A 26-week Treatment Randomized, Double-blind, Double Dummy, Parallel-group Study to Assess the Efficacy, Safety and Tolerability of QVA149 (Indacaterol / Glycopyrronium Bromide) Compared to Fluticasone/Salmeterol in Patients With Moderate to Severe Chronic Obstructive Pulmonary Disease
This study is currently recruiting participants.
Verified April 2013 by Novartis
Sponsor:
Novartis Pharmaceuticals
Information provided by (Responsible Party):
Novartis ( Novartis Pharmaceuticals )
ClinicalTrials.gov Identifier:
NCT01709903
First received: October 16, 2012
Last updated: April 17, 2013
Last verified: April 2013
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Purpose
To demonstrate the non-inferiority of QVA149 110/50 µg o.d. to fluticasone/salmeterol 500/50 µg b.i.d. in terms of trough Forced Expiratory Volume in one second (FEV1) (mean of 23 hours 15 min and 23 hours 45 min post QVA149 dose) following 26 weeks of treatment in patients with moderate to severe COPD
| Condition | Intervention | Phase |
|---|---|---|
|
Chronic Obstructive Pulmonary Disease |
Drug: QVA149 Drug: Fluticasone/salmeterol Drug: Pacebo to QVA149 Drug: Placebo to fluticasone/salmeterol |
Phase 3 |
| Study Type: | Interventional |
| Study Design: | Allocation: Randomized Endpoint Classification: Safety/Efficacy Study Intervention Model: Parallel Assignment Masking: Double Blind (Subject, Caregiver, Investigator, Outcomes Assessor) Primary Purpose: Treatment |
| Official Title: | A 26-week Treatment Randomized, Double-blind, Double Dummy, Parallel-group Study to Assess the Efficacy, Safety and Tolerability of QVA149 (Indacaterol / Glycopyrronium Bromide) Compared to Fluticasone/Salmeterol in Patients With Moderate to Severe Chronic Obstructive Pulmonary Disease |
Resource links provided by NLM:
MedlinePlus related topics:
COPD (Chronic Obstructive Pulmonary Disease)
Drug Information available for:
Glycopyrrolate
Fluticasone propionate
Salmeterol
Fluticasone
Salmeterol xinafoate
Indacaterol
U.S. FDA Resources
Further study details as provided by Novartis:
Primary Outcome Measures:
- Trough Forced Expiratory Volume in one second (FEV1) [ Time Frame: 26 weeks ] [ Designated as safety issue: No ]Mean of 23 hours 15 min and 23 hours 45 min post QVA149 dose
Secondary Outcome Measures:
- Standardized Forced Expiratory Volume in one second (FEV1) Area Under the Curve (AUC) 0-12 hours [ Time Frame: 12 and 26 weeks ] [ Designated as safety issue: No ]The trapezoidal rule will be used to calculate Forced Expiratory Volume in one second Area under the curve.
- Trough Forced Expiratory Volume in one second (FEV1) and Forced Vital Capacity (FVC) [ Time Frame: 12 and 26 weeks ] [ Designated as safety issue: No ]Average of Trough Forced Expiratory Volume in one second (FEV1) and Forced Vital Capacity (FVC) at 23 hours 15 min and the 23 hours 45 min post dose
- Standardized Forced Expiratory Volume in one second (FEV1) Area under the curve (AUC) 0-4 hours [ Time Frame: 12 and 26 weeks ] [ Designated as safety issue: No ]The trapezoidal rule will be used to calculate Forced Expiratory Volume in one second Area under the curve.
- Health Related Quality of Life [ Time Frame: 12 and 26 weeks ] [ Designated as safety issue: No ]The total score of St.George Respiratory Questionnaire (SGRQ)
- Dyspnea [ Time Frame: 12 and 26 weeks ] [ Designated as safety issue: No ]Dyspnea will be measured at baseline using the baseline dyspnea index (BDI) and during the treatment period using the transitional dyspnea index (TDI), which captures changes from baseline.
- Rescue medication use [ Time Frame: 12 and 26 weeks ] [ Designated as safety issue: No ]The number of puffs of rescue medication taken in the previous 12 hours will be recorded in the Patient Diary in the morning and evening.
- Symptoms reported using e-diary over 12 and 26 weeks of treatment [ Time Frame: 12 and 26 weeks ] [ Designated as safety issue: No ]Will be recorded in the Patient Diary in the morning and evening
- Safety and tolerability [ Time Frame: 26 weeks ] [ Designated as safety issue: Yes ]Electrocardiograms(ECGs), laboratory tests, blood pressure, heart rate and adverse events including Chronic Obstructive Pulmonary Disease (COPD) exacerbations and oral candidiasis.
| Estimated Enrollment: | 736 |
| Study Start Date: | November 2012 |
| Estimated Study Completion Date: | February 2014 |
| Estimated Primary Completion Date: | February 2014 (Final data collection date for primary outcome measure) |
| Arms | Assigned Interventions |
|---|---|
| Experimental: QVA149 |
Drug: QVA149
QVA149 110/50 µg capsules q.d. for inhalation, delivered via Novartis single dose dry powder inhaler (SDDPI).
