Back to resultsEffects of Indacaterol in Symptomatic COPD Patients With Low Risk of Exacerbations
Primary Purpose
Chronic Obstructive Pulmonary Disease
Status
Completed
Phase
Phase 4
Locations
Hong Kong
Study Type
Interventional
Intervention
Indacaterol
Placebo
Sponsored by
About this trial
This is an interventional treatment trial for Chronic Obstructive Pulmonary Disease focused on measuring COPD, FEV1, indacaterol
Eligibility Criteria
Inclusion criteria
- Male or female adults aged ≥40 years, who have provided their consent and signed an Informed Consent Form. Written informed consent must be obtained before any assessment is performed.
- Patients diagnosed with COPD at 40 years of age or older.
- Patients with smoking history of at least 10 pack years, both current and ex-smokers are eligible. (Ten pack years is defined as 20 cigarettes a day for 10 years, or 10 cigarettes a day for 20 years, etc)
- Patients with stable COPD in Patient Group B according to GOLD 2014.
Exclusion criteria
- Use of other investigational drugs within 5 half-lives of enrollment, or [within 30 days /until the expected PD effect has returned to baseline], whichever is longer.
- History of hypersensitivity to any of the study drugs or to drugs of similar chemical classes.
- Pregnant or nursing (lactating) women, where pregnancy is defined as the state of a female after conception and until the termination of gestation, confirmed by a positive hCG laboratory test.
- Patients who have had 2 or more COPD exacerbations that required treatment with antibiotics, systemic steroids (oral or intravenous) or 1 or more exacerbation resulting in hospitalization in the 12 months prior to Visit 1.
- Patients who have COPD exacerbation or infection 6 weeks prior to Visit 1.
- Patients who develop a moderate or severe COPD exacerbation during the period between Visit 1 and Visit 2.
- Patients with a history of asthma.
Sites / Locations
- Novartis Investigative Site
Arms of the Study
Arm 1
Arm 2
Arm Type
Experimental
Experimental
Arm Label
Placebo
Indacaterol 150 mcg
Arm Description
Matching placebo indacaterol capsules for inhalation once daily delivered via the Novartis single dose dry power inhaler (SDDPI) (Onbrez® Breezhaler®)
Indacaterol 150 mcg capsules for inhalation once daily delivered via the Novartis single dose dry power inhaler (SDDPI) (Onbrez® Breezhaler®)
Outcomes
Primary Outcome Measures
Trough Forced Expiratory Volume in 1 Second (FEV1) at 12 Weeks
To compare the effects of indacaterol 150ug once dialy (od) to placebo in GOLD 2014 Group B COPD patients, in terms of 24-hour postdose (trough) forced expiratory volume in 1 second (FEV1) after 12 weeks of dosing.
Secondary Outcome Measures
Full Information
NCT ID
NCT02418468
First Posted
April 13, 2015
Last Updated
April 19, 2017
Sponsor
Novartis Pharmaceuticals
1. Study Identification
Unique Protocol Identification Number
NCT02418468
Brief Title
Effects of Indacaterol in Symptomatic COPD Patients With Low Risk of Exacerbations
Official Title
Effects of Indacaterol in Symptomatic COPD Patients With Low Risk of Exacerbations
Study Type
Interventional
2. Study Status
Record Verification Date
April 2017
Overall Recruitment Status
Completed
Study Start Date
April 28, 2015 (Actual)
Primary Completion Date
April 19, 2016 (Actual)
Study Completion Date
April 19, 2016 (Actual)
3. Sponsor/Collaborators
Responsible Party, by Official Title
Sponsor
Name of the Sponsor
Novartis Pharmaceuticals
4. Oversight
Data Monitoring Committee
No
5. Study Description
Brief Summary
This study compared the efficacy of indacaterol versus placebo in COPD patients classified as GOLD 2014 Patient Group B.
This was a 2-arm parallel group study that recruited COPD patients classified by GOLD Patient Gorup B. On successful completion of run-in period, patients were randomized in the ratio 1:1 to receive prn salbutamol plus:
Indacaterol 150ug or
Placebo for indacaterol all once daily (od) for 26 weeks. The primary objective (trough FEV1) was assessed after 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
Keywords
COPD, FEV1, indacaterol
7. Study Design
Primary Purpose
Treatment
Study Phase
Phase 4
Interventional Study Model
Parallel Assignment
Masking
ParticipantInvestigator
Allocation
Randomized
Enrollment
24 (Actual)
8. Arms, Groups, and Interventions
Arm Title
Placebo
Arm Type
Experimental
Arm Description
Matching placebo indacaterol capsules for inhalation once daily delivered via the Novartis single dose dry power inhaler (SDDPI) (Onbrez® Breezhaler®)
Arm Title
Indacaterol 150 mcg
Arm Type
Experimental
Arm Description
Indacaterol 150 mcg capsules for inhalation once daily delivered via the Novartis single dose dry power inhaler (SDDPI) (Onbrez® Breezhaler®)
Intervention Type
Drug
Intervention Name(s)
Indacaterol
Intervention Description
Indacaterol 150µg capsules for inhalation daily
Intervention Type
Drug
Intervention Name(s)
Placebo
Intervention Description
Matching placebo indacaterol capsules for inhalation daily
Primary Outcome Measure Information:
Title
Trough Forced Expiratory Volume in 1 Second (FEV1) at 12 Weeks
Description
To compare the effects of indacaterol 150ug once dialy (od) to placebo in GOLD 2014 Group B COPD patients, in terms of 24-hour postdose (trough) forced expiratory volume in 1 second (FEV1) after 12 weeks of dosing.
Time Frame
at week 12
10. Eligibility
Sex
All
Minimum Age & Unit of Time
40 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
Inclusion criteria
Male or female adults aged ≥40 years, who have provided their consent and signed an Informed Consent Form. Written informed consent must be obtained before any assessment is performed.
Patients diagnosed with COPD at 40 years of age or older.
Patients with smoking history of at least 10 pack years, both current and ex-smokers are eligible. (Ten pack years is defined as 20 cigarettes a day for 10 years, or 10 cigarettes a day for 20 years, etc)
Patients with stable COPD in Patient Group B according to GOLD 2014.
Exclusion criteria
Use of other investigational drugs within 5 half-lives of enrollment, or [within 30 days /until the expected PD effect has returned to baseline], whichever is longer.
History of hypersensitivity to any of the study drugs or to drugs of similar chemical classes.
Pregnant or nursing (lactating) women, where pregnancy is defined as the state of a female after conception and until the termination of gestation, confirmed by a positive hCG laboratory test.
Patients who have had 2 or more COPD exacerbations that required treatment with antibiotics, systemic steroids (oral or intravenous) or 1 or more exacerbation resulting in hospitalization in the 12 months prior to Visit 1.
Patients who have COPD exacerbation or infection 6 weeks prior to Visit 1.
Patients who develop a moderate or severe COPD exacerbation during the period between Visit 1 and Visit 2.
Patients with a history of asthma.
Facility Information:
Facility Name
Novartis Investigative Site
City
Hong Kong
Country
Hong Kong
12. IPD Sharing Statement
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Effects of Indacaterol in Symptomatic COPD Patients With Low Risk of Exacerbations
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