12 Week Efficacy of Tiotropium Versus Placebo in Patients With Mild COPD According to Swedish Guidelines (SPIRIMILD)

NCT00144196 | Completed Phase 4

• 1 other identifier: 205.281
• Study Type: interventional
• Target: 224
• Locations: 1 country
• Sites: 27

Brief Summary

To show that treatment with tiotropium inhalation capsules (18 μg q.d.) via HandiHaler® improves lung function in patients with mild COPD according to Swedish guidelines.

Conditions

Pulmonary Disease, Chronic Obstructive

Outcome Measures

Primary Outcomes (1)

• The primary efficacy endpoint is defined as area under the curve of change in FEV1 from baseline for the time period from pre-dose to 2 hours post dose (AUC0 2hFEV1) after 12 weeks of randomised treatment.

  week 12

Secondary Outcomes (15)

• Change in trough FEV1 from baseline after 12 weeks of randomized treatment

  week 12

• Change in trough FEV1 % of predicted after 12 weeks of randomized treatment

  week 12

• AUC0-2h (FEV1 % of predicted) after 12 weeks of randomized treatment

  week 12

• Change in trough forced vital capacity (FVC) from baseline after 12 weeks of randomized treatment

  week 12

• AUC0-2hFVC after 12 weeks of randomized treatment

  week 12

Interventions

tiotropium (Spiriva) DRUG

Eligibility Criteria

• Age: 40 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• Patients who have signed an written informed consent consistent with ICH GCP guidelines and local legislations prior to participation in the trial.
• Patients with a diagnosis of COPD. COPD is defined as a disease state characterised by the presence of airflow obstruction often due to chronic bronchitis or emphysema; the airflow obstruction is generally progressive, may be accompanied by airway hyperreactivity, and may be partially reversible.
• Patients 40 years of age or older without any restriction to sex.
• Patients who currently smoke or who are ex-smokers with a cigarette smoking history of \>10 pack-years.
• Patients who have a relatively stable airway obstruction (at least 4 weeks free of COPD exacerbations) with a post bronchodilator FEV1 ? 60% of predicted normal, a post bronchodilation FEV1 \< 70% of FVC, and a MRC symptom score minimum of 2 at Visit 1

You may not qualify if:

• Patients with a history of asthma, allergic rhinitis, atopy, or who have a total (absolute) blood eosinophil count ? 600 per mm3 (= 0.6 \* 109/L) of the first determination at Visit 1
• Patients with known moderate or severe renal insufficiency.
• Patients with a recent history (i.e., 6 months or less prior to Visit 1) of myocardial infarction.
• Patients with any unstable or life threatening cardiac arrhythmia, including patients with a newly diagnosed, clinically relevant arrhythmia on the electrocardiogram (ECG) performed at Visit 1 as well as patients with cardiac arrhythmia requiring an intervention (i.e., hospitalisation, cardioversion, pacemaker placement, and automatic implantable cardiac defibrillator (AICD) placement) or a change in drug therapy during the last year prior to Visit 1.
• Patients who regularly use oxygen therapy.
• Patients with known active tuberculosis.
• Patients with a history of cancer within the last 5 years. Patients with treated basal cell carcinoma are allowed.
• Patients with a history of life threatening pulmonary obstruction or a history of cystic fibrosis or clinically evident bronchiectasis.
• Patients who have undergone thoracotomy with pulmonary resection.
• Patients who are currently in a pulmonary rehabilitation program or who have completed a pulmonary rehabilitation program in the 6 weeks prior to the screening visit (Visit 1).
• Patients with known hypersensitivity to anticholinergic drugs, lactose or any other components of the inhalation capsule delivery system.
• Patients with known symptomatic hyperplasia or bladder neck obstruction. Patients being treated for prostatic hyperplasia and report minimal symptoms may be included and should continue their medications.
• Patients with known narrow-angle glaucoma.

