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Completed

NCT Number: NCT01068613

Safety and Efficacy of Multiple Doses of QAX028 in Chronic Obstructive Pulmonary Disease (COPD) Patients

This study will assess the bronchodilator effects of multiple doses of QAX028 at two different dose levels when compared to tiotropium and placebo in a COPD population.

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Key information

Conditions

Chronic Obstructive Pulmonary Disease 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 2

Primary location

Advanced Clinical Research Institute, 1211 W. La Palma Ave, Anaheim, California, United States

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Who can participate

Healthy volunteers accepted: No

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

Inclusion criteria

  • Diagnosis of COPD according to GOLD guidelines
  • Post-bronchodilator 30%≤FEV1<80% of predicted normal and ost-bronchodilator FEV1/FVC <0.7
  • Smoking history of at least 10 pack years

Exclusion criteria

  • Requiring oxygen therapy on a daily basis
  • Exacerbation of airway disease in the 6 weeks prior to screening or between screening and dosing
  • Lung reduction surgery
  • Respiratory tract infection in the 6 weeks prior to screening
  • Significant cardiac history
  • History of asthma with onset of symptoms prior to age 40 years
  • Active use of certain COPD medications, beta blockers

Other protocol-defined inclusion/exclusion criteria may apply

Treatment and study plan

QAX028

Drug

QAX028 60 mcg via inhalation device

Tiotropium

Drug

Tiotropium via inhalation device

Placebo

Drug

Placebo to QAX028 via inhalation device

Primary outcomes

  1. Measure: Compare the efficacy of QAX028 at a high dose, as measured by trough forced expiratory volume in 1 second (FEV1), to tiotropium

    Time frame: 7 days treatment

Secondary outcomes

  1. Compare the efficacy of QAX028 at a low dose, as measured by trough FEV1, to tiotropium

    Time frame: 7 days treatment

  2. Measure: Compare the efficacy of QAX028 at two dose levels, as measured by trough FEV1, to placebo

    Time frame: 7 days treatment

  3. Measure: Evaluate the safety and tolerability of two dose levels of QAX028 in COPD patients

    Time frame: 7 days treatment

  4. Measure: Evaluate the pharmacokinetics of multiple inhaled does of QAX028

    Time frame: 7 days treatment

  5. Measure: Assess bronchodilatory profile, as measured by FEV1, of multiple inhaled doses of QAX028 in COPD patients

    Time frame: 7 days treatment

Sponsors and collaborators

Lead sponsor

Novartis Pharmaceuticals

Industry

Registry information

Official study title

A Randomized, Double-blind, Double-dummy, Three Period Incomplete Cross-over Study to Evaluate the Safety and Efficacy of Multiple Daily Doses of QAX028 as Compared to Tiotropium Bromide (Positive Control) and Placebo in COPD Patients

Important dates

Study start
2010
Primary completion
2010
Study completion
2010
First posted
Feb 15, 2010
Registry last updated
Dec 19, 2020

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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