Evaluation of the Lung Deposition Rate and Distribution Pattern of Tiotropium Via HandiHalerTM in Healthy Subjects and Patients With Chronic Obstructive Pulmonary Disease (COPD)

NCT02172456 | Completed Phase 3

• 1 other identifier: 205.238
• Study Type: interventional
• Target: 22
• Locations: 0 countries
• Sites: N/A

Brief Summary

Primary endpoint: whole lung deposition and in-vivo distribution pattern of a 99mTc-labelled tiotropium powder formulation following inhalation via HandiHalerTM in healthy subjects as well as in patients with mild, moderate and severe COPD Secondary endpoints: pharmacokinetics, pharmacodynamics (effect on lung function), safety and tolerability

Conditions

Pulmonary Disease, Chronic Obstructive

Outcome Measures

Primary Outcomes (1)

• Percentage of the total administered radioactivity of 99mTc-labelled tiotropium

  Day 15

Secondary Outcomes (21)

• Peak plasma concentration at steady state (Cmax,ss)

  Day 14

• Time to peak plasma concentration at steady state (Tmax,ss)

  Day 14

• Pre-dose plasma concentration (Cpre)

  Day 1

• Area under the curve from 0 to 4 hours at steady state (AUCss,0-4h )

  Day 14: 5, 10, 20 min, 1, 2, 4 hours after dosing

• Renal clearance (CLr)

  Day 14: 0-4 hours and 4-8 hours after drug administration

Study Arms (1)

Tiotropium

EXPERIMENTAL

Drug: 99mTc-radiolabelled tiotropium; Drug: non-radiolabelled tiotropium

Interventions

99mTc-radiolabelled tiotropium DRUG

Tiotropium

non-radiolabelled tiotropium DRUG

Tiotropium

Eligibility Criteria

• Age: 40 Years+
• Sex: all
• Healthy Volunteers: Yes
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• for healthy subjects and COPD patients:
• Males or females 40 years of age or older.
• Subjects/Patients must be able to inhale medication from the HandiHalerTM
• Subjects/Patients must be able to perform all study-related tests including acceptable pulmonary function tests, and must be able to maintain records during the study period as required in the protocol.
• All subjects/patients must sign an Informed Consent Form prior to participation in the trial in accordance with ICH-GCP and the local legislation, i.e., the COPD patients must give written informed consent prior to pre-study washout of their usual pulmonary medications.
• for healthy subjects:
• Normal spirometry as evidenced by a baseline FEV1 ≥ 80 % of predicted normal value for age, height and sex, and FEV1 ≥ 70% of FVC
• Lifelong non-smokers or ex-smokers with a non-smoking period of at least five years and a maximum of five pack-years.
• for COPD patients:
• All patients must have a diagnosis of relatively stable chronic obstructive pulmonary disease and must fulfil the spirometric criteria of the respective sub-group:
• Mild COPD: 50% ≤ FEV1 \< 70% of predicted normal; FEV1/FVC \< 70%.
• Moderate COPD: 35% ≤ FEV1 \< 50% of predicted normal; FEV1/FVC \< 70%.
• Severe COPD: FEV1 \< 35% of predicted normal; FEV1/FVC \< 70%.

You may not qualify if:

• for healthy subjects and COPD patients:
• All subjects/patients with serum glutamic-oxaloacetic transaminase (SGOT) \> 80 IU/L, serum glutamic-pyruvic transaminase (SGPT) \> 80 IU/L, bilirubin \>2.0 mg/dL or creatinine \> 2.0 mg/dL will be excluded regardless of clinical condition. Repeat laboratory evaluation will not be conducted in these subjects/patients.
• Subjects/Patients with a recent history (i.e., one year or less) of myocardial infarction.
• Subjects/Patients with any cardiac arrhythmia requiring drug therapy or who have been hospitalised for heart failure within the past three years.
• Subjects/Patients with known active tuberculosis.
• Subjects/Patients with a history of cancer within the last five years.
• Subjects/Patients with a history of life-threatening pulmonary obstruction, or a history of cystic fibrosis or bronchiectasis.
• Subjects/Patients who have undergone thoracotomy with pulmonary resection.
• Patients with any upper respiratory infection in the past six weeks prior to the Screening Visit (Visit 1) or during the run-in period
• Subjects/Patients with known hypersensitivity to anticholinergic drugs, lactose or any other components of the inhalation capsule delivery system
• Subjects/Patients with known symptomatic prostatic hyperplasia or bladder neck obstruction.
• Subjects/Patients with known narrow-angle glaucoma.
• Subjects/Patients with a history of asthma, allergic rhinitis or atopy or who have a total blood eosinophil count ≥ 600 mm3. A repeat eosinophil count will not be conducted in these subjects/patients.
• Subjects/Patients with a history of and/or active significant alcohol or drug abuse.
• Subjects/Patients who have taken an investigational drug within one month or six half lives (whichever is shorter) prior to Screening Visit (Visit 1).

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: NA
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: SINGLE GROUP
• Sponsor Type: INDUSTRY
• Responsible Party: SPONSOR

Study Record Dates

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

Record last verified: 2014-06