NCT02173691

Completed

Phase 3

A Multiple Dose Comparison of Tiotropium Inhalation Capsules, Salmeterol Inhalation Aerosol and Placebo in a Six-Month, Double-Blind, Double-Dummy, Safety and Efficacy Study in Patients With Chronic Obstructive Pulmonary Disease (COPD)

Boehringer Ingelheim0 sites584 target enrollmentFebruary 1999

ConditionsPulmonary Disease, Chronic Obstructive

InterventionsPlacebo inhalation powder capsules Salmeterol inhalation aerosol Placebo inhalation aerosol Tiotropium inhalation powder capsules

DrugsTiotropium inhalation powder capsules Salmeterol inhalation aerosol Placebo inhalation aerosol Placebo inhalation powder capsules

Overview

Phase: Phase 3
Intervention: Placebo inhalation powder capsules
Conditions: Pulmonary Disease, Chronic Obstructive
Sponsor: Boehringer Ingelheim
Enrollment: 584
Primary Endpoint: Trough forced expiratory volume in one second (FEV1) response
Status: Completed
Last Updated: 11 years ago

Overview Investigators Eligibility Criteria Arms & Interventions Outcomes Similar Trials

Overview

Brief Summary

The objective of this study is to compare the long-term (six month) bronchodilator efficacy and safety of tiotropium inhalation capsules, salmeterol inhalation aerosol and placebo inpatients with COPD.

Registry

clinicaltrials.gov

Start Date

February 1999

End Date

May 2000

Last Updated

11 years ago

Study Type

Interventional

Study Design

Parallel

Sex

All

Investigators

Sponsor

Boehringer Ingelheim

Responsible Party

Sponsor

Eligibility Criteria

Inclusion Criteria

•Age ≥ 40 years.
•A diagnosis of relatively stable, moderate to severe COPD with:
•Screening FEV1 ≤ 60% of predicted normal value (calculated according to European Community for Coal and Steel (ECCS) criteria and screening FEV1/FVC ≤ 70%
•Smoking history ≥ 10 pack-years (a pack-year is 20 cigarettes per day for one year or equivalent)
•Ability to be trained in the proper use of the HandiHaler® device and Metered Dose Inhaler (MDI).
•Ability to perform all study related tests including the Shuttle Walking Test, acceptable pulmonary function tests, including Peak expiratory flow rate (PEFR) measurements, and maintenance of diary card records.
•Ability to give written informed consent in accordance with Good Clinical Practice and local regulations.

Exclusion Criteria

•Clinically significant diseases other than COPD.
•Patients with clinically relevant abnormal baseline haematology, blood chemistry or urinalysis, if the abnormality defines a disease listed as an exclusion criterion, will be excluded.
•All patients with a 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.
•A recent history (i.e., one year or less) of myocardial infarction.
•Any cardiac arrhythmia requiring drug therapy or hospitalisation for heart failure within the past three years.
•Inability to abstain from regular daytime use of oxygen therapy for more than 1 hour per day.
•Known active tuberculosis.
•History of cancer within the last five years (excluding basal cell carcinoma)
•History of life-threatening pulmonary obstruction, or a history of cystic fibrosis or bronchiectasis.
•Patients who have undergone thoracotomy with pulmonary resection.

Arms & Interventions

Placebo

Intervention: Placebo inhalation powder capsules

Salmeterol

Intervention: Salmeterol inhalation aerosol

Salmeterol

Intervention: Placebo inhalation powder capsules

Placebo

Intervention: Placebo inhalation aerosol

Tiotropium

Intervention: Tiotropium inhalation powder capsules

Tiotropium

Intervention: Placebo inhalation aerosol

Outcomes

Primary Outcomes

Trough forced expiratory volume in one second (FEV1) response

Time Frame: 6 months

Transition Dyspnoea Index (TDI) focal score

Time Frame: 6 months

Secondary Outcomes

Occurrence of Adverse Events(27 weeks)
Average FEV1 response(30 and 60 min prior to and 30 and 60 min, 2 and 3 h post treatment on day 1, week 2, 8, 16, 24)
Peak FEV1 response(30 and 60 min prior to and 30 and 60 min, 2 and 3 h post treatment on day 1, week 2, 8, 16, 24)
Trough FVC (forced vital capacity) response(30 and 60 min prior to and 30 and 60 min, 2 and 3 h post treatment on day 1, week 2, 8, 16, 24)
Average FVC (forced vital capacity) response(30 and 60 min prior to and 30 and 60 min, 2 and 3 h post treatment on day 1, week 2, 8, 16, 24)
Peak FVC (forced vital capacity) response(30 and 60 min prior to and 30 and 60 min, 2 and 3 h post treatment on day 1, week 2, 8, 16, 24)
Individual FEV1 measurement(Day 1, weeks 2, 8, 16, 24)
Individual FVC measurement(Day 1, weeks 2, 8, 16, 24)
Patient peak expiratory flow rates (PEFR) twice daily(27 weeks)
Physician's global evaluation on an 8-point-scale(27 weeks)
COPD symptom scores (wheezing, shortness of breath, coughing and tightness of chest)(27 weeks)
Amount of salbutamol therapy used during the treatment period(27 weeks)
Number and length of exacerbations of COPD(27 weeks)
Number and length of hospitalizations for respiratory disease(27 weeks)
Changes from baseline in St. George's Hospital Respiratory Questionnaire (SGRQ)(Day 1, week 8, 16, 24 and 27)
Changes from baseline in Mahler Dyspnoea Index (Baseline Dyspnoea Index /Transitional Dyspnoea Index (BDI/TDI))(Baseline, week 8, 16, 24, 27)
Health resource utilisation(27 weeks)
Patient preference measures(Day 1 and week 24)
Changes from baseline in Shuttle walking tests (SWT) and Borg dyspnea score(Day 1, week 8, 16, 24, 27)
Changes from baseline in pulse rate and blood pressure in conjunction with spirometry(baseline, Day 1, week 2, 8, 16 and 24)
Changes from baseline in physical examination and ECG(baseline and week 24)
Changes from baseline in laboratory tests(baseline and week 24)