Efficacy, Safety, and Tolerability of Once Daily Indacaterol in Chronic Obstructive Pulmonary Disease (COPD) Using Formoterol Twice Daily as Active Control
This study has been completed.
Sponsor:
Novartis
Information provided by:
Novartis
ClinicalTrials.gov Identifier:
NCT00393458
First received: October 25, 2006
Last updated: July 22, 2011
Last verified: July 2011
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Purpose
This study was designed to assess the efficacy and long-term safety of 300 and 600 µg doses of indacaterol when delivered via a single-dose dry-powder inhaler (SDDPI) in patients with chronic obstructive pulmonary disease (COPD). Patients were randomized to receive either indacaterol 300 µg once daily, indacaterol 600 µg once daily, formoterol 12 µg twice daily, or placebo.
| Condition | Intervention | Phase |
|---|---|---|
|
Chronic Obstructive Pulmonary Disease |
Drug: Indacaterol Drug: Formoterol Drug: Placebo to indacaterol Drug: Placebo to formoterol |
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 52-week Treatment, Multicenter, Randomized, Double-blind, Double-dummy, Placebo-controlled, Parallel-group Study to Assess the Efficacy, Safety, and Tolerability of Indacaterol (300 and 600 µg Once Daily) in Patients With Chronic Obstructive Pulmonary Disease, Using Formoterol (12 µg Twice Daily) as an Active Control |
Resource links provided by NLM:
Further study details as provided by Novartis:
Primary Outcome Measures:
- Trough Forced Expiratory Volume in 1 Second (FEV1) at Week 12 + 1 Day, Day 85 [ Time Frame: Week 12 + 1 day, Day 85 ] [ Designated as safety issue: No ]FEV1 was measured with spirometry conducted according to internationally accepted standards. Trough FEV1 was defined as the average of measurements made 23 hours 10 minutes and 23 hours 45 minutes post-dose at the end of treatment. The analysis included baseline FEV1, FEV1 pre-dose and 30 minutes post-dose of salbutamol/albuterol during screening, and FEV1 pre-dose and 1 hour post-dose of ipratropium during screening as covariates.
Secondary Outcome Measures:
- Percentage of Days of Poor Control During 52 Weeks of Treatment [ Time Frame: Baseline to end of study (Week 52) ] [ Designated as safety issue: No ]Percentage of days of poor control was defined as the number of days in the patient diary with a score ≥ 2 (scale of 0-3, a higher number means more severe symptoms) for at least 2 of 5 symptoms (cough, wheeze, production of sputum, color of sputum, breathlessness) over 52 weeks divided by the number of evaluable days (days with ≥ 2 symptoms with scores). The analysis included baseline percentage of days of poor control, FEV1 pre-dose and 30 minutes post-dose of salbutamol/albuterol during screening, and FEV1 pre-dose and 1 hour post-dose of ipratropium during screening as covariates.
| Enrollment: | 1732 |
| Study Start Date: | October 2006 |
| Study Completion Date: | July 2008 |
| Primary Completion Date: | July 2008 (Final data collection date for primary outcome measure) |
| Arms | Assigned Interventions |
|---|---|
|
Experimental: Indacaterol 300 μg plus placebo to formoterol
Patients inhaled indacaterol 300 μg once daily via a single-dose dry-powder inhaler (SDDPI), placebo to indacaterol once daily via a SDDPI, and placebo to formoterol twice daily via the manufacturer's proprietary inhalation device (Aerolizer®). Indacaterol, placebo to indacaterol, and placebo to formoterol were taken in the morning between 8:00 and 10:00 AM; placebo to formoterol was taken again 12 hours later in the evening between 8:00 and 10:00 PM. Daily inhaled corticosteroid treatment (if applicable) was to remain stable throughout the study. The short-acting β2-agonist salbutamol/albuterol was available for rescue use throughout the study.
|
Drug: Indacaterol
Indacaterol was supplied in powder-filled capsules with a single-dose dry-powder inhaler (SDDPI).
Drug: Placebo to formoterol
Placebo to formoterol was supplied in powder-filled capsules with the manufacturer's proprietary inhalation device (Aerolizer®).
|
|
Experimental: Indacaterol 600 μg plus placebo to formoterol
Patients inhaled indacaterol 600 μg (two 300 μg capsules) once daily via single-dose dry-powder inhalers (SDDPI) plus placebo to formoterol twice daily via the manufacturer's proprietary inhalation device (Aerolizer®). Indacaterol and placebo to formoterol were taken in the morning between 8:00 and 10:00 AM; placebo to formoterol was taken again 12 hours later in the evening between 8:00 and 10:00 PM. Daily inhaled corticosteroid treatment (if applicable) was to remain stable throughout the study. The short-acting β2-agonist salbutamol/albuterol was available for rescue use throughout the study.
|
Drug: Indacaterol
Indacaterol was supplied in powder-filled capsules with a single-dose dry-powder inhaler (SDDPI).
