Inspiratory Flow Rates Achieved by the COPD Patients Through Breezhaler®, Ellipta® and Handihaler® Inhaler Devices

NCT02596009 | Completed Phase 4 Results

• 1 other identifier: CNVA237A2403
• Study Type: interventional
• Target: 97
• Locations: 1 country
• Sites: 5

Brief 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.

Conditions

Pulmonary Disease, Chronic Obstructive (COPD)

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

Outcome Measures

Primary Outcomes (2)

• Peak Inspiratory Flows Rates Summary by Inhalation Devices - PPS

  The peak inspiratory flows (PIF) rates obtained from the inhalation flow profiles generated by the COPD patients through the three dry powder inhalation (DPI) devices(Breezhaler®, Ellipta® and Handihaler®) were measured and compared (without drug or placebo administration). Each patient were required to generate inhalation flow profiles through all three DPI devices in a randomized cross-over sequence. The inspiratory measurements were taken in each of these devices in the same visit.

  Visit 2 (Day 1)

• Peak Inspiratory Flows Rates Summary by Inhalation Devices - FAS

  The peak inspiratory flows (PIF) rates obtained from the inhalation flow profiles generated by the COPD patients through the three dry powder inhalation (DPI) devices(Breezhaler®, Ellipta® and Handihaler®) were measured and compared (without drug or placebo administration). Each patient were required to generate inhalation flow profiles through all three DPI devices in a randomized cross-over sequence. The inspiratory measurements were taken in each of these devices in the same visit. This FAS dataset includes PIF data from additional patients with corrected inhaler internal resistance values.

  Visit 2 (Day 1)

Study Arms (3)

Breezhaler®

EXPERIMENTAL

Each patient was required to inhale via Breezhaler® in a randomized cross-over sequence. The randomization numbers were generated using 6 sequences: BEH, EHB, HBE, BHE, EBH, HEB (B: Breezhaler, E: Ellipta, H: Handihaler).

Device: Breezhaler®

Ellipta®

OTHER

Each patient were required to inhale via Ellipta® in a randomized cross-over sequence. The randomization numbers were generated using 6 sequences: BEH, EHB, HBE, BHE, EBH, HEB (B: Breezhaler, E: Ellipta, H: Handihaler).

Device: Ellipta®

Handihaler®

OTHER

Each patient were required to inhale via Handihaler® in a randomized cross-over sequence. The randomization numbers were generated using 6 sequences: BEH, EHB, HBE, BHE, EBH, HEB (B: Breezhaler, E: Ellipta, H: Handihaler).

Device: Handihaler®

Interventions

Breezhaler® 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.

Breezhaler®

Ellipta® 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.

Ellipta®

Handihaler® 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.

Handihaler®

Eligibility Criteria

• Age: 40 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• \- 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

You may not qualify if:

• 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

Sponsors & Collaborators

• Novartis Pharmaceuticals: lead

Study Sites (5)

Novartis Investigative Site

CABA, Buenos Aires, C1426ABP, Argentina

Location

Novartis Investigative Site

Florida, Buenos Aires, B1602DQD, Argentina

Location

Novartis Investigative Site

La Plata, Buenos Aires, 1900, Argentina

Location

Novartis Investigative Site

Mar del Plata, Buenos Aires, 7600, Argentina

Location

Novartis Investigative Site

Ciudad Autonoma de Bs As, C1425FVH, Argentina

Location

Related Publications (1)

• Altman P, Wehbe L, Dederichs J, Guerin T, Ament B, Moronta MC, Pino AV, Goyal P. Comparison of peak inspiratory flow rate via the Breezhaler(R), Ellipta(R) and HandiHaler(R) dry powder inhalers in patients with moderate to very severe COPD: a randomized cross-over trial. BMC Pulm Med. 2018 Jun 14;18(1):100. doi: 10.1186/s12890-018-0662-0.

  PMID: 29898702 DERIVED

MeSH Terms

Conditions

Lung Diseases; Pulmonary Disease, Chronic Obstructive; Wasting Syndrome; Weight Loss; Muscular Atrophy

Condition Hierarchy (Ancestors)

Respiratory Tract Diseases; Lung Diseases, Obstructive; Chronic Disease; Disease Attributes; Pathologic Processes; Pathological Conditions, Signs and Symptoms; Metabolic Diseases; Nutritional and Metabolic Diseases; Nutrition Disorders; Body Weight Changes; Body Weight; Signs and Symptoms; Neuromuscular Manifestations; Neurologic Manifestations; Nervous System Diseases; Atrophy; Pathological Conditions, Anatomical

Results Point of Contact

• Title: Study Director
• Organization: Novartis Pharmaceuticals

862-778-8300

Study Officials

• Novartis Pharma

  Novartis Pharmaceuticals

  STUDY DIRECTOR

Publication Agreements

• PI is Sponsor Employee: No
• Restriction Type: OTHER
• Restrictive Agreement: Yes

Study Design

• Study Type: interventional
• Phase: phase 4
• Allocation: RANDOMIZED
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: CROSSOVER
• Sponsor Type: INDUSTRY
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: October 14, 2015
• First Posted: November 4, 2015
• Study Start: December 16, 2015
• Primary Completion: April 29, 2016
• Study Completion: April 29, 2016
• Last Updated: June 26, 2018
• Results First Posted: June 26, 2018

Record last verified: 2018-06

Locations

AR (5)