Navitas Life Sciences supports effective treatment for Respiratory Illnesses by Managing Efficient Inhalation Studies

World Asthma Day (WAD) is celebrated to raise awareness about Asthma, and this year's theme is 'Closing Gaps in Asthma Care.' WHO recognizes Asthma as a major noncommunicable disease (NCD) that affects both adults and children. According to WHO, in 2019, an estimated 262 million people were affected by Asthma.

The impact of asthma on daily life

Asthma is often under-diagnosed and under-treated, particularly in low- and middle-income countries. People with under-treated asthma can suffer sleep disturbance, tiredness during the day, and poor concentration. Asthma sufferers and their families may miss school and work, with financial impact on the family and wider community. If symptoms are severe, people with asthma may need to receive emergency health care and they may be admitted to the hospital for treatment and monitoring.

Improving Care for Asthma

Asthma cannot be cured, but good management with inhaled medications can control the disease and enable people with asthma to enjoy a normal, active life. People with asthma and their families need to be educated to understand more about their asthma, their treatment, triggers to avoid, and how to manage their symptoms at home. It is also important to raise community awareness, to reduce the myths and stigma associated with asthma in some settings.

WHO strategy for prevention and control of asthma

Asthma is included in the WHO Global Action Plan for the Prevention and Control of NCDs and the United Nations 2030 Agenda for Sustainable Development. The WHO Package of Essential Noncommunicable Disease Interventions (PEN) was developed to help improve NCD management in primary health care in low-resource settings. PEN includes protocols for the assessment, diagnosis, and management of chronic respiratory diseases (asthma and chronic obstructive pulmonary disease), and modules on healthy lifestyle counselling, including tobacco cessation, and self-care. There are a number of gaps in asthma care which require intervention in order to reduce preventable suffering as well as the costs incurred by treating uncontrolled asthma.

Current gaps in asthma care include:

• Inequal access to diagnosis and treatment (medicine)
• Between wealthy and poorer communities and countries.
• In communication and care across the primary/secondary/tertiary care interface
• In prioritization between asthma and other long-term conditions
• Between prescribing inhalers and monitoring adherence and ability to use these devices.
• Exist for the general public’s (non-asthmatics) and health care professional’s awareness and understanding that asthma is a chronic (not acute) disease.
• Between scientific evidence and actual delivery of care for people with asthma.

Inhalation Studies Clinical Trials

Inhalation offers a significant advantage over other methods of administration of medication as the drug is delivered directly to the lungs, which ensures a high concentration of the active ingredient at the site of action, and low systemic levels of the active ingredient. Thus, inhalation drug delivery devices ensure high drug efficacy with minimal side effects, making it the most popular choice for management of respiratory diseases such like Asthma, pneumonia, chronic obstructive pulmonary disease (COPD), pulmonary fibrosis even for COVID-19. The inhalation studies are performed either in vitro or in vivo to assess the potential toxicity of materials that will be/or are likely to be inhaled.

The surface of human lungs is large and composed of a very permeable epithelium that allows inhaled drugs to be more easily accessible. Hence, inhaled drugs are generally localized to the target organ, which generally allows for a lower dose than is necessary with systemic delivery (oral or injection), and thus fewer and less severe adverse effects.

Benefits of inhaled route of drug administration

• Preferred by patients to injections
• Rapid absorption of drug to target site
• Requires smaller doses
• Better efficacy to safety ratio when compared with systemic
• High and long-term pulmonary efficacy

Experience World Class Infrastructure and Expertise of Qualified Experts for your Inhalation Studies

Navitas Life Sciences’ dedicated team of experts have the vast experience and in-depth domain knowledge to support your clinical trial needs. Leverage our ability to identify and mitigate risks and challenges by developing the appropriate study design to demonstrate the bioequivalence of your product effectively and scientifically.

Accreditation for Our Clinical laboratories

NABL- (National Accreditation Board for Laboratories; ISO15189-2012)

CAP- (College of American Pathologists)

Our facilities, systems and processes have been inspected successfully by

USFDA, WHO, EMA (ANSM/AGES), Thai FDA, NPRA & DCGI

We met with Dr. Kabilan k, Principal Investigator and Deputy Head-Clinical, Chennai, Navitas Life Sciences to understand how we support Inhalation studies and how our unique capabilities help bring lifesaving drugs for respiratory diseases to the market effectively.

