Tiotropium (18mcg) in Chronic Obstructive Pulmonary Disease (COPD) Patients With a Respiratory Infection
Condition: Pulmonary Disease, Chronic Obstructive
MeSH terms: Respiratory Tract Infections; Lung Diseases; Lung Diseases, Obstructive; Pulmonary Disease, Chronic Obstructive
Intervention: tiotropium; Placebo
Intervention description: 18mcg; placebo
Intervention MeSH terms: Tiotropium Bromide
Phase: Phase 4
Study type: Interventional
Primary purpose: Treatment
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: Double (Participant, Investigator)
Enrollment: 140.0
Sex: All
Minimum age: 40 Years
Healthy volunteers: No

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).