Bronchial AsthmaNCT05428956
Two Inhalation Methods Using a Pressurized Metered Dose Inhaler With Valved Holding Chamber to Assess Improvement in Lung Function After SABA Administration in Bronchial Asthma
A study testing Single Inhalation technique and Tidal inhalation technique in people with Bronchial Asthma, run by Post Graduate Institute of Medical Education and Research, Chandigarh at 2 sites in India.
Trial summary
Bronchial asthma is a chronic inflammatory disorder characterized by recurrent reversible episodes of breathlessness, wheezing, chest tightness and/ or cough. The prevalence of asthma in India is about 2%, and asthma is responsible for significant morbidity. Read more about this study
- Who is it for?
- Ages 18 to 60 years
- Conditions the study is for
- Bronchial Asthma
- What is being tested?
- Single Inhalation technique and Tidal inhalation technique
- Type of treatment
- Surgery or procedure
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 897 participants
- Where
- 2 sitesIndia
- Study dates
- 15 Jun 2022to 31 May 2023
- Phase
- Interventional
- 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 60 years
- All sexes
- No healthy volunteers
- Adult
Who may be able to join
- Patients with a physician diagnosis of bronchial asthma undergoing spirometry (b) ability to provide informed consent to participate in the study
Who cannot join
- Patients having active pulmonary tuberculosis; (b) pregnancy; (c) patients already on inhaled or oral bronchodilators or corticosteroids as part of asthma treatment; and, (d) failure to provide informed consent
Trial locations and contacts
2 sites in 1 country.
India2 sites
Bronchoscopy suite, PGIMER
Chandigarh, 160012
Chest clinic
Chandigarh, 160012
About this study
Official title: A Randomized Controlled Trial of Two Inhalation Methods Using a Pressurized Metered Dose Inhaler With Valved Holding Chamber to Assess Improvement in Lung Function After Short-acting Beta-2 Agonist Administration in Treatment-naïve Adult Patients With Bronchial Asthma
Bronchial asthma is a chronic inflammatory disorder characterized by recurrent reversible episodes of breathlessness, wheezing, chest tightness and/ or cough. The prevalence of asthma in India is about 2%, and asthma is responsible for significant morbidity. A diagnosis of asthma is made in the presence of clinical symptoms with or without reversibility on spirometry assessment.1 Treatment comprises of inhaled medications that are used either as controller medication or a reliever medications.
In a recent study involving asthmatic children, single maximal inhalation with breath hold was not found to be superior to tidal breathing for improvement in peak expiratory flow rates.
The authors hypothesized that both the techniques would improve FEV1 similarly.
Read the detailed description
Bronchial asthma is a chronic inflammatory disorder characterized by recurrent reversible episodes of breathlessness, wheezing, chest tightness and/ or cough.1 The prevalence of asthma in India is about 2%, and asthma is responsible for significant morbidity. A diagnosis of asthma is made in the presence of clinical symptoms with or without reversibility on spirometry assessment.1 Treatment comprises of inhaled medications that are used either as controller medication or a reliever medications.1 PEF measurements are known to be affected by the technique and the equipment by which it is measured, and thus proper instructions and training are essential for the patient.1 PEF measurements have been used in the past as a surrogate to FEV1 measurements, but the correlation between them is poor and hence they should not be used interchangeably. If PEF falls below 80% of personal best, it is suggestive of inadequate disease control.1 Inhaled medications are delivered through various device either as dry powder forms or in a pressurized meter dose inhaler (pMDI). However, the drug delivery is variable and a pMDI delivers only 10-20% of the nominal dose per actuation or puff, even when used correctly.2,3 Use of spacer improves the drug delivery and the recent Indian guidelines recommends use of pMDI with a spacer as an effective drug delivery system. Tidal breathing with a pMDI with spacer is as effective as the single breath method as per the British/Scottish Intercollegiate Guidelines Network (SIGN) recommendations.4 Breath-holding is usually recommended after the aerosol inhalation, but there is limited information on the clinical importance of breath-holding in adult asthmatic patients. In a recent study involving asthmatic children, single maximal inhalation with breath hold was not found to be superior to tidal breathing for improvement in peak expiratory flow rates.5 Information on comparative efficacy of either method is limited in adult asthmatics. The authors hypothesized that both the techniques would improve FEV1 similarly. Thus, the objective of the present study is to assess improvement in lung function (FEV1) after short-acting beta-2 agonist administration in treatment-naïve adult patients with bronchial asthma with a single maximal inhalation with breath-hold versus 5 tidal breaths during inhalation using a valved holding chamber.
