Safety and Efficacy of NVA237 as an add-on to Fixed Dose Combination LABA/ICS (GLOW8)

This study has been withdrawn prior to enrollment.
Sponsor:
Information provided by (Responsible Party):
Novartis ( Novartis Pharmaceuticals )
ClinicalTrials.gov Identifier:
NCT01757015
First received: December 17, 2012
Last updated: August 26, 2013
Last verified: August 2013
  Purpose

This study is to evaluate if add-on treatment with inhaled NVA237 (50 µg) once daily (o.d.) via single-dose dry-powder inhaler (SDDPI) further improves lung function and health status and is well tolerated compared to placebo in symptomatic COPD patients with moderate to severe airflow limitation who are already receiving maintenance therapy with inhaled fixed-dose-combination of salmeterol/fluticasone propionate (50/500 µg) twice daily (b.i.d.) via multi-dose dry powder inhaler (MDDPI).


Condition Intervention Phase
Chronic Obstructive Pulmonary Disease
Drug: NVA237
Drug: Placebo to NVA237
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 Multi-center Randomized Double-blind Study to Compare Efficacy and Safety of NVA237 Versus Placebo as an add-on to Maintenance Therapy With Fixed-dose Combination Salmeterol/Fluticasone Propionate in COPD Patients With Moderate to Severe Airflow Limitation

Resource links provided by NLM:


Further study details as provided by Novartis:

Primary Outcome Measures:
  • Trough Forced Expiratory Volume in 1 second (FEV1) [ Time Frame: after 12 weeks of treatment ] [ Designated as safety issue: No ]
    Comparison of NVA237 treatment versus placebo treatment in the trough FEV1 after 12 weeks of treatment


Secondary Outcome Measures:
  • Total score of St George's Respiratory Questionnaire for COPD patients (SGRQ-C). [ Time Frame: 26 weeks ] [ Designated as safety issue: No ]
    Comparison of NVA237 treatment versus placebo treatment in terms of change in SGRQ-C after 26 weeks of treatment

  • Trough Forced Expiratory Volume in 1 second (FEV1) [ Time Frame: week 4 , week 26 ] [ Designated as safety issue: No ]
    Comparison of effect of NVA237 treatment versus placebo treatment in FEV1 after 4 weeks and after 26 weeks of treatment

  • Total score of the Transition Dyspnea Index (TDI) [ Time Frame: Week 12 and week 26 ] [ Designated as safety issue: No ]
    Comparison of effect of NVA237 treatment versus placebo treatment in the total TDI score after 12 weeks and after 26 weeks of treatment

  • Assessment of safety and tolerability [ Time Frame: 26 Weeks ] [ Designated as safety issue: Yes ]
    All safety endpoints will be summarized for the safety set.


Enrollment: 0
Study Start Date: April 2013
Estimated Study Completion Date: April 2014
Estimated Primary Completion Date: April 2014 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
Placebo Comparator: Placebo
Placebo to NVA237 (50 μg) o.d. in the morning Patients will also receive open label salmeterol/fluticasone propionate (50/500 µg) b.i.d., in the morning and evening
Drug: Placebo to NVA237
Placebo to NVA237
Experimental: NVA237
NVA237 (50 μg) o.d. in the morning Patients will also receive open label salmeterol/fluticasone propionate (50/500 µg) b.i.d., in the morning and evening.
Drug: NVA237
NVA237 (50µg, o.d. via SDDPI) in the morning,

  Eligibility

Ages Eligible for Study:   40 Years and older
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   No
Criteria

Inclusion Criteria:

  • Current or ex-smokers who have a smoking history of at least 10 pack years (e.g., 10 pack years = 1 pack/day × 10 years, ½ pack/day × 20 years, etc.).
  • COPD (Chronic Obstructive Pulmonary Disease) patients with moderate to severe airflow limitation (Spirometry classification: GOLD 2 or 3) at Visit 2:
  • Post-bronchodilator FEV1 (Forced Expiratory Volume in one second) ≥30% and <60% of the predicted normal, and,
  • Post-bronchodilator FEV1/forced vital capacity (FVC) <0.70
  • Patients on maintenance treatment with fixed-dose combination of inhaled salmeterol and fluticasone propionate (50/500 µg) b.i.d. delivered via a proprietary MDDPI (multidose dry powder inhaler) device for at least 30 days prior to screening visit (Visit 1).
  • Patients in category Gold B or D with a CAT (COPD Assessment Test) total score ≥10 at screening (Visit 1) and before randomization (Visit 3).
  • Patients with a history of at least 1 moderate or severe COPD exacerbation within the previous year.

