 Boehringer Ingelheim Investigational Site
Tucson, Arizona
205.479.01019 Boehringer Ingelheim Investigational Site
Union, South Carolina
205.479.01008 Boehringer Ingelheim Investigational Site
Wilmington, North Carolina
About this study
Official title: A 12-week, Randomised, Placebo-controlled, Double-blind, Parallel Group, Multi-center Trial to Assess the Efficacy and Safety of Tiotropium Bromide (18 µg) Delivered Via the HandiHaler® in Patients With Newly Diagnosed and/or Maintenance Treatment naïve Chronic Obstructive Pulmonary Disease (COPD) Experiencing an Acute Respiratory Infection (TICARI 1: Tiotropium In COPD Patients With an Acute Respiratory Infection 1)
The aim of the study is to investigate whether the early introduction of maintenance bronchodilator therapy during an acute symptomatic episode of the disease shows benefits on the recovery of symptoms. It also represents an opportunity to identify COPD patients earlier in their disease state and start maintenance therapy, if appropriate.
- Conditions
- Pulmonary Disease, Chronic Obstructive
- Being tested
- tiotropium, 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.
tiotropiumDrug
18mcg
PlaceboDrug
placebo
| Study group | Role | What they receive |
|---|---|---|
| tiotropium 18mcg | Experimental | active Receives: Drug: tiotropium |
| Placebo | Placebo comparator | placebo Receives: Drug: Placebo |
What is being measured
The primary outcome is the main question the study is designed to answer.
Trough FEV1 After 12 Weeks on Study Drug
The primary endpoint was trough forced expiratory volume in 1 second (FEV1) after 12 weeks on study drug. Trough forced expiratory volume in 1 second (FEV1)was defined as the FEV1 measurement prior to the next dosing of study drug and approximately 24 hours after the last inhalation of study drug.
Measured: 12 weeks
Secondary outcomes (5)
Time to Recovery From Acute Respiratory Symptoms
Time to recovery was assessed with the EXACT-PRO questionnaire tool. The EXACT-PRO was designed to collect data to quantify frequency, severity, and duration of exacerbations in patients with COPD including the onset of and the recovery from COPD exacerbations.
The EXACT-PRO is a 14-item questionnaire. Each attribute or item was assessed on a five- or six-point ordinal scale and summed to yield a total score that was converted to a 0-100 scale, with higher scores indicating a more severe health state or exacerbation.
The EXACT-PRO was answered by the patients on a daily basis in the evening.
Measured: 12 weeks
Trough FVC (in Litres) at 12 Weeks
The trough Forced Vital Capacity (FVC) was defined as the FVC measurement prior to the next dosing of study drug and approximately 24 hours after the last inhalation of study drug.
Measured: 12 weeks
Responder Status at Week 4 Clinic Visit
Responder status was determined at each clinic visit. The number and percentage of subjects in each of the following 3 classes were presented:
- Subject recovered without change of therapy (subjects who received an additional course of antibiotics and/or systemic corticosteroids starting after Visit 1 were not included).
- Subject recovered but had a change in therapy (subject received an additional course of antibiotics and/or systemic corticosteroids starting after Visit 1).
- Subject did not recover.
Measured: 4 weeks
Responder Status at Week 12 Clinic Visit
Responder status was determined at each clinic visit. The number and percentage of subjects in each of the following 3 classes were presented:
- Subject recovered without change of therapy (subjects who received an additional course of antibiotics and/or systemic corticosteroids starting after Visit 1 were not included).
- Subject recovered but had a change in therapy (subject received an additional course of antibiotics and/or systemic corticosteroids starting after Visit 1).
- Subject did not recover.
Measured: 12 weeks
Weekly Rescue Medication Use Over the 12 Weeks of Study
Daily rescue albuterol use was recorded in the diary in response to the following question: How many puffs of rescue medication did you use during the last 24 hours? The weekly rescue medication use was derived by summing the daily uses over the 12 weeks and dividing this total by 12 weeks.
