12-week Treatment With Inhaled Tiotropium (18 mcg Once Daily) on Lung Function and Static Lung Volumes in Stable, Moderate to Severe Chronic Obstructive Pulmonary Disease (COPD) Patients. Correlation to Dyspnoea Scales

NCT02172378 | Completed Phase 3

• 1 other identifier: 205.215
• Study Type: interventional
• Target: 116
• Locations: 0 countries
• Sites: N/A

Brief Summary

Determine the effect of 12-week treatment with inhaled tiotropium bromide on lung function and static lung volumes, correlate this effect with dyspnoea in COPD patients.

Conditions

Pulmonary Disease, Chronic Obstructive

Outcome Measures

Primary Outcomes (1)

• trough FVC response at the end of the 12-week study

  after 12 weeks of treatment (day 84)

Secondary Outcomes (24)

• Determination of breathlessness (dyspnoea) as measured by the modified Borg scale

  Screening, day 0, day 42, day 84

• Evaluation of the Expiratory Flow Limitation (EFL) using the Negative Expiratory Pressure (NEP) method (optional)

  Screening, day 0, day 42, day 84

• Evaluation of inspiratory capacity (IC)

  Screening, day 0, day 42, day 84, day 98

• Evaluation of slow vital capacity (SVC)

  Screening, day 0, day 42, day 84, day 98

• Evaluation of FEV1 (Forced expiratory volume in one second)

  Screening, day 0, day 42, day 84, day 98

Study Arms (2)

Tiotropium inhalation capsules

EXPERIMENTAL

Drug: Tiotropium inhalation capsules

Placebo inhalation capsules

PLACEBO COMPARATOR

Drug: Placebo inhalation capsules

Interventions

Tiotropium inhalation capsules DRUG

Tiotropium inhalation capsules

Placebo inhalation capsules DRUG

Placebo inhalation capsules

Eligibility Criteria

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

You may qualify if:

• Male or female patients 40 years of age or older.
• All patients had to have a diagnosis of COPD and had to meet the following spirometric and static lung volume criteria:
• Patients had to have relatively stable, moderate to severe airway obstruction with:
• FEV1 ≤ 50 % of predicted value,
• FEV1/SVC ≤ 70 %.
• All patients had to have the presence of lung hyperinflation as demonstrated by RV ≥ 125 % of predicted value.
• Predicted normal values were calculated according to European Community Coal and Steel (ECCS)
• Males:
• FEV1 predicted (L) = 4.30 x height (metres) - 0.029 x age (years) - 2.49
• RV predicted (L) = 1.31 x height (metres) + 0.022 x age (years) - 1.23
• Females:
• FEV1 predicted (L) = 3.95 x height (metres) - 0.025 x age (years) - 2.60
• RV predicted (L) = 1.81 x height (metres) - 0.016 x age (years) - 2.00
• Patients had to be current or ex-smokers with a smoking history of more than 10 pack-years (p.y.). Patients who never smoked cigarettes were excluded.
• Number of p.y. = Number of cigarettes/day / 20 x years of smoking

You may not qualify if:

• Patients with a history of asthma, allergic rhinitis or atopy.
• Patients with significant diseases other than COPD were excluded. A significant disease was defined as a disease which in the opinion of the investigator may have either put the patient at risk because of participation in the study or a disease which may have influenced 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 a recent history (i.e. three years or less) of heart failure, pulmonary oedema, or patients with cardiac arrhythmia requiring drug therapy.
• Patients who regularly used daytime oxygen therapy for more than one hour per day and in the investigator.s opinion was unable to abstain from the use of oxygen therapy.
• Patients with known active tuberculosis.
• Patients with a history of cancer within the last five years. Patients with treated basal cell carcinoma were allowed.
• Patients with a history of life-threatening pulmonary obstruction, or a history of cystic fibrosis or bronchiectasis.
• Patients with lower respiratory tract infection in the past six weeks prior to the Screening Visit (Visit 1) or during the run-in period.
• Patients who were currently in a pulmonary rehabilitation programme or who completed a pulmonary rehabilitation programme in the six 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 prostatic hypertrophy or bladder neck obstruction.
• Patients with known narrow-angle glaucoma.
• Patients who were treated with β-blockers, cromolyn sodium or nedocromil.
• Patients who were treated with antihistamines (H1 receptor antagonists) or antileukotrienes.

Sponsors & Collaborators

• Boehringer Ingelheim: lead

MeSH Terms

Conditions

Pulmonary Disease, Chronic Obstructive

Condition Hierarchy (Ancestors)

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

Study Design

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

Study Record Dates

• First Submitted: June 20, 2014
• First Posted: June 24, 2014
• Study Start: May 1, 2000
• Primary Completion: January 1, 2002
• Last Updated: June 24, 2014

Record last verified: 2014-06