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Trial record 18 of 319 for:    FLUTICASONE AND SALMETEROL

A 12 Week Study of QVA149 Compared to Fluticasone/Salmeterol (Advair) for Treatment of COPD

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ClinicalTrials.gov Identifier: NCT01860066
Recruitment Status : Withdrawn
First Posted : May 22, 2013
Last Update Posted : November 11, 2013
Sponsor:
Information provided by (Responsible Party):
Novartis ( Novartis Pharmaceuticals )

Brief Summary:
Study is to show that QVA149 is superior to the standard of care, fluticasone/salmeterol, in patients with moderate to severe airflow limitation.

Condition or disease Intervention/treatment Phase
Chronic Obstructive Pulmonary Disease Drug: QVA149 Drug: fluticasone/salmeterol Phase 3

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Study Type : Interventional  (Clinical Trial)
Actual Enrollment : 0 participants
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Double (Participant, Investigator)
Primary Purpose: Treatment
Official Title: A 12-week Treatment, Multi-center, Randomized, Double-blind, Double-dummy, Parallel-group Study to Assess the Efficacy, Safety and Tolerability of QVA149 Compared to Fluticasone/Salmeterol in COPD Patients With Moderate to Severe Airflow Limitation
Study Start Date : December 2013
Estimated Primary Completion Date : September 2014
Estimated Study Completion Date : September 2014

Resource links provided by the National Library of Medicine


Arm Intervention/treatment
Experimental: QVA149
QVA149 study medication kit will contain blister strips and a unique inhaler. Patients will be instructed to inhale their medication twice a day for 12 weeks.
Drug: QVA149
QVA149 via inhaler twice a day

Active Comparator: fluticasone/salmeterol
Fluticasone/salmeterol study medication kit will contain an inhaler in the manufacturer's device. Patients will be instructed to inhale their medication twice a day for 12 weeks.
Drug: fluticasone/salmeterol
fluticasone/salmeterol via inhaler twice a day




Primary Outcome Measures :
  1. Area under the curve (AUC) 0-12 hours for FEV1 following 12 weeks of treatment [ Time Frame: 12 weeks ]
    Area under the curve (AUC) 0-12 hours for Forced Expiratory Volume in 1 second (FEV1) following 12 weeks of treatment. AUC will be calculated using the trapezoidal rule and standardized with respect to length of time from the first 5 minute to the last measurement at 12 hours


Secondary Outcome Measures :
  1. Trough Forced Expiratory Volume in 1 second (FEV1) following 12 weeks of treatment [ Time Frame: Day 1 and Week 12 ]
    Spiromtery testing conducted according to internationally accepted standards. FEV1 is the amount of air which can be forcibly exhaled from the lungs in the first second of a forced exhalation, measured through spirometry testing. The trough FEV1 will be will be defined as the mean from repeat measurements at Day 1 and week 12

  2. Peak Forced Expiratory Volume in 1 second (FEV1) within 4 hours post-dose [ Time Frame: Day 1 and Week 12 ]
    Spirometry testing conducted accorded to internationally accepted standards. Peak FEV1 defined as the maximum FEV1 during the first 4 hours post dosing. The Peak FEV1 will be defined as the mean from repeat measurements at Day 1 and week 12.

  3. Area under the curve (AUC) 0-4 hours for FEV1 [ Time Frame: Day 1 and Week 12 ]
    Area under the curve (AUC) 0-4 hours for Forced Expiratory Volume in 1 second (FEV1) at Day 1 and week 12. AUC will be calculated using the trapezoidal rule and standardized with respect to length of time from the first 5 minute to the last measurement at 12 hours.

  4. Transition Dyspnea Index (TDI) Focal Score [ Time Frame: Week 12 ]
    Transition Dyspnea Index (TDI) captures changes from baseline. The TDI score is based on three domains with each domain scored from -3 (major deterioration) to +3 (major improvement), to give an overall score of -9 to +9, a negative score indicating a deterioration from baseline. A TDI focal score of 1 is considered to be a clinically significant improvement from baseline; negative scores indicate deterioration. A TDI focal score of 1 unit is considered to be a minimal clinically important difference (MCID) from baseline.

  5. Quality of Lfe Assessment with St George's Respiratory Questionaire (SGRQ) [ Time Frame: Week 12 ]
    SGRQ is a health related quality of life questionnaire consisting of 51 items in three components: symptoms, activity, and impacts. The lowest possible value is zero and the highest 100. Higher values correspond to greater impairment in quality of life. Change from baseline in total score will be assessed.

  6. Change from baseline in daily number of puffs of rescue medication [ Time Frame: Week 12 ]
    Number of puffs of rescue medication in previous 12 hours is recorded in Patient Diary twice daily. The total number of puffs of rescue medication per day (daily use) over the active treatment period will be used to derive the mean daily number of puffs of rescue medication taken by the patient.

  7. Daily symptoms reported by patient [ Time Frame: Week 12 ]
    Patient's daily symptoms will be recorded twice daily using a patient diary. Mean daily total symptom score, mean morning and evening symptom score for each patient will be calculated over the 12 week study period.

