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A 12-week Treatment, Multi-center, Randomized, Double-blind, Parallel-group, Placebo and Active Controlled Study to Assess the Efficacy, Safety, and Tolerability of Indacaterol Maleate / Glycopyrronium Bromide in COPD Patients With Moderate to Severe Airflow Limitation.

This study is currently recruiting participants.
Verified January 2013 by Novartis
Sponsor:
Information provided by (Responsible Party):
Novartis ( Novartis Pharmaceuticals )
ClinicalTrials.gov Identifier:
NCT01727141
First received: November 12, 2012
Last updated: January 10, 2013
Last verified: January 2013
History of Changes
  Purpose

This study will assess the efficacy, safety and tolerability of QVA149 in patients with moderate to severe airflow limitation.


Condition Intervention Phase
Chronic Obstructive Pulmonary Disease (COPD)
 Drug: QVA149
Drug: Long acting muscarinic antagonist (LAMA)
Drug: Long acting B2 agonist (LABA)
Drug: Placebo
 Phase 3

Study Type: Interventional
Study Design: Allocation: Randomized
Endpoint Classification: Safety/Efficacy Study
Intervention Model: Parallel Assignment
Masking: Double Blind (Subject, Caregiver, Investigator)
Primary Purpose: Treatment
Official Title: A 12-week Treatment, Multi-center, Randomized, Double-blind, Parallel-group, Placebo and Active Controlled Study to Assess the Efficacy, Safety, and Tolerability of Indacaterol Maleate / Glycopyrronium Bromide in COPD Patients With Moderate to Severe Airflow Limitation.

Resource links provided by NLM:

U.S. FDA Resources

Further study details as provided by Novartis:

Primary Outcome Measures:
  • Standardized Forced Expiratory Volume in 1 second Area Under the Curve [ Time Frame: 12 Weeks ] [ Designated as safety issue: No ]
    Standardized Forced Expiratory Volume in 1 second Area Under the Curve following 12 weeks of treatment.


Secondary Outcome Measures:
  • Total St. George's Respiratory Questionnaire score [ Time Frame: 12 Weeks ] [ Designated as safety issue: No ]
    Change in health status as reported by the patients using the St. George's Respiratory Questionnaire (SGRQ), following 12 weeks of treatment.

  • Trough Forced Expiratory Volume in 1 second [ Time Frame: 12 Weeks ] [ Designated as safety issue: No ]
    Trough Forced Expiratory Volume in 1 second (mean of 23h 15 min and 23h 45 min post morning dose measurements) following 12 weeks of treatment.

  • Pre-dose Trough Forced Expiratory Volume in 1 second [ Time Frame: 12 Weeks ] [ Designated as safety issue: No ]
    Pre-dose Trough Forced Expiratory Volume in 1 second (mean of 15 min and 45 min pre morning dose measurements) following 12 weeks of treatment.

  • Transitional Dyspnea Index focal score [ Time Frame: 12 weeks ] [ Designated as safety issue: No ]
    Level of breathlessness experienced by the patients using the Transitional Dyspnea Index following 12 weeks of treatment.

  • Number of puffs of rescue medication [ Time Frame: 12 Weeks ] [ Designated as safety issue: No ]
    Rescue medication use (number of puffs) reported by the patients using the patient electronic diary, following 12 weeks of treatment.

  • Daily symptoms scores [ Time Frame: 12 Weeks ] [ Designated as safety issue: No ]
    Daily symptoms reported using the patient electronic diary, following 12 weeks of treatment.

  • Trough Forced Expiratory Volume in 1 second [ Time Frame: Day 1 ] [ Designated as safety issue: No ]
    Trough Forced Expiratory Volume in 1 second after day 1 of treatment.

  • Forced Expiratory Volume in 1 second at any time point [ Time Frame: 12 Weeks ] [ Designated as safety issue: No ]
    Forced Expiratory Volume in 1 second at all timepoints.

