Efficacy and Safety of Indacaterol in Patients With Chronic Obstructive Pulmonary Disease (COPD) Using Salmeterol as Active Control

This study has been completed.
Sponsor:
Information provided by:
Novartis
ClinicalTrials.gov Identifier:
NCT00567996
First received: December 4, 2007
Last updated: July 22, 2011
Last verified: July 2011
  Purpose

This study evaluated the safety and efficacy of 26 weeks treatment with indacaterol, placebo or salmeterol in patients with chronic obstructive pulmonary disease.


Condition Intervention Phase
Chronic Obstructive Pulmonary Disease (COPD)
Drug: Indacaterol 150 μg
Drug: Salmeterol 50 μg
Drug: Placebo to Indacaterol
Drug: Placebo to Salmeterol
Phase 3

Study Type: Interventional
Study Design: Allocation: Randomized
Endpoint Classification: Safety/Efficacy Study
Intervention Model: Parallel Assignment
Masking: Double Blind (Subject, Investigator, Outcomes Assessor)
Primary Purpose: Treatment
Official Title: A 26-week Treatment, Multi-center, Randomized, Double-blind, Double- Dummy, Placebo-controlled, Parallel-group Study to Assess the Efficacy, and Safety of Indacaterol (150 µg o.d.) in Patients With Chronic Obstructive Pulmonary Disease, Using Salmeterol (50 µg b.i.d.) 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) After 12 Weeks of Treatment [ Time Frame: Week 12 ] [ Designated as safety issue: No ]
    Spirometry was conducted according to internationally accepted standards. Trough FEV1 was defined as the average of the 23 hour 10 minute and 23 hour 45 minute post-dose FEV1 readings. Mixed model used baseline FEV1, FEV1 prior to and 10-15 minutes post inhalation of salbutamol/albuterol, and FEV1 prior to and 1 hour post inhalation of ipratropium as covariates.


Secondary Outcome Measures:
  • St. George's Respiratory Questionnaire (SGRQ) Total Score After 12 Weeks of Treatment [ Time Frame: Week 12 ] [ Designated as safety issue: No ]
    SGRQ is a health related quality of life questionnaire consisting of 76 items in three sections: symptoms, activity and impacts. The total score is 0 to 100 with a higher score indicating poorer health status. The mixed model used baseline SGRQ total score, FEV1 prior to and 30 minutes post inhalation of salbutamol/albuterol, and FEV1 prior to and one hour post inhalation of ipratropium as covariates.

  • Percentage of COPD "Days of Poor Control" During 26 Weeks of Treatment [ Time Frame: Up to 26 weeks ] [ Designated as safety issue: No ]
    Participants rated their symptoms on a scale of 0=none to 3=severe. A Chronic Obstructive Pulmonary Disease (COPD) "day of poor control" was defined as any day in the participants diary with a score >=2 (moderate or severe) for at least 2 of 5 symptoms (cough, wheeze, production of sputum, color of sputum, breathlessness). The mixed model used baseline percentage of "days of poor control", FEV1 prior to and 30 minutes post inhalation of salbutamol/albuterol, and FEV1 prior to and one hour post inhalation of ipratropium as covariates.


Enrollment: 1002
Study Start Date: November 2007
Primary Completion Date: January 2009 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
Experimental: Indacaterol 150 μg

Indacaterol 150 μg once daily in the morning, inhaled via a single dose dry powder inhaler (SDDPI). Placebo to Salmeterol delivered twice daily via a proprietary dry powder inhaler in the morning and in the evening.

Daily inhaled corticosteroid treatment (if applicable) was allowed to remain stable throughout the study. The short acting (beta) β2-agonist (SABA) salbutamol/albuterol was available for rescue use throughout the study.

Drug: Indacaterol 150 μg
Indacaterol 150 μg once daily (o.d) inhaled
Drug: Placebo to Salmeterol
Placebo to salmeterol delivered via a proprietary dry powder inhaler
Placebo Comparator: Placebo

Placebo to Indacaterol once daily in the morning, inhaled via a single dose dry powder inhaler (SDDPI). Placebo to Salmeterol delivered twice daily via a proprietary dry powder inhaler in the morning and in the evening.

Daily inhaled corticosteroid treatment (if applicable) was allowed to remain stable throughout the study. The short acting (beta) β2-agonist (SABA) salbutamol/albuterol was available for rescue use throughout the study.

