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 has been completed.
Sponsor:
Information provided by (Responsible Party):
Novartis ( Novartis Pharmaceuticals )
ClinicalTrials.gov Identifier:
NCT01712516
First received: October 19, 2012
Last updated: June 11, 2014
Last verified: June 2014
  Purpose

This study will assess the efficacy, safety and tolerability of indacaterol maleate/glycopyrronium bromide in patients with moderate to severe airflow limitation.


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


Further study details as provided by Novartis:

Primary Outcome Measures:
  • Standardized Forced Expiratory Volume in one second Area Under the Curve [ Time Frame: 12 weeks ] [ Designated as safety issue: No ]
    Standardized Forced Expiratory Volume in one second (FEV1) Area Under the Curve (AUC) 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, based on total score as well as the percentage of patients with clinically significant improvement, as reported by the patients using the St. George's Respiratory Questionnaire (SGRQ), following 12 weeks of treatment.

  • Trough Forced Expiratory Volume in one second [ Time Frame: 12 weeks ] [ Designated as safety issue: No ]
    Trough Forced Expiratory Volume in one second (FEV1) (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 one second [ Time Frame: 12 weeks ] [ Designated as safety issue: No ]
    Pre-dose trough Forced Expiratory Volume in one second (FEV1) (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 ]
    Evaluate level of breathlessness experienced by the patients evaluated using the Transitional Dyspnea Index (TDI) following 12 weeks of treatment.

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

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

  • Trough Forced Expiratory Volume in one second [ Time Frame: Day 1 ] [ Designated as safety issue: No ]
    Evaluate trough Forced Expiratory Volume in one second (FEV1) after day 1.

  • Forced Expiratory Volume in one second at any time point [ Time Frame: 12 weeks ] [ Designated as safety issue: No ]
    Evaluate Forced Expiratory Volume in one second (FEV1) at all timepoints.

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

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

  • Forced Vital Capacity at different time points [ Time Frame: 12 weeks ] [ Designated as safety issue: No ]
    Evaluate Forced Vital Capacity (FVC) at all timepoints.


Enrollment: 1001
Study Start Date: December 2012
Study Completion Date: February 2014
Primary Completion Date: February 2014 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
Experimental: LABA/LAMA Drug: LABA/LAMA
Indacaterol maleate/glycopyrronium 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.

  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 Chronic Obstructive Pulmonary Disease (COPD) according to GOLD 2011.
  • Patients with a post-bronchodilator Force Expiratory Volume in one second (FEV1) of >/= 30% and < 80% predicted and a post-bronchodilator FEV1/ Forced Vital capacity (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, Benign Prostatic Hyperplasia (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 hour per day.
  • Patients with a history of asthma.
  • 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
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: NCT01712516

  Show 95 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: NCT01712516     History of Changes
Other Study ID Numbers: CQVA149A2337
Study First Received: October 19, 2012
Last Updated: June 11, 2014
Health Authority: United States: Food and Drug Administration

Keywords provided by Novartis:
COPD

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

ClinicalTrials.gov processed this record on October 23, 2014