Clinical trial NCT01483625: Tiotropium (18mcg) in Chronic Obstructive Pulmonary Disease (COPD) Patients With a Respiratory Infection
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)
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: PHASE4
Conditions: Pulmonary Disease, Chronic Obstructive
Lead sponsor: Boehringer Ingelheim
Sponsor class: INDUSTRY
First posted: 2011-12-01
Enrollment: 140
Sex: ALL
Minimum age (years): 40
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

Brief 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. It also represents an opportunity to identify COPD patients earlier in their disease state and start maintenance therapy, if appropriate.


Eligibility criteria: Inclusion criteria:

1. 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.
2. Male or female patients 40 years of age or older.
3. Ability to independently read and understand English and/or Spanish.
4. Any self-reported history of smoking (e.g. = 100 cigarettes (\~5 packs) during life-time).
5. Acute respiratory symptoms for up to 7 days
6. 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.
7. The clinical assessment of the enrolled patient in the judgement of the investigator supports the introduction of COPD maintenance therapy.
8. Patients must be able to inhale medication in a competent manner from the HandiHaler® device and from a metered dose inhaler (MDI)

Exclusion criteria:

1. 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:
2. 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.
3. 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.
4. Any unstable or life-threatening cardiac arrhythmia requiring intervention or change in drug therapy during the last year.
5. Hospitalisation for cardiac failure (New York Heart Association (NYHA) Class III or IV) during the past year.
6. 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.
7. Known active tuberculosis.
8. Current asthma (patient treated for asthma in the last 2 years), cystic fibrosis, clinical diagnosis of bronchiectasis, interstitial lung disease, or pulmonary thromboembolic disease.
9. 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.
10. 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.
11. 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.
12. Known hypersensitivity to anticholinergic drugs, lactose, or any other components of the HandiHaler® or MDI inhalation solution delivery system.
13. Treatment with any restricted pulmonary medication
14. Requirement of supplemental oxygen therapy for = 24 hours during the previous 6 months.
15. Known moderate to severe renal impairment.
16. Known narrow angle glaucoma.
17. Significant symptomatic prostatic hyperplasia or bladder-neck obstruction. Patients whose symptoms are controlled on treatment may be included.
18. 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.
19. Significant alcohol or drug abuse within the past 12 months.
20. Actively participating in a pulmonary rehabilitation program.
21. Previously randomized in this study or currently participating in another interventional study.
22. Visual impairment that as judged by the investigator does not allow the patient to independently read and complete the questionnaires and electronic diary (eDiary).

Primary outcomes:
measure: Trough FEV1 After 12 Weeks on Study Drug
timeFrame: 12 weeks
Secondary outcomes:
measure: Time to Recovery From Acute Respiratory Symptoms
timeFrame: 12 weeks
measure: Trough FVC (in Litres) at 12 Weeks
timeFrame: 12 weeks
measure: Responder Status at Week 4 Clinic Visit
timeFrame: 4 weeks
measure: Responder Status at Week 12 Clinic Visit
timeFrame: 12 weeks
measure: Weekly Rescue Medication Use Over the 12 Weeks of Study
timeFrame: 12 weeks
Other outcomes:
Locations:
city: Tucson
country: United States
facility: 205.479.01017 Boehringer Ingelheim Investigational Site
state: Arizona
city: Riverside
country: United States
facility: 205.479.01036 Boehringer Ingelheim Investigational Site
state: California
city: San Diego
country: United States
facility: 205.479.01024 Boehringer Ingelheim Investigational Site
state: California
city: DeLand
country: United States
facility: 205.479.01043 Boehringer Ingelheim Investigational Site
state: Florida
city: St. Petersburg
country: United States
facility: 205.479.01040 Boehringer Ingelheim Investigational Site
state: Florida
city: Chelsea
country: United States
facility: 205.479.01022 Boehringer Ingelheim Investigational Site
state: Michigan
city: Picayune
country: United States
facility: 205.479.01041 Boehringer Ingelheim Investigational Site
state: Mississippi
city: St. Louis
country: United States
facility: 205.479.01037 Boehringer Ingelheim Investigational Site
state: Missouri
city: Tabor City
country: United States
facility: 205.479.01005 Boehringer Ingelheim Investigational Site
state: North Carolina
city: Wilmington
country: United States
facility: 205.479.01008 Boehringer Ingelheim Investigational Site
state: North Carolina
city: Cincinnati
country: United States
facility: 205.479.01003 Boehringer Ingelheim Investigational Site
state: Ohio
city: Pittsburgh
country: United States
facility: 205.479.01002 Boehringer Ingelheim Investigational Site
state: Pennsylvania
city: Tipton
country: United States
facility: 205.479.01044 Boehringer Ingelheim Investigational Site
state: Pennsylvania
city: Charleston
country: United States
facility: 205.479.01006 Boehringer Ingelheim Investigational Site
state: South Carolina
city: Columbia
country: United States
facility: 205.479.01001 Boehringer Ingelheim Investigational Site
state: South Carolina
city: Easley
country: United States
facility: 205.479.01007 Boehringer Ingelheim Investigational Site
state: South Carolina
city: Fort Mill
country: United States
facility: 205.479.01026 Boehringer Ingelheim Investigational Site
state: South Carolina
city: Gaffney
country: United States
facility: 205.479.01031 Boehringer Ingelheim Investigational Site
state: South Carolina
city: Greenville
country: United States
facility: 205.479.01012 Boehringer Ingelheim Investigational Site
state: South Carolina
city: Hodges
country: United States
facility: 205.479.01048 Boehringer Ingelheim Investigational Site
state: South Carolina
city: Spartanburg
country: United States
facility: 205.479.01004 Boehringer Ingelheim Investigational Site
state: South Carolina
city: Union
country: United States
facility: 205.479.01019 Boehringer Ingelheim Investigational Site
state: South Carolina
city: Rapid City
country: United States
facility: 205.479.01039 Boehringer Ingelheim Investigational Site
state: South Dakota
city: Chattanooga
country: United States
facility: 205.479.01033 Boehringer Ingelheim Investigational Site
state: Tennessee
city: Killeen
country: United States
facility: 205.479.01028 Boehringer Ingelheim Investigational Site
state: Texas
city: Ettrick
country: United States
facility: 205.479.01038 Boehringer Ingelheim Investigational Site
state: Virginia
city: Norfolk
country: United States
facility: 205.479.01047 Boehringer Ingelheim Investigational Site
state: Virginia
Study officials:
affiliation: Boehringer Ingelheim
name: Boehringer Ingelheim
role: STUDY_CHAIR
References: