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In Vivo Investigation of Novel Nano-vesicles of Salbutamol Sulphate

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details. Identifier: NCT03059017
Recruitment Status : Completed
First Posted : February 23, 2017
Last Update Posted : February 23, 2017
Information provided by (Responsible Party):
Mona Gamal Mohamed Afifi Arafa, British University In Egypt

Brief Summary:
The relative bioavailability of different salbutamol sulphate inhaler formulations will be studied in healthy male subjects according to the ethical regulations of World Medical Association Declaration of Helsinki (1996) after the approval of the ethical committee, Faculty of Pharmacy, The British University in Egypt.

Condition or disease Intervention/treatment Phase
Drug Effect Pulmonary Disease Drug: Salbutamol Sulphate Drug: Niosomes Phase 1

Detailed Description:

In this study, 20 healthy, non smoking, adult male volunteers (age: 30-45 years, weight: 65-80 kg) will carry out screening procedures which include instruction and practice with the placebo metered dose inhaler devices that will be used in the study. In addition, all subjects were fully informed in writing of the objectives and implications of the trial. No subject will be considered for the study if developed any symptoms of allergic disorders. Subjects will follow a normal diet and will not receive any other medications. Volunteers will be divided into two groups; each group contained 10 volunteers who will receive one formula of the selected formulae.

Each volunteer will inhale eight puffs (4 puffs at -5 min & 4 puffs at 0 min) which are equivalent to 0.8 mg of salbutamol sulphate . To inhale through metered dose inhalers, volunteers will be trained to exhale slowly to their residual volume (as far as comfortable), put the inhaler into their mouth and seal their lips round the mouth piece. Then they will be instructed to take a slow deep inspiration to their total lung capacity over approximately 5-10 seconds. At the end of each inhalation, they will hold their breath for 10 seconds and then breathe normally (Ball et al, 2002) . Three milliliters of blood will be withdrawn at 0, 0.5, 1, 2, 3, 4, 5 and 6 h after administration. The blood will be heparinized immediately and centrifuged at 3000 rpm for 10 minutes. The plasma samples will be stored at freeze temperature until analysis. Two different formulae will be compared during the first six hours following administration. The maximum plasma concentration (Cmax), the time required to reach maximum plasma concentration (Tmax) and the area under plasma concentration time curve (AUC) will be calculated using validated Excel software.

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Study Type : Interventional  (Clinical Trial)
Actual Enrollment : 20 participants
Allocation: Randomized
Intervention Model: Parallel Assignment
Intervention Model Description: Volunteers will be divided into two groups; each group contained 10 volunteers who will receive one formula of the selected formulae.
Masking: None (Open Label)
Primary Purpose: Treatment
Official Title: Novel Nano-vesicles of Salbutamol Sulphate in Metered Dose Inhalers: Formulation, Characterization, In Vitro and In Vivo Evaluation
Actual Study Start Date : February 5, 2017
Actual Primary Completion Date : February 5, 2017
Actual Study Completion Date : February 5, 2017

Arm Intervention/treatment
Experimental: Niosomal salbutamol sulphate inhalers
Drug: Niosomes
Other Name: nano-vesicles

Placebo Comparator: salbutamol sulphate inhalers
control testing
Drug: Salbutamol Sulphate
salbutamol sulphate packaged as aerosol

Primary Outcome Measures :
  1. The maximum plasma concentration (Cmax) [ Time Frame: Twenty Four Hours ]
    The maximum concentration of Salbutamol Sulphate in human blood after time intervals 0, 30, 1,2, 3,4 , 5 & 6 hs will be calculated using validated using Excel software.

Secondary Outcome Measures :
  1. The time required to reach maximum plasma (Tmax) [ Time Frame: Twenty Four Hours ]
    Time taken for Salbutamol Sulphate to reach its maximum concentration in human blood & will be calculated using validated using Excel software

Other Outcome Measures:
  1. The area under plasma concentration time curve (AUC) [ Time Frame: Twenty Four Hours ]
    The integral in a plot of concentration of Salbutamol Sulphate in blood plasma against time.

Information from the National Library of Medicine

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Ages Eligible for Study:   30 Years to 45 Years   (Adult)
Sexes Eligible for Study:   Male
Accepts Healthy Volunteers:   Yes

Inclusion Criteria:

  • Healthy

Exclusion Criteria:

  • Chronic disease
  • Smoking
  • Hospitalization
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Responsible Party: Mona Gamal Mohamed Afifi Arafa, Lecturer, British University In Egypt Identifier: NCT03059017    
Other Study ID Numbers: SSMDI-2017-01
First Posted: February 23, 2017    Key Record Dates
Last Update Posted: February 23, 2017
Last Verified: February 2017
Individual Participant Data (IPD) Sharing Statement:
Plan to Share IPD: Yes
Plan Description: Share of the results by Publication

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Studies a U.S. FDA-regulated Drug Product: Yes
Studies a U.S. FDA-regulated Device Product: No
Product Manufactured in and Exported from the U.S.: No
Additional relevant MeSH terms:
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Lung Diseases
Respiratory Tract Diseases
Skin Diseases, Vesiculobullous
Skin Diseases
Pathological Conditions, Anatomical
Bronchodilator Agents
Autonomic Agents
Peripheral Nervous System Agents
Physiological Effects of Drugs
Anti-Asthmatic Agents
Respiratory System Agents
Tocolytic Agents
Reproductive Control Agents
Adrenergic beta-2 Receptor Agonists
Adrenergic beta-Agonists
Adrenergic Agonists
Adrenergic Agents
Neurotransmitter Agents
Molecular Mechanisms of Pharmacological Action