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Completed

NCT Number: NCT00929708

Efficacy of AZD3199 in Chronic Obstructive Pulmonary Disease (COPD) Patients

The purpose of this study is to investigate the efficacy, safety and tolerability of 4 weeks treatment with AZD3199 in moderate to severe COPD.

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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 Respiration Disorders Respiratory Aspiration Respiratory Tract Diseases

Age range

40 year and older

Sex eligibility

All sexes

Study type

Interventional

Phase

Phase 2

Primary location

Research Site, Blagoevgrad, 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

  • COPD
  • Current or exsmokers, 10 pack years

Exclusion criteria

  • Asthma
  • Any clinically relevant abnormal findings at screening examinations
  • Recent COPD exacerbation

Treatment and study plan

AZD3199

Drug

Dry powder for inhalation, o.d., 4 weeks

Formoterol

Drug

Dry powder for inhalation, b.i.d., 4 weeks

Placebo

Drug

Dry powder for inhalation, b.i.d., 4 weeks

Primary outcomes

  1. FEV1, E0-4; the Average Value at Visit 5 From Before to 4 Hours After Morning Dose (Peak Effect)

    Time frame: 0,5 min, 15 min, 60 min, 2 h, 4 h

    change from baseline

  2. FEV1, E24-26; the Average Value at Visit 5 Between 24 and 26 Hours Following the Morning Dose (Trough Effect)

    Time frame: 24h, 26h

    change from baseline

Secondary outcomes

  1. Cmax; the Highest Plasma Concentration of AZD3199 Measured

    Time frame: 0,15 min, 1, 4 and 24 hours post dose

    PK is only measured for AZD3199

  2. AUC0-24; Area Under the Plasma Concentration Curve From Zero to 24 Hours After Dose

    Time frame: 0,15 min, 1, 4 and 24 hours post dose

    PK is only measured for AZD3199

  3. FEV1 Post Salbutamol Inhalation

    Time frame: Baseline (visit 2) and 26 h after the last morning dose (visit 5).

    Mean value of FEV1 pre and post salbutamol at visit 2 and visit 5

  4. Total Number of Reliever Medication Inhalations Per 24h

    Time frame: During day (from rising from bed until going to bed) and night (from going to bed until rising from bed) at visit 1 to visit 5 (24h), up to 4 weeks.

    Change from run-in

  5. Total AstraZeneca COPD Symptoms Scores (Included Breathlessness, Chest Tightness, Cough and Night-time Awakenings)

    Time frame: Daily, during run-in and treatment

    Score on a scale 5-point Likert-type scale, ranging from 0 (none) to 4 (severe) for each symptom, total score is the sum of each symptom ranged from 0 to 16. Change from run-in.

  6. Overall Mean CCQ (Clinical COPD Questionnaire)

    Time frame: Mean over week 0, mean over week 1, mean over week 2, and mean over week 4

    Change from baseline to treatment in score. The total scores vary between 0 (never/not limited at all) to 6 (almost all the time/totally limited). The data below represent the average of week 1,2,4 minus week 0.

  7. Total Score SGRQ-C (St George's Respiratory Questionnaire for COPD)

    Time frame: At baseline (visit 2) and after 4 weeks of treatment (visit 5).

    The total score is calculated using all questions including their weights and scores range from 0 (perfect health) to 100 (worst possible state)

Sponsors and collaborators

Lead sponsor

AstraZeneca

Industry

Registry information

Official study title

A 4-week, Phase-II, Double-blind, Placebo-controlled, Randomised, Parallel-group, Multi-centre Study to Assess the Efficacy and Tolerability/Safety of Inhaled AZD3199 Once Daily Compared to 9 μg Formoterol Bid and Placebo in Patients With Moderate to Severe COPD

Acronym: GLAD

Important dates

Study start
2009
Primary completion
2010
Study completion
2010
First posted
Jun 29, 2009
Registry last updated
Feb 17, 2014

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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