Drug: Placebo to fluticasone/salmeterol
Placebo to fluticasone/salmeterol with Accuhaler
|
| Active Comparator: fluticasone/salmeterol |
Drug: Fluticasone/salmeterol
Active fluticasone/salmeterol (500/50µg) b.i.d via a dry power inhaler Accuhaler® device.
Drug: Pacebo to QVA149
Placebo to QVA149 with SDDPI
|
Eligibility| Ages Eligible for Study: | 40 Years and older |
| Genders Eligible for Study: | Both |
| Accepts Healthy Volunteers: | No |
Criteria
Inclusion Criteria:
- Patients with moderate to severe stable COPD (Stage II or Stage III) according to Global Initiative for Chronic Obstructive Lung Disease (GOLD) Guideline.
Current or ex-smokers who have a smoking history of at least 10 pack years. Patients with a post-bronchodilator Forced Expiratory Volume in one second (FEV1) ≥ 30% and < 80% of the predicted normal, and post-bronchodilator FEV1/FVC < 0.7.
Modified Medical Research Council (mMRC) grade of at least 2 at Visit 2.
Exclusion Criteria:
- 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 Human Chorionic Gonadotropin (hCG) laboratory test.
Patents with narrow-angle glaucoma, symptomatic benign prostatic hyperplasia (BPH), bladder-neck obstruction, moderate to severe renal impairment or urinary retention. BPH patients who are stable on treatment can be considered.
Patients with a history of long QT syndrome or whose QTc measured at run-in (Visit 2) (Fridericia method) is prolonged (>450 ms for males and females) as confirmed by the central Electrocardiogram (ECG) assessor.
Patients with Type I or uncontrolled Type II diabetes. Patients who have not achieved spirometry result at Visit 2 in accordance with American Thoracic Society/European Respiratory Society (ATS/ERS) criteria for acceptability and repeatability.
Patients with, a) any history of asthma or, b) onset of respiratory symptoms prior to age 40 years.
Patients with concomitant pulmonary disease (e.g. lung fibrosis, primary bronchiectasis, sarcoidosis, interstitial lung disorder, pulmonary hypertension).
Other protocol-defined inclusion/exclusion criteria may apply
Contacts and Locations
Please refer to this study by its ClinicalTrials.gov identifier: NCT01709903
Show 69 Study Locations
Contacts
| Contact: Novartis Pharmaceuticals | +41613241111 | |
| Contact: Novartis Pharmaceuticals |
Show 69 Study LocationsSponsors and Collaborators
Novartis Pharmaceuticals
Investigators
| Study Director: | Novartis Pharmaceuticals | Novartis Pharmaceuticals |
More Information
No publications provided
| Responsible Party: | Novartis ( Novartis Pharmaceuticals ) |
| ClinicalTrials.gov Identifier: | NCT01709903 History of Changes |
| Other Study ID Numbers: | CQVA149A2331 |
| Study First Received: | October 16, 2012 |
| Last Updated: | April 17, 2013 |
| Health Authority: | United States: Food and Drug Administration Argentina: Administracion Nacional de Medicamentos, Alimentos y Tecnologia Medica Argentina: Human Research Bioethics Committee Argentina: Ministry of Health Brazil: Ethics Committee Brazil: Ministry of Health Brazil: National Committee of Ethics in Research Brazil: National Health Surveillance Agency Chile: Comisi?n Nacional de Investigaci?n Cient?fica y Tecnol?gica Chile: Instituto de Salud Publica de Chile China: Ethics Committee China: Ministry of Health China: Food and Drug Administration Taiwan: Center for Drug Evaluation Taiwan: Department of Health Taiwan: Institutional Review Board Taiwan: National Bureau of Controlled Drugs |
Keywords provided by Novartis:
|
chronic obstructive pulmonary disease |
Additional relevant MeSH terms:
|
Lung Diseases Respiration Disorders Pulmonary Disease, Chronic Obstructive Lung Diseases, Obstructive Respiratory Tract Diseases Glycopyrrolate Salmeterol Albuterol Fluticasone Fluticasone, salmeterol drug combination Adjuvants, Anesthesia Central Nervous System Agents Therapeutic Uses Pharmacologic Actions Muscarinic Antagonists |
Cholinergic Antagonists Cholinergic Agents Neurotransmitter Agents Molecular Mechanisms of Pharmacological Action Physiological Effects of Drugs Adrenergic beta-2 Receptor Agonists Adrenergic beta-Agonists Adrenergic Agonists Adrenergic Agents Bronchodilator Agents Autonomic Agents Peripheral Nervous System Agents Anti-Asthmatic Agents Respiratory System Agents Tocolytic Agents |
ClinicalTrials.gov processed this record on May 19, 2013