Comparison of Tiotropium Inhalation Capsules and Atrovent Metered Dose Inhaler (MDI) in a Efficacy and Safety Study in Adults With Chronic Obstructive Pulmonary Disease

NCT02172443 | Completed Phase 3

• 1 other identifier: 205.232
• Study Type: interventional
• Target: 50
• Locations: 0 countries
• Sites: N/A

Brief Summary

The objective of this study is to compare the bronchodilator efficacy and safety of tiotropium inhalation capsule (18 mcg once daily) and Atrovent MDI (2 puffs of 20 mcg q.i.d.) in patients with chronic obstructive pulmonary disease (COPD)

Conditions

Pulmonary Disease, Chronic Obstructive

Outcome Measures

Primary Outcomes (1)

• Change from baseline in trough forced expiratory volume in one second (FEV1)

  baseline, day 29

Secondary Outcomes (9)

• Change from baseline in forced expiratory volume in one second (FEV1), area under curve from 0 to 3 hours post drug administration

  baseline, day 29

• Change from baseline in forced vital capacity (FVC), area under curve from 0 to 3 hours post drug administration

  baseline, day 29

• Change from baseline in total score of patient evaluation questionnaire

  baseline, day 29

• Number of rescue medications

  Up to day 29

• Trough forced vital capacity (FVC) response

  baseline, day 29

Study Arms (2)

tiotropium inhalation capsules

EXPERIMENTAL

Drug: tiotropium inhalation powder capsules; Drug: placebo to tiotropium inhalation capsules

Atrovent MDI

ACTIVE COMPARATOR

Drug: Atrovent; Drug: placebo to Atrovent

Interventions

tiotropium inhalation powder capsules DRUG

tiotropium inhalation capsules

Atrovent DRUG

Atrovent MDI

placebo to Atrovent DRUG

Atrovent MDI

placebo to tiotropium inhalation capsules DRUG

tiotropium inhalation capsules

Eligibility Criteria

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

You may qualify if:

• COPD patients with an forced expiratory volume in one second (FEV1) \<= 65% of predicted normal and FEV1 \<= 70% of forced vital capacity (FVC)
• Male or female patients 40 years of age or older.
• Patient must have a smoking history of more than 10 pack-years. A pack-year is defined as the equivalent of smoking on pack of cigarettes per day for a year.
• Patient must be able to perform pulmonary function test as required in the protocol.
• Patient must be able to inhale medication from the handihaler device and should have a good technique of inhaling aerosol administered from MDI.
• All patients must sign an informed consent from prior to participation in the trail, prior to pre-study washout of their usual pulmonary medication.

You may not qualify if:

• Patient with significant disease other than COPD will be excluded. A significant disease is 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 result of the study or the patient's ability to participate in the study.
• All patients with a serum glutamic-oxaloacetic transaminase (SGOT) and serum glutamic-pyruvic transaminase (SGPT) twice the upper normal limit, bilirubin 150% or creatinine 125% of the upper normal limit will be excluded regardless of the clinical condition. Repeat laboratory evaluation will be not be conducted in these subjects.
• Patients with a recent history ( i.e. one year or less) of myocardial infarction.
• Patients with a recent history ( i.e. one year or less) of heart failure or patients with any cardiac arrhythmia requiring drug therapy.
• Patients with regular use of daytime oxygen therapy.
• Patients with known active tuberculosis.
• Patients with a history of cancer within the last five years. Patients with treated basal cell carcinoma are allowed.
• Patients with a history of life-threatening pulmonary, or history of cystic fibrosis or bronchiectasis.
• Patients who have undergone pulmonary resection or a thoracotomy for any reason.
• Patients with an upper respiratory tract infection in the past 2 weeks prior to the screening visit (= Visit 1) or during the baseline period of 2-weeks (run-in period).
• Patients with known hypersensitivity to anticholinergic drugs, lactose or any other component of the inhalation capsule delivery system.
• Patients with known symptomatic prostatic hypertrophy or bladder neck obstruction.
• Patients with known narrow-angle glaucoma.
• Patients who are being treated with cromolyn sodium or nedocromil sodium.
• Patients who are being treated with antihistamines.

Sponsors & Collaborators

• Boehringer Ingelheim: lead

MeSH Terms

Conditions

Pulmonary Disease, Chronic Obstructive

Interventions

Ipratropium

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)

Atropine Derivatives; Tropanes; Azabicyclo Compounds; Aza Compounds; Organic Chemicals; Belladonna Alkaloids; Solanaceous Alkaloids; Alkaloids; Heterocyclic Compounds; Bridged Bicyclo Compounds, Heterocyclic; Heterocyclic Compounds, Bridged-Ring

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: June 1, 2001
• Primary Completion: May 1, 2002
• Last Updated: August 31, 2018

Record last verified: 2018-08