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Efficacy and Safety Comparison of Tiotropium Daily + Salmeterol Daily or Twice Daily Versus Tiotropium Daily in Patients With COPD
This study is currently recruiting participants.
Verified by Boehringer Ingelheim Pharmaceuticals, April 2009
First Received: April 17, 2008   Last Updated: April 23, 2009   History of Changes
Sponsored by: Boehringer Ingelheim Pharmaceuticals
Information provided by: Boehringer Ingelheim Pharmaceuticals
ClinicalTrials.gov Identifier: NCT00662792
  Purpose

The primary objective of this trial is to establish superiority of the once-daily Tiotropium plus Salmeterol Inhalation Powder in daytime lung function response and non-inferiority in night-time lung function response over the comparator treatments inhaled in their established dose regimens when administered for 6-week periods to patients with chronic obstructive pulmonary disease (COPD). The main secondary objective is to evaluate the safety of the Tiotropium plus Salmeterol Inhalation Powder versus the comparator treatments.


Condition Intervention Phase
Pulmonary Disease, Chronic Obstructive
Drug: Tiotropium plus Salmeterol
Drug: Tiotropium
Drug: Salmeterol
Phase III

MedlinePlus related topics: COPD (Chronic Obstructive Pulmonary Disease)
Drug Information available for: Salmeterol Salmeterol xinafoate Tiotropium bromide Tiotropium
U.S. FDA Resources
Study Type: Interventional
Study Design: Treatment, Crossover Assignment, Safety/Efficacy Study
Official Title: A Randomised, Double-Blind Clinical Efficacy and Safety Comparison of Tiotropium/Salmeterol 7.5/25 Mcg Inhalation Powder in the Morning Via Tiotropium/Salmeterol HandiHaler, Tiotropium 18 Mcg Inhalation Powder in the Morning Via Spiriva HandiHaler, Salmeterol 50 Mcg MDPI in the Morning and Evening and the Free Combination Tiotropium 18 Mcg Inhalation Powder in the Morning Via Spiriva HandiHaler Plus Salmeterol 50 Mcg MDPI in the Morning and Evening Following Chronic Administration (6-Week Treatment Periods) in Patients With COPD

Further study details as provided by Boehringer Ingelheim Pharmaceuticals:

Primary Outcome Measures:
  • FEV1 (AUC0 to 12h, AUC12 to 24h, peak and trough) [ Time Frame: 30 weeks ]

Secondary Outcome Measures:
  • FEV1 (AUC0 to 24h; FVC (peak, trough, AUC0 to 12 h, AUC0 to 24h, AUC12 to 24h), twice daily PEFs and FEV1 recorded by the patients at home, daily rescue salbutamol use, COPD related night time awakenings [ Time Frame: 30 weeks ]

Estimated Enrollment: 140
Study Start Date: April 2008
Estimated Primary Completion Date: August 2009 (Final data collection date for primary outcome measure)
  Eligibility

Ages Eligible for Study:   40 Years and older
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   No
Criteria

Inclusion Criteria:

  1. All patients must sign an informed consent consistent with ICH-GCP guidelines and local legislations prior to any study-related procedures, which includes medication washout and restrictions. Final,
  2. All patients must have a diagnosis of COPD and must meet the following criteria:

    • relatively stable* airway obstruction with a post-bronchodilator FEV1 < 80% of predicted normal and post-bronchodilator FEV1 < 70% of post-bronchodilator FVC at Visit 1 (according to GOLD criteria).
    • The randomisation of patients with any respiratory infection or COPD exacerbation in the 6 weeks prior to the Screening Visit (Visit 1) or during the baseline period should be postponed. Patients may be randomised 6 weeks following recovery from the infection or exacerbation Predicted normal values will be calculated according to ECSC.
  3. Male or female patients 40 years of age or older.
  4. Patients must be current or ex-smokers with a smoking history of 10 pack-years.
  5. Patients must be able to perform technically acceptable pulmonary function tests
  6. Patients must be able to inhale medication in a competent manner.
  7. Patients must be able to perform all necessary recordings in the diary.

