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Completed

NCT Number: NCT01204034

Study to Assess the Effect of Formoterol and Beclomethasone Dipropionate in Patients With Chronic Obstructive Pulmonary Disease (COPD)

The objective of this study is to evaluate the effect of the combination of formoterol and beclometasone dipropionate on central and peripheral airway dimensions in COPD patients using Computational Fluid Dynamics (CFD). Further more, the effect of this combination therapy on lung function (spirometry, body plethysmography), the BODE index, COPD assessment test (CAT) and Borg CR10 scale will be assessed and the safety will be evaluated.

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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 3

Primary location

University Hospital of Antwerp

Edegem (Antwerp), Antwerp, B-2650, Belgium

Who can participate

Healthy volunteers accepted: No

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

Inclusion criteria

  • Patients with documented COPD based on the following criteria:

Smoking history of at least 10 pack-years Decreased Tiffeneau index: FEV1/FVC < 0.70

  • Male or female patients aged ≥ 40 years
  • Patients should be treated according to the 'Global initiative for chronic Obstructive Lung Disease' (GOLD) guidelines
  • Patients who present
  • Moderate COPD with an FEV1 between 50 and 80% of predicted GOLD 2)
  • Severe COPD with an FEV1 between 30 and 50% of predicted (GOLD 3)
  • Very severe COPD with an FEV1 lower than 30% of predicted (GOLD 4)
  • Patients will be maintained on stable respiratory medications for 6 weeks prior to screening
  • Patients with a co-operative attitude and ability to be trained to correctly use the pMDI
  • Written informed consent obtained

Exclusion criteria

  • Pregnant or lactating females or females at risk of pregnancy
  • Unstable patients who developed an exacerbation during the last 4 weeks
  • Inability to carry out pulmonary function testing
  • Diagnosis of asthma as defined by the current 'Global Initiative for Asthma' (GINA) guidelines
  • Patients with an uncontrolled disease or any condition that might, in the judgement of the investigator, place the patient at undue risk or potentially compromise the results or interpretation of the study
  • Patients with a QTc interval (Bazett's formula) at the screening visit electrocardiogram (ECG) test >450 msec
  • Cancer or any other chronic disease with poor prognosis and /or affecting patient status
  • History of alcohol or drug abuse
  • Allergy, sensitivity or intolerance to study drugs and/or study drug formulation ingredients
  • Patients unlikely to comply with the protocol or unable to understand the nature, scope and possible consequences of the study
  • Patients who received any investigational new drug within the last 4 weeks prior to the screening visit
  • Patients treated with any non-permitted concomitant medication

Treatment and study plan

Inuvair

Drug

6 µg formoterol and 100 µg beclometasone dipropionate combination spray pMDI aerosol

Primary outcomes

  1. Peripheral airway resistance (from 4th bifurcation on) for the segmented airways

    Time frame: at baseline and after 6 months of treatment

  2. Total airway volume for the segmented airways

    Time frame: at baseline and after 6 months of treatment

  3. Peripheral airway volume (from the 4th bifurcation on) for the segmented airways

    Time frame: at baseline and after 6 months of treatment

  4. Relative compliance for each lobe

    Time frame: at baseline and after 6 months of treatment

  5. Density of the lung parenchyma given per predefined lung zone

    Time frame: at baseline and after 6 months of treatment

  6. Total airway resistance for the segmented airways

    Time frame: at baseline and after 6 months of treatment

Secondary outcomes

  1. BODE index

    Time frame: at baseline (visit 2), after 3 months of treatment (visit 5) and after 6 months of treatment (visit 8)

    The BODE index is a multidimensional index of disease severity . The index uses following parameters:

    • body mass index (BMI)
    • degree of airflow obstruction (Forced Expiratory Volume in 1 second (FEV1): % of predicted)
    • functional dyspnea (Modified Medical Reseach Council (MMRC) dyspnea scale)
    • exercise capacity (6 minute walk distance (6MWD) - m)

  2. COPD assessment test

    Time frame: at screening (visit 1), at baseline (visit 2), after 3 months of treatment (visit 5) and after 6 months of treatment (visit 8)

    The COPD assessment measures the impact of COPD on a person's life.

  3. Borg CR10 Scale

    Time frame: At screening, at baseline both pre and post dose (visit 2), after 3 months of treatment (visit 5) and after 6 months of treatment both pre and post dose (visit 8)

    The Borg CR10 Scale measures the present dyspnea.

  4. Adverse events as a measure of safety

    Time frame: during the study patients will record record each day taken medication and any possible comments on the daily diary cards

    During the study patients will record record each day taken medication and any possible comments on the daily diary cards. Further more, patients are contacted at least once a month (either by phone or at a visit in the hospital).

  5. Forced expiratory volume in 1 second (FEV1)

    Time frame: At screening, at baseline both pre and post dose (visit 2), after 3 months of treatment (visit 5) and after 6 months of treatment both pre and post dose (visit 8)

  6. Forced Vital Capacity (FVC)

    Time frame: At screening, at baseline both pre and post dose (visit 2), after 3 months of treatment (visit 5) and after 6 months of treatment both pre and post dose (visit 8)

  7. Peak Expiratory Flow (PEF)

    Time frame: At screening, at baseline both pre and post dose (visit 2), after 3 months of treatment (visit 5) and after 6 months of treatment both pre and post dose (visit 8)

  8. Maximum expiratory flow rate at 50% of vital capacity (MEF50)

    Time frame: At screening, at baseline both pre and post dose (visit 2), after 3 months of treatment (visit 5) and after 6 months of treatment both pre and post dose (visit 8)

  9. Maximal expiratory flow rate at 25% of vital capacity (MEF25)

    Time frame: At screening, at baseline both pre and post dose (visit 2), after 3 months of treatment (visit 5) and after 6 months of treatment both pre and post dose (visit 8)

  10. Vital capacity (VC)

    Time frame: At screening, at baseline both pre and post dose (visit 2), after 3 months of treatment (visit 5) and after 6 months of treatment both pre and post dose (visit 8)

  11. Inspiratory vital capacity (IVC)

    Time frame: At screening, at baseline both pre and post dose (visit 2), after 3 months of treatment (visit 5) and after 6 months of treatment both pre and post dose (visit 8)

  12. Functional residual capacity (FRC)

    Time frame: At screening, at baseline both pre and post dose (visit 2), after 3 months of treatment (visit 5) and after 6 months of treatment both pre and post dose (visit 8)

  13. Total Lung Capacity (TLC)

    Time frame: At screening, at baseline both pre and post dose (visit 2), after 3 months of treatment (visit 5) and after 6 months of treatment both pre and post dose (visit 8)

  14. Airway resistance (Raw)

    Time frame: At baseline both pre and post dose (visit 2), after 3 months of treatment (visit 5) and after 6 months of treatment both pre and post dose (visit 8)

  15. Specific airways conductance (SGaw)

    Time frame: At baseline both pre and post dose (visit 2), after 3 months of treatment (visit 5) and after 6 months of treatment both pre and post dose (visit 8)

Sponsors and collaborators

Lead sponsor

University Hospital, Antwerp

Other

Collaborators

  • Chiesi Farmaceutici S.p.A.

Registry information

Official study title

Open-label, Prospective Exploratory Study to Assess the Effects of Formoterol and Beclometasone Dipropionate Combination Therapy on Central and Peripheral Airway Dimensions in COPD Patients

Important dates

Study start
2010
Primary completion
2012
Study completion
2012
First posted
Sep 17, 2010
Registry last updated
Jul 3, 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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