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OpenTrials
Completed

NCT Number: NCT00281567

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

Comparison of lung function response between tiotropium inhalation solution and Spiriva HandiHaler.

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Key information

Conditions

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

Age range

40 year and older

Sex eligibility

All sexes

Study type

Interventional

Phase

Phase 3

Primary location

Boehringer Ingelheim Investigational Site, Study Chairs Or Principal Investigators, Belgium

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Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

Inclusion criteria

  • Diagnosis of COPD
  • FEV1 < 60% predicted
  • FEV1 < 70% of FVC
  • Smoking history of 10 pack-years

Exclusion criteria

  • Significant other disease than COPD
  • Recent history of MI (1 year or less)
  • Cardiac arrhythmia requiring drug therapy
  • History of asthma, allergic rhinitis or eosinophil count > 600 mm3
  • Symptomatic prostatic hypertrophy or bladder neck obstruction
  • Known narrow-angle glaucoma
  • Abnormal baseline hematology, blood chemistry or urinalysis
  • History of cancer within last 5 years
  • Life-threatening pulmonary obstruction
  • Cystic fibrosis or bronchiectasis
  • Tuberculosis
  • Pulmonary resection

Treatment and study plan

Tiotropium

Drug

Respimat SMI

Device

HANDIHALER

Device

Primary outcomes

  1. Comparison of trough FEV1 values at the end of 4-week treatment with tiotropium inhalation solution (5 mcg, 10 mcg) to that achieved with tiotropium inhalation powder (Spiriva 18 mcg).

Secondary outcomes

  1. Trough forced vital capacity (FVC) response after 4 weeks (change from baseline)

    Time frame: baseline until week 28

  2. Peak response (FEV1 and FVC) to first dose

    Time frame: within 3 hours to first dose

  3. Peak response (FEV1 and FVC) after 4 weeks

    Time frame: within 3 hours after 4 weeks

  4. FEV1 AUC0-12h and FVC AUC0-12h response after 4 weeks

    Time frame: after 4 weeks

  5. FEV1 AUC0-3h and FVC AUC0-3h response after the first dose and after 4 weeks

    Time frame: after first dose and after 4 weeks

  6. Individual FEV1and FVC measurements at each time point

    Time frame: up to 28 weeks

  7. Pre-dose morning and evening peak expiratory flow rate (PEFR) measured by patients

    Time frame: up to 28 weeks

  8. Number of occasions of rescue therapy used as required (p.r.n. salbutamol)

    Time frame: up to 28 weeks

  9. Median time to onset of therapeutic response after first dose

    Time frame: after 4 weeks

  10. Number of patients with 15% response above baseline for each treatment at each timepoint after first dose

    Time frame: at week 4, 12, 20

  11. Number of patients with 15% response above baseline for each treatment at each timepoint after 4 weeks

    Time frame: at week 8, 16, 24

Sponsors and collaborators

Lead sponsor

Boehringer Ingelheim

Industry

Registry information

Official study title

A Randomised, Double-blind, Double-dummy, Placebo-controlled, Crossover Efficacy and Safety Comparison of 4-week Treatment Periods of Two Doses [5 μg (2 Actuations of 2.5 μg) and 10 μg (2 Actuations of 5 μg)] of Tiotropium Inhalation Solution Delivered by the Respimat Inhaler, Tiotropium Inhalation Powder Capsule (18μg) Delivered by the HandiHaler in Patients With Chronic Obstructive Pulmonary Disease (COPD)

Important dates

Study start
2002
Primary completion
2003
First posted
Jan 25, 2006
Registry last updated
Nov 1, 2013

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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