Give us a snapshot of your professional background

I completed my MBBS (undergraduate) at Madras Medical College of Dr. MGR Medical University, Chennai and completed my MD Pharmacology (postgraduate) at SRM University, Chennai. I have been working at Navitas Life Sciences since August 2018.

Currently, I am the Principal Investigator and Deputy Head Clinical-Chennai, BABE Clinical Wing, with 35+ highly qualified experts working in this clinical division.

What are the different types of asthma drug products that you have worked with?

We have executed, handled, and successfully completed the inhalational studies at clinical end for the listed aerosol molecules.

Dr. Kabilan K

Principal Investigator and Deputy Head-Clinical, Chennai

Navitas Life Sciences

• Mometasone
• Fluticasone
• Formoterol
• Albuterol
• Budesonide
• Beclomethasone

What are Navitas Life Sciences’ unique capabilities to support inhalation studies?

We have a well-formed in-house study team with a passion for inhalation studies to provide effective training on using inhalation drug products for participating volunteers.

There are certain challenges in conducting inhalation studies that we have been able to successfully overcome like cross contamination and skill sets for dosage administration, along with training of the volunteers.

We have a negative air chamber, which is a unique infrastructure, in multiple facilities, and our volunteers are trained for dosage administration, which takes care of challenges associated with Inhalation studies.

Tell us about the technology/equipment support for efficient clinical trials?

• Our trained in-house staff can perform Spirometry test during screening by explaining briefly to the volunteers to not cough or release droplets from his/her mouth by covering the lips properly around the mouthpiece of the spirometer during forced expiration.
• Experienced investigators aid in evaluating spirograms according to accepted guidelines like American Thoracic Society (ATS) and European Respiratory Society (ERS)
• Infrastructure like Negative air chamber, and Training devices (In check dial, Vitalograph, Spirometry), are other specifalised equipment available.

Exclusively Designed Study Conduct

• Good Volunteer Access: Focused subject selection & training on Metered Dose Inhalation
• Adequate Handling: Dosing in segregated area & videography
• Proper Dosing Facility: Negative air chambers to prevent cross contamination
• Focus on Optimum Dosing: Canisters weighed before and after dosing
• Competitive Expertise: Extensive expertise across multiple inhalation studies

Describe an interesting anecdote/ a situation where you went the extra mile to support customer needs?

As a principal investigator, I have successfully completed approximately 70 clinical studies (Inhalation studies, Phase 1 study, IM route studies, oral solid, drops, suspension and female volunteer study) over the past 2.5 years, with the responsibility to ensure the ethical conduct of the study in line with protecting human subjects' rights, safety and welfare, protocol compliance, and adherence to institutional, state and federal regulations and guidance.

I've been involved in the U.S. FDA and DCGI regulatory inspections to date, and I've done a number of sponsor audits successfully.

As a principal investigator, I successfully completed mutiple studies on inhalation by performing spirometry tests and handling of MDI and DPI devices, which is an essential attribute for the success of the study, even during the COVID pandemic.

I am responsible for the critical inhalational training and assessing the eligible volunteers using an In- check dial, Aerosol inhalation monitor (AIM) and Placebo training devices.

Navitas Life Sciences has highly qualified experts, and the necessary technical expertise as well as facilities like inhalation chambers and state of the art instrumentation.

• We have specially designed inhalation booths (Negative air chamber) to be used for dosing of volunteers in aerosol inhalation studies which the chambers designed in such a way that air is taken through blowers inside the chamber from the top and streamed down towards the floor.
• The floor of booths containing vents through which the air is sucked out through a common exhaust all the chambers are supplied air from room in which the booths are situated and the air is expelled out through the exhaust
• The residual air that might remain inside the booths after dosing of a subject, is sucked out through the exhaust system so that the drug dosed previously does not remain inside the chamber when the next scheduled dosing activity happens
• We have the expertise to support the entire study, from enrolling and training volunteers to report delivery.

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