Efficacy and Safety of QVA149 in Patients With Chronic Ob... | NCT00570778

NCT00570778

Status Module

Sponsor/Collaborators Module

Oversight Module

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No data is available for this block.

Description Module

Conditions Module

Design Module

Interventional Study Design

Biospecimen

No data available

No data is available for this block.

Arms/Interventions Module

Arm Groups

Label	Type	Description	Intervention Names
indacaterol/glycopyrrolate 300/50 μg	Experimental	One indacaterol/glycopyrrolate 300/50 μg capsule + 1 placebo capsule inhaled once daily via a single dose dry powder inhaler for 7 days.	Drug: indacaterol/glycopyrrolate
indacaterol 600 μg	Active Comparator	Two indacaterol 300 μg capsules inhaled once daily via a single dose dry powder inhaler for 7 days.	Drug: indacaterol
indacaterol 300 μg	Active Comparator	One capsule indacaterol 300 μg + one placebo capsule inhaled once daily via a single dose dry powder inhaler for 7 days.	Drug: indacaterol
placebo	Placebo Comparator	Two placebo capsules inhaled once daily via a single dose dry powder inhaler for 7 days.	Drug: placebo

Interventions

Name	Type	Description	Arm Group Labels	Other Names
indacaterol/glycopyrrolate	Drug	Inhalation capsule indacaterol/glycopyrrolate 300/50 μg inhaled once daily via a single dose dry powder inhaler for 7 days.	indacaterol/glycopyrrolate 300/50 μg

Outcomes Module

Primary Outcomes

Measure	Description	Time Frame
Change From Baseline in Trough Forced Expiratory Volume in 1 Second (FEV1) at Day 7	Spirometry testing was performed in accordance with American Thoracic Society standards. Trough FEV1 was defined as the average of the 23 hour 15 minute and 23 hour 45 minute measurements post dosing. Baseline FEV1 is the mean of the 45 minute and 15 minute pre-dose FEV1 values at day 1 of each period. Least square means are based on the Analysis of Covariance Trough FEV1 at day 7 = sequence effect + patient(sequence) + period effect + treatment effect + (period) baseline FEV1 + error.	Baseline, Day 7

Secondary Outcomes

Measure	Description	Time Frame
Standardized Forced Expiratory Volume in 1 Second (FEV1) Area Under Curve (AUC) 5 Minutes-12 Hours at Day 7	Spirometry testing was performed in accordance with American Thoracic Society standards. FEV1 was assessed at 5, 15, 30 minutes, 1, 2, 3, 4, 5, 6, 8, 10 and 12 hours post dose on Day 7. Standardized (with respect to time) AUC (5 minutes-12 hours) for FEV1 on day 7 was calculated using the trapezoidal rule. Least square means are based on the Analysis of Covariance: FEV1 AUC = sequence effect + patient (sequence) + period + treatment + baseline FEV1 (period) + error.

Eligibility Module

Eligibility Criteria

Inclusion Criteria:

Male or female adults aged ≥40 years, who have signed an Informed Consent Form prior to initiation of any study-related procedure.
Patients with moderate to severe stable Chronic Obstructive Pulmonary Disease (COPD) according to the Global Initiative for Obstructive Lung Disease (GOLD) Guidelines 2006.
Patients who have smoking history of at least 10 pack years.
Patients with a post-bronchodilator Forced Expiratory Volume in 1 second (FEV1) ≥30% and < 80% of the predicted normal and post-bronchodilator FEV1/Forced Vital Capacity (FVC) <0.70.

Exclusion Criteria:

Pregnant or nursing women, or women of child-bearing potential, regardless of whether or not sexually active if they are not using acceptable methods of contraception.
Patients requiring long term oxygen therapy (> 15 hours a day) on a daily basis for chronic hypoxemia, or who have been hospitalized or visited an emergency department for a COPD exacerbation or as result of their airways disease 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, pulmonary tuberculosis (unless confirmed by chest x-ray to be no longer active) or clinically significant bronchiectasis.
Patients with any history of asthma indicated by (but not limited to) a blood eosinophil count > 400/mm3.
Patients who, in the judgment of the investigator or the responsible Novartis personnel, have a clinically relevant laboratory abnormality or a clinically significant condition.
Patients with uncontrolled Type I and Type II diabetes.
History of malignancy of any organ system (including lung cancer), treated or untreated, within the past 5 years.
Patients who are contraindicated for or who have shown an untoward reaction to inhaled anticholinergic agents.
Patients with a history of long QT syndrome or whose QTc interval (Fridericia method) measured at screening is prolonged (>450 ms for males or >470 ms for females).
Patients with a history of untoward reactions to sympathomimetic amines, inhaled medication or any component thereof, or any of the study drugs or drugs with similar chemical structures.

