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ADDITIONAL EFFECT OF TIOTROPIUM BROMIDE ON EXERCISE TOLERANCE IN COPD PATIENTS. PILOT STUDY - ND

ADDITIONAL EFFECT OF TIOTROPIUM BROMIDE ON EXERCISE TOLERANCE IN COPD PATIENTS. PILOT STUDY - ND

Status
Active, not recruiting
Phases
Unknown
Study type
Interventional
Source
EU CTR
Registry ID
EUCTR2010-019047-19-IT
Enrollment
Unknown
Registered
2010-05-17
Start date
2010-05-10
Completion date
Unknown
Last updated
2012-10-29

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

COPD (Chronic Obstructive Pulmonary Disease)

Interventions

Pharmaceutical Form: Inhalation powder INN or Proposed INN: Tiotropium bromide Concentration unit: µg microgram(s) Concentration type: equal Concentration number: 18-

Sponsors

Pneumologia c/o Villa Pineta
Lead Sponsor

Eligibility

Sex/Gender
All

Inclusion criteria

Inclusion criteria: Confirmed diagnosis of COPD Use of inhaled bronchodilators but not Tiotropium Are the trial subjects under 18? no Number of subjects for this age range: F.1.2 Adults (18-64 years) yes F.1.2.1 Number of subjects for this age range F.1.3 Elderly (>=65 years) no F.1.3.1 Number of subjects for this age range

Exclusion criteria

Exclusion criteria: Clinical instability within previous 4 week Inability to perform effort test

Design outcomes

Primary

MeasureTime frame
Main Objective: Absolute change of exercise tolerance (ET)by comparing usual therapy (UT) or UT+Tiotropim;Secondary Objective: Absolute and percentage change of hyperinflation as assessed by residual volume-VR, residual functional capacity-CFR, total lung capacity-CPT; absolute change of individual BODE index;Primary end point(s): Absolute change of exercise tolerance (ET)—

Countries

Italy

Outcome results

None listed

Source: EU CTR (via WHO ICTRP) · Data processed: Feb 4, 2026