- Conditions
- Bronchial Asthma
- Being tested
- Single Inhalation technique, Tidal inhalation technique
- Medical subject headings
- Asthma
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Single Inhalation techniqueProcedure or surgery
Single maximal inhalation with breath hold technique
Tidal inhalation techniqueProcedure or surgery
5 tidal breaths technique
| Study group | Role | What they receive |
|---|---|---|
| Single breath technique | Active comparator | The technique of single maximal inhalation will be demonstrated to all the patients by a technician. In brief the patient will be asked to inhale slowly and maximally and hold the breath for at least 5 seconds. After the breath holding maneuver the patient will be asked to exhale. Salbutamol (100µg) be administered in a dose of 2 puffs, each after a one minute interval. The duration of the breath hold will be measured by a stop watch. Receives: Procedure: Single Inhalation technique; Procedure: Tidal inhalation technique |
| Tidal breath technique | Experimental | The technique of 5 tidal breaths will be demonstrated to all the patients by a technician. In brief the patient will be asked to inhale 5 tidal breaths after administrating salbutamol in the spacer. After each breath patient will be asked to breathe out in the spacer. The spacer has a one way-valve and does not allow the exhaled air to enter in to the chamber, thus preventing rebreathing and dilution of the inhaled medicine. Salbutamol (100µg) be administered in a dose of 2 puffs, each after a one minute interval Receives: Procedure: Single Inhalation technique; Procedure: Tidal inhalation technique |
What is being measured
The primary outcome is the main question the study is designed to answer.
Change in FEV1 (ml)
absolute change in FEV1 after inhaled salbutamol administered with a valved spacer using single maximal inhalation with breath hold and 5-tidal breaths technique.
Measured: 48 hours
Secondary outcomes (5)
percentage change in FEV1
percentage change in FEV1 after inhaled salbutamol administered with a valved spacer using single maximal inhalation with breath hold and 5-tidal breaths technique
Measured: 48 hours
Change in FVC in mL
absolute change in FVC, and PEFR after inhaled salbutamol administered with a valved spacer using single maximal inhalation with breath hold and 5-tidal breaths technique
Measured: 48 hours
percentage change in FVC
percentage change in FVC after inhaled salbutamol administered with a valved spacer using single maximal inhalation with breath hold and 5-tidal breaths technique
Measured: 48 hours
percentage change in PEFR
percentage change in PEFR after inhaled salbutamol administered with a valved spacer using single maximal inhalation with breath hold and 5-tidal breaths technique
Measured: 48 hours
Change in PEFR, in mL
absolute change in PEFR after inhaled salbutamol administered with a valved spacer using single maximal inhalation with breath hold and 5-tidal breaths technique
Measured: 48 hours
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted23 Jun 2022
- Study start15 Jun 2022
- Primary completion30 Apr 2023
- Study completion31 May 2023
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Bronchial AsthmaStudies 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 N/A
- Primary purpose
- Other
- Allocation
- Randomised
- Intervention model
- Crossover
- Model description
- All the patients will receive inhaled salbutamol using two techniques during lung function testing on two successive days. Patient will be randomized 1:1 to receive inhaled salbutamol by performing either a single breath holding maneuver or by five tidal breaths on the first day of evaluation. Each patient will undergo spirometry using the other alternative procedure on the next day. The randomization sequence will be computer generated. The sequence generated will be kept in a sealed opaque envelope and will be opened at the time of procedure
- Masking
- Quadruple blind
- Who is masked
- Participant, Care provider, Investigator, Outcomes assessor
- Enrolment
- 897 participants (actual)
Sponsor and investigators
- Lead sponsor
- Post Graduate Institute of Medical Education and Research, Chandigarh
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Inderpaul singh, Post Graduate Institute of Medical Education and Research, Chandigarh
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT05428956