Other protocol-defined inclusion/exclusion criteria may apply.

Contacts/Locations Module

Name	Affiliation	Role
Novartis Pharmaceuticals	Novartis Pharmaceuticals	Study Chair

Facility	Status	City	State	ZIP	Country	Contacts
Novartis Investigator Site		St Louis	Missouri		United States
Novartis Investigator Site

References Module

Citations

PubMed Identifier	Type	Citation	Retractions
20978028	Derived	van Noord JA, Buhl R, Laforce C, Martin C, Jones F, Dolker M, Overend T. QVA149 demonstrates superior bronchodilation compared with indacaterol or placebo in patients with chronic obstructive pulmonary disease. Thorax. 2010 Dec;65(12):1086-91. doi: 10.1136/thx.2010.139113. Epub 2010 Oct 26.

IPD Sharing Statement Module

No data available

No data is available for this block.

Results Section

Participant Flow Module

Arm/Group Information

ID	Title	Description
FG000	A: Ind 300 μg- Ind 600 μg- Placebo- Ind/Glyc 300/50 μg	Treatment Period 1: One indacaterol (Ind) 300 μg capsule and one placebo capsule inhaled once daily via a single dose dry powder inhaler (SDDPI) for 7 days. Treatment Period 2: Two indacaterol 300 μg capsules inhaled once daily via a SDDPI for 7 days. Treatment Period 3: Two placebo capsules inhaled once daily via a SDDPI for 7 days. Treatment Period 4: One indacaterol/glycopyrrolate (Ind/Glyc) 300/50 μg and one placebo capsule inhaled once daily via a SDDPI for 7 days.

Baseline Characteristics Module

Outcome Measures Module

Adverse Events Module

More Info Module

Annotation Section

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No data is available for this block.

Document Section

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No data is available for this block.

Derived Section

Miscellaneous Info Module

Submission Tracking

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No data is available for this block.

Condition Browse Module

Intervention Browse Module

Masking Info

Type of Units Analyzed

Arm/Group Information

ID	Title	Description
BG000	Overall Population	Participants were randomized and received the following 4 treatments: 1-Two placebo capsules inhaled once daily via a SDDPI for 7 days, 2-One indacaterol/glycopyrrolate (Ind/Glyc) 300/50 μg and one placebo capsule inhaled once daily via a SDDPI for 7 days, 3-One Indacaterol (Ind) 300 μg capsule and one placebo capsule inhaled once daily via a SDDPI for 7 days and 4-Two Indacaterol 300 μg capsules inhaled once daily via a SDDPI for 7 days. There was a 7 day washout period between the four treatment periods.

Baseline Measures

Title

Description

Population Description

Parameter Type

Dispersion Type

Unit of Measure

Calculate Percentage

Denominator Units Selected

Denominators

Classes

Age, Continuous

Baseline characteristics are based on the Safety Population that consists of all participants who received study drug.

Mean

Standard Deviation

years

Title

Denominators

Categories

Title	Measurements
	OG0001.512± 0.0143 OG0011.389± 0.0144 OG0021.395± 0.0143 OG003

Secondary

Standardized Forced Expiratory Volume in 1 Second (FEV1) Area Under Curve (AUC) 5 Minutes-12 Hours at Day 7

Spirometry testing was performed in accordance with American Thoracic Society standards. FEV1 was assessed at 5, 15, 30 minutes, 1, 2, 3, 4, 5, 6, 8, 10 and 12 hours post dose on Day 7. Standardized (with respect to time) AUC (5 minutes-12 hours) for FEV1 on day 7 was calculated using the trapezoidal rule. Least square means are based on the Analysis of Covariance: FEV1 AUC = sequence effect + patient (sequence) + period + treatment + baseline FEV1 (period) + error.

Participants from the Modified Intent-to-treat population (includes all participants who received study drug) with data available for analysis.

Posted

Least Squares Mean

Standard Error

Liters

Day 7

ID	Title	Description
OG000	Indacaterol/Glycopyrrolate 300/50 μg	One indacaterol/glycopyrrolate 300/50 μg capsule + 1 placebo capsule inhaled once daily via a single dose dry powder inhaler for 7 days.
OG001	Indacaterol 300 μg	One capsule indacaterol 300 μg + one placebo capsule inhaled once daily via a single dose dry powder inhaler for 7 days.
OG002	Indacaterol 600 μg	Two indacaterol 300 μg capsules inhaled once daily via a single dose dry powder inhaler for 7 days.

