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Efficacy and Safety of Tiotropium Compared to Salmeterol and Placebo in Patients With Chronic Obstructive Bronchitis (COPD)

This study has been completed.
Sponsor:
Information provided by (Responsible Party):
Boehringer Ingelheim
ClinicalTrials.gov Identifier:
NCT02173691
First received: June 20, 2014
Last updated: June 25, 2014
Last verified: June 2014
  Purpose
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.

Condition Intervention Phase
Pulmonary Disease, Chronic Obstructive Drug: Tiotropium inhalation powder capsules Drug: Salmeterol inhalation aerosol Drug: Placebo inhalation aerosol Drug: Placebo inhalation powder capsules Phase 3

Study Type: Interventional
Study Design: Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Double Blind (Participant, Investigator)
Primary Purpose: Treatment
Official Title: 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)

Resource links provided by NLM:


Further study details as provided by Boehringer Ingelheim:

Primary Outcome Measures:
  • Trough forced expiratory volume in one second (FEV1) response [ Time Frame: 6 months ]
  • Transition Dyspnoea Index (TDI) focal score [ Time Frame: 6 months ]

Secondary Outcome Measures:
  • Average FEV1 response [ Time Frame: 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 [ Time Frame: 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 [ Time Frame: 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 [ Time Frame: 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 [ Time Frame: 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 [ Time Frame: Day 1, weeks 2, 8, 16, 24 ]
  • Individual FVC measurement [ Time Frame: Day 1, weeks 2, 8, 16, 24 ]
  • Patient peak expiratory flow rates (PEFR) twice daily [ Time Frame: 27 weeks ]
  • Physician's global evaluation on an 8-point-scale [ Time Frame: 27 weeks ]
  • COPD symptom scores (wheezing, shortness of breath, coughing and tightness of chest) [ Time Frame: 27 weeks ]
  • Amount of salbutamol therapy used during the treatment period [ Time Frame: 27 weeks ]
  • Number and length of exacerbations of COPD [ Time Frame: 27 weeks ]
  • Number and length of hospitalizations for respiratory disease [ Time Frame: 27 weeks ]
  • Changes from baseline in St. George's Hospital Respiratory Questionnaire (SGRQ) [ Time Frame: Day 1, week 8, 16, 24 and 27 ]
  • Changes from baseline in Mahler Dyspnoea Index (Baseline Dyspnoea Index /Transitional Dyspnoea Index (BDI/TDI)) [ Time Frame: Baseline, week 8, 16, 24, 27 ]
  • Health resource utilisation [ Time Frame: 27 weeks ]
  • Patient preference measures [ Time Frame: Day 1 and week 24 ]
    patient satisfaction questionnaire score

  • Changes from baseline in Shuttle walking tests (SWT) and Borg dyspnea score [ Time Frame: Day 1, week 8, 16, 24, 27 ]
  • Occurrence of Adverse Events [ Time Frame: 27 weeks ]
  • Changes from baseline in pulse rate and blood pressure in conjunction with spirometry [ Time Frame: baseline, Day 1, week 2, 8, 16 and 24 ]
  • Changes from baseline in physical examination and ECG [ Time Frame: baseline and week 24 ]
  • Changes from baseline in laboratory tests [ Time Frame: baseline and week 24 ]

Enrollment: 584
Study Start Date: February 1999
Primary Completion Date: May 2000 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
Experimental: Tiotropium Drug: Tiotropium inhalation powder capsules Drug: Placebo inhalation aerosol
Active Comparator: Salmeterol Drug: Salmeterol inhalation aerosol Drug: Placebo inhalation powder capsules
Placebo Comparator: Placebo Drug: Placebo inhalation aerosol Drug: Placebo inhalation powder capsules

  Eligibility

Ages Eligible for Study:   40 Years and older   (Adult, Senior)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
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.
  • Any upper respiratory infection in the past six weeks prior to the screening visit or during the run-in period.
  • Current participation in a pulmonary rehabilitation programme or completion of a pulmonary rehabilitation programme in the six week prior to the screening visit.
  • Known hypersensitivity to anticholinergic drugs, salmeterol, or any of the components of the lactose powder capsule or MDI delivery systems.
  • Known symptomatic prostatic hypertrophy or bladder neck obstruction.
  • Patients with known narrow-angle glaucoma.
  • Current treatment with cromolyn sodium or nedocromil sodium.
  • Current treatment with antihistamines (H1 receptor antagonists).
  • Oral corticosteroid medication at unstable doses (i.e., less than six weeks on a stable dose) or at doses in excess of the equivalent of 10 mg of prednisolone per day or 20 mg every other day.
  • Current use of β-blocker medication.
  • Current treatment with monoamine oxidase inhibitors or tricyclic antidepressants.
  • Pregnant or nursing women or women of childbearing potential not using a medically approved means of contraception.
  • Patients with a history of asthma, allergic rhinitis or atopy or who have a total blood eosinophil count > 600mm3.
  • History of and/or active significant alcohol or drug abuse.
  • Concomitant or recent use of an investigational drug within one month or six half lives (whichever is greater) prior to the screening visit.
  • Changes in the pulmonary therapeutic plan within the six weeks prior to the screening visit.
  • Inability to comply with the medication restrictions specified in Section 4.2 of the trial protocol
  Contacts and Locations
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

No Contacts or Locations Provided
  More Information

Responsible Party: Boehringer Ingelheim
ClinicalTrials.gov Identifier: NCT02173691     History of Changes
Other Study ID Numbers: 205.137
Study First Received: June 20, 2014
Last Updated: June 25, 2014

Additional relevant MeSH terms:
Lung Diseases
Pulmonary Disease, Chronic Obstructive
Chronic Disease
Respiratory Tract Diseases
Lung Diseases, Obstructive
Disease Attributes
Pathologic Processes
Tiotropium Bromide
Salmeterol Xinafoate
Bronchodilator Agents
Autonomic Agents
Peripheral Nervous System Agents
Physiological Effects of Drugs
Anti-Asthmatic Agents
Respiratory System Agents
Parasympatholytics
Cholinergic Antagonists
Cholinergic Agents
Neurotransmitter Agents
Molecular Mechanisms of Pharmacological Action
Adrenergic beta-2 Receptor Agonists
Adrenergic beta-Agonists
Adrenergic Agonists
Adrenergic Agents

ClinicalTrials.gov processed this record on June 23, 2017