Exclusion Criteria:

  1. Significant diseases other than COPD
  2. Patients with clinically significant abnormal baseline haematology, blood chemistry or urinalysis, if the abnormality defines a significant disease as defined in exclusion criterion No. 1.
  3. Patients with a recent history of myocardial infarction.
  4. Patients with any unstable or life-threatening cardiac arrhythmia requiring intervention or change in drug therapy during the past year.
  5. Hospitalisation for cardiac failure during the past year.
  6. Malignancy within the last five years excluded basal cell carcinoma.
  7. Patients with a history of asthma or who have a total blood eosinophil count 600/mm3.
  8. Patients with a history of life threatening pulmonary obstruction, or a history of cystic fibrosis or clinically evident bronchiectasis.
  9. Known active tuberculosis.
  10. Patients with a history of alcohol or drug abuse.
  11. Thoracotomy with pulmonary resection.
  12. Rehabilitation program within the last six weeks
  13. Patients who regularly use daytime oxygen therapy
  14. Patients who have taken an investigational drug within 30 days
  15. Use of not allowed medications
  16. Known hypersensitivity to used drugs or other components of the study medication.
  17. Pregnant or nursing women
  18. Women of childbearing potential not using a highly effective method of birth control. Highly effective methods of birth control are defined as those which result in a low failure rate (i.e. less than 1% per year) when used consistently and correctly such as implants, injectables, combined oral contraceptives, some IUDs, sexual abstinence or vasectomised partner. Female patients will be considered to be of childbearing potential unless surgically sterilised by hysterectomy or bilateral tubal ligation, or post-menopausal for at least two years.
  19. Patients who are currently participating in another study.
  Contacts and Locations
Please refer to this study by its ClinicalTrials.gov identifier: NCT00662792

Contacts
Contact: Boehringer Ingelheim Study Coordinator 1-800-243-0127 clintriage.rdg@boehringer-ingelheim.com

Locations
Germany
1184.13.1301 Boehringer Ingelheim Investigational Site Completed
Mannheim, Germany
1184.13.1305 Boehringer Ingelheim Investigational Site Recruiting
Mainz, Germany
1184.13.1306 Boehringer Ingelheim Investigational Site Recruiting
Rodgau-Dudenhofen, Germany
1184.13.1307 Boehringer Ingelheim Investigational Site Recruiting
Schwerin, Germany
1184.13.1308 Boehringer Ingelheim Investigational Site Active, not recruiting
Cottbus, Germany
1184.13.1302 Boehringer Ingelheim Investigational Site Recruiting
Berlin, Germany
1184.13.1304 Boehringer Ingelheim Investigational Site Recruiting
Wiesbaden, Germany
1184.13.1310 Boehringer Ingelheim Investigational Site Active, not recruiting
Rüdersdorf, Germany
1184.13.1311 Boehringer Ingelheim Investigational Site Active, not recruiting
Großhansdorf, Germany
1184.13.1312 Boehringer Ingelheim Investigational Site Active, not recruiting
Hamburg, Germany
1184.13.1303 Boehringer Ingelheim Investigational Site Recruiting
Wiesloch, Germany
1184.13.1309 Boehringer Ingelheim Investigational Site Recruiting
Berlin, Germany
Sponsors and Collaborators
Boehringer Ingelheim Pharmaceuticals
Investigators
Study Chair: Boehringer Ingelheim Boehringer Ingelheim Pharmaceuticals
  More Information

No publications provided

Responsible Party: Boehringer Ingelheim ( Boehringer Ingelheim, Study Chair )
Study ID Numbers: 1184.13, n.a.
Study First Received: April 17, 2008
Last Updated: April 23, 2009
ClinicalTrials.gov Identifier: NCT00662792     History of Changes
Health Authority: Germany: Federal Institute for Drugs and Medical Devices;   United States: Food and Drug Administration

Study placed in the following topic categories:
Neurotransmitter Agents
Salmeterol
Cholinergic Antagonists
Adrenergic Agents
Adrenergic beta-Agonists
Anti-Asthmatic Agents
Cholinergic Agents
Adrenergic Agonists
Lung Diseases, Obstructive
Respiratory Tract Diseases
Lung Diseases
Chronic Disease
Peripheral Nervous System Agents
Tiotropium
Bronchodilator Agents
Pulmonary Disease, Chronic Obstructive

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

ClinicalTrials.gov processed this record on May 07, 2009