Sponsors & Collaborators

• Boehringer Ingelheim: lead

Study Sites (27)

Boehringer Ingelheim Investigational Site

?tvidaberg, 597 26, Sweden

Location

Boehringer Ingelheim Investigational Site

Alvesta, 342 36, Sweden

Location

Boehringer Ingelheim Investigational Site

Boden, 961 44, Sweden

Location

Boehringer Ingelheim Investigational Site

Dalum, 520 25, Sweden

Location

Boehringer Ingelheim Investigational Site

Gislaved, 332 30, Sweden

Location

Boehringer Ingelheim Investigational Site

Gothenburg, 411 53, Sweden

Location

Boehringer Ingelheim Investigational Site

Gothenburg, 416 65, Sweden

Location

Boehringer Ingelheim Investigational Site

Hässelby, 165 55, Sweden

Location

Boehringer Ingelheim Investigational Site

Helsingborg, 254 43, Sweden

Location

Boehringer Ingelheim Investigational Site

Helsingborg, 254 67, Sweden

Location

Boehringer Ingelheim Investigational Site

Höllviken, 236 51, Sweden

Location

Jakobsbergs sjukhus, Birgittavagen 4

Jarfalla, 17731, Sweden

Location

Boehringer Ingelheim Investigational Site

Kalmar, 393 50, Sweden

Location

Boehringer Ingelheim Investigational Site

Karlstad, 65224, Sweden

Location

Boehringer Ingelheim Investigational Site

Kristianstad, 291 38, Sweden

Location

Boehringer Ingelheim Investigational Site

Linköping, 581 88, Sweden

Location

Boehringer Ingelheim Investigational Site

Lule?, 971 89, Sweden

Location

KvartersAkuten, Timmermansgatan 26

Lule?, 972 31, Sweden

Location

Boehringer Ingelheim Investigational Site

Lund, 221 85, Sweden

Location

Boehringer Ingelheim Investigational Site

Motala, 591 36, Sweden

Location

Boehringer Ingelheim Investigational Site

Skärholmen, 127 37, Sweden

Location

Boehringer Ingelheim Investigational Site

Stockholm, 114 86, Sweden

Location

Halsocentralen, Hans?kervagen 1A

Stugun, 830 76, Sweden

Location

Alno V?rdcentral, Raholmsvagen 24

Sundsvall, 865 31, Sweden

Location

Boehringer Ingelheim Investigational Site

Sunne, 686 22, Sweden

Location

Boehringer Ingelheim Investigational Site

Ulricehamn, 523 26, Sweden

Location

Boehringer Ingelheim Investigational Site

Uppsala, 754 27, Sweden

Location

MeSH Terms

Conditions

Pulmonary Disease, Chronic Obstructive

Interventions

Tiotropium Bromide

Condition Hierarchy (Ancestors)

Lung Diseases, Obstructive; Lung Diseases; Respiratory Tract Diseases; Chronic Disease; Disease Attributes; Pathologic Processes; Pathological Conditions, Signs and Symptoms

Intervention Hierarchy (Ancestors)

Scopolamine Derivatives; Tropanes; Azabicyclo Compounds; Aza Compounds; Organic Chemicals; Alkaloids; Heterocyclic Compounds; Bridged Bicyclo Compounds, Heterocyclic; Heterocyclic Compounds, Bridged-Ring

Study Officials

• Boehringer Ingelheim Study Coordinator

  B.I. Sweden AB

  STUDY CHAIR

Study Design

• Study Type: interventional
• Phase: phase 4
• Allocation: RANDOMIZED
• Masking: DOUBLE
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: INDUSTRY
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: September 2, 2005
• First Posted: September 5, 2005
• Study Start: March 11, 2004
• Primary Completion: July 25, 2005
• Study Completion: July 25, 2005
• Last Updated: December 5, 2023

Record last verified: 2023-11

Locations

SE (27)