  • Morning symptoms scores [ Time Frame: 12 Weeks ] [ Designated as safety issue: No ]
    Morning symptoms reported using the patient electronic diary, following 12 weeks of treatment.

  • Evening symptoms scores [ Time Frame: 12 Weeks ] [ Designated as safety issue: No ]
    Evening symptoms reported using the patient electronic diary, following 12 weeks of treatment.

  • Forced Vital Capacity at any time point [ Time Frame: 12 Weeks ] [ Designated as safety issue: No ]
    Forced Vital Capacity at various timepoints.


Estimated Enrollment: 1000
Study Start Date: November 2012
Estimated Study Completion Date: January 2014
Estimated Primary Completion Date: January 2014 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
Experimental: QVA149 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) Drug: Long acting B2 agonist (LABA)
LABA will be supplied in capsule form in blister packs for use in the Novartis Consept1 SDDPI.
Active Comparator: Long acting muscarinic antagonist (LAMA) Drug: Long acting muscarinic antagonist (LAMA)
LAMA will be supplied in capsule form in blister packs for use in the Novartis Concept1 SDDPI.
Placebo Comparator: Placebo Drug: Placebo
Placebo will be supplied in capsule form in blister packs for use in the Novartis Concept1 SDDPI.

Detailed Description:

NOTE: Detailed Description: data not entered

  Eligibility

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

Inclusion Criteria:

  • Male and female patients that have signed informed consent and are >/= 40 years of age.
  • Patients with stable COPD according to GOLD 2011.
  • Patients with a post-bronchodilator FEV1 of >/= 30% and < 80% predicted and a post-bronchodilator FEV1/FVC <0.70.
  • Current or ex-smokers who have a smoking history of at least 10 pack years.
  • Patients with an mMRC grade 2 or greater.

Exclusion Criteria:

  • Patients contraindicated for muscarinic antagonist agents and beta-2 agonists.
  • Patients with a history of malignancy of any organ system, treated or untreated, within the last five years.
  • Patients with narrow-angle glaucoma, BPH or bladder-neck obstruction or moderate-severe renal impairment or urinary retention.
  • Patients who had a COPD exacerbation within 6 weeks prior to screening.
  • Patients who have a respiratory tract infection within 4 weeks prior to screening.
  • Patients requiring long term oxygen therapy prescribed for more than 12 hr per day.
  • Patients with a history of asthma. 8. Patients with an onset of respiratory symptoms, including COPD diagnosis, prior to age 40 years.
  • Patients with a blood eosinophil count of greater than 600 mm/3 during run-in.
  • Patients with concomitant pulmonary disease.
  • Patients with a history of certain cardiovascular co-morbid conditions
  • Patients with a diagnosis of alpha-1 anti-trypsin deficiency.
  • Patients with active pulmonary tuberculosis.
  • Patients in the active phase of a pulmonary rehabilitation programme.
  • Other protocol-defined inclusion/exclusion criteria may apply
  Contacts and Locations
Please refer to this study by its ClinicalTrials.gov identifier: NCT01727141

Contacts
Contact: Novartis Pharmaceuticals +1(862)778-8300

  Show 65 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: NCT01727141     History of Changes
Other Study ID Numbers: CQVA149A2336
Study First Received: November 12, 2012
Last Updated: January 10, 2013
Health Authority: United States: Food and Drug Administration

Keywords provided by Novartis:
COPD, QVA149

Additional relevant MeSH terms:
Lung Diseases
Respiration Disorders
Pulmonary Disease, Chronic Obstructive
Lung Diseases, Obstructive
Respiratory Tract Diseases
Muscarinic Antagonists
Glycopyrrolate
Cholinergic Antagonists
 Cholinergic Agents
Neurotransmitter Agents
Molecular Mechanisms of Pharmacological Action
Pharmacologic Actions
Physiological Effects of Drugs
Adjuvants, Anesthesia
Central Nervous System Agents
Therapeutic Uses

ClinicalTrials.gov processed this record on May 23, 2013