Exclusion Criteria:

  • Pregnant or nursing (lactating) women
  • Women of child-bearing potential, unless they are using effective methods of contraception during the study
  • Patients with a history of long QT syndrome or whose QTc measured at run-in (Visit 2) (Fridericia method) is prolonged (>450 ms). (These patients cannot be re-screened.)
  • Patients with evidence (upon visual inspection) of oropharyngeal candidiasis at baseline with or without treatment.
  • Patients who have not achieved an acceptable spirometry result at run-in (Visit 2) in accordance with American Thoracic Society (ATS)/European Respiratory Society (ERS) criteria for acceptability and repeatability.
  • Patients who have had a COPD exacerbation that required treatment with antibiotics or oral corticosteroids or hospitalization in the 6 weeks prior to screening (Visit 1).
  • Patients who have had a respiratory tract infection within 4 weeks prior to screening (Visit 1).
  • Patients requiring long term oxygen therapy prescribed for >12 hours per day.
  • Patients with allergic rhinitis who use an H1 antagonist or intra-nasal corticosteroids intermittently. (Treatment with a stable dose or regimen is permitted.)
  • Patients with concomitant pulmonary disease (e.g., lung fibrosis, sarcoidosis, interstitial lung disease, or pulmonary hypertension), clinically significant bronchiectasis, or history of pulmonary lobectomy, lung volume reduction surgery, or lung transplantation.
  • Patients with active pulmonary tuberculosis, unless confirmed by imaging to be no longer active.

Other protocol-defined inclusion/exclusion criteria may apply.

  Contacts and Locations
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. 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: NCT01757015

Sponsors and Collaborators
Novartis Pharmaceuticals
Investigators
Study Director: Novartis Pharmaceuticals Novartis Pharmaceuticals
  More Information

No publications provided

Responsible Party: Novartis ( Novartis Pharmaceuticals )
ClinicalTrials.gov Identifier: NCT01757015     History of Changes
Other Study ID Numbers: CNVA237A2311, 2012-002854-21
Study First Received: December 17, 2012
Last Updated: August 26, 2013
Health Authority: Austria: Federal Office for Safety in Health Care
India: Drugs Controller General of India
Malaysia: Ministry of Health
Philippines: Bureau of Food and Drug Administration
Singapore: Health Sciences Authority
Thailand: Food and Drug Administration
Czech Republic: State Institute for Drug Control Germany: Federal Institute for Drugs and Medical Devices Hungary: National Institute of Pharmacy
Italy: The Italian Medicines Agency
Poland: Office for Registration of Medicinal Products, Medical Devices and Biocidal Products
Portugal: National Pharmacy and Medicines Institute
Romania: National Medicines Agency
Russia: Ministry of Health of the Russian Federation
Slovakia: State Institute for Drug Control
Spain: Spanish Agency of Medicines
Argentina: Administracion Nacional de Medicamentos, Alimentos y Tecnologia Medica
Brazil: Agencia Nacional de Vigilancia Sanitaria (ANVISA)
Chile: Instituto de Salud Publica de Chile (ISP)
Colombia: INVIMA Instituto Nacional de Vigilancia de Medicamentos y Alimentos
Guatemala: Ministerio de Salud Publica y Asistencia Social (MSPAS, Ministry of Public Health and Social Assistance), through "Comision para la Evaluacion de Ensayos Clinicos (Comission for the Evaluation of Clinical Trials)".
Mexico: Secretaria de Salud (SSA, Ministry of Health) through Comision Federal para la Proteccion contra Riesgos Sanitarios (COFEPRIS) / Federal Commission for Sanitary Risks Protection
Peru: Ministry of Health (Two regulatory bodies involved: "Instituto Nacional de Salud: Oficina General de Investigacion y Transferencia Tecnologica (OGITT)" and "Autoridad Nacional de Productos Farmaceuticos, Dispositivos Medicos y Productos Sanitarios (

Keywords provided by Novartis:
COPD
Chronic Obstructive Pulmonary Disease
Moderate to severe airflow limitation
GOLD spirometric classification 2 and 3
GOLD group B and D
NVA237
Salmeterol fluticasone propionate

Additional relevant MeSH terms:
Lung Diseases
Lung Diseases, Obstructive
Pulmonary Disease, Chronic Obstructive
Respiratory Tract Diseases
Fluticasone
Salmeterol
Adrenergic Agents
Adrenergic Agonists
Adrenergic beta-2 Receptor Agonists
Adrenergic beta-Agonists
Anti-Allergic Agents
Anti-Asthmatic Agents
Anti-Inflammatory Agents
Autonomic Agents
Bronchodilator Agents
Dermatologic Agents
Molecular Mechanisms of Pharmacological Action
Neurotransmitter Agents
Peripheral Nervous System Agents
Pharmacologic Actions
Physiological Effects of Drugs
Respiratory System Agents
Therapeutic Uses

ClinicalTrials.gov processed this record on October 23, 2014