Efficacy and Safety of Tiotropium and Atrovent in Subjects With Chronic Obstructive Pulmonary Disease (COPD)

NCT02172469 | Completed Phase 3

• 1 other identifier: 205.243
• Study Type: interventional
• Target: 215
• Locations: 0 countries
• Sites: N/A

Brief Summary

To compare the bronchodilator efficacy and safety of tiotropium inhalation capsules (18 µg once daily) and Atrovent® MDI (2 puffs of 20µg q.i.d.) among Filipino patients with COPD

Conditions

Pulmonary Disease, Chronic Obstructive

Outcome Measures

Primary Outcomes (1)

• Change from baseline in trough Forced Expiratory Volume in one second (FEV1) - Trough FEV1 response -

  Baseline and week 4

Secondary Outcomes (10)

• Through FEV1 response

  week 2

• FEV1 for the first 3 hours post drug administration on each pulmonary function test day

  Day 1, 15 and 29

• Trough Forced Vital Capacity (FVC) response

  week 2 and 4

• Individual FEV1 measurements

  Day 1, 15 and 29

• Individual FVC measurements

  Day 1, 15 and 29

Study Arms (2)

Tiotropium & Placebo

EXPERIMENTAL

Drug: Tiotropium inhalation powder capsule; Drug: Placebo Metered Dose Inhaler

Atrovent & Placebo

ACTIVE COMPARATOR

Drug: Ipratropium Bromide Metered Dose Inhaler; Drug: Placebo inhalation powder capsule

Interventions

Tiotropium inhalation powder capsule DRUG

Tiotropium & Placebo

Placebo Metered Dose Inhaler DRUG

Tiotropium & Placebo

Ipratropium Bromide Metered Dose Inhaler DRUG

Also known as: Atrovent®

Atrovent & Placebo

Placebo inhalation powder capsule DRUG

Atrovent & Placebo

Eligibility Criteria

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

You may qualify if:

• All patients had a diagnosis of chronic obstructive pulmonary disease according to the following criteria:
• Patients had relatively stable airway obstruction with an FEV1 less than or equal to 65% of predicted normal and FEV1 less than or equal to 70% of FVC.
• Predicted normal values were based on the guidelines for standardised lung function testing in the Philippines.
• Male or female patients 40 years of age or older.
• Patients had a smoking history of more than 10 pack-years. A pack-year is defined as the equivalent of smoking one pack of cigarettes per day for a year.
• Patients performed pulmonary function tests as required in the protocol.
• Patients were able to inhale medication from the Handihaler device and had a good technique of inhaling aerosol administered from an MDI.
• All patients signed an Informed Consent Form prior to participation in the trial i.e., prior to pre-study washout of their usual pulmonary medications.

You may not qualify if:

• Patients with significant diseases other than COPD were excluded. A significant disease was defined as a disease which in the opinion of the investigator could either put the patient at risk because of participation in the study or a disease which could influence the results of the study or the patient's ability to participate in the study.
• All patients with a serum glutamate oxalacetate transaminase (SGOT) and serum glutamate pyruvate transaminase (SGPT) twice the normal range, bilirubin 150% or creatinine 125% of the normal range were excluded regardless of the clinical condition. Repeated laboratory evaluations were not conducted in these subjects.
• Patients with a recent history (i.e. one year or less) of myocardial infarction were excluded.
• Patients with a recent history (i.e. three years or less) of heart failure or patients with any cardiac arrhythmia requiring drug therapy were excluded.
• Patients on regular use of daytime oxygen therapy were excluded.
• Patients with known active tuberculosis were excluded.
• Patients with a history of cancer within the last five years were excluded. 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 were excluded.
• Patients who have undergone pulmonary resection or a thoracotomy for any reason were excluded.
• Patients with an upper respiratory tract infection in the past 6 weeks prior to the screening visit (=visit 1) or during the baseline period of 2 weeks (run-in period) were excluded.
• Patients with known hypersensitivity to anticholinergic drugs, lactose or any other component of the inhalation capsule delivery system or the MDI were excluded.
• Patients with known symptomatic prostatic hypertrophy or bladder neck obstruction were excluded.
• Patients with known narrow-angle glaucoma were excluded.
• Patients who were being treated with cromolyn sodium or nedocromil sodium were excluded.
• Patients who were being treated with antihistamines were excluded.

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: May 1, 2001
• Primary Completion: April 1, 2002
• Last Updated: June 24, 2014

Record last verified: 2014-06