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Completed

NCT Number: NCT01498081

A Single-dose Study to Investigate the Effects of 3 Different Doses of Inhaled AZD2115 in COPD Patients

This study in COPD patients will investigate the bronchodilatory effect of AZD2115. AZD2115 will be tested versus placebo and active comparators. The safety and tolerability of AZD2115 including investigations of clinically relevant systemically mediated effects will also be investigated.

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Key information

Conditions

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 2

Primary location

Research Site, Bialystok, Poland

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About this study

A randomised, double-blind, placebo and active controlled, multi-centre, 6 way cross-over, single-dose Phase IIa study to investigate the local and systemic effects of 3 different doses of inhaled AZD2115 in patients with chronic obstructive pulmonary disease (COPD)

Who can participate

Healthy volunteers accepted: No

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

Inclusion criteria

  • Provision of informed consent prior to any study specific procedures
  • Male or female of non-childbearing potential (post-menopausal or surgically sterilised), age ≥40 years at Visit 1
  • Clinical diagnosis of COPD for more than 1 year at Visit 1, according to GOLD guidelines
  • Post-bronchodilator FEV1 ≥ 40 to < 80% of the predicted normal value and post-bronchodilator FEV1/FVC < 70%
  • Reversible airway obstruction

Exclusion criteria

  • Significant disease or disorder which, in the opinion of the Investigator, may either put the patient at risk because of participation in the study, or influence the result of the study, or the patient's ability to participate in the study.
  • An exacerbation of COPD within 6 weeks prior to Visit 1
  • Treatment with systemic glucocorticosteroids with 6 weeks of Visit 2.
  • Recent or ongoing respiratory tract infection during enrolment period.
  • Need for long-term oxygen therapy and/or saturation O2 < 92%.

Treatment and study plan

AZD2115

Drug

AZD2115 administered via inhalation

Placebo

Drug

Placebo administered via inhalation

Indacaterol

Drug

Indacaterol administered via inhalation

Indacaterol + Tiotropium

Drug

Indacaterol + Tiotropium administered inhalation

Primary outcomes

  1. Peak Forced Expiratory Volume in 1 second (FEV1) defined as the maximum FEV1 from the spirometry assessments

    Time frame: During the first 24 hours following administration

  2. Trough FEV1defined as the average FEV1 from the spirometry assessments

    Time frame: During 22 to 26 hours following administration

Secondary outcomes

  1. Average FEV1

    Time frame: FEV1 0-24h post-dose

  2. Peak, average and trough Forced Vital Capacity (FVC)

    Time frame: FVC peak and average 0-24h post-dose and trough 22-26h post-dose

  3. Systemic effect by assessment of blood pressure (BP)

    Time frame: Peak and average 0-4 h post dose

  4. Systemic effect by assessment of heart rate (HR) and QT interval corrected for heart rate using Fridericia's formula (QTcF)

    Time frame: Peak and average 0-4 h post dose

  5. Systemic effect by assessment of Potassium and Glucose

    Time frame: Peak and average 0-4 h post dose

  6. Safety and tolerability of 3 different single doses of AZD2115

    Time frame: At screening, during 0-26 h post-dose and at follow-up

  7. Plasma concentrations of AZD2115 after 3 different single doses measured as area under the curve over the time (AUC) and maximum concentration (Cmax), and time to maximum concentration (tmax)

    Time frame: 0-24h post dose

Sponsors and collaborators

Lead sponsor

AstraZeneca

Industry

Registry information

Official study title

A Randomised, Double-blind, Placebo and Active Controlled, Multi-centre, 6 Way Cross-over, Single-dose Phase IIa Study to Investigate the Local and Systemic Effects of 3 Different Doses of Inhaled AZD2115 in Patients With Chronic Obstructive Pulmonary Disease (COPD)

Important dates

Study start
2012
Primary completion
2012
Study completion
2012
First posted
Dec 23, 2011
Registry last updated
Oct 26, 2012

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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