Long Term Safety Study of NVA237 vs QAB149 in COPD Patients

This study is ongoing, but not recruiting participants.
Sponsor:
Information provided by (Responsible Party):
Novartis ( Novartis Pharmaceuticals )
ClinicalTrials.gov Identifier:
NCT01697696
First received: September 28, 2012
Last updated: May 20, 2014
Last verified: May 2014
  Purpose

The purpose of the study is to provide long term safety data of NVA237. This study will assess the safety and tolerability of a single dose strength of NVA237.


Condition Intervention Phase
Chronic Obstructive Pulmonary Disease (COPD)
Drug: NVA237
Drug: Long-acting beta 2-agonist (LABA)
Drug: Placebo
Phase 3

Study Type: Interventional
Study Design: Allocation: Randomized
Endpoint Classification: Safety Study
Intervention Model: Parallel Assignment
Masking: Double Blind (Subject, Caregiver, Investigator, Outcomes Assessor)
Primary Purpose: Treatment
Official Title: A Multi-center, Randomized, Double-blind, 52-week Study to Assess the Safety of NVA237 Compared to QAB149 in Patients With Chronic Obstructive Pulmonary Disease (COPD) Who Have Moderate to Severe Airflow Limitation

Resource links provided by NLM:


Further study details as provided by Novartis:

Primary Outcome Measures:
  • Overall adverse event reporting rate [ Time Frame: 52 weeks ] [ Designated as safety issue: Yes ]
    The overall rate of adverse events reported from initiation through to the last dose.


Secondary Outcome Measures:
  • Safety of NVA237 compared to QAB149 [ Time Frame: 52 weeks ] [ Designated as safety issue: Yes ]
  • Time to treatment discontinuation [ Time Frame: 52 weeks ] [ Designated as safety issue: Yes ]
  • Mean Forced Expiratory Volume in one second at different time points pre-dose [ Time Frame: 52 weeks ] [ Designated as safety issue: No ]
  • Forced Expiratory Volume in one second at all post baseline timepoints [ Time Frame: 52 weeks ] [ Designated as safety issue: No ]
  • COPD symptoms reported [ Time Frame: 52 weeks ] [ Designated as safety issue: No ]
  • Daily number of puffs of rescue medication [ Time Frame: 52 weeks ] [ Designated as safety issue: No ]
  • Time to first exacerbation [ Time Frame: 52 weeks ] [ Designated as safety issue: No ]
  • Forced Vital Capacity at all post-baseline timepoints [ Time Frame: 52 weeks ] [ Designated as safety issue: No ]

Enrollment: 513
Study Start Date: October 2012
Estimated Study Completion Date: December 2014
Estimated Primary Completion Date: December 2014 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
Experimental: NVA237 dose 1
NVA237 dose 1
Drug: NVA237
NVA237 will be supplied in capsule form in blister packs for use in the Novartis Concept 1 SDDPI
Active Comparator: Long-acting beta 2-agonist (LABA)
QAB149
Drug: Long-acting beta 2-agonist (LABA)
QAB149 and matching placebo will be supplied in capsule form in blister packs for use in the Novartis Concept 1 SDDPI
Drug: Placebo
Placebo to match QAB149

  Eligibility

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

Inclusion Criteria:

  1. Male or female patients with COPD according to GOLD 2011 who have signed informed consent.
  2. Patients with airflow limitation of 30-80% post-bronchodilator FEV1 at run-in.
  3. Current or ex-smokers with a smoking history of at least 10 pack years
  4. Patients with a mMRC score of at least 2 at run-in.

Exclusion Criteria:

  1. Patients contraindicated for muscarinic antagonist agents and beta-2 agonists
  2. Patients with a history of malignancy of any organ system, treated or untreated, within the last five years
  3. Patients with narrow-angle glaucoma, BPH or bladder-neck obstruction or moderate-severe renal impairment or urinary retention
  4. Patients who had a COPD exacerbation within 6 weeks prior to screening.
  5. Patients requiring long term oxygen therapy prescribed for more than 12 hr per day.
  6. Patients with a history of asthma.
  7. Patients with an onset of respiratory symptoms, including COPD diagnosis, prior to 40 years of age.
  8. Patients with a blood eosinophil count of greater than 600 mm/3 during run-in
  9. Patients with concomitant pulmonary disease
  10. Patients with a history of certain cardiovascular co-morbid conditions
  11. Patients with a diagnosis of alpha-1 anti-trypsin deficiency
  12. Patients with active pulmonary tuberculosis
  13. Patients in the active phase of a pulmonary rehabilitation programme
  14. 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: NCT01697696

  Show 61 Study Locations
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: NCT01697696     History of Changes
Other Study ID Numbers: CNVA237A2319, 2012-002728-34
Study First Received: September 28, 2012
Last Updated: May 20, 2014
Health Authority: United States: Food and Drug Administration

Keywords provided by Novartis:
COPD, NVA237, QAB149, glycopyrronium bromide

Additional relevant MeSH terms:
Lung Diseases
Respiration Disorders
Pulmonary Disease, Chronic Obstructive
Lung Diseases, Obstructive
Respiratory Tract Diseases

ClinicalTrials.gov processed this record on July 22, 2014