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Completed

NCT Number: NCT01682863

A Multi-centre Randomized Double Blind 52-week Study to Assess the Safety of QVA149 Compared to QAB149 in Patients With COPD Who Have Moderate to Severe Airflow Limitation

This study is to assess the safety and tolerability of two different doses of QVA149 and QAB149 in patients with moderate to severe airflow limitation.

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Key information

Conditions

Chronic Obstructive Pulmonary Disease (COPD) Chronic Disease Disease Attributes Lung Diseases Lung Diseases, Obstructive Pathologic Processes Pathological Conditions, Signs and Symptoms Pulmonary Disease, Chronic Obstructive Respiratory Tract Diseases

Age range

40 year and older

Sex eligibility

All sexes

Study type

Interventional

Phase

Phase 3

Primary location

Novartis Investigative Site, Rousse, Bulgaria

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Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

Inclusion criteria

  • Male and female adults aged ≥40 years
  • Patients with stable COPD according to GOLD strategy (GOLD 2011).
  • Patients with airflow limitation indicated by a post-bronchodilator FEV1 ≥ 30% and <80% of the predicted normal, 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

Exclusion criteria

  • History of long QT syndrome or prolonged QTc
  • Patients who have had a COPD exacerbation that required treatment with antibiotics and/or systemic corticosteroids and/or hospitalization in the 6 weeks prior to Visit 1.
  • Patients with Type I or uncontrolled Type II diabetes
  • Patients with a history of asthma or have concomitant pulmonary disease
  • Patients with paroxysmal (e.g. intermittent) atrial fibrillation. Only patients with persistent atrial fibrillation and controlled with a rate control strategy for at least six months could be eligible
  • Patients who have clinically significant renal, cardiovascular, neurological, endocrine, immunological, psychiatric, gastrointestinal, hepatic, or hematological abnormalities which could interfere with the assessment of safety
  • Other protocol defined inclusion/exclusion criteria may apply

Treatment and study plan

QVA149

Drug

QVA149 will be supplied in a capsule form in blister packs for use in the Novartis Concept1 SDDPI

QAB149

Drug

QAB149 and matching placebo will be supplied in capsule form in blister packs for use in the Novartis Concept1 SDDPI

Placebo

Drug

To mimic QAB149

Primary outcomes

  1. Number of Patients With Adverse Events, Serious Adverse Events, and Death

    Time frame: 56 weeks

    The overall rate of adverse events reported from initiation through 30 days post last dose.

Secondary outcomes

  1. Time to Premature Discontinuation of Treatment

    Time frame: 56 weeks

    methodTime to premature treatment discontinuation for each treatment group was displayed using a Kaplan-Meier curve. The date of last dose of study medication was considered as the event date and also as the censoring date for those patients who did not discontinue treatment earl

  2. Change From Baseline in Pre-dose Trough FEV1

    Time frame: Day 29, 57,, 85, 141, 197, 253, 309 and 365

    Pulmonary function assessments were performed using centralized spirometry according to international standards. Baseline FEV1 was defined as the average of the pre-dose FEV1 measured at -45 minutes (min) and -15 min at day 1. A mixed model for repeated measures (MMRM), used for this analysis, included terms of treatment, baseline FEV1 measurements, smoking status at baseline, baseline inhaled corticosteroid (ICS) use, region, baseline FEV1 * visit interaction, and visit, treatment * visit interaction.

  3. Change From Baseline in 1 Hour Post-dose FEV1 Measurements

    Time frame: Day 1, 29, 57, 85, 141, 197, 253, 309, and 365

    Pulmonary function assessments were performed using centralized spirometry according to international standards. Baseline FEV1 was defined as the average of the pre-dose FEV1 measured at -45 minutes (min) and -15 min at day 1. A mixed model for repeated measures (MMRM), used for this analysis, included terms of treatment, baseline FEV1 measurements, smoking status at baseline, baseline inhaled corticosteroid (ICS) use, region, baseline FEV1 * visit interaction, and visit, treatment * visit interaction.

  4. Change From Baseline in FVC Measurement at All Post-baseline Time Points

    Time frame: Day1, 29, 57, 85, 141, 197, 253, 309, and 365

    Pulmonary function assessments were performed using centralized spirometry according to international standards.

  5. Percentage of Participants Experiencing Moderate or Severe COPD Exacerbation

    Time frame: 52 weeks

    Percentage of participants experiencing moderate or severe Chronic Obstructive Pulmonary Disease (COPD)

  6. Change From Baseline in Mean Total Daily Symptom Scores

    Time frame: 52 weeks

    The participant recorded symptom scores twice daily in the eDiary. The daily clinical symptoms included: cough, wheezing, shortness of breath, sputum volume, sputum color, and night time awakening. The range of scores for each assessment is 0 to 3 where 0 indications No symptom and 3 indicates a Severe symptom. The maximum daytime total score is 27 and the maximum nighttime total score is 27. The total daily symptom score is obtained by adding the scores for the morning and evening symptoms for each day. The maximum possible total daily score is 54. A negative change from baseline indicated improvement.

  7. Change From Baseline in the Daily Number of Puffs of Rescue Medication Over the 52 Week Period

    Time frame: 52 weeks

    Participants completed an electronic diary (eDiary) twice daily at the same time in the morning and evening to record the number of puffs of rescue medication taken in the previous 12 hours.

Sponsors and collaborators

Lead sponsor

Novartis Pharmaceuticals

Industry

Registry information

Important dates

Study start
2012
Primary completion
2014
Study completion
2014
First posted
Sep 11, 2012
Registry last updated
Mar 30, 2016

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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