Drug: Placebo to formoterol
Placebo to formoterol was supplied in powder-filled capsules with the manufacturer's proprietary inhalation device (Aerolizer®).
|
|
Active Comparator: Formoterol 12 μg plus placebo to indacaterol
Patients inhaled formoterol 12 μg twice daily via the manufacturer's proprietary inhalation device (Aerolizer®) plus placebo to indacaterol once daily via a single-dose dry-powder inhaler (SDDPI). Formoterol and placebo to indacaterol were taken in the morning between 8:00 and 10:00 AM; formoterol was taken again 12 hours later in the evening between 8:00 and 10:00 PM. Daily inhaled corticosteroid treatment (if applicable) was to remain stable throughout the study. The short-acting β2-agonist salbutamol/albuterol was available for rescue use throughout the study.
|
Drug: Formoterol
Formoterol was supplied in powder-filled capsules with the manufacturer's proprietary inhalation device (Aerolizer®).
Drug: Placebo to indacaterol
Placebo to indacaterol was supplied in powder-filled capsules with a single-dose dry-powder inhaler (SDDPI).
|
|
Placebo Comparator: Placebo to indacaterol plus placebo to formoterol
Patients inhaled placebo to indacaterol once daily via a single-dose dry-powder inhaler (SDDPI) plus placebo to formoterol twice daily via the manufacturer's proprietary inhalation device (Aerolizer®). Placebo to indacaterol and placebo to formoterol were taken in the morning between 8:00 and 10:00 AM; placebo to formoterol was taken again 12 hours later in the evening between 8:00 and 10:00 PM. Daily inhaled corticosteroid treatment (if applicable) was to remain stable throughout the study. The short-acting β2-agonist salbutamol/albuterol was available for rescue use throughout the study.
|
Drug: Placebo to indacaterol
Placebo to indacaterol was supplied in powder-filled capsules with a single-dose dry-powder inhaler (SDDPI).
Drug: Placebo to formoterol
Placebo to formoterol was supplied in powder-filled capsules with the manufacturer's proprietary inhalation device (Aerolizer®).
|
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 ≥ 40 years, with a diagnosis of chronic obstructive pulmonary disease (COPD) according to Global Initiative for Chronic Obstructive Lung Disease (GOLD) guidelines 2005 and:
- Smoking history of at least 20 pack years
- Post-bronchodilator forced expiratory volume in 1 second (FEV1) < 80% and ≥ 30% of the predicted normal value
Post-bronchodilator FEV1/FVC (forced volume capacity) < 70% (Post refers to within 30 minutes after inhalation of 400 μg of salbutamol)
Exclusion Criteria:
- Patients who were hospitalized for a COPD exacerbation in the 6 weeks prior to screening.
- Patients who 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 co-morbid conditions.
Other protocol-defined inclusion/exclusion criteria applied to the study.
Contacts and Locations
Please refer to this study by its ClinicalTrials.gov identifier: NCT00393458
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Sponsors and Collaborators
Novartis
Investigators
| Principal Investigator: | Novartis Investigator Site | Novartis |
More Information
No publications provided by Novartis
Additional publications automatically indexed to this study by ClinicalTrials.gov Identifier (NCT Number):
| Responsible Party: | External Affairs, Novartis |
| ClinicalTrials.gov Identifier: | NCT00393458 History of Changes |
| Other Study ID Numbers: | CQAB149B2334 |
| Study First Received: | October 25, 2006 |
| Results First Received: | July 22, 2011 |
| Last Updated: | July 22, 2011 |
| Health Authority: | Argentina: Administracion Nacional de Medicamentos, Alimentos y Tecnologia Medica Belgium: Federal Agency for Medicinal Products and Health Products Switzerland: Federal Office of Public Health Chile: Instituto de Salud Publica de Chile Colombia: INVIMA Instituto Nacional de Vigilancia de Medicamentos y Alimentos Czech Republic: State Institute for Drug Control Germany: Federal Institute for Drugs and Medical Devices Denmark: Danish Medicines Agency Ecuador: Public Health Ministry Egypt: Ministry of Health and Population Spain: Spanish Agency of Medicines Estonia: The State Agency of Medicine France: Afssaps - Agence française de sécurité sanitaire des produits de santé (Saint-Denis) United Kingdom: Medicines and Healthcare Products Regulatory Agency Hungary: National Institute of Pharmacy Israel: Ministry of Health Italy: National Monitoring Centre for Clinical Trials - Ministry of Health Korea: Food and Drug Administration Lithuania: State Medicine Control Agency - Ministry of Health Latvia: State Agency of Medicines Netherlands: Medicines Evaluation Board (MEB) Peru: Ministry of Health Romania: Ministry of Public Health Russia: Ministry of Health of the Russian Federation Slovakia: State Institute for Drug Control Sweden: Medical Products Agency Turkey: Ministry of Health |
Keywords provided by Novartis:
|
chronic obstructive pulmonary disease COPD indacaterol long-acting β2 agonist |
Additional relevant MeSH terms:
|
Lung Diseases Respiration Disorders Pulmonary Disease, Chronic Obstructive Lung Diseases, Obstructive Respiratory Tract Diseases Formoterol 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 |
ClinicalTrials.gov processed this record on May 21, 2013