Exacerbation Study (INVIGORATE)

This study has been completed.
Sponsor:
Information provided by (Responsible Party):
Novartis ( Novartis Pharmaceuticals )
ClinicalTrials.gov Identifier:
NCT00845728
First received: February 15, 2009
Last updated: September 16, 2013
Last verified: September 2013
  Purpose

This study compares indacaterol with tiotropium in terms of bronchodilation over 52 weeks


Condition Intervention Phase
Chronic Obstructive Pulmonary Disease
Drug: Indacaterol 150 µg
Drug: Tiotropium
Phase 3

Study Type: Interventional
Study Design: Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Double Blind (Subject, Caregiver, Investigator, Outcomes Assessor)
Primary Purpose: Treatment
Official Title: A Phase IIIb Multicenter, 52 Week Treatment, Randomized, Blinded, Double Dummy, Parallel Group Efficacy Study Comparing the Effect of Inhaled Indacaterol 150 µg o.d. vs Inhaled Tiotropium 18 µg o.d. on Lung Function, Rate of Exacerbations and Related Outcomes in Patients With COPD

Resource links provided by NLM:


Further study details as provided by Novartis:

Primary Outcome Measures:
  • Trough Forced Expiratory Volume in 1 Second (FEV1). [ Time Frame: 12 weeks ] [ Designated as safety issue: No ]
    The primary objective of the study was to demonstrate the non-inferiority of indacaterol vs. tiotropium with respect to 24 hour post dose (trough) FEV1 after 12 weeks of treatment in patients with severe COPD. Trough FEV1 was defined as the average of the 23 hours 10 min and the 23 hours 45 min post dose values. Trough FEV1 was analyzed using a mixed model for the PPS-S. The model contained treatment as a fixed effect with the baseline FEV1, FEV1 prior to inhalation and FEV1 15 min post-inhalation of salbutamol/albuterol (components of SABA reversibility at Visit 2), FEV1 prior to inhalation and FEV1 60 min post-inhalation of ipratropium (components of anti-cholinergic reversibility at Visit 3) as covariates. Smoking history (current or ex-smoker) was included as a factor in the model.


Secondary Outcome Measures:
  • Rate of COPD Exacerbations [ Time Frame: 52 weeks ] [ Designated as safety issue: No ]
    COPD exacerbations were defined as :Worsening of 2 or more major symptoms for at least 2 consecutive days: dyspnea; sputum volume; suputum purulence AND requiring treatment with systemic corticosteroids and/or antibiotics OR Worsening of any 1 major symptom together with any 1 of the following minor symptoms for at least 2 consecutive days: Sore throat; colds; fever without other cause; increased cough; increase wheeze AND requiring treatment with systemic glucocorticosteroids and/or antibiotics. The rate was analyzed using a linear model assuming a negative binomial distribution for the PPS-E. The time at risk for a patient was defined as the length of time the patient was in the study and the log(length of time in the study) was used as the offset variable in the model.


Enrollment: 3439
Study Start Date: March 2009
Study Completion Date: July 2012
Primary Completion Date: July 2012 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
Experimental: Indacaterol
Indacaterol 150 µg o.d. delivered via single-dose dry powder inhaler (SDDPI)
Drug: Indacaterol 150 µg
Indacaterol 150 µg o.d. delivered via SDDPI
Active Comparator: Tiotropium
Tiotropium 18 µg o.d. delivered via the handihaler®
Drug: Tiotropium
Tiotropium 18 µg o.d. delivered via handihaler®

  Eligibility

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

Inclusion Criteria:

  • Male and female adults aged ≥40 years, who have signed an Informed Consent form prior to initiation of any study-related procedure
  • Patients diagnosed with COPD at age 40 and over and with a current diagnosis of severe COPD and including:

    1. Smoking history of at least 10 pack years, both current and ex-smokers are eligible
    2. A documented history of at least 1 moderate or severe exacerbation in the previous 12 months

Exclusion Criteria:

  • Patients who have received systemic corticosteroids and/or antibiotics for a COPD exacerbation in the 6 weeks prior to screening or during the run-in period
  • Patients who have had a respiratory tract infection within 6 weeks prior to screening
  • Patients with concomitant pulmonary disease
  • Patients with a history of asthma
  • Patients with diabetes Type I or uncontrolled diabetes Type II
  • Any patient with lung cancer or a history of lung cancer
  • Patients with a history of certain cardiovascular comorbid conditions

Other protocol-defined inclusion/exclusion criteria may apply

  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.

Please refer to this study by its ClinicalTrials.gov identifier: NCT00845728

  Show 424 Study Locations
Sponsors and Collaborators
Novartis Pharmaceuticals
Investigators
Study Director: Novartis Pharmaceuticals Novartis Pharmaceuticals
  More Information

No publications provided by Novartis

Additional publications automatically indexed to this study by ClinicalTrials.gov Identifier (NCT Number):
Responsible Party: Novartis ( Novartis Pharmaceuticals )
ClinicalTrials.gov Identifier: NCT00845728     History of Changes
Other Study ID Numbers: CQAB149B2348, 2008-007944-33
Study First Received: February 15, 2009
Results First Received: July 3, 2013
Last Updated: September 16, 2013
Health Authority: United States: Food and Drug Administration
Austria: Federal Office for Safety in Health Care
Slovakia: State Institute for Drug Control
Canada: Health Canada
Israel: Ministry of Health
Spain: Spanish Agency of Medicines
Estonia: The State Agency of Medicine
Lithuania: State Medicine Control Agency - Ministry of Health
Finland: Finnish Medicines Agency
Belgium: Federal Agency for Medicinal Products and Health Products
United Kingdom: Medicines and Healthcare Products Regulatory Agency
France: Afssaps - Agence française de sécurité sanitaire des produits de santé (Saint-Denis)
India: Drugs Controller General of India
Hungary: National Institute of Pharmacy
Iceland: Icelandic Medicines Control Agency
Colombia: INVIMA Instituto Nacional de Vigilancia de Medicamentos y Alimentos
Australia: Department of Health and Ageing Therapeutic Goods Administration
Denmark: Danish Medicines Agency
Czech Republic: State Institute for Drug Control
Turkey: Ministry of Health
Latvia: State Agency of Medicines
Philippines: Bureau of Food and Drugs
Russia: FSI Scientific Center of Expertise of Medical Application
Germany: Federal Institute for Drugs and Medical Devices
Netherlands: The Central Committee on Research Involving Human Subjects (CCMO)
Poland: Office for Registration of Medicinal Products, Medical Devices and Biocidal Products
Argentina: Administracion Nacional de Medicamentos, Alimentos y Tecnologia Medica
Portugal: National Authority of Medicines and Health Products (INFARMED, I.P.)
Taiwan: Department of Health
Sweden: Medical Products Agency
Switzerland: Swissmedic
Romania: National Medicines Agency
Peru: Instituto Nacional de Salud
Costa Rica: Ministry of Health Costa Rica
Italy: The Italian Medicines Agency
South Africa: Medicines Control Council
China: Food and Drug Administration
Venezuela: Ministry of Health and Social Development
Brazil: National Health Surveillance Agency
Thailand: Food and Drug Administration
Mexico: National Institute of Public Health, Health Secretariat
New Zealand: Ministry of Health

Keywords provided by Novartis:
Indacaterol
Tiotropium
COPD

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

ClinicalTrials.gov processed this record on August 19, 2014