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Swiss studY for the Treatment of COPD Patients With the Free combiNation of indacatERol and GlYcopyrroniumbromide. (SYNERGY)
This study has been completed.
Sponsor:
Novartis Pharmaceuticals
Information provided by (Responsible Party):
Novartis ( Novartis Pharmaceuticals )
ClinicalTrials.gov Identifier:
NCT01699685
First received: September 28, 2012
Last updated: January 11, 2016
Last verified: January 2016
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Purpose
The study purpose is to evaluate the effect of QAB149
- NVA237 vs. QAB149 on static lung hyperinflation.
| Condition | Intervention | Phase |
|---|---|---|
| Chronic Obstructive Pulmonary Disease: COPD | Drug: QAB149 Drug: Placebo Drug: NVA237 | Phase 3 |
| Study Type: | Interventional |
| Study Design: | Allocation: Randomized Intervention Model: Crossover Assignment Masking: Double Blind (Participant, Investigator) Primary Purpose: Treatment |
| Official Title: | A Multicenter, Randomized, Double-blind, Single-dose Study to Assess the Effect of the QAB149 and NVA237 Combination Versus QAB149 Alone on Inspiratory Capacity in Patients With Moderate or Severe COPD. |
Resource links provided by NLM:
Further study details as provided by Novartis ( Novartis Pharmaceuticals ):
Primary Outcome Measures:
- Inspiratory Capacity (IC) Peak Value [ Time Frame: Day (0) 30minutes, 1, 2, 3, and 4 hours; Day (6) 30 minutes, 1, 2, 3, and 4 hours ]IC was measured with spirometry conducted according to internationally accepted standards. Peak IC was defined as the maximum IC of the mean at one of the post-dose measurements (30min, 60min, 120min, 180min and 240min).
Secondary Outcome Measures:
- Forced Expiratory Volume in One Second (FEV1) [ Time Frame: Day (0) 30minutes, 1, 2, 3, and 4 hours; Day (6) 30 minutes, 1, 2, 3, and 4 hours ]FEV1 was measured with spirometry conducted according to internationally accepted standards. FEV1 was at 30, 60, 120, 180, and 240 minutes post-dose. Spirometry equipment and performance of spirometric testing had to be in accordance with standards as outlined in the American Thoracic Society for the Standardization of Spirometry recommendations. The spirometry equipment used during the study had to meet or exceed these minimal ATS recommendations
- Inspiratory Capacity (IC) [ Time Frame: within 4h after dosing ]During the 4 hours following inhalation of the study treatment, inspiratory capacity (IC) was measured with spirometry conducted according to internationally accepted standards. IC was measured at 30, 60, 120, 180, and 240 minutes post-dose
- Forced Volume Capacity (FVC) [ Time Frame: Day (0) 30minutes, 1, 2, 3, and 4 hours; Day (6) 30 minutes, 1, 2, 3, and 4 hours ]FVC was measured with spirometry conducted according to internationally accepted standards. Measurements were made 30, 60, 120, 180, and 240 minutes post-dose. The standardized AUC FEV1 was calculated as the sum of trapezoids divided by the length of time
- Total Lung Capacity (TLC) [ Time Frame: Day (0) 30minutes, 1, 2, 3, and 4 hours; Day (6) 30 minutes, 1, 2, 3, and 4 hours ]TLC was measured with spirometry conducted according to internationally accepted standards. Peak TLC was calculated as the mean of the three Functional Residual Capacity peak measurements plus the mean of the three Inspiratory Capacity measurements which were measured each at 30, 60, 120, 180 and 240 minutes post dose
- Airway Resistance (Raw) [ Time Frame: Day (0) 30minutes, 1, 2, 3, and 4 hours; Day (6) 30 minutes, 1, 2, 3, and 4 hours ]Raw was measured with spirometry conducted according to internationally accepted standards. Raw was the mean of the measurements which were measured each at 30, 60, 120, 180 and 240 minutes
| Enrollment: | 79 |
| Study Start Date: | November 2012 |
| Study Completion Date: | June 2014 |
| Primary Completion Date: | June 2014 (Final data collection date for primary outcome measure) |
| Arms | Assigned Interventions |
|---|---|
|
Placebo Comparator: Sequence A
Patients will inhale QAB149 (capsule form in blister packs) + Placebo via Novartis Concept 1 SDDPI
|
Drug: QAB149
Capsule form in blister packs inhaled with the Novartis Concept 1 SDDPI
Drug: Placebo
Capsule form in blister packs inhaled with the Novartis Concept 1 SDDPI
|
|
Active Comparator: Sequence B
Patients will inhale QAB149 plus NVA237 (capsule form in blister packs) via Novartis Concept 1 SDDPI
|
Drug: QAB149
Capsule form in blister packs inhaled with the Novartis Concept 1 SDDPI
Drug: NVA237
Capsule form in blister packs inhaled with the Novartis Concept 1 SDDPI
|
Detailed Description:
This is a multicenter, randomized, double-blinded, single-dose, cross-over, placebo-controlled study. The primary endpoint was chosen to demonstrate the superiority of a single-dose of the combined inhalation vs. the mono inhalation regarding the Inspiratory Capacity (IC) peak value. A total of 78 patients will be randomized to complete two visits with two single doses of treatment. Patients will be randomized in a cross-over manner. Treatment visits will be separated by a study medication wash-out period.Treatments will be administered in a blinded fashion.
