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

This study has been terminated.
Sponsor:
Information provided by:
Boehringer Ingelheim
ClinicalTrials.gov Identifier:
NCT00662740
First received: April 17, 2008
Last updated: October 31, 2013
Last verified: October 2013
  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
Endpoint Classification: Safety/Efficacy Study
Intervention Model: Parallel Assignment
Masking: Double-Blind
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 ] [ Designated as safety issue: No ]
  • FEV1AUC 0 8h response [ Time Frame: 12 Weeks, 24 Weeks and 48 Weeks ] [ Designated as safety issue: No ]
  • Mahler TDI focal score [ Time Frame: 12 Weeks, 24 Weeks and 48 Weeks ] [ Designated as safety issue: No ]
  • SGRQ total score [ Time Frame: 12 Weeks, 24 Weeks and 48 Weeks ] [ Designated as safety issue: No ]
  • Time to first moderate to severe COPD exacerbation [ Time Frame: 12 Weeks, 24 Weeks and 48 Weeks ] [ Designated as safety issue: No ]

Secondary Outcome Measures:
  • FEV1 AUC0-8h response [ Time Frame: 4, 36 and 48 weeks ] [ Designated as safety issue: No ]
  • Trough FEV1 response [ Time Frame: 4, 36 and 48 weeks ] [ Designated as safety issue: No ]
  • Peak FEV1 response [ Time Frame: 12, 24, 36 and 48 weeks ] [ Designated as safety issue: No ]
  • Use of rescue medication (weekly mean number of puffs of as-needed salbutamol/albuterol per day, daytime and night-time) [ Time Frame: 24 hours ] [ Designated as safety issue: No ]
  • FVC (forced vital capacity) AUC0-8h and trough FVC response [ Time Frame: 48 weeks ] [ Designated as safety issue: No ]
  • Individual FEV1, FVC and PEF measurements [ Time Frame: 48 weeks ] [ Designated as safety issue: No ]
  • 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 ] [ Designated as safety issue: No ]
  • Weekly mean number of COPD related night time awakenings [ Time Frame: 1 week ] [ Designated as safety issue: No ]
  • Mahler TDI focal score [ Time Frame: 4, 36 and 48 weeks ] [ Designated as safety issue: No ]
  • Mahler Dyspnoea Indices (Functional Impairment, Magnitude of Task and Magnitude of Effort) [ Time Frame: 4, 12, 24, 36 and 48 weeks ] [ Designated as safety issue: No ]
  • SGRQ total score, and the impact, activity and symptoms domain scores from the SGRQ [ Time Frame: 4, 12, 36 and 48 weeks ] [ Designated as safety issue: No ]
  • All adverse events [ Time Frame: 48 weeks ] [ Designated as safety issue: No ]
  • Vital signs: pulse rate and blood pressure [ Time Frame: Baseline and 4 weeks ] [ Designated as safety issue: No ]
  • Routine blood chemistry, haematology and urinalysis [ Time Frame: Baseline and 48 weeks ] [ Designated as safety issue: No ]
  • Vital status of randomised patients [ Time Frame: 48 weeks ] [ Designated as safety issue: No ]
  • Number of days in hospital (including ambulance transportation [ Time Frame: 48 weeks ] [ Designated as safety issue: No ]
  • Number of unscheduled health care provider visits [ Time Frame: 48 weeks ] [ Designated as safety issue: No ]
  • Number of visits in emergency room (including ambulance transportation) [ Time Frame: 48 weeks ] [ Designated as safety issue: No ]
  • Number of days in intensive care unit [ Time Frame: 48 weeks ] [ Designated as safety issue: No ]
  • Concomitant medications (for instance antibiotics and systemic steroids). [ Time Frame: 48 weeks ] [ Designated as safety issue: No ]

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

Ages Eligible for Study:   40 Years and older
Genders Eligible for Study:   Both
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
Please refer to this study by its ClinicalTrials.gov identifier: NCT00662740

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

No publications provided

Responsible Party: Boehringer Ingelheim, Study Chair, Boehringer Ingelheim
ClinicalTrials.gov Identifier: NCT00662740     History of Changes
Other Study ID Numbers: 1184.14, 2007-005134-36
Study First Received: April 17, 2008
Last Updated: October 31, 2013
Health Authority: Austria: Federal Office for Safety in Health Care
Belgium: Federal Agency for Medicines and Health Products, FAMHP
Canada: Therapeutic Products Directorate
Denmark: The Danish Medicines Agency
Estonia: State Agency of Medicines, EE-5041Tartu
Finland: Finnish Medicines Agency
France: AGENCE FRANCAISE DE SECURITE SANITAIRE DES PRODUITS DE SANTE
Germany: Federal Institute for Drugs and Medical Devices
Greece: National Organization of Medicines (EOF) National Ethics Committee
Hungary: National Institute of Pharmacy, H-1051 Budapest
Italy: Comitato Etico per la sperim. clinica dei medicinali dell'A.O. Universitaria Pisana di Pisa
Korea, Republic of: Korea Food and Drug Administration
Latvia: State Agency of Medicines, LV-1003 Riga
Lithuania: State Medicines Control Agency, LT-01132 Vilnius
Netherlands: The Central Committee on Research Involving Human Subjects (CCMO)
Slovakia: SUKL (state institute for drug control), SK-825 08 Bratislava 26
Sweden: Medical Products Agency Regional Ethics Committee of Lund
United States: Food and Drug Administration

Additional relevant MeSH terms:
Chronic Disease
Lung Diseases
Respiration Disorders
Pulmonary Disease, Chronic Obstructive
Disease Attributes
Pathologic Processes
Respiratory Tract Diseases
Lung Diseases, Obstructive
Salmeterol
Albuterol
Tiotropium
Adrenergic beta-2 Receptor Agonists
Adrenergic beta-Agonists
Adrenergic Agonists
Adrenergic Agents
Neurotransmitter Agents
Molecular Mechanisms of Pharmacological Action
Pharmacologic Actions
Physiological Effects of Drugs
Bronchodilator Agents
Autonomic Agents
Peripheral Nervous System Agents
Anti-Asthmatic Agents
Respiratory System Agents
Therapeutic Uses
Tocolytic Agents
Reproductive Control Agents
Parasympatholytics
Cholinergic Antagonists
Cholinergic Agents

ClinicalTrials.gov processed this record on April 17, 2014