Inspiratory Flow Rates Achieved by the COPD Patients Through Breezhaler®, Ellipta® and Handihaler® Inhaler Devices
Condition: Pulmonary Disease, Chronic Obstructive (COPD)
MeSH terms: Lung Diseases; Pulmonary Disease, Chronic Obstructive
Intervention: Breezhaler®; Ellipta®; Handihaler®
Intervention description: No active drug or placebo were administered to patients during this study. Each patient were required to inhale via all three (03) study devices (Breezhaler®, Ellipta® and Handihaler®). Each patient was required to produce at least three (03) inhalational profiles via each inhalational device, following the training and demonstration for correct inhalational procedure, for each device.; No active drug or placebo were administered to patients during this study. Each patient were required to inhale via all three (03) study devices (Breezhaler®, Ellipta® and Handihaler®). Each patient was required to produce at least three (03) inhalational profiles via each inhalational device, following the training and demonstration for correct inhalational procedure, for each device.; No active drug or placebo were administered to patients during this study. Each patient were required to inhale via all three (03) study devices (Breezhaler®, Ellipta® and Handihaler®). Each patient was required to produce at least three (03) inhalational profiles via each inhalational device, following the training and demonstration for correct inhalational procedure, for each device.
Phase: Phase 4
Study type: Interventional
Primary purpose: Treatment
Allocation: Randomized
Intervention model: Crossover Assignment
Masking: None (Open Label)
Enrollment: 97.0
Sex: All
Minimum age: 40 Years
Healthy volunteers: No
Keywords: COPD; Cachexia due to chronic obstructive pulmonary disease; wasting syndrome; Loss of weight; muscle atrophy; loss of body mass; signficant loss of appetite; cachectic syndrome

Summary:

      The purpose of this study was to compare dynamic inspiratory flow rates achieved by a
      population of Chronic Obstructive Pulmonary Disease (COPD) patients through the Breezhaler®,
      Ellipta® and Handihaler® dry powder inhaler (DPI) devices. No active drug or placebo were
      administered to patients in this study.
    

Eligibility criteria:

        Inclusion Criteria:

        - Current or ex-smokers who have a smoking history of at least 10 pack years (e.g., 10 pack
        years = 1 pack/day × 10 years, ½ pack/day × 20 years, etc.).

        Note: A pack of cigarettes is equal to 20 cigarettes. Occasional smoking of cigars is not
        relevant to smoking history.

        An ex-smoker is defined as a patient who has not smoked for ≥6 months at screening.

          -  COPD patients with moderate to very severe airflow limitation (spirometric
             classification: GOLD 2, 3 or 4) at time of screening,

               -  Post-bronchodilator FEV1 < 80% of the predicted normal, and

               -  Post-bronchodilator FEV1/forced vital capacity (FVC) <0.70. (Post-bronchodilator
                  refers to 1 hour after sequential inhalation of 84 µg ipratropium bromide and 400
                  µg salbutamol)

          -  Willing patients assessed as suitable by investigator to reproducibly perform
             inhalational manoeuvers through study devices as required by the standard protocol

          -  Willing patients assessed as suitable by investigator to comprehend and follow the
             instructions for use of the inhalational devices to be tested in the study

        Exclusion Criteria:

          -  Patients with a history of asthma or onset of respiratory symptoms prior to the age of
             40 years

          -  Use of short acting bronchodilating agent (SABA) as rescue (reliever) medication
             within 6 hours prior to or during inhalational profile assessments for the study
             [Note: Use of rescue medication should not be restricted if patient feels the need of
             the rescue/ reliever medication because of the diseased state. Safety and disease
             management should be priority and the suitability of such a patient for the study or
             relevance of the (study) assessments done for the study should be reviewed, as
             appropriate.]

          -  Patients with any history of premature birth less than 33 weeks gestation or
             significant level of respiratory care including mechanical ventilation required as
             neonate affecting the respiratory tract or chronic lung diseases, which in the opinion
             of the investigator or designated study personnel at site may interfere with the study
             evaluation or optimal participation in the study.

          -  Any major chronic illness including but not limited to a diagnosis of non-skin cancer,
             cystic fibrosis, bronchiectasis, α-1 anti-trypsin deficiency, myelomeningocele, sickle
             cell anemia, endocrine disease, congenital heart disease, unstable arrhythmia,
             congestive heart failure, stroke, severe hypertension, insulin-dependent diabetes
             mellitus, renal failure, liver disorders, immunodeficiency states, significant
             neurodevelopmental delay or behavioral disorders (excluding mild attention deficit
             hyperactivity disorder).

          -  Patients who have had a COPD exacerbation that required treatment with antibiotics or
             oral corticosteroids or hospitalization in the 6 weeks prior to screening

          -  Patients who, within 7 days prior to the screening visit (Visit 1) OR prior to Visit
             2, increased use of rescue bronchodilators amounting to more than double the average
             number of puffs used in the preceding week or more than 8 puffs of SABA on any 3
             consecutive days or more than 12 puffs of SABA on any 2 consecutive days

          -  Respiratory tract infections (sinus, middle ear, oropharyngeal, upper or lower
             respiratory tract infection) within the 4weeks before the visit