The patients will be male and female patients, ≥40 years of age, with a documented diagnosis of moderate or severe COPD according to Global Initiative for Chronic Obstructive Lung Disease (GOLD) criteria and >10-pack years history of smoking, FEV1 <80% and ≥30% of the predicted normal value.
Eligibility| Ages Eligible for Study: | 40 Years and older (Adult, Senior) |
| Sexes Eligible for Study: | All |
| Accepts Healthy Volunteers: | No |
Criteria
Inclusion criteria:
- Male and female patients, ≥40 years of age, with a documented diagnosis of moderate or severe COPD according to Global Initiative for Chronic Obstructive Lung Disease (GOLD) criteria and >10-pack year history of smoking
- FEV1 <80% and ≥30% of the predicted normal value who have signed an informed consent form prior to the initiation of any study-related procedure
Exclusion criteria:
- No COPD exacerbations within 6 weeks prior to dosing
- No concomitant lung disease such as asthma
- Nno requirement for long term oxygen treatment or history of lung reduction surgery
- No medical conditions that would interfere with the performance of spirometry
- No other medical condition that in the opinion of the investigator may cause the patient to be unsuitable for completion of the study or place the patient at potential risk form being in the study e.g. uncontrolled hypertension or unstable ischemic heart disease.
Contacts and Locations
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To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below.
For general information, see Learn About Clinical Studies.
Please refer to this study by its ClinicalTrials.gov identifier: NCT01699685
Please refer to this study by its ClinicalTrials.gov identifier: NCT01699685
Locations
| Switzerland | |
| Novartis Investigative Site | |
| Faltigberg-Wald, ZH, Switzerland, 8639 | |
| Novartis Investigative Site | |
| Barmelweid, Switzerland, 5017 | |
| Novartis Investigative Site | |
| Basel, Switzerland, 4031 | |
| Novartis Investigative Site | |
| Bern, Switzerland, 3010 | |
| Novartis Investigative Site | |
| Bern, Switzerland, 3013 | |
| Novartis Investigative Site | |
| Crans-Montana, Switzerland, 3963 | |
| Novartis Investigative Site | |
| Lausanne, Switzerland, 1011 | |
| Novartis Investigative Site | |
| Locarno, Switzerland, 6600 | |
| Novartis Investigative Site | |
| Lugano, Switzerland, 6900 | |
| Novartis Investigative Site | |
| St. Gallen, Switzerland, 9007 | |
| Novartis Investigative Site | |
| Walenstadtberg, Switzerland, 8881 | |
Sponsors and Collaborators
Novartis Pharmaceuticals
Investigators
| Study Director: | Corinne Wild, PhD | Novartis Pharmaceuticals |
| Study Chair: | Corinne Wild, PhD | Novartis Pharmaceuticals |
| Principal Investigator: | Martin Brutsche, Prof. Dr. med. | Kantonsspital St. Gallen, Switzerland |
More Information
Publications automatically indexed to this study by ClinicalTrials.gov Identifier (NCT Number):
| Responsible Party: | Novartis Pharmaceuticals |
| ClinicalTrials.gov Identifier: | NCT01699685 History of Changes |
| Other Study ID Numbers: |
CNVA237ACH01 2012-002362-13 ( EudraCT Number ) |
| Study First Received: | September 28, 2012 |
| Results First Received: | June 26, 2015 |
| Last Updated: | January 11, 2016 |
Keywords provided by Novartis ( Novartis Pharmaceuticals ):
|
Moderate to severe COPD patients are included NVA QAB |
Additional relevant MeSH terms:
|
Lung Diseases Lung Diseases, Obstructive Pulmonary Disease, Chronic Obstructive Respiratory Tract Diseases Glycopyrrolate Lactitol Adjuvants, Anesthesia Muscarinic Antagonists |
Cholinergic Antagonists Cholinergic Agents Neurotransmitter Agents Molecular Mechanisms of Pharmacological Action Physiological Effects of Drugs Cathartics Gastrointestinal Agents |
ClinicalTrials.gov processed this record on June 28, 2017