Drug: Placebo to Indacaterol
Placebo to Indacaterol inhaled via SDDPI.
Drug: Placebo to Salmeterol
Placebo to salmeterol delivered via a proprietary dry powder inhaler
Active Comparator: Salmeterol 50 μg

Salmeterol 50 μg twice daily delivered via a proprietary dry powder inhaler in the morning and in the evening. Placebo to Indacaterol daily in the morning, inhaled via a single dose dry powder inhaler (SDDPI).

Daily inhaled corticosteroid treatment (if applicable) was allowed to remain stable throughout the study. The short acting (beta) β2-agonist (SABA) salbutamol/albuterol was available for rescue use throughout the study.

Drug: Salmeterol 50 μg
Salmeterol 50 μg twice daily (b.i.d) delivered via a proprietary dry powder inhaler
Drug: Placebo to Indacaterol
Placebo to Indacaterol inhaled via SDDPI.

  Eligibility

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

Inclusion Criteria:

Clinical diagnosis of moderate to severe Chronic Obstructive Pulmonary Disease (COPD) as per the Global Initiative for Chronic Obstructive Lung Disease (GOLD) 2006 Guidelines (mandatory) and including:

  • Smoking history of at least 20 pack years
  • Post-bronchodilator Forced Expiratory Volume in 1 second (FEV1) < 80% predicted and >or= 30% of predicted normal value
  • Post-bronchodilator FEV1/FVC < 70%

("Post" defined as within 30 minutes of inhalation of 400 µg salbutamol)

Exclusion Criteria:

  • Pregnant or nursing (lactating) women and women of child-bearing potential UNLESS they meet pre-specified definitions of post-menopausal or are using pre-specified acceptable methods of contraception
  • Hospitalisation for COPD exacerbation in the 6 weeks prior to Visit 1 or during run-in
  • Patients requiring oxygen therapy for chronic hypoxemia (typically >15h/day)
  • Respiratory tract infection within 6 weeks prior to Visit 1 and during the run-in period
  • Concomitant pulmonary disease
  • Asthma history (eosinophils > 400/mm3; symptoms prior to age 40). Includes history of childhood asthma
  • History of long QTc syndrome or QTc interval > 450 ms for males and >470 ms for females
  • Patients who have a clinically significant condition or a clinically relevant laboratory abnormality
  • History of reactions to sympathomimetic amines or inhaled medication
  • Inability to use the dry powder devices or perform spirometry
  • Irregular day/night, wake/sleep cycles, e.g. shift workers
  • Certain medications for COPD and allied conditions such as long acting bronchodilators must not be used prior to Visit 1 and for a pre-specified minimum washout period
  • Patients unable or unwilling to complete a patient diary

Other protocol-defined inclusion/exclusion criteria may apply.

  Contacts and Locations
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Please refer to this study by its ClinicalTrials.gov identifier: NCT00567996

  Show 130 Study Locations
Sponsors and Collaborators
Novartis
Investigators
Study Chair: Novartis Pharma AG Novartis Pharmaceuticals
  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: NCT00567996     History of Changes
Other Study ID Numbers: CQAB149B2336
Study First Received: December 4, 2007
Results First Received: July 22, 2011
Last Updated: July 22, 2011
Health Authority: Brazil: Ministry of Health
Canada: Health Canada
Colombia: INVIMA Instituto Nacional de Vigilancia de Medicamentos y Alimentos
Czech Republic: State Institute for Drug Control
Denmark: Danish Medicines Agency
Germany: Federal Institute for Drugs and Medical Devices
Hungary: National Institute of Pharmacy
Iceland: Icelandic Medicines Control Agency
India: Ministry of Health
Italy: Ministry of Health
Norway: Norwegian Medicines Agency
Peru: Ministry of Health
Russia: Ministry of Health of the Russian Federation
Slovakia: State Institute for Drug Control
Taiwan: Department of Health
Finland: Finnish Medicines Agency

Keywords provided by Novartis:
Chronic obstructive pulmonary disease, indacaterol, salmeterol, placebo controlled

Additional relevant MeSH terms:
Lung Diseases
Pulmonary Disease, Chronic Obstructive
Lung Diseases, Obstructive
Respiratory Tract Diseases
Salmeterol
Bronchodilator Agents
Autonomic Agents
Peripheral Nervous System Agents
Physiological Effects of Drugs
Pharmacologic Actions
Anti-Asthmatic Agents
Respiratory System Agents
Therapeutic Uses
Adrenergic beta-2 Receptor Agonists
Adrenergic beta-Agonists
Adrenergic Agonists
Adrenergic Agents
Neurotransmitter Agents
Molecular Mechanisms of Pharmacological Action

ClinicalTrials.gov processed this record on August 21, 2014