Measured: 12 weeks
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted1 Dec 2011 (estimated)
- Study startNov 2011
- Primary completionDec 2012
- Study completionDec 2012
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
- Who is masked
- Participant, Investigator
- Enrolment
- 140 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
- NCT01483625
- Sponsor's protocol ID
- 205.479
- Status last verified
- Mar 2014
- First submitted
- 30 Nov 2011
- Last updated
- 9 Jun 2014
- Results posted
- Yes, on ClinicalTrials.gov
Study at a glance
From the registry record, last updated by the sponsor on 9 Jun 2014. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- A 12-week, Randomised, Placebo-controlled, Double-blind, Parallel Group, Multi-center Trial to Assess the Efficacy and Safety of Tiotropium Bromide (18 µg) Delivered Via the HandiHaler® in Patients With Newly Diagnosed and/or Maintenance Treatment naïve Chronic Obstructive Pulmonary Disease (COPD) Experiencing an Acute Respiratory Infection (TICARI 1: Tiotropium In COPD Patients With an Acute Respiratory Infection 1)
- ClinicalTrials.gov ID
- NCT01483625
- Acronym / sponsor ID
- 205.479
- Conditions
- Pulmonary Disease, Chronic Obstructive
- Phase
- Phase 4
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 140 participants (actual)
- Lead sponsor
- Boehringer IngelheimIndustry (pharma, biotech, devices)
- Study start
- Nov 2011
- Primary completion
- Dec 2012 (actual)
- Study completion
- Dec 2012 (actual)
- First posted
- 1 Dec 2011 (estimated)
- Results
- Posted 10 Apr 2014
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
The aim of the study is to investigate whether the early introduction of maintenance bronchodilator therapy during an acute symptomatic episode of the disease shows benefits on the recovery of symptoms. It also represents an opportunity to identify COPD patients earlier in their disease state and start maintenance therapy, if appropriate.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Double blind (participant, investigator)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| tiotropium 18mcg | Experimental | Drug: tiotropiumactive |
| Placebo | Placebo comparator | Drug: Placeboplacebo |
Who may qualify
- Ages
- 40 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (8 listed)
- All patients must sign an informed consent consistent with International Conference on Harmonization - Good Clinical Practice (ICH-GCP) guidelines prior to participation in the trial and conducting any study procedures.
- Male or female patients 40 years of age or older.
- Ability to independently read and understand English and/or Spanish.
- Any self-reported history of smoking (e.g. = 100 cigarettes (~5 packs) during life-time).
- Acute respiratory symptoms for up to 7 days
Key exclusion criteria (23 listed)
- Therapy with any long-acting bronchodilator, short-acting anticholinergic, inhaled corticosteroid or regular maintenance use (>14 consecutive days) of systemic corticosteroid (the latter for respiratory indications) during the previous 6 months (short course of systemic corticosteroid for up to 14 days for respiratory indications allowed); in case of use of systemic corticosteroid medication for other than respiratory conditions, then exclusion of unstable doses (i.e., less than six weeks on stable dose) or at doses in excess of the equivalent of 10 mg prednisolone-equivalent per day. In addition, daily use of short-acting beta2-agonist for more than a week prior to Visit 0 not allowed.
- Significant diseases other than COPD. A significant disease is defined as a disease or condition which, in the opinion of the investigator, may put the patient at risk because of participation in the study or may influence the patient¿s ability to participate in the study.
- A recent history (i.e., six months or less) of myocardial infarction. Patients being stable with a history of cardiac stents prior to six month are permitted.
- Any unstable or life-threatening cardiac arrhythmia requiring intervention or change in drug therapy during the last year.
- Hospitalisation for cardiac failure (New York Heart Association (NYHA) Class III or IV) during the past year.
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 |
|---|---|---|
| tiotropium18mcg | Drug | tiotropium 18mcg |
| Placeboplacebo | Drug | Placebo |
Primary outcome
Trough FEV1 After 12 Weeks on Study Drug
Time frame: 12 weeks
The primary endpoint was trough forced expiratory volume in 1 second (FEV1) after 12 weeks on study drug. Trough forced expiratory volume in 1 second (FEV1)was defined as the FEV1 measurement prior to the next dosing of study drug and approximately 24 hours after the last inhalation of study drug.
5 secondary outcomes
Time to Recovery From Acute Respiratory Symptoms
Time frame: 12 weeks
Trough FVC (in Litres) at 12 Weeks
Time frame: 12 weeks
Responder Status at Week 4 Clinic Visit
Time frame: 4 weeks
Responder Status at Week 12 Clinic Visit
Time frame: 12 weeks
Weekly Rescue Medication Use Over the 12 Weeks of Study
Time frame: 12 weeks
Results and safety
Loading the posted results from ClinicalTrials.gov…
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 9 Jun 2014.
- Posted resultsParticipant flow, baseline, all outcome measures and adverse events.
- Related InfoLink provided by the sponsor.
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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.
Boehringer Ingelheim study chair
Boehringer Ingelheim
27 sites in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 4 study testing tiotropium in people with Pulmonary Disease, Chronic Obstructive, run by Boehringer Ingelheim at 27 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 23 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 9 Jun 2014. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 27 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 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 10 Apr 2014). 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?
Trough FEV1 After 12 Weeks on Study Drug (time frame: 12 weeks). 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 9 Jun 2014.