Inhalation Studies
Expertise in Inhalation Clinical Trials
Early-phase clinical studies for inhaled medications demand precision and speed. We specialize in early-phase clinical trials for inhaled medications across a wide range of therapeutic areas. Our expert teams operate in purpose-built inhalation suites designed for precision, safety, and speed. With tailored facilities and comprehensive clinical trial support, we help you move from concept to clinic quickly—without ever compromising on quality or patient safety.
We’ve conducted a wide range of early-phase inhalation studies across multiple indications, including COVID-19, RSV, PAH, asthma, COPD, allergies, addiction, and more. With a database of over 400,000 trial participants, we enable rapid recruitment and accelerated study start-up.
Leveraging our extensive experience with the following devices, along with dedicated negative-pressure rooms equipped with advanced ventilation systems, we deliver quality data for early-phase inhalation studies with:
- Pressurized Metered Dose Inhalers (pMDIs)
- Dry Powder Inhalers (DPIs)
- Soft Mist Inhalers (SMIs)
- Nebulizers
- Vaporizers
- Nasal Sprays
- Insufflation
Consistent, Rapid Study Conduct for Inhaled Therapeutics
Altasciences has dedicated negative pressure space for early-phase inhalation clinical trials, and comprehensive standard operating procedures (SOPs) that ensure consistent, accurate use of inhalation devices, regardless of the therapeutic area. Our pharmacies are accustomed to compounding test articles for inhalation studies, from simple to complex.
All participants and staff receive standardized training on device use and dosing according to the study protocol, ensuring consistent dosing, minimizing contamination risk, and enhancing reliability.
If your delivery device is itself novel, our regulatory experts can help you obtain the necessary regulatory approvals and design an efficient, integrated development program for both the device and the drug.
Contact us today to initiate your inhalation study.
Rapid and Efficient Study Start-Up for Inhalation Studies
We move at the speed of your science. Delivering inhalation studies on time and tailored to your needs is not just an objective—it’s built into how we operate.
As a trusted leader in early-phase inhalation studies, we’re known for our agility. In fact, we’ve launched clinical trials in as little as four weeks. How? It starts with a collaborative mindset— combining clear communication, strategic foresight, and a dual project management model that keeps our internal teams and yours in perfect sync.
From startup through conduct, we ensure fast, flexible decision-making and rapid issue resolution—so nothing stands between your innovation and the next phase of development.
By streamlining contract execution, regulatory document preparation, and participant recruitment, Altasciences delivers on its commitment to efficiency and timely clinical trial outcomes. Our proactive project management and sponsor collaboration significantly reduce startup times.
With three clinical pharmacology units and co-located bioanalytical laboratories in the U.S. and Canada, we provide dual regulatory pathways—Investigational New Drug(IND) and Clinical Trial Application (CTA). Our focus on efficiency ensures rapid start-up and streamlined timelines for your inhalation studies.
Start your inhalation study today—talk with our experts now.
Turnkey Solutions for Inhalation Studies
Our turnkey solution manages healthy volunteer studies from start to finish.
Protocol review/writing:
Whether starting from scratch or refining an existing protocol, our team of clinical experts ensures we streamline the process to support informed decision-making and meet critical study milestones.. With our deep understanding of inhaled therapeutics and early phase clinical trials, we ensure comprehensive, regulatory-compliant study design. We tailor protocols to meet the specific requirements of drug development, focusing on efficient timelines and precise data collection.
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Clinical conduct:
Our three state-of-the-art clinics across North America are fully equipped to run your inhalation study, with expert teams managing compounding, dosing, sampling, and associated pulmonary function tests and challenges.
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CRA/Clinical monitoring:
Real-time tracking of pharmacokinetics (PK) and pharmacodynamics (PD) data, safety assessments, and adverse event reporting, ensuring compliance with regulatory requirements and maintaining data integrity throughout the inhaled therapeutic trial.
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Bioanalytical services:
Our state-of-the-art, co-located bioanalytical labs are equipped with a wide range of methods and assays, ensuring precise and timely PK data, biomarkers of inflammation and others as appropriate. Leveraging these established methods, we provide the reliable data you need to meet regulatory standards, enabling faster decision-making and supporting clear labeling.
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Consult our Validated Assay List
Data Services and Reporting:
We handle data management, analysis, and comprehensive reporting to deliver timely, high-quality results.
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Regulatory Consulting:
Need support navigating regulatory requirements? Our regulatory experts can assist with a detailed plan for your early-phase pulmonary studies. If your inhalation device requires regulatory review, we can help with this as well. Contact us to learn about our expertise in this area, and how we can integrate services for a fast, comprehensive development plan.
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We bring together expert recruitment, seamless clinical conduct, and on-time delivery—all tailored to your inhalation study’s unique needs—ensuring your inhalation studies progress rapidly and accurately.
Altasciences’ Analgesic Drug Development Case Studies and Resources
FAQ
Which pulmonary function tests does Altasciences conduct for inhalation studies?
Pulmonary function tests are key elements of respiratory clinical trials, allowing for investigation of the impact of inhaled therapies on lung function. Your product, delivered by inhalation, MDI, vaporizer, nebulizer, nasal spray or other, will be safely and thoroughly assessed by our expert clinical teams.
All our clinics are equipped with pulmonary function testing/spirometry equipment and well-trained staff. Spirometry is a common, well-established method of measuring lung function.
Spirometry Measures
- Forced Expiratory Volume in One Second (FEV1)
- Expiratory Reserve Volume (ERV)
- Forced Vital Capacity (FVC)
- Forced Expiratory Flow (FEF)
- Functional Residual Capacity (FRC)
- Maximum Voluntary Ventilation (MVV)
- Residual Volume (RV)
- Peak Expiratory Flow (PEF)
- Slow Vital Capacity (SVC)
- Total Lung Capacity (TLC)
Our clinic staff undergoes certification training on the spirometry system being used per the protocol. Each technician completes identical training to ensure consistent and accurate coaching of study subjects.
Does Altasciences perform pulmonary challenge testing?
Altasciences has experience with methacholine and inhaled allergens. We perform challenge tests where study subjects perform a baseline lung function test, then inhale a small dose of an irritant to simulate the respiratory impact of a condition such as asthma, COPD, common cold, allergies, etc. Once the disease condition is simulated and symptoms triggered, the study drug is dosed, and the effects measured.