Subjects Undergoing Flexible BronchoscopyPhase 2/3NAFCOFNCT06376942
A RCT to Compare the Effectiveness of Nebulized Anticholinergics for Cough Suppression During Flexible Bronchoscopy
A Phase 2/3 study testing Glycopyrronium, Ipratropium and Saline in people with Subjects Undergoing Flexible Bronchoscopy, run by Post Graduate Institute of Medical Education and Research, Chandigarh at 1 site in India.
Trial 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. Read more about this study
- Who is it for?
- Ages 18 to 85 years
- Conditions the study is for
- Subjects Undergoing Flexible Bronchoscopy
- What is being tested?
- Glycopyrronium, Ipratropium and Saline
- Could I receive a placebo?
- Yes, some participants may receive a placebo
- How many people
- 1,050 participants
- Where
- 1 siteIndia
- Study dates
- 24 Apr 2024to 15 Jun 2025
- Phase
- Phase 2/3
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 to 85 years
- All sexes
- No healthy volunteers
- Adult, Older adult
Inclusion Criteria: Consecutive patients with indication for flexible bronchoscopy will be enrolled in the study if they meet all the following criteria:
- age ≥18 years
- hemodynamically stable
- willing to provide a written informed consent
Exclusion Criteria: Patients with any of the following will be excluded:
- 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
Trial locations and contacts
1 site in 1 country.
About this study
Official title: A Randomized, Double-blind, Placebo-controlled Trial to Compare the Effectiveness of Nebulized Anticholinergics for Cough Suppression During Flexible Bronchoscopy
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.
Read the detailed description
Bronchoscopy is a minimally invasive endoscopic technique for direct visualization of airways, with diagnostic and therapeutic intent. In 1897, Killian laid the foundation of bronchoscopy by extracting an animal bone from the right main bronchus of a farmer using rigid esophagoscope. In 1966, Shigeto Ikeda developed a prototype of flexible bronchoscope. Since its inception, flexible bronchoscope has undergone advancements in design and technology. The technological advancements in the recent decades have improved diagnostic yield and safety, with low morbidity and mortality. Unfortunately, the occurrence of cough during flexible bronchoscopy makes the procedure difficult and increases procedure time with patient discomfort.
Owing to the lack of clinical benefits and possible hemodynamic changes, the British Thoracic Society and Joint Indian Chest Society recommend not to use anticholinergic premedication via the parenteral route for preventing cough before bronchoscopy.
bronchoscopy. A few studies have evaluated inhaled anticholinergic premedication. Inoue et al. (in 1994) studied the effects of inhaled ipratropium bromide on bronchoconstriction in 29 subjects underwent for diagnostic bronchoscopy. They concluded that ipratropium protects against the deleterious effects resulting from topical lidocaine anesthesia during bronchoscopy. Wang et al. evaluated the efficacy of ipratropium bromide in 250 patients in a placebo-controlled trial. They reported that nebulized ipratropium bromide could reduce airway secretions and patient discomfort.
To our knowledge, 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.
- Being tested
- Glycopyrronium, Ipratropium, Saline
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
GlycopyrroniumDrug
Nebulized glycopyrronium 50 mcg
IpratropiumDrug
Nebulized iptratropium 500 mcg
SalineOther
0.9% saline 2 ml
| Study group | Role | What they receive |
|---|---|---|
| Glycopyrronium | Experimental | Nebulized glycopyrronium 50 mcg (2 ml) administered via a jet nebulizer over 10 minutes Receives: Drug: Glycopyrronium |
| Ipratropium | Active comparator | Nebulized ipratropium bromide 500 mcg (2 ml) administered via a jet nebulizer over 10 minutes Receives: Drug: Ipratropium |
| Saline | Placebo comparator | Nebulized saline 0.9% (2 ml) administered via a jet nebulizer over 10 minutes Receives: Other: Saline |
What is being measured
The primary outcome is the main question the study is designed to answer.