- Sponsor's protocol ID
- INT/IEC/2016/976
- Status last verified
- Nov 2023
- First submitted
- 15 Jun 2022
- Last updated
- 18 Nov 2023
- Results posted
- No
- Data monitoring committee
- Yes
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- Undecided: Will share IPD on request
Study at a glance
From the registry record, last updated by the sponsor on 18 Nov 2023. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- A Randomized Controlled Trial of Two Inhalation Methods Using a Pressurized Metered Dose Inhaler With Valved Holding Chamber to Assess Improvement in Lung Function After Short-acting Beta-2 Agonist Administration in Treatment-naïve Adult Patients With Bronchial Asthma
- ClinicalTrials.gov ID
- NCT05428956
- Acronym / sponsor ID
- INT/IEC/2016/976
- Conditions
- Bronchial Asthma
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 897 participants (actual)
- Lead sponsor
- Post Graduate Institute of Medical Education and Research, ChandigarhUniversity, hospital or other
- Study start
- 15 Jun 2022 (actual)
- Primary completion
- 30 Apr 2023 (actual)
- Study completion
- 31 May 2023 (actual)
- First posted
- 23 Jun 2022 (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.
Bronchial asthma is a chronic inflammatory disorder characterized by recurrent reversible episodes of breathlessness, wheezing, chest tightness and/ or cough. The prevalence of asthma in India is about 2%, and asthma is responsible for significant morbidity. A diagnosis of asthma is made in the presence of clinical symptoms with or without reversibility on spirometry assessment.1 Treatment comprises of inhaled medications that are used either as controller medication or a reliever medications.
In a recent study involving asthmatic children, single maximal inhalation with breath hold was not found to be superior to tidal breathing for improvement in peak expiratory flow rates.
The authors hypothesized that both the techniques would improve FEV1 similarly.
Detailed description
Bronchial asthma is a chronic inflammatory disorder characterized by recurrent reversible episodes of breathlessness, wheezing, chest tightness and/ or cough.1 The prevalence of asthma in India is about 2%, and asthma is responsible for significant morbidity. A diagnosis of asthma is made in the presence of clinical symptoms with or without reversibility on spirometry assessment.1 Treatment comprises of inhaled medications that are used either as controller medication or a reliever medications.1 PEF measurements are known to be affected by the technique and the equipment by which it is measured, and thus proper instructions and training are essential for the patient.1 PEF measurements have been used in the past as a surrogate to FEV1 measurements, but the correlation between them is poor and hence they should not be used interchangeably. If PEF falls below 80% of personal best, it is suggestive of inadequate disease control.1 Inhaled medications are delivered through various device either as dry powder forms or in a pressurized meter dose inhaler (pMDI). However, the drug delivery is variable and a pMDI delivers only 10-20% of the nominal dose per actuation or puff, even when used correctly.2,3 Use of spacer improves the drug delivery and the recent Indian guidelines recommends use of pMDI with a spacer as an effective drug delivery system. Tidal breathing with a pMDI with spacer is as effective as the single breath method as per the British/Scottish Intercollegiate Guidelines Network (SIGN) recommendations.4 Breath-holding is usually recommended after the aerosol inhalation, but there is limited information on the clinical importance of breath-holding in adult asthmatic patients. In a recent study involving asthmatic children, single maximal inhalation with breath hold was not found to be superior to tidal breathing for improvement in peak expiratory flow rates.5 Information on comparative efficacy of either method is limited in adult asthmatics. The authors hypothesized that both the techniques would improve FEV1 similarly. Thus, the objective of the present study is to assess improvement in lung function (FEV1) after short-acting beta-2 agonist administration in treatment-naïve adult patients with bronchial asthma with a single maximal inhalation with breath-hold versus 5 tidal breaths during inhalation using a valved holding chamber.