  8. COPD assessment (CAT) test [ Time Frame: Week 12 ]
    COPD assessment test (CAT) contains 8 questions regarding patient symptoms. Patient will complete questions using a 6 point scale and total score out of a possible score of 40 will be summed and reported.

  9. Safety and tolerability [ Time Frame: Over 12 weeks ]
    All adverse events and serious adverse events (SAEs) will be reported.



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Ages Eligible for Study:   Child, Adult, Older Adult
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
Criteria

Inclusion Criteria: - Age >= 40 years, patients with airflow limitation indicated by post-bronchdilation FEV1 >=30% and <80% of predicted normal, current or ex-smokers with a 10 pack year smoking history, patients with a mMRC grade 2 or greater Exclusion Criteria: - prolonged QTCF >450 ms, paroxysmal atrial fibrillation, Type I or uncontrolled Type II diabetes, history of asthma, COPD diagnosis before age 40, receiving treatments not allowed in the study, other concomitant pulmonary diseases.

Other protocol-defined inclusion/exclusion criteria may apply.


Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT01860066


Locations
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Argentina
Novartis Investigative Site
San Miguel de Tucuman, Tucuman, Argentina, 4000
Novartis Investigative Site
Buenos Aires, Argentina, 1425
Novartis Investigative Site
Buenos Aires, Argentina, C1115AAB
Novartis Investigative Site
Buenos Aires, Argentina, C1122AAK
Novartis Investigative Site
Buenos Aires, Argentina
Novartis Investigative Site
Mendoza, Argentina, 5500
Novartis Investigative Site
Mendoza, Argentina, M5500CBA
Belgium
Novartis Investigative Site
Antwerpen, Belgium, 2060
Novartis Investigative Site
Bruxelles, Belgium, 1000
Novartis Investigative Site
Genk, Belgium, 3600
Novartis Investigative Site
Gilly, Belgium, 6060
Novartis Investigative Site
Hasselt, Belgium, 3500
Novartis Investigative Site
Jambes, Belgium, 5100
Colombia
Novartis Investigative Site
Barranquilla, Colombia
Novartis Investigative Site
Florida Blanca, Colombia
Novartis Investigative Site
Medellín, Colombia
Czech Republic
Novartis Investigative Site
Kyjov, CZE, Czech Republic, 697 70
Novartis Investigative Site
Cvikov, Czech Republic, 471 54
Novartis Investigative Site
Jindrichuv Hradec, Czech Republic, 377 01
Novartis Investigative Site
Karlovy Vary, Czech Republic, 360 66
Novartis Investigative Site
Kurim, Czech Republic, 664 34
Novartis Investigative Site
Pardubice, Czech Republic, 530 09
Novartis Investigative Site
Teplice, Czech Republic, 415 01
India
Novartis Investigative Site
Guntur, Andhra Pradesh, India, 522 001
Novartis Investigative Site
Ahmedabad, Gujarat, India, 380 008
Novartis Investigative Site
Faridabad, Haryana, India, 121 001
Novartis Investigative Site
Bangalore, Karnataka, India, 560 002
Novartis Investigative Site
Nagpur, Maharashtra, India, 400 012
Novartis Investigative Site
Pune, Maharashtra, India, 411004
Novartis Investigative Site
Jaipur, Rajasthan, India, 302004
Novartis Investigative Site
Karamsad, India, 388225
Sponsors and Collaborators
Novartis Pharmaceuticals
Investigators
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Study Director: Novartis Pharmaceuticals Novartis Pharmaceuticals

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Responsible Party: Novartis Pharmaceuticals
ClinicalTrials.gov Identifier: NCT01860066     History of Changes
Other Study ID Numbers: CQVA149A2328
First Posted: May 22, 2013    Key Record Dates
Last Update Posted: November 11, 2013
Last Verified: November 2013
Keywords provided by Novartis ( Novartis Pharmaceuticals ):
COPD
Additional relevant MeSH terms:
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Fluticasone
Salmeterol Xinafoate
Fluticasone-Salmeterol Drug Combination
Lung Diseases, Obstructive
Pulmonary Disease, Chronic Obstructive
Lung Diseases
Respiratory Tract Diseases
Glycopyrrolate
Anti-Inflammatory Agents
Bronchodilator Agents
Autonomic Agents
Peripheral Nervous System Agents
Physiological Effects of Drugs
Anti-Asthmatic Agents
Respiratory System Agents
Dermatologic Agents
Anti-Allergic Agents
Adrenergic beta-2 Receptor Agonists
Adrenergic beta-Agonists
Adrenergic Agonists
Adrenergic Agents
Neurotransmitter Agents
Molecular Mechanisms of Pharmacological Action
Adjuvants, Anesthesia
Muscarinic Antagonists
Cholinergic Antagonists
Cholinergic Agents
Glucocorticoids
Hormones
Hormones, Hormone Substitutes, and Hormone Antagonists