Efficacy and Safety Comparison of Tiotropium Inhalation Solution (Respimat Inhaler) and Spiriva HandiHaler in COPD

NCT00239447 | Completed Phase 3

• 1 other identifier: 205.249
• Study Type: interventional
• Target: 131
• Locations: 2 countries
• Sites: 11

Brief Summary

Non-inferiority of lung function response to Tiotropium inhalation solution compared to Spiriva HandiHaler

Conditions

Pulmonary Disease, Chronic Obstructive

Outcome Measures

Primary Outcomes (1)

• Trough FEV1 response determined at the end of each 4-week period of randomised treatment.

  at the end of each 4-week period

Secondary Outcomes (10)

• Tiotropium plasma concentration data and urinary excretion data

  at the end of each 4-week period

• Trough forced vital capacity (FVC) response

  after 4 weeks

• Peak response (FEV1 and FVC)

  within 3 hours after first dose, after 4 weeks

• FEV1 AUC 0-12h and FVC AUC 0-12h response

  after 4 weeks

• FEV1 AUC 0-3h and FVC AUC 0-3h response

  after the first dose, after 4 weeks

Interventions

Tiotropium DRUG

HandiHaler DEVICE

Respimat SMI DEVICE

Eligibility Criteria

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

You may qualify if:

• All patients had to sign an informed consent consistent with International Conference of Harmonization-Good Clinical Practice (ICH-GCP) guidelines prior to participation in the trial, which includes medication washout and restrictions.
• All patients had to have a diagnosis of chronic obstructive pulmonary disease.
• Patients had to have relatively stable, moderate to severe airway obstruction with an forced expiratory volume in one second (FEV1) ≤ 60% of predicted normal and FEV1 ≤ 70% of forced vital capacity FVC (Visits 1 and 2).
• Male or female patients 40 years of age or older.
• Patients had to be current or ex-smokers with a smoking history of more than 10 pack-years.
• Patients had to be able to perform technically acceptable pulmonary function tests and peak expiratory flow rate (PEFR) measurements, and had to be able to maintain records (Patient Daily Diary Card) during the study period as required in the protocol.
• Patients had to be able to inhale medication in a competent manner from the Respimat inhaler, the HandiHaler and from a metered dose inhaler (MDI).

You may not qualify if:

• Patients with significant diseases other than chronic obstructive pulmonary disease (COPD) had to be excluded. A significant disease was defined as a disease which in the opinion of the investigator may either put the patient at risk because of participation in the study or a disease which may influence the results of the study or the patient's ability to participate in the study.
• Patients with a recent history (i.e., one year or less) of myocardial infarction.
• Patients with any cardiac arrhythmia requiring drug therapy or who had been hospitalised for heart failure within the past three years.
• Patients with a history of cancer within the last five years. Patients with treated basal cell carcinoma were allowed.
• Patients with known symptomatic prostatic hypertrophy or bladder neck obstruction.
• Patients with known narrow-angle glaucoma.
• Patients with a history of asthma, allergic rhinitis or who have a total blood eosinophil count ≥600 mm3.

Sponsors & Collaborators

• Boehringer Ingelheim: lead

Study Sites (11)

Division of Pulmonary and Critical Care Medicine

Little Rock, Arkansas, 72205, United States

Location

Boehringer Ingelheim Investigational Site

San Diego, California, 92120, United States

Location

San Jose Clinical Research

San Jose, California, 95128, United States

Location

Boehringer Ingelheim Investigational Site

Stockton, California, 95207, United States

Location

National Jewish Medical and Research Center

Denver, Colorado, 80206-2762, United States

Location

LSU MC-Sheveport

Shreveport, Louisiana, 71103, United States

Location

Minisota Lung Center

Minneapolis, Minnesota, 55407, United States

Location

Wake Forest University School of Medicine

Winston-Salem, North Carolina, 27157, United States

Location

Spartanburg Medical Research

Spartanburg, South Carolina, 29303, United States

Location

Boehringer Ingelheim Investigational Site

Tacoma, Washington, 98405, United States

Location

Montreal Chest Institute - McGill University Health Centre

Montreal, Quebec, H2X 2P4, Canada

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

  Boehringer Ingelheim BV/Alkmaar

  STUDY CHAIR

Study Design

• Study Type: interventional
• Phase: phase 3
• Allocation: RANDOMIZED
• Masking: DOUBLE
• Purpose: TREATMENT
• Intervention Model: CROSSOVER
• Sponsor Type: INDUSTRY
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: October 14, 2005
• First Posted: October 17, 2005
• Study Start: November 26, 2002
• Primary Completion: April 29, 2004
• Study Completion: April 29, 2004
• Last Updated: December 1, 2023

Record last verified: 2023-11

Locations

US (10); CA (1)