Back to resultsEfficacy of Indacaterol 150 µg Versus Formoterol
Primary Purpose
Chronic Obstructive Pulmonary Disease (COPD)
Status
Withdrawn
Phase
Phase 4
Locations
Study Type
Interventional
Intervention
Indacaterol
Formoterol
Sponsored by
About this trial
This is an interventional treatment trial for Chronic Obstructive Pulmonary Disease (COPD) focused on measuring COPD, Indacaterol, Formoterol
Eligibility Criteria
Inclusion Criteria:
Diagnosis of COPD (moderate-to-severe as classified by the Global Initiative for Chronic Obstructive Lung Disease (GOLD) Guidelines, 2009) and:
- Post-bronchodilator FEV1 <80% and ≥40% of the predicted normal value
- Post-bronchodilator FEV1/FVC (forced vital capacity) <70%
- Smoking history of at least 10 pack-years
Exclusion Criteria:
- Patients who have had a COPD exacerbation in the 6 weeks prior to screening
- 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
Sites / Locations
Arms of the Study
Arm 1
Arm 2
Arm Type
Experimental
Active Comparator
Arm Label
Indacaterol
Formoterol
Arm Description
Indacaterol 150 µg once daily (od) via single-dose dry powder inhaler (SDDPI)
Formoterol 12 µg twice daily (bid) via single-dose dry powder inhaler (SDDPI)
Outcomes
Primary Outcome Measures
24-h post-dose trough forced expiratory volume in 1 second (FEV1)
Secondary Outcome Measures
24-h post-dose trough inspiratory capacity (IC)
Full Information
1. Study Identification
Unique Protocol Identification Number
NCT01377428
Brief Title
Efficacy of Indacaterol 150 µg Versus Formoterol
Official Title
A 12-week Treatment, Multicenter, Randomized, Double Blind, Double Dummy, Parallel-group Study to Assess the Efficacy of Indacaterol (150 μg o.d.) in Patients With Chronic Obstructive Pulmonary Disease, Using Formoterol (12 μg b.i.d.) as an Active Control
Study Type
Interventional
2. Study Status
Record Verification Date
May 2012
Overall Recruitment Status
Withdrawn
Study Start Date
September 2011 (undefined)
Primary Completion Date
February 2012 (Anticipated)
Study Completion Date
February 2012 (Anticipated)
3. Sponsor/Collaborators
Responsible Party, by Official Title
Sponsor
Name of the Sponsor
Novartis Pharmaceuticals
4. Oversight
5. Study Description
Brief Summary
The study will be a 12 week treatment (84 days), parallel group, randomized, double blind, double dummy, study to assess the superiority of indacaterol (150 μg o.d.) versus formoterol (12 μg b.i.d.) in terms of trough forced expiratory volume in 1 second (FEV1).
Patients will be enrolled after giving informed consent and then begin a screening/run-in period for 14 days. Patients will be randomized to one of two treatment groups using an allocation ratio of 1:1 to receive either indacaterol (150 μg o.d.) and placebo to formoterol, or formoterol (12 μg b.i.d.) and placebo to indacaterol for a treatment period of 12 weeks.
6. Conditions and Keywords
Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Chronic Obstructive Pulmonary Disease (COPD)
Keywords
COPD, Indacaterol, Formoterol
7. Study Design
Primary Purpose
Treatment
Study Phase
Phase 4
Interventional Study Model
Parallel Assignment
Masking
ParticipantCare ProviderInvestigatorOutcomes Assessor
Allocation
Randomized
Enrollment
0 (Actual)
8. Arms, Groups, and Interventions
Arm Title
Indacaterol
Arm Type
Experimental
Arm Description
Indacaterol 150 µg once daily (od) via single-dose dry powder inhaler (SDDPI)
Arm Title
Formoterol
Arm Type
Active Comparator
Arm Description
Formoterol 12 µg twice daily (bid) via single-dose dry powder inhaler (SDDPI)
Intervention Type
Drug
Intervention Name(s)
Indacaterol
Intervention Description
Indacaterol 150 µg once daily (od) via single-dose dry powder inhaler (SDDPI)
Intervention Type
Drug
Intervention Name(s)
Formoterol
Intervention Description
Formoterol 12 µg twice daily (bid) via single-dose dry powder inhaler (SDDPI)
Primary Outcome Measure Information:
Title
24-h post-dose trough forced expiratory volume in 1 second (FEV1)
Time Frame
After 84 days of treatment
Secondary Outcome Measure Information:
Title
24-h post-dose trough inspiratory capacity (IC)
Time Frame
After 84 days of treatment
10. Eligibility
Sex
All
Minimum Age & Unit of Time
40 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
Inclusion Criteria:
Diagnosis of COPD (moderate-to-severe as classified by the Global Initiative for Chronic Obstructive Lung Disease (GOLD) Guidelines, 2009) and:
Post-bronchodilator FEV1 <80% and ≥40% of the predicted normal value
Post-bronchodilator FEV1/FVC (forced vital capacity) <70%
Smoking history of at least 10 pack-years
Exclusion Criteria:
Patients who have had a COPD exacerbation in the 6 weeks prior to screening
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
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Novartis Pharmaceuticals
Organizational Affiliation
Novartis Pharmaceuticals
Official's Role
Study Director
12. IPD Sharing Statement
Learn more about this trial
Efficacy of Indacaterol 150 µg Versus Formoterol
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