Compare the Effects of Seretide® Evohaler and a Generic Salmeterol/Fluticasone Hydrofluoroalkane (HFA) Pressurized Metered-dose Inhaler (pMDI) on Functional Respiratory Imaging Parameters in Asthmatic Patients

FLUIDDA

Status and phase: Completed; Phase 3

Conditions: Asthma

Treatments: Drug: Salmeterol xinafoate and Fluticasone propionate HFA pMDI; Radiation: Functional Respiratory Imaging; Drug: Placebo of Test product; Drug: Placebo of Reference product; Drug: Seretide Evohaler

Study type: Interventional

Funder types: Industry

Identifiers

NCT01795664

2012-005789-36 (EudraCT Number)

E-RES/12/12-Q13 (Other Identifier)

FLUI-2012-94

Details and patient eligibility

About

This study will be conducted as a randomized, double blind, double dummy two period crossover study in stable asthma patients. A total of 16 stable asthma patients treated in accordance with the Global Initiative for Asthma (GINA) guidelines, will be included.

Objectives:

• The primary objective of this study is to evaluate the effect of both the study drugs under investigation on Functional Respiratory Imaging (FRI) parameters and to evaluate the particle deposition in the lungs using Computational Fluid Dynamic (CFD)
• The secondary objectives are to assess the effect of both the study drugs on lung function (spirometry and body plethysmography), on exercise capacity (6 Minutes Walking Test = 6MWT) and on dyspnea (Borg Category (C) Ratio (R) 10 Scale and Visual Analog Scale (VAS) dyspnea). Furthermore the safety of the 2 products under investigation will be evaluated through monitoring of adverse events (AEs) throughout the study.

Enrollment: 16 patients

Sex: All

Ages: 18+ years old

Volunteers: No Healthy Volunteers

Inclusion criteria

• Male or female patient ≥ 18 years old
• Written informed consent obtained
• Patient with a documented diagnosis of asthma according to the GINA guidelines
• Patient with a co-operative attitude and ability to be trained to correctly use the pMDI
• Female patient of childbearing potential who confirm that a contraception method was used at least 14 days before visit 1 and will continue to use a contraception method during the study
• Patient must be stable and treated in accordance with the GINA guidelines
• Patient must be a non-smoker or ex-smoker who have stopped smoking at least 1 year prior to visit 1 and has a smoking history of < 10 pack years
• Patient must be able to understand and complete the protocol requirements, instructions, questionnaires and protocol-stated restrictions

Exclusion criteria

• Pregnant or lactating female
• Unstable patient who developed an exacerbation during the last 8 weeks
• Patient with upper or lower airways infection
• Patient unable to carry out pulmonary function testing
• Patient 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
• Patient with cancer or any other chronic disease with poor prognosis and /or affecting patient status
• Patient with allergy, sensitivity or intolerance to study drugs and/or study drug formulation ingredients
• Patient unlikely to comply with the protocol or unable to understand the nature, scope and possible consequences of the study
• Patient who received oral corticosteroids within the last 4 weeks prior to visit 1
• Patient who received any investigational new drug within the last 4 weeks prior to visit 1 or twice the duration of the biological effect of any drug (whichever is longer)
• Patient with a history of alcohol or substance abuse that in the opinion of the investigator may be of clinical significance
• Patient who has undergone major surgery in the last 12 weeks before the visit 1 or has planned to undergo a major surgery before the end of the trial
• Patient with diagnosis of chronic obstructive pulmonary disease (COPD)

Trial design

Primary purpose: Treatment

Allocation: Randomized

Interventional model: Crossover Assignment

Masking: Triple Blind

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16 participants in 2 patient groups

Seretide Evohaler

Active Comparator group

Description:

Salmeterol xinafoate and Fluticasone propionate combination HFA pMDI (Seretide Evohaler, Allen \& Hanburys, UK) Strength: 25/250 mcg per actuation; Dose: single dose of 2 puffs; a total dose of 50/500 mcg

Treatment:

Radiation: Functional Respiratory Imaging

Drug: Seretide Evohaler

Drug: Placebo of Test product

Salmeterol xinafoate and Fluticasone propionate HFA pMDI

Experimental group

Description:

Salmeterol xinafoate and Fluticasone propionate combination HFA pMDI (Cipla Ltd., India) Strength: 25/250 mcg per actuation; Dose: single dose of 2 puffs; a total dose of 50/500 mcg

Treatment:

Radiation: Functional Respiratory Imaging

Drug: Placebo of Reference product

Drug: Salmeterol xinafoate and Fluticasone propionate HFA pMDI