Study design
- Primary purpose
- Other
- Allocation
- Randomised
- Intervention model
- Crossover
- Masking
- Quadruple blind (participant, care provider, investigator, outcomes assessor)
- Number of arms
- 2
- Model description
- All the patients will receive inhaled salbutamol using two techniques during lung function testing on two successive days. Patient will be randomized 1:1 to receive inhaled salbutamol by performing either a single breath holding maneuver or by five tidal breaths on the first day of evaluation. Each patient will undergo spirometry using the other alternative procedure on the next day. The randomization sequence will be computer generated. The sequence generated will be kept in a sealed opaque envelope and will be opened at the time of procedure
| Arm | Type | Receives |
|---|---|---|
| Single breath technique | Active comparator | Procedure: Single Inhalation technique, Procedure: Tidal inhalation techniqueThe technique of single maximal inhalation will be demonstrated to all the patients by a technician. In brief the patient will be asked to inhale slowly and maximally and hold the breath for at least 5 seconds. After the breath holding maneuver the patient will be asked to exhale. Salbutamol (100µg) be administered in a dose of 2 puffs, each after a one minute interval. The duration of the breath hold will be measured by a stop watch. |
| Tidal breath technique | Experimental | Procedure: Single Inhalation technique, Procedure: Tidal inhalation techniqueThe technique of 5 tidal breaths will be demonstrated to all the patients by a technician. In brief the patient will be asked to inhale 5 tidal breaths after administrating salbutamol in the spacer. After each breath patient will be asked to breathe out in the spacer. The spacer has a one way-valve and does not allow the exhaled air to enter in to the chamber, thus preventing rebreathing and dilution of the inhaled medicine. Salbutamol (100µg) be administered in a dose of 2 puffs, each after a one minute interval |
Who may qualify
- Ages
- 18 to 60 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult
Key inclusion criteria (1 listed)
- Patients with a physician diagnosis of bronchial asthma undergoing spirometry (b) ability to provide informed consent to participate in the study
Key exclusion criteria (1 listed)
- Patients having active pulmonary tuberculosis; (b) pregnancy; (c) patients already on inhaled or oral bronchodilators or corticosteroids as part of asthma treatment; and, (d) failure to provide informed consent
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 |
|---|---|---|
| Single Inhalation techniqueSingle maximal inhalation with breath hold technique | Procedure or surgery | Single breath technique, Tidal breath technique |
| Tidal inhalation technique5 tidal breaths technique | Procedure or surgery | Single breath technique, Tidal breath technique |
Primary outcome
Change in FEV1 (ml)
Time frame: 48 hours
absolute change in FEV1 after inhaled salbutamol administered with a valved spacer using single maximal inhalation with breath hold and 5-tidal breaths technique.
5 secondary outcomes
percentage change in FEV1
Time frame: 48 hours
Change in FVC in mL
Time frame: 48 hours
percentage change in FVC
Time frame: 48 hours
percentage change in PEFR
Time frame: 48 hours
Change in PEFR, in mL
Time frame: 48 hours
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 18 Nov 2023.
- Individual participant dataSharing planned: Undecided. Will share IPD on request
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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.
The record lists no contact. Use the official record to reach the sponsor.
2 sites in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Single Inhalation technique and Tidal inhalation technique in people with Bronchial Asthma, run by Post Graduate Institute of Medical Education and Research, Chandigarh at 2 sites in India.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 1 inclusion and 1 exclusion criteria. 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: finished, as of the sponsor's last update on 18 Nov 2023. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 2 sites 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. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Change in FEV1 (ml) (time frame: 48 hours). 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 18 Nov 2023.