A RCT to Compare the Effectiveness of Nebulized Anticholinergics for Cough Suppression During Flexible Bronchoscopy
NAFCOF
A Randomized, Double-blind, Placebo-controlled Trial to Compare the Effectiveness of Nebulized Anticholinergics for Cough Suppression During Flexible Bronchoscopy
1 other identifier
interventional
1,050
1 country
1
Brief Summary
No study has examined the role of inhaled glycopyrrolate on mucus secretion. We hypothesize that nebulized glycopyrrolate will improve bronchoscopy procedure by effectively suppressing airway mucus secretion, thereby decreasing cough, and thus improving patient comfort during bronchoscopy. In this study, we aim to compare the efficacy of nebulized glycopyrrolate versus nebulized ipratropium in suppression of cough during flexible bronchoscopy.
Trial Health
Trial Health Score
Automated assessment based on enrollment pace, timeline, and geographic reach
participants targeted
Target at P75+ for phase_2
Started Apr 2024
Shorter than P25 for phase_2
1 active site
Health score is calculated from publicly available data and should be used for screening purposes only.
Trial Relationships
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Study Timeline
Key milestones and dates
First Submitted
Initial submission to the registry
April 17, 2024
CompletedFirst Posted
Study publicly available on registry
April 22, 2024
CompletedStudy Start
First participant enrolled
April 24, 2024
CompletedPrimary Completion
Last participant's last visit for primary outcome
April 25, 2025
CompletedStudy Completion
Last participant's last visit for all outcomes
June 15, 2025
CompletedApril 22, 2024
April 1, 2024
1 year
April 17, 2024
April 17, 2024
Conditions
Outcome Measures
Primary Outcomes (1)
Cough count
Objectively measured using condenser microphone and voice recording application though a smartphone
Intra-procedure
Secondary Outcomes (5)
Operator-estimated airway secretion
Intra-procedure
Operator-rated secretions on a visual analogue scale (VAS)
Immedidate post-procedure
Operator-rated cough intensity on a visual analogue scale (VAS)
Immedidate post-procedure
Patient-rated comfort on a visual analogue scale (VAS)
Immedidate post-procedure
Adverse reactions
1-hour post-procedure
Study Arms (3)
Glycopyrronium
EXPERIMENTALNebulized glycopyrronium 50 mcg (2 ml) administered via a jet nebulizer over 10 minutes
Ipratropium
ACTIVE COMPARATORNebulized ipratropium bromide 500 mcg (2 ml) administered via a jet nebulizer over 10 minutes
Saline
PLACEBO COMPARATORNebulized saline 0.9% (2 ml) administered via a jet nebulizer over 10 minutes
Interventions
Eligibility Criteria
You may qualify if:
- age ≥18 years
- hemodynamically stable
- willing to provide a written informed consent
You may not qualify if:
- intubated or tracheostomized patients
- patients with airway stent in situ
- patients with a history of glaucoma
- baseline oxygen saturation \<90%
- patients with hemodynamic instability (SBP \<90 mm Hg)
- patients undergoing sedation for bronchoscopy
- failure to provide informed consent
Contact the study team to confirm eligibility.
Sponsors & Collaborators
Study Sites (1)
Bronchoscopy suite, PGIMER
Chandigarh, 160012, India
MeSH Terms
Interventions
Intervention Hierarchy (Ancestors)
Central Study Contacts
Study Design
- Study Type
- interventional
- Phase
- phase 2
- Allocation
- RANDOMIZED
- Masking
- QUADRUPLE
- Who Masked
- PARTICIPANT, CARE PROVIDER, INVESTIGATOR, OUTCOMES ASSESSOR
- Purpose
- PREVENTION
- Intervention Model
- PARALLEL
- Sponsor Type
- OTHER
- Responsible Party
- PRINCIPAL INVESTIGATOR
- PI Title
- Professor of Pulmonary Medicine
Study Record Dates
First Submitted
April 17, 2024
First Posted
April 22, 2024
Study Start
April 24, 2024
Primary Completion
April 25, 2025
Study Completion
June 15, 2025
Last Updated
April 22, 2024
Record last verified: 2024-04
Data Sharing
- IPD Sharing
- Will not share