Inspiratory Flow Rates Achieved by the COPD Patients Through Breezhaler®, Ellipta® and Handihaler… (NCT02596009) | Clinical Trial Compass
CompletedPhase 4
Inspiratory Flow Rates Achieved by the COPD Patients Through Breezhaler®, Ellipta® and Handihaler® Inhaler Devices
Argentina97 participantsStarted 2015-12-16
Plain-language 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.
Who can participate
Age range40 Years
SexALL
See this in plain English?
AI-rewrites the medical criteria so a patient or caregiver can understand them. Always confirm with the trial site.
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 th…
What they're measuring
1
Peak Inspiratory Flows Rates Summary by Inhalation Devices - PPS
Timeframe: Visit 2 (Day 1)
2
Peak Inspiratory Flows Rates Summary by Inhalation Devices - FAS