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Completed

NCT Number: NCT00542880

Evaluation of Onset of Effect in Patients With Severe Chronic Obstructive Pulmonary Disease (COPD) Treated With Symbicort® Compared to Seretide®

This study is to assess the effects with two different inhaled respiratory medications with regards to improvement of lung function, symptoms and morning activities.

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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 4

Primary location

Research Site, Monte Grande, Buenos Aires, Argentina

Loading trial locations.

Who can participate

Healthy volunteers accepted: No

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

Inclusion criteria

  • Outpatient, female or male aged ≥40 years, diagnosis of COPD with symptoms for at least 2 years
  • FEV1 ≤50% of predicted normal value, pre-bronchodilator, FEV1/VC <70%
  • Pre-bronchodilator

Exclusion criteria

  • Current respiratory tract disorder other than COPD
  • History of asthma or rhinitis
  • Significant or unstable cardiovascular disorder

Treatment and study plan

Symbicort Turbuhaler (budesonide/formoterol) 320/9 μg

Drug

Seretide Diskus (salmeterol/fluticasone) 50/500 μg

Drug

Primary outcomes

  1. Peak Expiratory Flow (PEF) 5 Minutes After Morning Dose

    Time frame: Baseline (daily records during run-in, and washout) and daily records during the treatment period of 7 days

    The change from baseline in PEF was calculated using the average over baseline (the last 7 days of run-in and washout period respectively), and all days of treatment, with baseline as covariate.

Secondary outcomes

  1. PEF Before Morning Dose

    Time frame: Baseline (daily records during run-in, and washout) and daily records during the treatment period of 7 days

    The change from baseline was calculated using the average over baseline (the last 7 days of run-in and washout period respectively), and over all days of treatment, with baseline as covariate.

  2. PEF 15 Minutes After Morning Dose

    Time frame: Baseline (daily records during run-in, and washout) and daily records during the treatment period of 7 days

    The change from baseline was calculated using the average over baseline (the last 7 days of run-in and washout period respectively), and over all days of treatment, with baseline as covariate.

  3. PEF Before Evening Dose

    Time frame: Baseline (daily records during run-in, and washout) and daily records during the treatment period of 7 days

    The change from baseline was calculated using the average over baseline (the last 7 days of run-in and washout period respectively), and over all days of treatment, with baseline as covariate.

  4. Forced Expiratory Volume in 1 Second (FEV1) Before Morning Dose

    Time frame: Baseline (daily records during run-in, and washout) and daily records during the treatment period of 7 days

    The change from baseline was calculated using the average over baseline (the last 7 days of run-in and washout period respectively), and over all days of treatment, with baseline as covariate.

  5. FEV1 15 Minutes After Morning Dose

    Time frame: Baseline (daily records during run-in, and washout) and daily records during the treatment period of 7 days

    The change from baseline was calculated using the average over baseline (the last 7 days of run-in and washout period respectively), and over all days of treatment, with baseline as covariate.

  6. FEV1 Before Evening Dose

    Time frame: Baseline (daily records during run-in, and washout) and daily records during the treatment period of 7 days

    The change from baseline was calculated using the average over baseline (the last 7 days of run-in and washout period respectively), and over all days of treatment, with baseline as covariate.

  7. Change in PEF From Before Dose to 5 Minutes After Dose in the Morning

    Time frame: Baseline (daily records during run-in, and washout) and daily records during the treatment period of 7 days

    The change from pre-dose was calculated using the average over baseline (the last 7 days of run-in and washout period respectively), and over all days of treatment, with pre-dose run-in/washout as covariate.

  8. Change in PEF From Before Dose to 15 Minutes After Dose in the Morning

    Time frame: Baseline (daily records during run-in, and washout) and daily records during the treatment period of 7 days

    The change from pre-dose was calculated using the average over baseline (the last 7 days of run-in and washout period respectively), and over all days of treatment, with mean pre-dose run-in/washout as covariate.

  9. Change in FEV1from Before Dose to 5 Minutes After Dose in the Morning

    Time frame: Baseline (daily records during run-in, and washout) and daily records during the treatment period of 7 days

    The change from pre-dose was calculated using the average over baseline (the last 7 days of run-in and washout period respectively), and over all days of treatment, with mean pre-dose run-in/washout as covariate.

  10. Change in FEV1 From Before Dose to 15 Minutes After Dose in the Morning

    Time frame: Baseline (daily records during run-in, and washout) and daily records during the treatment period of 7 days

    The change from pre-dose was calculated using the average over baseline (the last 7 days of run-in and washout period respectively), and over all days of treatment, with mean pre-dose run-in/washout as covariate.

  11. Change in FEV1 From Before Dose to 5 Minutes After Dose at the Clinic

    Time frame: Baseline (run-in, and washout) and day 1 of treatment period

    The change from pre-dose was calculated using the pre-dose baseline value (run-in and washout period respectively), and pre-dose value at day 1, with pre-dose run-in/washout as covariate.

  12. Change in Forced Vital Capacity (FVC) From Before Dose to5 Minutes After Dose at the Clinic

    Time frame: Baseline (run-in, and washout) and day 1 of treatment period

    The change from pre-dose was calculated using the pre-dose baseline value (run-in and washout period respectively), and pre-dose value at day 1, with pre-dose run-in/washout as covariate.

  13. Capacity of Daily Living in the Morning (CDLM) (Change From Pre to End of Treatment)

    Time frame: Baseline (daily records during run-in, and washout) and daily records during the treatment period of 7 days

    The change from baseline was calculated using the average over baseline (the last 7 days of run-in and washout period respectively), and over all days of treatment, with baseline as covariate. Score scale 0 - 5 with 0=worst and 5 = best.

  14. Difficulty in Getting Out From Bed (MASQ) (Change From Pre to End of Treatment)

    Time frame: Baseline (daily records during run-in, and washout) and daily records during the treatment period of 7 days

    The change from baseline was calculated using the average over baseline (the last 7 days of run-in and washout period respectively), and over all days of treatment, with baseline as covariate. Score scale 0 - 5 with 0=worst and 5 = best.

  15. The Clinical Chronic Obstructive Pulmonary Disease (COPD) Questionnaire (Change From Pre to End of Treatment)

    Time frame: Baseline (daily records during run-in, and washout) and daily records during the treatment period of 7 days

    The change from baseline was calculated using the average over baseline (the last 7 days of run-in and washout period respectively), and over all days of treatment, with baseline as covariate. Score scale 0 - 6 with 0=worst and 6 = best.

Sponsors and collaborators

Lead sponsor

AstraZeneca

Industry

Registry information

Official study title

A Double-blind, Randomised, Cross-over, Multi-centre Study, to Evaluate Onset of Effect in the Morning in Patients With Severe Chronic Obstructive Pulmonary Disease (COPD) Treated With Symbicort®Turbuhaler® 320/9 μg, Compared With Seretide® Diskus® 50/500 μg, Both Given as One Inhalation Twice Daily for One Week Each.

Acronym: SPEED

Important dates

Study start
2007
Primary completion
2008
Study completion
2008
First posted
Oct 12, 2007
Registry last updated
Aug 30, 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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