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Tiotropium/Salmeterol Inhalation Powder (Spiriva Handihaler and Salmeterol PE Capsule) in COPD

This study has been terminated.
Sponsor:
ClinicalTrials.gov Identifier:
NCT00662740
First Posted: April 21, 2008
Last Update Posted: May 16, 2014
The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details.
Information provided by:
Boehringer Ingelheim
  Purpose
The primary objectives of this study are to assess bronchodilator efficacy as determined by FEV1, the effect on dyspnoea as determined by the BDI/TDI, the effect on health status as determined by the SGRQ and the effect on COPD exacerbations.

Condition Intervention Phase
Pulmonary Disease, Chronic Obstructive Drug: Tiotropium/Salmeterol QD Drug: Placebo Drug: Salmeterol Drug: Tiotropium/Salmeterol QD+ Salmeterol Drug: Tiotropium Phase 3

Study Type: Interventional
Study Design: Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Double
Primary Purpose: Treatment
Official Title: 1-yr Study Comparing TioSal Combo Regimens Versus Single Agent Therapies (Spiriva HandiHaler and Salmeterol PE Capsule)

Resource links provided by NLM:


Further study details as provided by Boehringer Ingelheim:

Primary Outcome Measures:
  • Trough FEV1 response [ Time Frame: 12 Weeks, 24 Weeks and 48 Weeks ]
  • FEV1AUC 0 8h response [ Time Frame: 12 Weeks, 24 Weeks and 48 Weeks ]
  • Mahler TDI focal score [ Time Frame: 12 Weeks, 24 Weeks and 48 Weeks ]
  • SGRQ total score [ Time Frame: 12 Weeks, 24 Weeks and 48 Weeks ]
  • Time to first moderate to severe COPD exacerbation [ Time Frame: 12 Weeks, 24 Weeks and 48 Weeks ]

Secondary Outcome Measures:
  • FEV1 AUC0-8h response [ Time Frame: 4, 36 and 48 weeks ]
  • Trough FEV1 response [ Time Frame: 4, 36 and 48 weeks ]
  • Peak FEV1 response [ Time Frame: 12, 24, 36 and 48 weeks ]
  • Use of rescue medication (weekly mean number of puffs of as-needed salbutamol/albuterol per day, daytime and night-time) [ Time Frame: 24 hours ]
  • FVC (forced vital capacity) AUC0-8h and trough FVC response [ Time Frame: 48 weeks ]
  • Individual FEV1, FVC and PEF measurements [ Time Frame: 48 weeks ]
  • Weekly mean morning pre-dose and evening pre-dose PEFs (peak expiratory flow) and FEV1 (recorded by AM2+); PEFs determined by spirometry ] [ Time Frame: 48 weeks ]
  • Weekly mean number of COPD related night time awakenings [ Time Frame: 1 week ]
  • Mahler TDI focal score [ Time Frame: 4, 36 and 48 weeks ]
  • Mahler Dyspnoea Indices (Functional Impairment, Magnitude of Task and Magnitude of Effort) [ Time Frame: 4, 12, 24, 36 and 48 weeks ]
  • SGRQ total score, and the impact, activity and symptoms domain scores from the SGRQ [ Time Frame: 4, 12, 36 and 48 weeks ]
  • All adverse events [ Time Frame: 48 weeks ]
  • Vital signs: pulse rate and blood pressure [ Time Frame: Baseline and 4 weeks ]
  • Routine blood chemistry, haematology and urinalysis [ Time Frame: Baseline and 48 weeks ]
  • Vital status of randomised patients [ Time Frame: 48 weeks ]
  • Number of days in hospital (including ambulance transportation [ Time Frame: 48 weeks ]
  • Number of unscheduled health care provider visits [ Time Frame: 48 weeks ]
  • Number of visits in emergency room (including ambulance transportation) [ Time Frame: 48 weeks ]
  • Number of days in intensive care unit [ Time Frame: 48 weeks ]
  • Concomitant medications (for instance antibiotics and systemic steroids). [ Time Frame: 48 weeks ]

Enrollment: 220
Study Start Date: April 2008
Primary Completion Date: November 2008 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
Experimental: Tiotropium/Salmeterol QD
Tiotropium/Salmeterol Inhalation Powder, Hard Polyethylene Capsule
Drug: Tiotropium/Salmeterol QD
Tiotropium/Salmeterol Inhalation Powder, Hard Polyethylene Capsule
Active Comparator: Tiotropium QD
Tiotropium Inhalation Powder, hard gelatine capsule (Spiriva®)
Drug: Tiotropium
Tiotropium
Active Comparator: Salmeterol BID
Salmeterol Inhalation Powder, hard PE capsule
Drug: Salmeterol
Salmeterol Inhalation Powder, hard PE capsule
Active Comparator: Tiotropium/Salmeterol QD+ Salmeterol
Tiotropium/Salmeterol Inhalation Powder, Hard Polyethylene Capsule, plus Salmeterol Inhalation Powder, hard PE capsule
Drug: Tiotropium/Salmeterol QD+ Salmeterol
Tiotropium/Salmeterol Inhalation Powder, Hard Polyethylene Capsule, plus Salmeterol Inhalation Powder, hard PE capsule
Placebo Comparator: Placebo
Placebo Inhalation Powder, hard PE capsule / hard gelatine capsule
Drug: Placebo
Placebo Inhalation Powder, hard PE capsule / hard gelatine capsule

  Eligibility

Information from the National Library of Medicine

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, Learn About Clinical Studies.


Ages Eligible for Study:   40 Years and older   (Adult, Senior)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
Criteria

Inclusion criteria:

Main:

Diagnosis of COPD Post-bronchodilator FEV1<80% predicted and FEV1/FVC<70% predicted

Exclusion criteria:

Main:

Significant other diseases then COPD Recent MI Unstable or life-threatening arrythmia requiring intervention or change in drug therapy Hospitalisation for cardiac failure in past year History of asthma

  Contacts and Locations
Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT00662740


  Show 72 Study Locations
Sponsors and Collaborators
Boehringer Ingelheim
Investigators
Study Chair: Boehringer Ingelheim Boehringer Ingelheim
  More Information

Responsible Party: Boehringer Ingelheim, Study Chair, Boehringer Ingelheim
ClinicalTrials.gov Identifier: NCT00662740     History of Changes
Other Study ID Numbers: 1184.14
2007-005134-36 ( EudraCT Number: EudraCT )
First Submitted: April 17, 2008
First Posted: April 21, 2008
Last Update Posted: May 16, 2014
Last Verified: April 2014

Additional relevant MeSH terms:
Lung Diseases
Chronic Disease
Pulmonary Disease, Chronic Obstructive
Respiratory Tract Diseases
Disease Attributes
Pathologic Processes
Lung Diseases, Obstructive
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