Secondary

Number of Participants With Adverse Events, Serious Adverse Events and Discontinuations Due to Adverse Events

Additional information about adverse events can be found in the Adverse Event Section.

Safety population includes all participants who received at least 1 dose of study drug.

Posted

Number

Participants

47 days

ID	Title	Description
OG000	Indacaterol/Glycopyrrolate 300/50 μg	One indacaterol/glycopyrrolate 300/50 μg capsule + 1 placebo capsule inhaled once daily via a single dose dry powder inhaler for 7 days.
OG001	Indacaterol 300 μg	One capsule indacaterol 300 μg + one placebo capsule inhaled once daily via a single dose dry powder inhaler for 7 days.
OG002	Indacaterol 600 μg	Two indacaterol 300 μg capsules inhaled once daily via a single dose dry powder inhaler for 7 days.
OG003	Placebo	Two placebo capsules inhaled once daily via a single dose dry powder inhaler for 7 days.

Arm/Groups

ID	Title	Description	Serious Events (Affected)	Serious Events (At Risk)	Other Events (Affected)	Other Events (At Risk)
EG000	Indacaterol/Glycopyrrolate 300/50 μg	One indacaterol/glycopyrrolate 300 μg /50 μg capsule + 1 placebo capsule inhaled once daily via a single dose dry powder inhaler for 7 days.	2	142	12	142
EG001	Indacaterol 300 μg	One capsule indacaterol 300 μg + one placebo capsule inhaled once daily via a single dose dry powder inhaler for 7 days.	0	141	14	141
EG002	Indacaterol 600 μg	Two indacaterol 300 μg capsules inhaled once daily via a single dose dry powder inhaler for 7 days.	0	141	15	141
EG003	Placebo	Two placebo capsules inhaled once daily via a single dose dry powder inhaler for 7 days.	0	143	15	143

Serious Adverse Events

Term	Organ System	Source Vocabulary	Assessment Type	Statistical Information
Fall	Injury, poisoning and procedural complications	MedDRA	Systematic Assessment	EG0001 affected142 at risk EG0010 affected141 at risk EG0020 affected141 at risk EG0030 affected143 at risk
Humerus fracture	Injury, poisoning and procedural complications	MedDRA	Systematic Assessment	EG0001 affected142 at risk EG0010 affected141 at risk EG0020 affected141 at risk EG003
Chronic obstructive pulmonary disease	Respiratory, thoracic and mediastinal disorders	MedDRA	Systematic Assessment	EG0001 affected142 at risk EG0010 affected141 at risk EG0020 affected141 at risk EG003

Other Adverse Events

Term	Organ System	Source Vocabulary	Assessment Type	Statistical Information
Diarrhoea	Gastrointestinal disorders	MedDRA	Systematic Assessment	EG0000 affected142 at risk EG0013 affected141 at risk EG0022 affected141 at risk EG0032 affected143 at risk
Nasopharyngitis	Infections and infestations	MedDRA	Systematic Assessment	EG0001 affected142 at risk EG0016 affected141 at risk EG0022 affected141 at risk EG003
Headache	Nervous system disorders	MedDRA	Systematic Assessment	EG0007 affected142 at risk EG0012 affected141 at risk EG0026 affected141 at risk EG003
Cough	Respiratory, thoracic and mediastinal disorders	MedDRA	Systematic Assessment	EG0004 affected142 at risk EG0011 affected141 at risk EG0023 affected141 at risk EG003
Dyspnoea	Respiratory, thoracic and mediastinal disorders	MedDRA	Systematic Assessment	EG0002 affected142 at risk EG0012 affected141 at risk EG0024 affected141 at risk EG003

ID	Term
D029424	Pulmonary Disease, Chronic Obstructive

Ancestor Terms

ID	Term
D008173	Lung Diseases, Obstructive
D008171	Lung Diseases
D012140	Respiratory Tract Diseases
D002908	Chronic Disease
D020969	Disease Attributes
D010335	Pathologic Processes
D013568	Pathological Conditions, Signs and Symptoms

ID	Term
C510790	indacaterol
D006024	Glycopyrrolate
C554862	indacaterol-glycopyrronium combination

Ancestor Terms

ID	Term
D000644	Quaternary Ammonium Compounds
D000588	Amines
D009930	Organic Chemicals
D009861	Onium Compounds
D011759	Pyrrolidines
D006573	Heterocyclic Compounds, 1-Ring
D006571	Heterocyclic Compounds