Text Size

A Multi-centre Randomized Double Blind 52-week Study to Assess the Safety of QVA149 Compared to QAB in Patients With COPD Who Have Moderate to Severe Airflow Limitation

This study is currently recruiting participants.
Verified March 2013 by Novartis
Sponsor:
Information provided by (Responsible Party):
Novartis ( Novartis Pharmaceuticals )
ClinicalTrials.gov Identifier:
NCT01682863
First received: September 7, 2012
Last updated: March 26, 2013
Last verified: March 2013
History of Changes
  Purpose

This study is to assess the safety and tolerability of two different dose levels of QVA149


Condition Intervention Phase
Chronic Obstructive Pulmonary Disease (COPD)
 Drug: QVA149
Drug: Long acting b2-agonist
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-centre Randomized Double Blind 52-week Study to Assess the Safety of QVA149 Compared to QAB in Patients With COPD Who Have Moderate to Severe Airflow Limitation

Resource links provided by NLM:

Drug Information available for: Indacaterol
U.S. FDA Resources

Further study details as provided by Novartis:

Primary Outcome Measures:
  • overall adverse event reporting rate [ Time Frame: 56 weeks ] [ Designated as safety issue: Yes ]
    The overall rate of adverse events reported from initiation through 30 days post last dose.


Secondary Outcome Measures:
  • ECG [ Time Frame: 52 weeks ] [ Designated as safety issue: Yes ]
    ECG

  • Time to discontinuation [ Time Frame: 52 weeks ] [ Designated as safety issue: Yes ]
  • Forced expiratory volume in 1 second [ Time Frame: 52 weeks ] [ Designated as safety issue: No ]
  • Forced expiratory volume in 1 second at all post-baseline time points [ Time Frame: 52 weeks ] [ Designated as safety issue: No ]
  • Time to first exacerbation [ Time Frame: 52 weeks ] [ Designated as safety issue: No ]
  • Symptoms reported over the 52 week period [ Time Frame: 52 weeks ] [ Designated as safety issue: No ]
  • Number of puffs of rescue medication over the 52 week period [ Time Frame: 52 weeks ] [ Designated as safety issue: No ]
  • Forced vital capacity at all post-baseline time points [ Time Frame: 52 weeks ] [ Designated as safety issue: No ]
  • Blood pressure [ Time Frame: 52 weeks ] [ Designated as safety issue: Yes ]
    Systolic and diastolic blood pressure

  • Laboratory evaluations [ Time Frame: 52 weeks ] [ Designated as safety issue: Yes ]
    Blood hematology and blood chemistry


Estimated Enrollment: 600
Study Start Date: October 2012
Estimated Study Completion Date: June 2014
Estimated Primary Completion Date: June 2014 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
Experimental: QVA149 dose 1
QVA149 dose 1
 Drug: QVA149
QVA149 will be supplied in a capsule form in blister packs for use in the Novartis Concept1 SDDPI
Experimental: QVA149 dose 2
QVA149 dose 2
 Drug: QVA149
QVA149 will be supplied in a capsule form in blister packs for use in the Novartis Concept1 SDDPI
Active Comparator: Long acting b2-agonist (LABA)
QAB149
 Drug: Long acting b2-agonist
QAB149 and matching placebo will be supplied in capsule form in blister packs for use in the Novartis Concept1 SDDPI
Drug: Placebo
To mimic 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 packs 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. 11. Patients with a history of malignancy of any organ system, treated or untreated, within the last five years.
  2. Patients with narrow-angle glaucoma, BPH or bladder-neck obstruction or moderate-severe renal impairment or urinary retention.
  3. Patients who had a COPD exacerbation within 6 weeks prior to screening.
  4. Patients who have a respiratory tract infection within 4 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 age 40 years.
  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
Please refer to this study by its ClinicalTrials.gov identifier: NCT01682863

Contacts
Contact: Novartis Pharmaceuticals, Study Director 1-888-669-6682
Contact: Novartis Pharmaceuticals

  Show 105 Study Locations
Sponsors and Collaborators
Novartis Pharmaceuticals
  More Information

No publications provided

Responsible Party: Novartis ( Novartis Pharmaceuticals )
ClinicalTrials.gov Identifier: NCT01682863     History of Changes
Other Study ID Numbers: CQVA149A2340, 2012-001998-93
Study First Received: September 7, 2012
Last Updated: March 26, 2013
Health Authority: United States: Food and Drug Administration

Keywords provided by Novartis:
COPD, QAB149, QVA149, indacaterol maleate, gylcopyrronium 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 May 21, 2013