Cough count
Objectively measured using condenser microphone and voice recording application though a smartphone
Measured: Intra-procedure
Secondary outcomes (5)
Operator-estimated airway secretion
Recorded as: almost none, needing saline to wash out, and excessive, making it difficult to visualize the airways and requires 5 ml aliquots of saline
Measured: Intra-procedure
Operator-rated secretions on a visual analogue scale (VAS)
100 mm VAS anchored as no secretion at one and maximal secretions at the other
Measured: Immedidate post-procedure
Operator-rated cough intensity on a visual analogue scale (VAS)
100 mm VAS anchored as no cough at one and maximal cough at the other
Measured: Immedidate post-procedure
Patient-rated comfort on a visual analogue scale (VAS)
100 mm VAS anchored as maximal comfort at one and maximal discomfort at the other
Measured: Immedidate post-procedure
Adverse reactions
Arrhythmia, glaucoma, nausea, headache
Measured: 1-hour post-procedure
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted22 Apr 2024
- Study start24 Apr 2024 (estimated)
- Primary completion25 Apr 2025 (estimated)
- Study completion15 Jun 2025 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Subjects Undergoing Flexible BronchoscopyStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase 2/3
- Primary purpose
- Prevention
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Quadruple blind
- Who is masked
- Participant, Care provider, Investigator, Outcomes assessor
- Enrolment
- 1,050 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Post Graduate Institute of Medical Education and Research, Chandigarh
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Ritesh Agarwal, Post Graduate Institute of Medical Education and Research, Chandigarh
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT06376942
- Sponsor's protocol ID
- Int/IEC/2024/SPL-5
- Acronym
- NAFCOF
- Status last verified
- Apr 2024
- First submitted
- 17 Apr 2024
- Last updated
- 22 Apr 2024
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Study at a glance
From the registry record, last updated by the sponsor on 22 Apr 2024. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- A Randomized, Double-blind, Placebo-controlled Trial to Compare the Effectiveness of Nebulized Anticholinergics for Cough Suppression During Flexible Bronchoscopy
- ClinicalTrials.gov ID
- NCT06376942
- Acronym / sponsor ID
- NAFCOF / Int/IEC/2024/SPL-5
- Phase
- Phase 2/3
- Study type
- Interventional
- Recruitment status
- Unknown status
- Enrolment
- 1,050 participants (estimated)
- Lead sponsor
- Post Graduate Institute of Medical Education and Research, ChandigarhUniversity, hospital or other
- Study start
- 24 Apr 2024 (estimated)
- Primary completion
- 25 Apr 2025 (estimated)
- Study completion
- 15 Jun 2025 (estimated)
- First posted
- 22 Apr 2024 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Detailed description
Bronchoscopy is a minimally invasive endoscopic technique for direct visualization of airways, with diagnostic and therapeutic intent. In 1897, Killian laid the foundation of bronchoscopy by extracting an animal bone from the right main bronchus of a farmer using rigid esophagoscope. In 1966, Shigeto Ikeda developed a prototype of flexible bronchoscope. Since its inception, flexible bronchoscope has undergone advancements in design and technology. The technological advancements in the recent decades have improved diagnostic yield and safety, with low morbidity and mortality. Unfortunately, the occurrence of cough during flexible bronchoscopy makes the procedure difficult and increases procedure time with patient discomfort.
Owing to the lack of clinical benefits and possible hemodynamic changes, the British Thoracic Society and Joint Indian Chest Society recommend not to use anticholinergic premedication via the parenteral route for preventing cough before bronchoscopy.
bronchoscopy. A few studies have evaluated inhaled anticholinergic premedication. Inoue et al. (in 1994) studied the effects of inhaled ipratropium bromide on bronchoconstriction in 29 subjects underwent for diagnostic bronchoscopy. They concluded that ipratropium protects against the deleterious effects resulting from topical lidocaine anesthesia during bronchoscopy. Wang et al. evaluated the efficacy of ipratropium bromide in 250 patients in a placebo-controlled trial. They reported that nebulized ipratropium bromide could reduce airway secretions and patient discomfort.
To our knowledge, 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.
Study design
- Primary purpose
- Prevention
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Quadruple blind (participant, care provider, investigator, outcomes assessor)
- Number of arms
- 3
| Arm | Type | Receives |
|---|---|---|
| Glycopyrronium | Experimental | Drug: GlycopyrroniumNebulized glycopyrronium 50 mcg (2 ml) administered via a jet nebulizer over 10 minutes |
| Ipratropium | Active comparator | Drug: IpratropiumNebulized ipratropium bromide 500 mcg (2 ml) administered via a jet nebulizer over 10 minutes |
| Saline | Placebo comparator | Other: SalineNebulized saline 0.9% (2 ml) administered via a jet nebulizer over 10 minutes |
Who may qualify
- Ages
- 18 to 85 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| GlycopyrroniumNebulized glycopyrronium 50 mcg | Drug | Glycopyrronium |
| IpratropiumNebulized iptratropium 500 mcg | Drug | Ipratropium |
| Saline0.9% saline 2 ml | Other | Saline |
Primary outcome
Cough count
Time frame: Intra-procedure
Objectively measured using condenser microphone and voice recording application though a smartphone
5 secondary outcomes
Operator-estimated airway secretion
Time frame: Intra-procedure
Operator-rated secretions on a visual analogue scale (VAS)
Time frame: Immedidate post-procedure
Operator-rated cough intensity on a visual analogue scale (VAS)
Time frame: Immedidate post-procedure
Patient-rated comfort on a visual analogue scale (VAS)
Time frame: Immedidate post-procedure
Adverse reactions
Time frame: 1-hour post-procedure
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 22 Apr 2024.
- Individual participant dataSharing planned: No
Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 2/3 study testing Glycopyrronium, Ipratropium and Saline in people with Subjects Undergoing Flexible Bronchoscopy, run by Post Graduate Institute of Medical Education and Research, Chandigarh at 1 site in India.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: status not confirmed, as of the sponsor's last update on 22 Apr 2024. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in India. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. Some participants in this study may receive a placebo. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
What does this combined phase mean?
Phase 2 studies give the treatment to a larger group to see whether it has the intended effect and to keep checking safety.
Phase 3 studies compare the treatment with the current standard treatment or a placebo in a large group, to confirm how well it works and watch for side effects.
Not every study follows the same path, and some studies (observational studies, device studies) have no phase.
Are results available for this study?
Results are not available in the source record.
How can a doctor refer a patient or contact the research team?
Contact Ritesh Agarwal (7087007625, agarwal.ritesh@outlook.in), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Cough count (time frame: Intra-procedure). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 22 Apr 2024.